http://fasb.org/srt/2026#ChiefExecutiveOfficerMember 1 1 P3Y 0001074871 FY false 0001074871 2025-04-01 2026-03-31 0001074871 us-gaap:SubsequentEventMember modd:MaximATMAgreementMember 2026-04-23 2026-04-23 0001074871 us-gaap:SubsequentEventMember us-gaap:CommonStockMember modd:MaximATMAgreementMember 2026-04-23 2026-04-23 0001074871 us-gaap:SubsequentEventMember modd:AprilTwoThousandTwentySixOfferingMember 2026-04-19 2026-04-19 0001074871 us-gaap:SubsequentEventMember us-gaap:CommonStockMember modd:AprilTwoThousandTwentySixOfferingMember 2026-04-23 2026-04-23 0001074871 us-gaap:RelatedPartyMember 2017-07-31 2017-07-31 0001074871 us-gaap:RelatedPartyMember 2017-07-31 0001074871 srt:ExecutiveOfficerMember 2025-04-01 2026-03-31 0001074871 srt:ExecutiveOfficerMember 2024-04-01 2025-03-31 0001074871 modd:BridgeNoteMember us-gaap:RelatedPartyMember 2026-01-01 2026-03-31 0001074871 modd:BridgeNoteMember us-gaap:RelatedPartyMember 2026-03-31 0001074871 2026-03-31 0001074871 2026-02-01 2026-02-28 0001074871 modd:BoardMemberTwoMember 2025-04-01 2026-03-31 0001074871 modd:BoardMemberOneMember 2025-04-01 2026-03-31 0001074871 modd:ManchesterManagementCompanyLLCMember modd:MrBesserMember 2025-04-01 2026-03-31 0001074871 modd:ManchesterManagementCompanyLLCMember modd:TwoThousandTwentyFivePlacementMember 2025-04-01 2026-03-31 0001074871 modd:MrBesserMember 2025-03-01 2025-03-31 0001074871 modd:ManchesterManagementCompanyLLCMember 2025-03-01 2025-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember us-gaap:AccountsPayableMember modd:VendorEMember 2025-04-01 2026-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorDMember us-gaap:AccountsPayableMember 2025-04-01 2026-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorCMember us-gaap:AccountsPayableMember 2024-04-01 2025-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorBMember us-gaap:AccountsPayableMember 2024-04-01 2025-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorAMember us-gaap:AccountsPayableMember 2024-04-01 2025-03-31 0001074871 modd:ChiefOperatingDecisionMakerMember 2024-04-01 2025-03-31 0001074871 modd:ChiefOperatingDecisionMakerMember 2025-04-01 2026-03-31 0001074871 2024-04-01 2025-03-31 0001074871 modd:CaliforniasMember 2024-04-01 2025-03-31 0001074871 modd:CaliforniasMember 2025-04-01 2026-03-31 0001074871 2025-03-31 0001074871 us-gaap:StateAndLocalJurisdictionMember 2025-04-01 2026-03-31 0001074871 us-gaap:DomesticCountryMember 2025-04-01 2026-03-31 0001074871 modd:FivePointFourZeroToFiveHundredAndThirtyOnePointZeroZeroMember 2026-03-31 0001074871 modd:FivePointFourZeroToFiveHundredAndThirtyOnePointZeroZeroMember 2025-04-01 2026-03-31 0001074871 modd:TwoHundredAndFiftyEightPoinThreeZeroToFiveHundrtedAndThirtyOnePointZeroZeroMember 2026-03-31 0001074871 modd:TwoHundredAndFiftyEightPoinThreeZeroToFiveHundrtedAndThirtyOnePointZeroZeroMember 2025-04-01 2026-03-31 0001074871 modd:HundredAndEighteenPointFiveZeroToTwoHundredAndTwentyFivePoinThreeZeroMember 2026-03-31 0001074871 modd:HundredAndEighteenPointFiveZeroToTwoHundredAndTwentyFivePoinThreeZeroMember 2025-04-01 2026-03-31 0001074871 modd:FivePointFourZeroToSixtyEightPointFourZeroMember 2026-03-31 0001074871 modd:FivePointFourZeroToSixtyEightPointFourZeroMember 2025-04-01 2026-03-31 0001074871 us-gaap:RestrictedStockUnitsRSUMember 2026-03-31 0001074871 us-gaap:RestrictedStockUnitsRSUMember 2025-04-01 2026-03-31 0001074871 us-gaap:RestrictedStockUnitsRSUMember 2025-03-31 0001074871 us-gaap:RestrictedStockUnitsRSUMember 2024-04-01 2025-03-31 0001074871 us-gaap:RestrictedStockUnitsRSUMember 2024-03-31 0001074871 2024-03-31 0001074871 srt:MaximumMember 2024-04-01 2025-03-31 0001074871 srt:MinimumMember 2024-04-01 2025-03-31 0001074871 srt:MaximumMember 2025-04-01 2026-03-31 0001074871 srt:MinimumMember 2025-04-01 2026-03-31 0001074871 us-gaap:StockCompensationPlanMember 2024-04-01 2025-03-31 0001074871 us-gaap:StockCompensationPlanMember 2025-04-01 2026-03-31 0001074871 us-gaap:CommonStockMember 2026-02-01 2026-02-28 0001074871 2026-03-16 0001074871 modd:Milestone1OptionsVestedMember 2025-12-31 0001074871 us-gaap:CommonStockMember 2025-04-01 2025-04-30 0001074871 modd:TwoThousandAndSeventeenEquityIncentivePlanMember 2026-01-31 0001074871 modd:TwoThousandAndSeventeenEquityIncentivePlanMember 2025-02-28 0001074871 modd:TwoThousandAndSeventeenEquityIncentivePlanMember 2024-02-28 0001074871 modd:TwoThousandAndSeventeenEquityIncentivePlanMember 2023-01-31 0001074871 2021-08-31 0001074871 2020-01-31 0001074871 modd:TwoThousandAndSeventeenEquityIncentivePlanMember 2017-10-31 0001074871 2026-01-01 2026-03-31 0001074871 2025-12-31 0001074871 2025-04-01 2025-12-31 0001074871 us-gaap:MeasurementInputExpectedDividendRateMember 2026-01-23 0001074871 us-gaap:MeasurementInputPriceVolatilityMember 2026-01-23 0001074871 us-gaap:MeasurementInputRiskFreeInterestRateMember 2026-01-23 0001074871 modd:UnderwriterWarrantsAndOverAllotmentWarrantsMember us-gaap:MeasurementInputExpectedDividendRateMember 2026-03-31 0001074871 modd:UnderwriterWarrantsAndOverAllotmentWarrantsMember us-gaap:MeasurementInputPriceVolatilityMember 2026-03-31 0001074871 modd:UnderwriterWarrantsAndOverAllotmentWarrantsMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2026-03-31 0001074871 modd:FirmWarrantsAndUnderwriterWarrantsMember us-gaap:MeasurementInputExpectedDividendRateMember 2026-03-31 0001074871 modd:FirmWarrantsAndUnderwriterWarrantsMember us-gaap:MeasurementInputPriceVolatilityMember 2026-03-31 0001074871 modd:FirmWarrantsAndUnderwriterWarrantsMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockTwelveMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockTwelveMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockElevenMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockElevenMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockTenMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockTenMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockNineMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockNineMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockEightMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockEightMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockSevenMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockSevenMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockSixMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockSixMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockFiveMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockFiveMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockFourMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockFourMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockThreeMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockThreeMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockTwoMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockTwoMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockOneMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockOneMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStocksMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStocksMember 2026-03-31 0001074871 us-gaap:WarrantMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockWarrantsExercisedTwoMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockWarrantsExercisedTwoMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockWarrantsExercisedOneMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockWarrantsExercisedOneMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockWarrantsExercisedMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:CommonStockWarrantsExercisedMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsFourMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsFourMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsThreeMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsThreeMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsOneMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsOneMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsTwoMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsTwoMember 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:IssuanceOfCommonStockWarrantsMember 2026-03-31 0001074871 us-gaap:WarrantMember 2025-03-31 0001074871 us-gaap:CommonStockMember us-gaap:WarrantMember 2024-04-01 2025-03-31 0001074871 us-gaap:CommonStockMember us-gaap:WarrantMember 2025-04-01 2026-03-31 0001074871 modd:UnderwriterWarrantMember modd:November2024PublicOfferingMember 2025-05-21 0001074871 modd:UnderwriterWarrantMember modd:November2024PublicOfferingMember 2025-05-21 2025-05-21 0001074871 modd:November2024PublicOfferingMember 2025-04-01 2026-03-31 0001074871 modd:November2024PublicOfferingMember 2024-11-25 2024-11-25 0001074871 modd:TitanPartnersGroupLLCMember modd:November2024PublicOfferingMember 2024-11-30 0001074871 modd:TitanPartnersGroupLLCMember modd:November2024PublicOfferingMember 2024-11-30 2024-11-30 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-02-10 2025-02-10 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-02-10 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2026-03-31 0001074871 2025-03-20 2025-03-20 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-03-26 2025-03-26 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember modd:OfficersAndDirectorsMember 2025-03-20 2025-03-20 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-03-20 0001074871 modd:MarchTwoThousandTwentyFivePrivatePlacementMember 2025-03-20 2025-03-20 0001074871 2025-09-01 2025-09-30 0001074871 modd:WarrantInducementOfferingMember 2025-04-01 2026-03-31 0001074871 modd:September2025WarrantsMember 2025-09-30 0001074871 modd:September2025WarrantsMember 2026-03-31 0001074871 us-gaap:PrivatePlacementMember modd:SeptemberTwentyTwentyFiveWarrantInducementOfferingMember 2026-03-31 0001074871 modd:MarchTwoThousandTwentyFiveWarrantsMember 2026-03-31 0001074871 modd:SeptemberTwentyTwentyFiveWarrantInducementOfferingMember 2025-09-30 0001074871 modd:TwoThousandTwentyThreeWarrantsMember 2025-09-30 0001074871 modd:SeptemberTwentyTwentyFiveWarrantInducementOfferingMember 2025-09-30 2025-09-30 0001074871 modd:UnderwriterWarrantMember 2025-12-01 2025-12-31 0001074871 modd:DecemberTwoThousandTwentyFiveOfferingMember us-gaap:WarrantMember 2025-12-22 0001074871 modd:DecemberTwoThousandTwentyFiveOfferingMember modd:UnderwriterWarrantMember 2026-03-31 0001074871 us-gaap:OverAllotmentOptionMember modd:UnderwriterWarrantMember modd:PlacementAgencyOfferingMember 2025-04-01 2026-03-31 0001074871 us-gaap:OverAllotmentOptionMember modd:PlacementAgencyOfferingMember 2025-12-22 0001074871 modd:UnderwriterWarrantMember modd:PlacementAgencyOfferingMember 2025-04-01 2026-03-31 0001074871 modd:PublicOfferingMember modd:UnderwriterWarrantMember 2025-12-22 0001074871 2025-12-31 2025-12-31 0001074871 us-gaap:OverAllotmentOptionMember us-gaap:WarrantMember 2025-12-22 2025-12-22 0001074871 modd:PublicOfferingMember 2025-12-11 0001074871 us-gaap:OverAllotmentOptionMember 2025-12-11 2025-12-11 0001074871 us-gaap:OverAllotmentOptionMember modd:UnderwritingAgreementMember 2025-12-11 2025-12-11 0001074871 2025-12-11 0001074871 modd:PublicOfferingMember us-gaap:WarrantMember 2025-12-11 0001074871 modd:DecemberTwoThousandTwentyFiveOfferingMember 2025-04-01 2026-03-31 0001074871 modd:PublicOfferingMember 2025-12-11 2025-12-11 0001074871 modd:PublicOfferingMember us-gaap:WarrantMember 2025-12-31 0001074871 modd:PublicOfferingMember modd:NewbridgeSecuritiesCorporationMember 2025-12-31 2025-12-31 0001074871 modd:PlacementAgencyOfferingMember modd:CommonWarrantMember 2026-03-31 0001074871 modd:PlacementAgencyOfferingMember 2025-04-01 2026-03-31 0001074871 us-gaap:WarrantMember modd:PlacementAgencyOfferingMember 2026-03-31 0001074871 modd:PlacementAgencyOfferingMember 2026-03-31 0001074871 us-gaap:CommonStockMember 2026-03-31 0001074871 modd:PrefundedWarrantsMember 2026-03-31 0001074871 modd:ATMAgreementMember 2024-04-01 2025-03-31 0001074871 modd:ATMAgreementMember 2025-04-01 2026-03-31 0001074871 modd:ATMAgreementMember 2023-11-30 0001074871 us-gaap:CommonStockMember srt:MaximumMember 2026-01-23 0001074871 us-gaap:CommonStockMember srt:MinimumMember 2026-01-23 0001074871 modd:ThornmintRoadSanDiegoCAMember 2026-03-31 0001074871 modd:ThornmintRoadSanDiegoCAMember 2025-04-01 2026-03-31 0001074871 us-gaap:OfficeEquipmentMember 2025-03-31 0001074871 us-gaap:OfficeEquipmentMember 2026-03-31 0001074871 us-gaap:LeaseholdImprovementsMember 2025-03-31 0001074871 us-gaap:LeaseholdImprovementsMember 2026-03-31 0001074871 us-gaap:ConstructionInProgressMember 2025-03-31 0001074871 us-gaap:ConstructionInProgressMember 2026-03-31 0001074871 us-gaap:ComputerEquipmentMember 2025-03-31 0001074871 us-gaap:ComputerEquipmentMember 2026-03-31 0001074871 us-gaap:MachineryAndEquipmentMember 2025-03-31 0001074871 us-gaap:MachineryAndEquipmentMember 2026-03-31 0001074871 us-gaap:WarrantMember 2024-04-01 2025-03-31 0001074871 us-gaap:WarrantMember 2025-04-01 2026-03-31 0001074871 modd:UnvestedRestrictedStockUnitsMember 2024-04-01 2025-03-31 0001074871 modd:UnvestedRestrictedStockUnitsMember 2025-04-01 2026-03-31 0001074871 us-gaap:StockOptionMember 2024-04-01 2025-03-31 0001074871 us-gaap:StockOptionMember 2025-04-01 2026-03-31 0001074871 srt:MaximumMember 2026-03-31 0001074871 us-gaap:RetainedEarningsMember 2026-03-31 0001074871 us-gaap:AdditionalPaidInCapitalMember 2026-03-31 0001074871 us-gaap:RetainedEarningsMember 2025-04-01 2026-03-31 0001074871 us-gaap:AdditionalPaidInCapitalMember 2025-04-01 2026-03-31 0001074871 us-gaap:CommonStockMember 2025-04-01 2026-03-31 0001074871 us-gaap:RetainedEarningsMember 2025-03-31 0001074871 us-gaap:AdditionalPaidInCapitalMember 2025-03-31 0001074871 us-gaap:CommonStockMember 2025-03-31 0001074871 us-gaap:RetainedEarningsMember 2024-04-01 2025-03-31 0001074871 us-gaap:AdditionalPaidInCapitalMember 2024-04-01 2025-03-31 0001074871 us-gaap:CommonStockMember 2024-04-01 2025-03-31 0001074871 us-gaap:RetainedEarningsMember 2024-03-31 0001074871 us-gaap:AdditionalPaidInCapitalMember 2024-03-31 0001074871 us-gaap:CommonStockMember 2024-03-31 0001074871 2026-06-22 0001074871 2025-09-30 0001074871 country:US 2024-04-01 2025-03-31 0001074871 modd:OtherStatesMember 2025-04-01 2026-03-31 0001074871 modd:OtherStatesMember 2024-04-01 2025-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorAMember us-gaap:AccountsPayableMember 2025-04-01 2026-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorBMember us-gaap:AccountsPayableMember 2025-04-01 2026-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorCMember us-gaap:AccountsPayableMember 2025-04-01 2026-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember modd:VendorDMember us-gaap:AccountsPayableMember 2024-04-01 2025-03-31 0001074871 us-gaap:SupplierConcentrationRiskMember us-gaap:AccountsPayableMember modd:VendorEMember 2024-04-01 2025-03-31 0001074871 srt:MinimumMember 2026-03-31 0001074871 country:US 2025-04-01 2026-03-31 xbrli:pure xbrli:shares iso4217:USD iso4217:USD xbrli:shares modd:Segment

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended: March 31, ~~2025~~2026

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period ~~from~~ ~~___________to ____________~~from __________ to __________

Commission file number: 001-41277

MODULAR MEDICAL, INC.

(Exact name of registrant as specified in its charter)

Nevada		87-0620495
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)
10740 Thornmint Road, San Diego, California		92127
(Address of principal executive offices)		(Zip Code)

10470 Thornmint Road, San Diego, California		92127
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 800-3500

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		MODD		The Nasdaq Stock Market, LLC

Securities registered pursuant to Section 12(g) of the Act:

(Title of class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No ☒

Indicate by check mark if the registrant is(1) ~~not~~has ~~required~~filed ~~to file~~all reports ~~pursuant~~required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☐ ☒ No ☒☐

Indicate by check mark if the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated Filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation ~~received~~ received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D- 1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

~~Yes~~ ~~☐ No ☒~~The aggregate market value of the voting and non-voting common stock held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on the Nasdaq Stock Market on September 30, 2025 was $37,453,403.

The ~~aggregate~~number ~~market~~of ~~value~~shares of the ~~voting and~~registrant’s ~~non-voting~~ common stock ~~held~~outstanding, bypar ~~non-affiliates~~value of$0.001 ~~the~~per ~~Registrant~~share, ~~based~~as ~~on the closing price~~ of ~~the~~June ~~shares~~22, ~~of common stock on the Nasdaq Stock Market on September 30~~2026, ~~2024~~ was ~~$62~~5,~~273~~413,~~909~~160.

The number of shares of the registrant’s common stock outstanding, par value $0.001 per share, as of June 16, 2025, was 54,247,388.

ANNUAL REPORT ON FORM 10-K

FOR THE YEAR ENDED MARCH 31, ~~2025~~ 2026

TABLE OF CONTENTS

	Special Note Regarding Forward Looking Statements and Other Information	ii
			Page
	Part I
	Special Note Regarding Forward Looking Statements and Other Information		ii
Item 1.	Business	1
	Part I
Item 1A.	Risk Factors	17
Item 1	Business		1
Item 1B.	Unresolved Staff Comments	36
Item 1A	Risk Factors		19
Item 1C	Cybersecurity	36
Item 1B	Unresolved Staff Comments		39
Item 2.	Properties	36
Item 1C	Cybersecurity		39
Item 3.	Legal Proceedings	36
Item 2	Properties		40
Item 4.	Mine Safety Disclosures	36
Item 3	Legal Proceedings		40
	Part II
Item 4	Mine Safety Disclosures		40
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	37
	Part II
Item 6.	Reserved	38
Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities		41
Item 7.	Management’s Discussion and Analy sis of Financial Condition and Results of Operations	38
Item 6	Reserved		42
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	42
Item 7	Management’s Discussion and Analy sis of Financial Condition and Results of Operations		42
Item 8.	Financial Statements and Supplementary Data	F-1
Item 7A	Quantitative and Qualitative Disclosures about Market Risk		45
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	43
Item 8	Financial Statements and Supplementary Data		F-1
Item 9A.	Controls and Procedures	43
Item 9	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure		46
Item 9B.	Other Information	43
Item 9A	Controls and Procedures		46
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	43
Item 9B	Other Information		47
	Part III
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections		47
Item 10.	Directors, Executive Officers and Corporate Governance	44
	Part III
Item 11.	Executive Compensation	49
Item 10	Directors, Executive Officers and Corporate Governance		48
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	54
Item 11	Executive Compensation		54
Item 13.	Certain Relationships and Related Transactions, and Director Independence	57
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		58
Item 14.	Principal Accountant Fees and Services	57
Item 13	Certain Relationships and Related Transactions, and Director Independence		60
	Part VI
Item 14	Principal Accountant Fees and Services		61
Item 15.	Exhibits	58
	Part IV
Item 16.	Form 10K Summary	59
Item 15	Exhibits		62
	Signatures	60
Item 16	Form 10K Summary		64
	Signatures		65

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION

This Annual Report on Form 10-K (this “Report”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that relate to future events or to our future operations or financial performance. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement.

Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” “scheduled” ~~and~~ and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Although we believe that we have a reasonable basis for each forward- looking statement contained in this report, we caution you that these statements are based on our estimates or projections of of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward- looking statement. Actual results, level of activity, performance, experience or achievements may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including our critical accounting policies and risks and uncertainties relating to:

●

our strategies, prospects, plans, expectations, forecasts or objectives;

●

our ability to achieve marketable products (i.e., our insulin pump products) and the costs and timing thereof;

●

acceptance of our product by our target market and our ability to compete in such market;

●

our ability to raise additional financing when needed and the terms and timing thereof;

●

our ability to expand, protect and maintain our intellectual property rights;

●

our future operations, financial position, revenues, costs, expenses, uses of cash, capital requirements, our need for additional financing or the period for which our existing cash resources will be sufficient to meet our operating requirements;

●

our analysis of the target market for our insulin pump;

●

our ability to obtain regulatory approvals and clearances relating to our insulin pump products, including those of the United States Food and Drug Administration, or FDA;

●

regulatory developments in the United States and other countries;

●

the timing and costs of our obtaining all regulatory approvals and clearances identified immediately above;

● our compliance with all applicable laws, rules and regulations, including those of the Securities and Exchange Commission, or SEC, and the Food and Drug Administration, or FDA;

●

our ability to compete in the diabetes marketplace with larger and more substantial medical device companies;

●

general economic, business, political and social conditions;

●

our reliance on and our ability to retain (and if necessary, timely recruit and replace) our officers, directors and key employees and their ability to timely and competently perform at levels expected of them;

●

our ability to generate significant revenues and achieve profitability;

●

our ability to manage the growth of our business;

●

our commercialization, marketing and manufacturing capabilities and strategies;

●

our ability to expand, protect and maintain our intellectual property position;

●

the success of competing third-party products;

●

our ability to comply with regulatory requirements relating to our business, and the costs of compliance with those requirements, including those on data privacy and security;

●

the specific risk factors discussed under the heading “Risk Factors” set forth in this Report; and

●

various other matters, many of which are beyond our control.

Our fiscal year ends on March 31 of each calendar year. Each reference to a fiscal year in this Report refers to the fiscal year ended March 31 of the calendar year indicated (for example, fiscal ~~2025~~2026 refers to the fiscal year ended March 31, ~~2025~~2026). Unless the context requires otherwise, references to “we,” “us,” “our,” and the “Company” refer to Modular Medical, Inc. and its consolidated subsidiary.

Note Regarding Reverse Stock Split

We effected a reverse stock split of our outstanding common stock at a ratio of 1-for-30, effective as of March 31, 2026, for the purpose of complying with Nasdaq Listing Rule 5550(a)(2). We have reflected the reverse stock split herein, unless otherwise indicated.

iii

PART I

ITEM 1. BUSINESS

Overview

We are a ~~pre-revenue,~~ medical device company focused on the design, development, and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace. ~~Through~~ Through the creation of an innovative two-part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and ~~access~~ access to the higher standards of care that presently require considerable motivation from the patient to use the available insulin ~~pumps~~pump offerings. By simplifying and streamlining the user experience from the initial introduction of the patient to our product, prescription assistance, establishing insurance reimbursement, streamlined training and day-to-day use with strong clinical support, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” to expand the category into the mass market. Our product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets for those individuals requiring multiple daily doses of insulin. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration, or the FDA, for our initial insulin pump product, the MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. WeIn ~~are~~August ~~actively~~2025, ~~working~~we toannounced ~~manufacture~~the ~~and~~first ~~commercialize~~human use of our MODD1 ~~product~~pump ~~and~~delivering ~~commence~~insulin ~~initial~~to ~~shipments~~a ~~during~~human ~~the~~patient. ~~quarter~~In ~~ending~~addition, ~~September~~in ~~30,~~August 2025., Wewe ~~are~~announced ~~currently~~our ~~preparing~~next-generation apatch ~~second~~pump, ~~510(k)~~branded ~~premarket~~as ~~notification application~~Pivot™, toand ~~the~~began converting ~~FDA~~our ~~for~~cartridge anmanufacturing ~~updated~~line ~~version~~to ofPivot ~~the~~production. ~~MODD1,~~Our ~~called the~~ Pivot, ~~which~~product is a tubeless ~~version~~insulin ofdelivery ~~the~~system ~~product~~ that integrates the infusion set under the removable pump into a true tubeless patch. The Pivot ~~will~~is expected to provide us with cost and usability improvements and improved manufacturability, allowing our marketing to be focused on low cost, ~~and~~ ease of use and learnability. We ~~believe~~submitted wea ~~will~~510(k) premarket ~~submit~~notification to the ~~notification~~FDA for ~~the~~our Pivot ~~by October~~product ~~31,~~in November 2025, and, wein ~~believe~~April 2026, we ~~could~~received ~~obtain~~FDA ~~regulatory~~ clearance to market and sell ~~launch~~our Pivot ~~during~~pump in the ~~three~~United ~~months ending March 31, 2026~~States. We do not intend to ~~replace~~commercialize ~~the~~our MODD1 ~~with~~product. ~~the~~In ~~Pivot~~June 2026, aswe ~~soon~~announced ascommercial ~~the~~availability, and ~~required~~commenced ~~regulatory~~initial ~~approval~~shipments ~~from~~of, our Pivot insulin delivery system in the ~~FDA~~United isStates. ~~received~~We intend to expand commercial activities across metropolitan markets by late 2026. We also intend to obtain Conformite Europeenne, or CE, mark clearance for ~~both~~ our ~~MODD1 and~~ Pivot ~~products~~product, which would allow us to market and sell in ~~European~~Europe and certain other international markets. We expect to obtain CE mark clearance inby the second ~~first~~ quarter of ~~2026~~2027.

Differentiation

We believe that there are a number of shortcomings and issues with currently available insulin pumps that prevent a substantial number of people, estimated to be almost two-thirds of individuals with diabetes, who require insulin on a daily basis from choosing an insulin pump to treat their diabetes. We believe that, by tailoring our insulin pump to address such factors, we can expand the scope and adoption rate of insulin pump usage by the less capable, less motivated sector of the market. We believe that to achieve broader market acceptance, an insulin pump must be easier to learn to use, be less time-consuming to operate, more intuitive to both patients and physicians, and meet the standards for coverage by insurance providers so that co-payments required from patients are affordable and the hurdles to insurance coverage are significantly reduced.

Among the more prominent issues are:

●

Complexity: Many existing pumps are highly complex and require significant technical expertise to use effectively. We believe such pumps were designed for “super users,” who have high levels of motivation and technical competence. The complexity of pumps can be daunting to less technically inclined, less motivated users.

●

Cumbersome: We believe that a majority of existing pumps are bulky and difficult to manage, requiring a means of carrying the pump around and up to 48 inches of tubing to the injection site to connect the catheter to a pump. The tubing and the cartridge, which holds the insulin, must be replaced every few days. This requires users to carry spare parts and other equipment adding to the difficulty of using the pump. In comparison, our product only requires a cartridge change every few days.

● Cost: Costs associated with insulin pump therapy can be high and prohibitive, especially for those on fixed or limited incomes. These costs vary by pump and insurance coverage, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to possible additional co-payments on consumables, can easily place current pumps out of reach for many patients. The leading patch pump on the market today also discards all the electronics required for pumping and communication every three days, creating a higher cost architecture and significant waste. We believe the reusability of our product will provide us with a significant cost advantage in the marketplace with our reusable pumping system. ● Outdated style: Consumer electronics devices have evolved in both form and function. Diabetes pumps have not experienced similar progress. We believe that consumers will be more receptive of products designed with the user experience in mind and that many have low tolerance for complex, difficult procedures for use and maintenance of products. ● Pump mechanism limitations: Traditional pumps generally utilize a syringe and plunger mechanism to deliver insulin. We believe this design limits the ability to reduce the size of the pump, and also potentially exposes the user to the unintended delivery of the full volume of insulin within the pump, which can cause hypoglycemia or death. We believe that the fear of adverse health events due to technical malfunctions related to traditional pump mechanism limitations deters the adoption of insulin pump therapy.

Our team has substantial knowledge of the diabetes industry and experience in developing, obtaining marketing authorization for, and bringing insulin pumps to market. Based on this experience, we believe that our innovative insulin pump, using a new and proprietary method of pumping insulin, can address most or all of these shortcomings. It provides a state-of-the-art insulin pump capable of both basal (steady flow) and bolus (mealtime dosing) insulin disbursement. It also has been designed considering a natural migration path to multi-chamber/multi-liquid pumps, potentially offering an exciting array of new therapies to patients with diabetes and other conditions.1

1● Outdated style: Consumer electronics devices have evolved in both form and function. Diabetes pumps have not experienced similar progress. We believe that consumers will be more receptive of products designed with the user experience in mind and that many have low tolerance for complex, difficult procedures for use and maintenance of products.

~~Our~~● ~~goal~~Pump ismechanism tolimitations: ~~become~~Traditional ~~the~~pumps ~~leader~~generally inutilize ~~expanding access~~a syringe and plunger mechanism to deliver insulin. ~~pump~~We ~~technology~~believe this design limits the ability to areduce ~~wider~~the ~~portion~~size of ~~diabetes~~the ~~sufferers~~pump, and ~~provide~~also ~~not~~potentially ~~just~~exposes ~~care~~the ~~for~~user to the ~~super~~unintended ~~users~~delivery of the full volume of insulin within the pump, ~~but~~which ~~“diabetes care~~can ~~for~~cause hypoglycemia or death. We believe that the ~~rest~~fear of usadverse health events due to technical malfunctions related to traditional pump mechanism limitations deters the adoption of insulin pump therapy.”

~~While~~Our team ~~our~~has ~~initial~~substantial ~~target~~knowledge ~~market~~of isthe ~~people~~diabetes ~~with~~industry ~~Type~~and 1experience ~~diabetes~~in developing, ~~we believe~~obtaining ~~there~~marketing isauthorization afor, ~~substantial~~and ~~opportunity~~bringing insulin pumps to ~~penetrate~~market. ~~the~~Based ~~type~~on 2this ~~marketplace~~experience, ~~first~~we ~~through~~believe that our ~~initial~~innovative ~~MODD1~~insulin pump, using a new and ~~then~~proprietary ~~with~~method ~~the~~of ~~future~~pumping ~~introduction~~insulin, can address most or all of ~~Pivot,~~these ~~which~~shortcomings. ~~would~~It beprovides a state-of-the-art ~~only~~insulin 3pump ~~milliliter~~capable of both basal (steady flow) and bolus (mealtime dosing) insulin disbursement. It also has been designed considering a natural migration path to multi-chamber/multi-liquid pumps, ~~tubeless~~potentially ~~removable~~offering ~~patch~~an ~~pump~~exciting onarray ~~the~~of ~~market~~new therapies to patients with diabetes and other conditions.

~~The~~With ~~MODD1~~the ~~and~~commercial ~~its~~launch ~~successor~~of ~~product~~our ~~the~~ Pivot ~~are~~ ~~high-precision~~pump, ~~pumps~~our ~~that~~goal weis ~~believe~~to ~~represent~~ become the ~~best~~leader ~~choice~~in ~~for~~expanding ~~new~~access to insulin pump ~~patients~~technology ~~because~~to ~~they~~a ~~are~~wider portion of people with diabetes by delivering an affordable, easy -to ~~learn and~~ -use, solution ~~and~~— ~~has~~not ajust ~~revolutionary~~for ~~design~~the ~~and~~highly ~~internal~~motivated ~~technology~~“super ~~that~~users,” ~~enable~~but ~~precision~~“diabetes ~~with~~care ~~low-cost~~for ~~manufacture~~the ~~and~~rest ~~high~~of ~~reproducibility~~us.”

~~Key~~While ~~features~~our ~~include:~~initial target market is people with Type 1 diabetes, we believe there is a substantial opportunity to penetrate the Type 2 marketplace, through our Pivot product, which would be the only 3 milliliter, tubeless removable patch pump on the market. People with Type 2 diabetes tend to use more insulin than the present pump offerings can hold, requiring more frequent changes of the pump and incurring higher expense.

●The Pivot ~~Three~~is ~~parts~~a high-precision ~~one reusable~~pump, ~~two~~which ~~disposable~~we (believe represent the ~~cartridge~~best ~~and~~choice ~~the~~for ~~set)~~new -pump ~~snap~~patients ~~together~~because it is affordable, easy to ~~form~~learn and ~~the~~use, ~~working~~and ~~system;~~has a revolutionary design and internal technology that enable precision with low-cost manufacture and high reproducibility.

●Key features ~~One button interface, easy to learn and use;~~include:

● ~~Phone~~Three ~~software~~parts ~~for~~— ~~those~~one ~~who~~reusable, ~~want~~two todisposable ~~access~~(the ~~more~~cartridge ~~information~~and onthe set) — snap together to form the ~~product~~working system;

● ~~90-day~~One ~~reusable~~button interface, ~~3-day~~easy ~~disposable~~to learn and use;

● ~~Removable~~Phone ~~system~~software for those who want to access more information on the product;

● No90-day ~~external controller required~~reusable, no3-day ~~charging, no battery replacement~~disposable; ~~and~~

● ~~Slim~~Removable ~~profile, lighter weight.~~system;

A● ~~proprietary~~No ~~survey~~external ofcontroller ~~American~~required, ~~healthcare~~no ~~payors representing~~charging, 50no ~~million~~battery ~~covered~~replacement; lives (approximately one-third of total U.S. covered lives) performed for us by industry leading survey firm ISA in 2019 has demonstrated that payors are willing to grant equivalent or preferential coverage for a product with this feature set at launch in exchange for discounts of approximately 20%.and

~~Diabetes~~● ~~Classifications~~Slim ~~and~~profile, ~~Therapies~~lighter weight.

~~Diabetes is typically classified as either type 1 or type~~ 2:

●Diabetes Classifications ~~Type~~and 1 diabetes, or T1D, is an auto-immune condition characterized by the body’s nearly complete inability to produce insulin. It is frequently diagnosed during childhood or adolescence, although it can sometimes have onset in adulthood. Individuals with T1D require daily insulin therapy to survive.Therapies

●Diabetes ~~Type 2 diabetes, or T2D, represents over 90% of all individuals diagnosed with diabetes and~~ is ~~characterized~~typically byclassified ~~the~~as ~~body’s inability to~~ either ~~properly~~Type ~~utilize~~1 ~~insulin~~ or ~~produce~~Type sufficient insulin. Initially, many people with T2D attempt to manage their condition with improvements in diet and exercise and/or the use of oral medications and/or injection of glucagon-like peptide-1 (GLP-1) drugs. However, as their diabetes advances, patients often progress to requiring insulin therapies such as once-daily long-acting insulin and ultimately to intensified mealtime rapid-acting insulin therapy. This represents an important portion of the diabetes market with an estimated 1.6 million individuals with T2D intensively treated with insulin currently in the United States.2:

~~Glucose,~~● ~~the~~Type ~~primary~~1 ~~source of energy for cells~~diabetes, ~~must~~ beor ~~maintained at certain levels in the blood in order to permit optimal cell function and health. The brain works on pure glucose~~T1D, ~~and,~~ ~~when sufficient glucose~~ is ~~available,~~an ~~the~~auto-immune ~~brain~~condition ~~allows~~characterized ~~insulin~~by ~~to be released that allows~~ the ~~cells~~body’s tonearly ~~absorb~~complete ~~glucose.~~inability ~~In people with diabetes, blood glucose levels are not well controlled by the brain due~~ to ~~the~~produce ~~shortage of~~ insulin. ~~Frequently,~~It ~~blood~~is ~~glucose~~frequently ~~levels become~~diagnosed ~~very~~during ~~high,~~childhood ~~a condition known as hyperglycemia,~~ or ~~very low~~adolescence, aalthough ~~condition~~it ~~called hypoglycemia. Hyperglycemia~~ can ~~lead~~sometimes tohave ~~serious long-term~~onset ~~complications,~~in ~~including blindness, kidney disease, nervous system disorders, occlusive vascular diseases, lower-limb amputation, stroke, cardiovascular disease, and death~~adulthood. ~~Hypoglycemia~~Individuals ~~can~~with ~~lead~~T1D torequire ~~confusion~~daily orinsulin ~~loss~~therapy ~~of consciousness, often requiring a visit~~ to ~~the emergency room or, in certain cases, result in seizures, coma, and/or death~~survive.

~~All~~● ~~people~~Type ~~with~~2 ~~T1D~~diabetes, ~~which~~or T2D, represents over 90% of all individuals diagnosed with diabetes and is ~~our~~characterized ~~primary~~by ~~market, require~~the ~~daily~~body’s inability to either properly utilize insulin or produce sufficient insulin. ~~According~~Initially, many people with T2D attempt to manage their condition with improvements in diet and exercise and/or the ~~Seagrove~~use ~~2023~~of ~~Diabetes~~oral ~~Blue~~medications ~~Book,~~and/or ~~there~~injection ~~are~~of ~~approximately~~glucagon-like 3peptide-1 (GLP-1) drugs.6 ~~million~~However, ~~potential~~as ~~users~~their ~~for~~diabetes ~~insulin pumps~~advances, ~~split~~patients ~~evenly~~often ~~between~~progress ~~type~~to 1requiring insulin therapies such as once-daily long-acting insulin and ~~type~~ultimately 2to intensified mealtime rapid-acting insulin therapy. InThis ~~this~~represents ~~Report,~~an weimportant ~~refer~~portion toof ~~people~~the diabetes market with ~~T1D~~an ~~and~~estimated ~~people~~1.6 million individuals with T2D ~~who~~intensively ~~require~~treated ~~mealtime~~with insulin as ~~“insulin-requiring~~currently ~~people~~in ~~with~~the ~~diabetes~~United States.”

2Glucose, the primary source of energy for cells, must be maintained at certain levels in the blood in order to permit optimal cell function and health. The brain works on pure glucose, and, when sufficient glucose is available, the brain allows insulin to be released that allows the cells to absorb glucose. In people with diabetes, blood glucose levels are not well controlled by the brain due to the shortage of insulin. Frequently, blood glucose levels become very high, a condition known as hyperglycemia, or very low, a condition called hypoglycemia. Hyperglycemia can lead to serious long-term complications, including blindness, kidney disease, nervous system disorders, occlusive vascular diseases, lower-limb amputation, stroke, cardiovascular disease, and death. Hypoglycemia can lead to confusion or loss of consciousness, often requiring a visit to the emergency room or, in certain cases, result in seizures, coma, and/or death.

~~Currently,~~All ~~there are two primary therapies available for insulin-requiring~~ people with ~~diabetes: multiple daily insulin injections directly into the body through syringes or insulin pens (a type of syringe)~~T1D, ~~referred~~which tois asour ~~Multiple~~primary ~~Daily Injection~~market, require ordaily ~~MDI therapy, or the use of an~~ insulin. ~~pump~~According to ~~deliver~~the ~~mealtime~~Seagrove ~~insulin boluses~~2026 toDiabetes ~~help~~Blue ~~with glucose absorption after carbohydrate consumption and a continuous subcutaneous insulin infusion~~Book, orthere ~~CSII~~are ~~therapy, into~~approximately ~~the body~~4.2 ~~Generally,~~million ~~CSII~~potential ~~therapy~~users isfor ~~considered to provide a number of advantages over MDI therapy, primarily an improvement in glycemic~~insulin ~~control~~pumps, assplit ~~measured~~evenly bybetween ~~certain~~type ~~diabetes~~1 ~~management tests such as hemoglobin A1c (HbA1c) measure~~ and ~~more~~type ~~recently~~2. ~~Time~~In ~~in Range (TIR) where a continuous glucose measuring device is used to calculate~~ this ~~test. Among other clinical benefits~~Report, awe ~~study~~refer ~~conducted~~to bypeople ~~Tandem Diabetes~~with ~~Care,~~T1D ~~Inc.,~~and orpeople ~~Tandem,~~with inT2D ~~2021,~~who ~~demonstrated~~require ~~that~~mealtime insulin ~~pump use can decrease glucose variability, reduce the number of hypoglycemia~~ ~~events,~~as ~~and~~“insulin-requiring ~~reduce~~people ~~the~~with ~~fear of hypoglycemia~~diabetes.”

~~Notwithstanding~~Currently, there ~~these~~are ~~advantages,~~two weprimary ~~believe~~therapies ~~the difficulty~~available infor ~~use~~insulin-requiring ~~resulting~~people ~~from~~with ~~the~~diabetes: ~~complexity~~multiple ~~and~~daily ~~cumbersome~~insulin ~~design~~injections ofdirectly ~~available~~into the body through syringes or insulin ~~pumps~~pens (a type of syringe), asreferred ~~well~~to as ~~high~~Multiple ~~and~~Daily ~~often~~Injection, ~~prohibitive costs~~or ~~for~~MDI ~~both~~therapy, or the ~~patient~~use ~~and~~of an ~~insurance~~insulin ~~provider,~~pump ~~has~~to ~~resulted~~deliver ~~not~~mealtime ~~only~~insulin inboluses ~~dissatisfaction~~to ~~among~~help ~~many~~with ~~existing~~glucose ~~pump~~absorption ~~users.~~after Wecarbohydrate ~~believe the~~consumption ~~cost~~ and ~~complexity~~a tocontinuous ~~the~~subcutaneous insulin ~~user~~infusion, ~~has~~or ~~severely~~CSII ~~limited~~therapy, into the ~~adoption~~body. ~~rate~~Generally, ofCSII ~~insulin~~therapy ~~pumps~~is byconsidered ato ~~large~~provide ~~segment~~a number of ~~the~~advantages ~~diabetes~~over ~~population using~~ MDI therapy, primarily ~~whom~~an weimprovement ~~refer~~in toglycemic incontrol, ~~this~~as ~~Report~~measured by certain diabetes management tests such as ~~“Almost~~hemoglobin ~~Pumpers~~A1c (HbA1c) measure and more recently Time in Range (TIR) where a continuous glucose measuring device is used to calculate this test.”

~~We define Almost Pumpers as insulin-requiring~~Notwithstanding ~~people~~these ~~with~~advantages, ~~diabetes~~we ~~who~~believe ~~are~~the ~~aware~~difficulty ofin ~~pumps~~use ~~and~~resulting ~~their~~from ~~potential~~the ~~benefits but because of past experiences, pump shortcomings, cost,~~ complexity~~, and~~ ~~time~~ and ~~learning~~cumbersome ~~required~~design toof ~~adopt and utilize currently~~ available insulin pumps, ~~continue to receive their daily insulin through~~as ~~MDI~~well ~~therapy.~~as Wehigh ~~undertook~~and ~~one-on-one~~often ~~interviews~~prohibitive ~~with~~costs ~~over~~for ~~200~~both ofthe ~~these~~patient ~~individuals~~and toinsurance ~~understand~~provider, ~~their~~has ~~past~~resulted ~~experiences~~not ononly orin ~~considering~~dissatisfaction among ~~pumps,~~many existing pump ~~shortcomings,~~users. We believe the cost and ~~insurance challenges,~~ complexity to ~~learn~~the ~~and~~user ~~time~~has ~~and~~severely ~~complexity~~limited tothe ~~operate~~adoption ~~that~~rate ~~drives them~~of toinsulin ~~remain~~pumps onby ~~MDI. With this detailed understanding, we brought~~ a large ~~series~~segment of ~~prototype~~the ~~models~~diabetes topopulation ~~them~~using toMDI ~~react to~~therapy, sowhom we ~~could~~refer ~~refine the design and include features that would motivate them~~ to bein ~~able to use~~ this ~~technology~~Report ~~to better care for their diabetes. Our MODD1 pump has been well received by these individuals and our clinical advisors,~~ as ~~applicable~~“Almost ~~for this sector of the marketplace~~Pumpers.”

~~Our~~We ~~research,~~define ~~along~~“Almost ~~with~~Pumpers” ~~marketplace~~as ~~data~~insulin-requiring ~~provided~~people bywith ~~Seagrove~~diabetes inwho ~~2023,~~are ~~estimates~~aware ~~that~~of ~~33%~~pumps ofand ~~Americans~~their ~~with~~potential ~~T1D~~benefits ~~have~~but anbecause ~~insulin~~of past experiences, pump ~~and~~shortcomings, ~~28%~~cost, ofcomplexity, and ~~Americans~~time ~~with~~and ~~T1D~~learning ~~(44%~~required ofto ~~those~~adopt ~~who~~and ~~currently~~ utilize ~~MDI)~~currently ~~can~~available beinsulin ~~classified~~pumps, ascontinue ~~having~~to anreceive ~~interest~~their indaily ~~pump~~insulin ~~adoption~~through MDI ~~and~~therapy. ~~meeting~~We ~~the~~undertook ~~American~~one-on-one ~~Diabetes~~interviews ~~Association~~with ~~guidelines~~over 200 of ~~glucose control~~these ifindividuals ~~their~~to ~~objections~~understand totheir ~~the~~past ~~currently~~experiences ~~available~~on ~~suite~~or ofconsidering pumps, ~~products~~existing ~~can~~pump beshortcomings, ~~overcome.~~the ~~They~~cost doand ~~not~~insurance ~~want~~challenges, complexity to ~~closely~~learn ~~manage~~and ~~their~~time ~~glucose levels~~ and ~~incur~~complexity ~~the~~to ~~associated~~operate ~~time~~that ~~and~~drives them ~~effort~~to ~~involved;~~remain ~~however,~~on ~~they~~MDI. ~~understand,~~With orthis ~~are~~detailed ~~advised~~understanding, bywe ~~their~~brought ~~clinical~~a ~~care~~series ~~team,~~of ~~that~~prototype ~~they need~~models to dothem ~~more~~to react to, ~~achieve~~so awe ~~reasonable~~could ~~level~~refine the ofdesign ~~glucose.~~and ~~They~~include ~~are~~features ~~the~~that ~~Almost~~would ~~Pumpers.~~motivate Wethem ~~have~~to ~~developed~~be ~~what~~able weto ~~believe~~use this technology to bebetter ~~the~~care ~~most technologically~~for ~~advanced~~their ~~delivery~~diabetes. ~~system~~Our ~~overcome~~pump offering ~~the~~has ~~objections~~been ~~and~~well ~~provide~~received ~~motivation~~by ~~for~~these ~~this~~individuals ~~market.~~and Weour ~~believe~~clinical ~~that~~advisors, ~~there~~as ~~are~~applicable ~~four addressable~~for ~~hurdles~~this tosector ~~adoption:~~of the marketplace.

~~● Usability: the device needs to be easy to learn and to operate;~~3

●Our ~~Affordability:~~research, wealong ~~will~~with ~~focus~~marketplace ondata ~~overcoming~~provided ~~copay~~by Seagrove in 2026, estimates that 43% of Americans with T1D have an insulin pump and ~~insurance~~28% ~~hurdles~~of ~~rather~~Americans ~~than~~with ~~leaving~~T1D (44% of those who currently utilize MDI) can be classified as having an interest in pump adoption and meeting the ~~“insurance~~American ~~journey”~~Diabetes Association guidelines of glucose control if their objections to the ~~clinician~~currently available suite of products can be overcome. They do not want to closely manage their glucose levels and ~~patient~~incur the associated time and effort involved; however, they understand, or are advised by their clinical care team, that they need to do more to achieve a reasonable level of glucose. They are the Almost Pumpers. We have developed what we believe to be the most technologically advanced delivery system overcome the objections and provide motivation for this market. We believe that there are four addressable hurdles to adoption:

● ~~Accessibility and Education~~Usability: wethe ~~will~~device ~~seek~~needs to ~~engage~~be ~~patients~~easy to ~~sample~~learn ~~this new technology by supplying clinicians with free samples~~ and ~~simple training~~ to ~~allow people to see first-hand the typical barriers to adoption that have been overcome~~operate; ~~and~~

● ~~Service and Support~~Affordability: ~~where~~ we will ~~answer~~focus ~~their~~on ~~questions~~overcoming copay and ~~concerns~~insurance ~~during~~hurdles ~~this~~rather ~~diabetes~~than ~~experience.~~leaving the “insurance journey” to the clinician and patient;

We● ~~believe~~Accessibility ~~this~~and ~~conversion~~Education: ~~process,~~we ~~engaging~~will ~~people~~ seek to ~~try~~engage ~~and~~patients ~~thereby~~to ~~receive~~sample ~~the~~this ~~benefits~~new ~~of our~~ technology ~~will~~by ~~substantially~~supplying ~~increase~~clinicians ~~adoption of insulin pumps among~~ with ~~patients~~free ~~with T1D~~samples and ~~T2D~~simple ~~who~~training ~~remain~~to ~~reliant~~allow ~~upon~~people ~~multiple~~to ~~daily~~see ~~injections.~~first-hand ~~Diabetes is a disease that appears randomly throughout~~ the ~~world.~~typical ~~Therefore, we~~barriers ~~cannot segment the market by socioeconomics, education or level of care. We intend~~ to ~~create~~adoption ~~an insulin pump~~ that ~~appeals~~have tobeen ~~all~~overcome; ~~Almost Pumpers.~~and

~~Market~~● Service and Support: where we will answer their questions and concerns during this diabetes experience.

~~The~~We ~~International~~believe ~~Diabetes~~this ~~Federation~~conversion ~~estimated that~~process, inengaging ~~2021,~~people ~~approximately~~to ~~537~~try ~~million~~and ~~people~~thereby receive ~~were~~the ~~living~~benefits of our technology will substantially increase adoption of insulin pumps among with ~~diabetes~~patients ~~worldwide,~~with T1D and byT2D ~~2045~~who remain reliant upon MDI. Diabetes is a disease that appears randomly throughout the world. Therefore, ~~this~~we ~~number~~cannot ~~will~~segment ~~increase~~the tomarket ~~approximately~~by ~~783~~socioeconomics, ~~million~~education ~~people~~or level of care. We intend to create an insulin pump that appeals to all Almost Pumpers.

An estimated 34 million people in the United States live with diabetes. Within this group, T1D accounts for approximately 1.8 million people with the remainder being T2D. All people with T1D require daily insulin. However, of the approximately 32.2 million people with T2D, about 1.6 million of them require MDI therapy to manage their diabetes. This represents a large and growing market with the effects of diabetes accounting for roughly 25% of all healthcare dollars spent annually in the United States.Market

3The International Diabetes Federation estimated that, in 2025, approximately 357 million people were diagnosed with diabetes worldwide, and, by 2045, this number will increase to approximately 456 million people.

~~According~~An toestimated ~~the~~34 ~~National~~million ~~Diabetes~~people ~~Health~~in ~~Care~~the United ~~Provider~~States ~~Survey~~live ~~conducted~~with bydiabetes. ~~Seagrove~~Within ~~Partners,~~this ~~LLC~~group, orT1D ~~Seagrove,~~accounts infor ~~2021,~~ approximately ~~25%~~2.1 million people with the remainder being T2D. All people with T1D require daily insulin. However, of the 1approximately 32.62 million ~~highly~~people ~~insulin~~with ~~intensive~~T2D, about 2.1 million of them require MDI therapy ~~individuals~~to manage their diabetes. This represents a large and growing market with ~~T2D~~the ~~have~~effects ~~considered~~of ~~going~~diabetes ~~“on~~accounting ~~pump~~for roughly 25% of all healthcare dollars spent annually in the United States.”

Insulin pumps have been shown to provide a higher level of care for insulin-dependent people with diabetes and result in better glycemic control, fewer comorbidities, fewer trips to the emergency room, and higher overall quality of life. They also result in lower overall costs to the healthcare system, reducing typical expense per patient year from approximately $27,000 to $17,000.

Despite these benefits, only 1 in 3 (33%) of the 1.8 million Americans with T1D and very few of the 1.6 million T2D intensively treated with insulin currently use an insulin pump, for a total of approximately 670,000 current users, with only a slow increase of insulin pump use. The remaining 68% of individuals with T1D and virtually all with T2D rely on MDI therapy for glucose control. Decades of advances in technology advances have left these non-pumpers at a significant disadvantage from a control perspective versus their “pumping” counterparts.

We have identified a large segment of the market that we refer to as “Almost Pumpers.” Almost Pumpers are those insulin-requiring people with diabetes (T1D or T2D) who feel that they would adopt the pump if it were less expensive, less time consuming, less technically intimidating, and if there was no separate controller. We believe that they represent approximately 32% of the T1D market correlating to a $1.9 billion ~~growth~~market opportunity.

Insulin pumps on the market today require a substantial amount of time to manage the therapy, have high out-of-pocket costs that place these technologies out of reach for a large part of the population, and are feature-heavy with complex systems, which we believe have hampered adoption and intimidated many users. The most commonly used insulin pumps today require extensive training and hours of daily management. The average pump user must go through 42 steps of setup and refill process every 72 hours to “stay on track.” Our product only requires nine steps for setup and refill every 72 hours.4

~~The~~Insulin pumps ~~current~~on ~~reluctance~~the market today require a substantial amount of time to ~~adopt~~manage the ~~insulin~~therapy, ~~pump~~have high out-of-pocket costs that place these ~~has~~technologies ~~had~~out ~~serious~~of ~~consequences~~reach onfor ~~the~~a ~~healthcare~~large ~~system.~~part Inof the ~~United States~~population, ~~people~~and ~~living~~are feature-heavy with ~~T1D~~complex ~~have~~systems, ~~struggled~~which towe ~~attain~~believe ~~glycemic~~have hampered ~~targets.~~adoption Aand ~~2019~~intimidated ~~analysis~~many ofusers. ~~the~~The ~~large~~most ~~T1D~~commonly ~~Exchange~~used ~~clinical~~insulin ~~registry~~pumps ~~found~~today ~~that~~require ~~only~~extensive ~~21%~~training ofand ~~U.S.~~hours ~~adults~~of ~~with~~daily ~~T1D~~management. The ~~achieved~~average ~~the~~pump ~~ADA~~user ~~A1c goal~~must ~~(<7.0%).~~go ~~Further,~~through ~~according~~42 tosteps aof ~~study~~setup ~~published~~and inrefill ~~JAMA~~process ~~Internal~~every ~~Medicine,~~72 ~~researchers~~hours ~~found~~to no“stay ~~significant~~on ~~improvements~~track.” inOur ~~diabetes~~product ~~care~~only ~~between~~requires ~~2005~~nine ~~and~~steps ~~2016,~~for ~~with~~setup ~~persistent~~and ~~gaps~~refill inevery ~~care~~72 ~~related to socioeconomic status~~hours.

~~Another~~The ~~transition~~current inreluctance ~~the~~to ~~care~~adopt ~~of diabetes is~~ the ~~measuring~~insulin ~~of glucose from finger-stick tests to continuous glucose monitoring, or CGM, sensors, which are wearable devices. These~~pump ~~sensors~~has ~~are~~had ~~placed~~serious ~~under~~consequences ~~the~~on ~~skin and give a reading every five minutes of~~ the ~~user’s~~healthcare ~~glucose level~~system. ~~While~~In ~~Dexcom~~the ~~has~~United ~~been a market leader in this field~~States, ~~the~~people ~~introduction~~living ~~and~~with ~~rapid~~T1D ~~adoption~~have ofstruggled ~~the~~to ~~Freestyle~~attain ~~Libre by Abbott Labs has made CGM easier and more affordable,~~glycemic ~~expanded~~targets. ~~the~~According ~~product~~to ~~category, and doubled~~ the ~~market~~American ~~size.~~Diabetes ~~The Freestyle Libre product is a more affordable~~Association, ~~easier~~only to23% ~~use and smaller version~~ of ~~the popular Dexcom, Inc~~U. ~~(Dexcom) CGM product~~S. ~~Now,~~adults ~~for~~and ~~the~~17% ~~first~~of ~~time,~~children ~~there~~with isT1D anachieved ~~easy,~~the ~~less~~ADA ~~painful,~~A1c igoal (<7.e0%)., ~~no more finger sticks~~Further, ~~way~~according ~~for patients~~ to ~~have~~a ~~the~~study ~~data~~published ~~they~~in ~~need~~JAMA toInternal ~~understand~~Medicine, ~~more~~researchers ~~about~~found ~~their~~no ~~glucose~~significant ~~levels~~improvements ~~and~~in ~~their insulin requirements. Access~~diabetes tocare ~~such~~between ~~data~~2005 ~~has motivated patients to ask their diabetes clinician how they can achieve better glycemic control~~ and ~~made~~2016, ~~them more comfortable~~ with ~~using~~persistent ~~technology~~gaps ~~and~~in ~~wearables to treat their diabetes. Pumps offer a clear pathway to better control and better overall~~ care. ~~We believe~~related ~~that the insulin pump market is ready for a similar transition as that experienced in the CGM space. Our MODD1 pump represents a new and better offering~~ to ~~assist~~socioeconomic ~~and induce a wide variety of patients to make the transition and overcome the objections to superior control by becoming a “pumper~~status.”

4Another transition in the care of diabetes is the measuring of glucose from finger-stick tests to continuous glucose monitoring, or CGM, sensors, which are wearable devices. These sensors are placed under the skin and give a reading every five minutes of the user’s glucose level. While Dexcom has been a market leader in this field, the introduction and rapid adoption of the Freestyle Libre by Abbott Labs has made CGM easier and more affordable, expanded the product category, and doubled the market size. The Freestyle Libre product is a more affordable, easier to use and smaller version of the popular Dexcom, Inc. (Dexcom) CGM product. Now, for the first time, there is an easy, less painful, i.e., no more finger sticks, way for patients to have the data they need to understand more about their glucose levels and their insulin requirements. Access to such data has motivated patients to ask their diabetes clinician how they can achieve better glycemic control and made them more comfortable with using technology and wearables to treat their diabetes. Pumps offer a clear pathway to better control and better overall care. We believe that the insulin pump market is ready for a similar transition as that experienced in the CGM space. We believe our Pivot pump represents a new and better offering, which can assist and induce a wide variety of patients to make the transition and overcome the objections to superior control by becoming a “pumper.”

We believe the present pump marketplace is approximately a $1.9 billion market, comprising 33% of T1D pumpers and a small group of T2D pumpers. Seagrove surveyed clinicians, and, in ~~its~~a 2021 report, estimated that 28% of T1D patients and 25% of T2D patients would adopt technology that was easier to use, learn and access and ~~eligible~~ eligible for insurance reimbursement. We believe this represents a total addressable market of approximately $3 billion for us, assuming prescription cartridge revenue of approximately $4,100 per patient, per year.

We are dedicated to helping all people with diabetes gain access to high quality care. We aim to help people with diabetes - especially Almost Pumpers and the historically underserved communities - gain access to insulin pump technology by making it affordable and easy to use.5

~~Diabetes~~We are ~~Care~~dedicated isto athelping anall ~~Inflection~~people ~~Point~~with diabetes gain access to high quality care. We aim to help people with diabetes — especially Almost Pumpers and the historically underserved communities — gain access to insulin pump technology by making it affordable and easy to use.

WeDiabetes Care ~~believe~~is ~~that the insulin pump market stands~~ at aan ~~crossroads~~Inflection ~~as a confluence of events makes the timing for a new product introduction ideal.~~Point

~~At the same time, reimbursement for patch pumps~~We ~~has~~believe ~~been~~that ~~increasingly~~the ~~moving~~insulin topump amarket ~~pharmacy~~stands ~~benefits~~at ~~manager (PBM) model, which simplifies reimbursement and will further aid in~~ a ~~“frictionless launch.”~~crossroads ~~This~~as ~~represents~~ a ~~fundamental~~confluence ~~shift~~of inevents makes the ~~insulin~~timing ~~pump~~for ~~market, making onboarding rapid and simplifying~~ a ~~previously~~new ~~complex and~~product ~~time-consuming “insurance journey~~introduction ideal.”

WeAt the ~~believe~~same ~~these~~time, ~~CGM~~reimbursement ~~device~~for ~~users~~patch ~~are~~pumps ~~increasingly interested~~has inbeen ~~adopting~~increasingly ~~technology~~moving ~~and wearables~~ to ~~manage their diabetes. We believe CGM device users are~~ a ~~natural~~pharmacy ~~market~~benefits ~~for~~manager a(PBM) ~~new type of pump~~model, ifwhich itsimplifies reimbursement ~~can meet their needs~~ and ~~address~~will ~~their~~further ~~objections~~aid ~~and~~in ~~that~~a ~~the~~“frictionless ~~conjunction~~launch.” ofThis ~~the above trends~~ represents a ~~unique~~fundamental ~~opportunity~~ shift in the insulin pump market~~’s history. The CGM device provides glucose-level data~~, ~~and, as necessary, the user can respond to address~~ ~~any~~making ~~issues~~onboarding ~~with~~rapid aand ~~simple~~simplifying ~~button push on~~ a ~~pump~~previously tocomplex ~~deliver their insulin versus taking out a syringe~~ and ~~injecting~~time-consuming ~~glucose~~“insurance journey.”

~~Diabetes~~We believe these CGM device users are increasingly interested in adopting technology ~~companies~~and ~~understand~~wearables ~~that~~to manage their diabetes. We believe weCGM ~~are~~device atusers are a ~~turning~~natural ~~point~~market ~~with~~for a new ~~markets~~type ~~(T2D~~of pump, ~~T1D~~if it can meet their needs and address their objections and that ~~are~~the ~~currently~~conjunction of ~~not~~the ~~using~~above ~~technologies)~~trends represents a unique opportunity in the insulin pump market’s history. ~~This~~The CGM device provides glucose-level data, and, as necessary, the user can berespond ~~seen~~to address any issues with ~~increased~~a ~~discussion around~~simple ~~this~~button ~~topic~~push ~~during~~on ~~recent~~a ~~national~~pump ~~diabetes~~to ~~conferences,~~deliver astheir ~~well~~insulin asversus taking anout ~~increase~~a insyringe ~~marketing~~and ~~promotion~~injecting glucose.

~~All~~Diabetes technology ~~these~~companies ~~recent~~understand ~~changes~~that ~~support~~we ~~the~~are ~~high~~at ~~proportion of~~a ~~T1D~~turning ~~and~~point ~~T2D~~with ~~intensively~~new ~~treated~~markets ~~with~~(T2D, ~~insulin~~T1D that weare ~~consider~~currently tonot beusing ~~Almost~~technologies). This ~~Pumpers,~~can ~~and~~be weseen ~~expect~~with ~~the~~increased ~~number~~discussion ofaround ~~Almost~~this ~~Pumpers~~topic toduring ~~grow in~~recent ~~the~~national ~~coming~~diabetes ~~years~~conferences, ~~and~~as bewell ~~more~~as ~~reachable~~an ~~with~~increase ~~appropriate~~in marketing ~~strategies~~ promotion.

~~Our~~All these ~~Insulin~~recent ~~Pump~~changes support the high proportion of T1D and T2D intensively treated with insulin that we consider to be Almost Pumpers, and we expect the number of Almost Pumpers to grow in the coming years and be more reachable with appropriate marketing strategies.

~~Instead of building complex, bespoke, and difficult to manufacture~~Our ~~and~~Insulin maintain pumping and control systems, we began with the technology and the user in mind. Using proprietary methods of insulin measurement, we were able to eschew complex mechanisms and instead built a product, our MODD1, using only parts from high volume consumer electronics manufacturing lines, breaking the cost vs functionality curve that has existed in the insulin pump space and representing the first truly modern insulin pump design. We consider this to be a new kind of product for a new kind of patient.Pump

InInstead of ~~September~~building ~~2024~~complex, webespoke, ~~received~~and ~~clearance~~difficult ~~from the FDA~~ to ~~market~~manufacture and ~~sell~~maintain ~~our~~pumping ~~MODD1~~and ~~product~~control insystems, ~~the~~we ~~United~~began ~~States.~~with Wethe ~~plan~~technology toand the ~~launch~~user ~~this pump~~ in amind. ~~single~~Using ~~region~~proprietary ~~during~~methods ~~the~~of ~~quarter~~insulin ~~ending September 30~~measurement, ~~2025.~~we Wewere ~~expect~~able to ~~submit~~eschew ~~our~~complex ~~successor~~mechanisms ~~product,~~and ~~our~~instead ~~Pivot~~built ~~pump, which is~~ a ~~tubeless pump~~ product, ~~for clearance by October~~ ~~31, 2025. A good part of~~ our ~~focus~~MODD1, ~~has~~using ~~shifted~~only toparts ~~managing~~from ~~the~~high ~~process~~volume ofconsumer ~~preparing~~electronics ~~to move our initial production line to our~~ manufacturing ~~partner,~~ ~~Phillips Medisize~~lines, abreaking ~~Molex~~the ~~company,~~cost avs ~~large~~functionality ~~tier-one~~curve ~~medical~~that has ~~device~~existed ~~manufacturer,~~in ~~which~~the ~~will~~insulin ~~manage~~pump space and ~~operate~~representing ~~our~~the ~~production to~~first ~~produce~~truly ~~products~~modern ~~for~~insulin ~~human~~pump ~~use~~design. We ~~believe~~consider ~~that~~this ~~Phillips~~to ~~Medisize will~~ be ~~able~~a tonew ~~rapidly scale our production to higher volumes at~~kind ~~lower~~of ~~cost.~~product Wefor ~~continue~~a tonew ~~devote~~kind ~~substantial time and resources, including exhibiting at major diabetes conferences, to better understand the needs and preferences~~ of ~~Almost Pumpers and the specific~~ patient~~/provider/payor requirements to motivate change from MDI therapy~~. ~~By making the bolus delivery at meals simple, we believe we will drive improved health outcomes.~~

5In September 2024, we received clearance from the FDA to market and sell our MODD1 product in the United States, and, in August 2025, we demonstrated the first human use of our MODD1 pump delivering insulin to a human patient. We announced our next-generation patch pump, branded as Pivot, in August 2025, and we began converting our cartridge manufacturing line to Pivot production. Our Pivot product is a tubeless insulin delivery system that integrates the set into a true tubeless patch. The Pivot is expected to provide us with cost and usability improvements and improved manufacturability, allowing our marketing to be focused on low cost, ease of use and learnability. In April 2026, we received FDA clearance to market and sell our Pivot pump in the United States. We do not intend to commercialize our MODD1 product. In June 2026, we announced commercial availability of, and commenced initial shipments of, our Pivot insulin delivery system in the United States, and we intend to expand commercial activities across metropolitan markets by late 2026.

~~Our~~We have ~~Pivot~~established ~~product~~our ~~has~~initial ~~several~~production ~~distinguishing~~line ~~features:~~with our manufacturing partner, Phillips Medisize, a Molex company, a large tier-one medical device manufacturer, which will manage and operate our production for human use. We believe that Phillips Medisize will be able to rapidly scale our production to higher volumes at lower cost. We continue to devote substantial time and resources, including exhibiting at major diabetes conferences, to better understand the needs and preferences of Almost Pumpers and the specific patient/provider/payor requirements to motivate change from MDI therapy. By making the bolus delivery at meals simple, we believe we will drive improved health outcomes.

(1) The pump has a simple button to press to deliver insulin as the patient requires it. The electronic pump uses a simple motor for rotating a cam to motivate the insulin into the patient along with low power Bluetooth and near-field communication (NFC) chips to optionally allow the patient to communicate with a smart phone, tablet, or other mobile computing device.6

~~(2)~~Our Pivot ~~The~~product ~~pump~~has ~~snaps~~several ~~together~~distinguishing ~~with a three-day disposable cartridge, which the patient fills with insulin for delivery. It includes a simple coin cell, which allows it to run through the 80-hour life of the cartridge.~~features:

(31) The ~~infusion~~pump ~~set~~has isa ~~built~~simple ~~into~~button ~~the~~to ~~adhesive~~press ~~pad~~to ~~that~~deliver insulin as the patient requires it. The electronic pump ~~attaches~~uses toa ~~and~~simple ~~the~~motor ~~needle~~for ~~can~~rotating bea ~~safely~~cam ~~removed~~to ~~and~~motivate ~~discarded~~the byinsulin into the ~~user~~patient ~~after~~along ~~application.~~with ~~Despite~~low ~~this~~power ~~true~~Bluetooth ~~patch~~and ~~form~~near-field ~~factor,~~communication ~~the~~(NFC) ~~pump~~chips isto ~~removable~~optionally byallow the ~~user~~patient ~~during~~to ~~the~~communicate ~~three~~with ~~days~~a ofsmart ~~wear~~phone, tablet, or other mobile computing device.

(2) The ~~system~~pump ~~will~~snaps ~~deliver~~together awith ~~small continuous rate called~~ a ~~basal~~three-day ~~that will~~disposable ~~provide approximately 50% of the total daily dose required~~cartridge, ~~and~~which the ~~user~~patient ~~will~~fills ~~use~~with ~~the~~insulin ~~on-pump~~for ~~button to administer boluses, typically before and after meals~~delivery. ~~The~~It ~~objective~~includes isa ~~to make the product~~ simple tocoin ~~acquire and take home~~cell, ~~simple~~which toallows ~~learn~~it ~~and most importantly, simple~~ to ~~use~~run ~~and~~through ~~live~~the ~~with,~~80-hour tolife ~~expand~~of the ~~pump market, drive adoption and, ultimately, improve clinical outcomes~~cartridge.

~~Technological~~(3) ~~Advantages~~The infusion set is built into the adhesive pad that the pump attaches to and the needle can be safely removed and discarded by the user after application. Despite this true patch form factor, the pump is removable by the user during the three days of wear.

The system ~~adoption of new ultra-high volume technologies~~ will ~~result~~deliver ina ~~far easier~~small ~~manufacturing~~continuous ~~scale~~rate ~~up,~~called asa ~~parts~~basal ~~sourcing~~that ~~and~~will ~~assembly~~provide ~~processes~~approximately ~~are~~50% ~~far~~of ~~easier. The MODD1 was designed from~~ the ~~beginning~~total ~~for mass~~daily ~~manufacturing~~dose required, and the weuser ~~have~~will ~~partnered~~use ~~with~~the ~~a tier~~on-~~one~~pump ~~medical~~button ~~device~~to ~~manufacturer,~~administer ~~Phillips Medisize~~boluses, totypically ~~establish~~before ~~processes~~ and ~~“lights out”~~after ormeals. ~~near~~The ~~lights~~objective ~~out~~is ~~production~~to ~~assembly~~make ~~lines whereby a minimal number of workers will be required in~~ the ~~production~~product ~~facility.~~simple ~~This~~to ~~advantage~~acquire isand ~~compounded~~take byhome, ~~the~~simple ~~high~~to ~~availability~~learn and ~~already~~most ~~optimized cost reduction in its components. When we achieve production scale~~importantly, wesimple ~~believe~~to ~~this~~use ~~should~~and ~~result~~live ~~in a cost of goods for MODD1~~with, ~~estimated~~to onexpand the ~~competitors’~~pump ~~announced~~market, ~~margins~~drive adoption and, ~~sales~~ultimately, ~~of approximately~~improve ~~50%~~clinical ~~lower than our closest patch pump competitor~~outcomes.

~~The adoption of modern, miniaturized technologies~~Technological has led to numerous other advantages, as well. For example, our MODD1 pump is smaller in overall volume than Insulet’s popular Omnipod product and has a lower profile to the skin. Despite this, the MODD1 holds a full 3 milliliter, or mL, (300 units) of insulin, in line with full sized pumps such as those offered by Tandem and Medtronic, 50% more than the 2mL reservoir in the Omnipod. We believe that this volume advantage over other patch pumps will be significant as 24% of type 1 and over 50% of the rapidly growing type 2 market require more than 2mL of insulin every three days (the expected wear time of patch pumps).Advantages

InThe ~~addition,~~adoption ~~our~~of new ~~pumping~~ultra-high ~~modality~~volume ~~will~~manufacturing ~~provide~~technologies will ~~what~~result wein ~~believe~~far iseasier production scale up, as parts sourcing and assembly processes are far easier. Our pump products have been designed from the ~~most~~beginning ~~even~~for (mass manufacturing, and ~~thus~~we ~~closest~~have partnered with Phillips Medisize to ~~the~~establish ~~function~~processes ofand a“lights ~~healthy~~out” or ~~pancreas)~~near ~~delivery~~lights out production assembly lines whereby a minimal number of ~~basal~~workers ~~insulin~~will be required in the ~~industry~~production facility. WeThis advantage ~~intend~~is tocompounded ~~demonstrate~~by the ~~impact~~high ofavailability ~~our~~and ~~system~~already onoptimized ~~glycemic~~cost ~~control~~reduction in its components. When we achieve production scale, we believe this should result in a ~~clinical~~cost ~~study~~of ~~specifically~~goods ~~focused~~for onour ~~improved~~Pivot ~~adherence~~pump, ~~more bolus~~estimated ~~deliveries~~on ~~per~~the ~~day~~competitors’ announced margins and ~~providing~~sales, ~~the~~of ~~clinicians~~approximately 50% ~~with~~lower ~~clear~~than ~~data~~our onclosest ~~patient~~patch ~~use~~pump competitor.

6The adoption of modern, miniaturized technologies has led to numerous other advantages, as well. For example, our Pivot pump is smaller in overall volume than Insulet’s popular Omnipod product and has a lower profile to the skin. Despite this, our Pivot pump holds a full 3 milliliter, or mL, (300 units) of insulin, in line with full sized pumps such as those offered by Tandem and Medtronic, 50% more than the 2 mL reservoir in the Omnipod. We believe that this volume advantage over other patch pumps will be significant as 24% of type 1 and over 50% of the rapidly growing Type 2 market require more than 2mL of insulin every three days (the expected wear time of patch pumps).

The technology allows the patient to simply add insulin and operate. The battery is included in each cartridge, and the device is operated without a controller. As a result, no charging is required. MODD1 has also been made push-button simple to deliver insulin to appeal to a wider audience of users.7

~~This~~In addition, our new ~~technology~~pumping ~~has~~modality ~~made~~will ~~the~~provide ~~MODD1~~what ~~lighter than~~we ~~existing~~believe ~~offerings.~~is ~~Compared to~~ the ~~Insulet~~most ~~Omnipod,~~even ~~MODD1 weighs 20 grams~~ (~~vs.~~and 26thus ~~grams)~~closest ~~empty~~to ~~and~~the 23function ~~grams~~of ~~(vs.~~a 28healthy ~~grams~~pancreas) ~~fully~~ ~~filled~~delivery ~~(despite~~of ~~carrying~~basal ~~50% more~~ insulin), ~~reductions~~in ofthe ~~23% and 18%, respectively~~industry. ~~Also,~~We ~~unlike~~intend ~~existing~~to ~~patch~~demonstrate ~~pumps,~~ the ~~MODD1~~impact ~~can be~~of ~~removed~~our ~~from~~system ~~the~~on ~~needle~~glycemic ~~and~~control ~~taken off and replaced later if the user desires. This avoids loss of insulin~~ in a ~~pump~~clinical ~~due to accidental~~study ~~dislodging~~specifically offocused ~~the~~on ~~soft~~improved ~~canula~~adherence, anmore ~~issue~~bolus ~~for~~deliveries ~~other~~per ~~patch~~day ~~pumps~~and ~~with~~providing ~~which~~the ~~users~~clinicians ~~have~~with ~~expressed~~clear ~~considerable~~data ~~dissatisfaction~~on patient use.

~~Our approach to the care of diabetes can be further~~The ~~enhanced~~technology byallows ~~leveraging~~ the ~~MODD1~~patient ~~single-pumping chamber technology and reusable pump approach~~ to ~~apply~~simply toadd ~~dual~~insulin ~~(or~~and ~~more) chamber pumping solutions~~operate. WeThe ~~believe~~battery ~~that~~is ~~such~~included ~~multi-chamber pumps will be integral to the realization of high time-~~in~~-range~~ ~~artificial~~each ~~pancreas solutions that require no human intervention because of the application of~~cartridge, ~~for instance, drugs to raise glucose levels coupled with drugs to lower glucose. They will be the next step forward from the cumbersome~~ and ~~awkward solutions today that require~~ the ~~user~~device tois ~~announce meals, count~~operated ~~and~~without ~~input~~a ~~carbohydrates, and adjust delivery for exercise and sleep to prevent overdosing of insulin~~controller. ~~Instead,~~As if a ~~user overdosed insulin~~result, ~~the~~ ~~user~~no ~~would~~charging ~~simply~~is ~~pump~~required. inThe aPivot ~~drug~~pump tohas ~~release~~also ~~sugar~~been ~~stores~~made ~~to raise it up. We believe that a pre~~push-~~filled~~button ~~peel~~simple ~~and~~to ~~stick~~deliver ~~patch~~insulin ~~pump with~~to ~~the~~appeal ~~ability~~ to ~~function in~~ a ~~fully~~wider ~~autonomous~~audience ~~closed loop system with a CGM device, which is measuring and transmitting glucose-level information, represents the next generation~~ of ~~diabetes care~~users. ~~We believe that we have demonstrated our technology and have secured, and will continue securing, intellectual property protection on our approach.~~

WeThis ~~believe~~new ~~this~~ technology, ~~especially~~has ~~applied~~made our Pivot pump lighter than existing offerings. inCompared ato ~~dual~~the ~~chamber~~Insulet ~~capacity~~Omnipod, ~~will~~our ~~open~~Pivot uppump ~~numerous~~weighs ~~applications~~20 ~~outside~~grams of(vs. ~~diabetes~~26 ~~where~~grams) ~~medication~~empty ~~compliance~~and of23 ~~complex~~grams ~~therapy~~(vs. ~~regimes~~28 grams) fully filled (despite iscarrying ~~difficult.~~50% ~~Example~~more ~~applications~~insulin), ~~would~~reductions ~~include~~of ~~weight~~23% ~~loss~~and 18%, ~~fertility~~respectively. Also, unlike existing patch pumps, our Pivot pump can be removed from the needle and ~~simplifying~~taken off and replaced later if the ~~delivery~~user desires. This avoids loss of ~~complex~~insulin ~~multi-drug~~in ~~cocktails,~~a pump due to accidental dislodging ~~especially~~of ~~those~~the soft canula, an issue for other patch pumps with ~~diverse~~which ~~and~~users ~~challenging~~have ~~dosing~~expressed ~~schedules~~considerable dissatisfaction.

Our approach ~~Solution~~to the care of diabetes can be further enhanced by leveraging our single-pumping chamber technology and reusable pump approach to apply to dual (or more) chamber pumping solutions. We believe that such multi-chamber pumps will be integral to the realization of high time-in-range artificial pancreas solutions that require no human intervention because of the application of, for instance, drugs to raise glucose levels coupled with drugs to lower glucose. They will be the next step forward from the cumbersome and awkward solutions today that require the user to announce meals, count and input carbohydrates, and adjust delivery for exercise and sleep to prevent overdosing of insulin. Instead, if a user overdosed insulin, the user would simply pump in a drug to release sugar stores to raise it up. We believe that a pre-filled peel and stick patch pump with the ability to function in a fully autonomous closed loop system with a CGM device, which is measuring and transmitting glucose-level information, represents the next generation of diabetes care. We believe that we have demonstrated our technology and have secured, and will continue securing, intellectual property protection on our approach.

~~Our proposed pump has been designed and developed~~We tobelieve ~~address~~this ~~the aforementioned shortcomings of the existing pump market and to appeal to: (i) the substantial group of Almost-Pumpers~~technology, ~~who~~ ~~may~~especially beapplied ~~interested~~ in ~~using~~a andual ~~insulin~~chamber ~~pump~~capacity, ~~but~~will ~~have~~open ~~not~~up ~~done~~numerous soapplications ~~because~~outside of ~~the~~diabetes ~~complexity, cost or cumbersome nature of existing~~where ~~products~~medication ~~and~~compliance ~~(ii) people who are using one~~ of ~~the~~complex ~~currently~~therapy ~~available~~regimes ~~insulin~~is ~~pumps~~difficult. ~~but~~Example ~~are~~applications ~~dissatisfied~~would ~~with~~include ~~such~~weight ~~products. We believe that~~loss, ~~owing to our new proprietary technology~~fertility, ~~our~~and ~~proposed~~simplifying the ~~insulin~~delivery ~~pump~~of ~~will~~complex bemulti-drug ~~the~~cocktails, ~~simplest~~especially ~~and~~those ~~least~~with ~~expensive~~diverse ~~product on the market~~ and ~~the~~challenging ~~easiest~~dosing ~~for providers to prescribe~~schedules.

Our ~~current pump has been built to test what we~~ believe to be our novel approach to insulin pumps. By providing a pump that we believe will establish industry standards in terms of technology, simplicity to understand, ease of use and price, we believe our MODD 1 pump will offer the vast majority of benefits afforded by more expensive and complex pumps, but it will remain accessible to a substantially greater percentage of diabetes sufferers requiring daily insulin therapy.Solution

WeOur ~~believe~~Pivot ~~people~~pump ~~generally~~has ~~will~~been ~~not~~designed ~~use~~and ~~technology that~~developed ~~intimidates~~to ~~them,~~address ~~especially~~the ~~for~~aforementioned shortcomings aof ~~life-sustaining~~the ~~therapy.~~existing Inpump ~~addition,~~market weand ~~believe~~to ~~that~~appeal ~~physicians~~to: ~~are~~(i) ~~hesitant~~the tosubstantial ~~prescribe~~group ~~such technology~~of ~~due~~Almost-Pumpers, towho ~~the~~may ~~level~~be ofinterested ~~training~~in ~~and~~using an ~~support~~insulin ~~required~~pump, ~~with~~but ~~the~~have ~~present~~not ~~pump~~done ~~product~~so ~~offerings.~~because Itof isthe ~~our~~complexity, ~~belief~~cost ~~that~~or ~~broadly-needed medical~~cumbersome nature of existing products, ~~such~~and as(ii) ispeople ~~intended~~who ~~with~~are using ~~our~~one ~~proposed~~of ~~pump,~~the ~~must~~currently beavailable ~~user-friendly~~insulin ~~and~~pumps ~~affordable.~~but Weare ~~believe~~dissatisfied ~~this~~with ~~approach~~such isproducts. ~~fundamentally different~~We ~~from~~believe that, ~~applied~~owing to ~~the~~our ~~existing~~new ~~pump~~proprietary technology, ~~market~~our ~~today,~~Pivot ~~where~~pump ~~most~~is ~~pumps~~the ~~are~~simplest ~~continuously~~and ~~adding~~least ~~complex~~expensive ~~features~~product ~~appealing~~on ~~to super~~the ~~users~~market and ~~leaving~~ the ~~other~~easiest ~~people~~for ~~with~~providers ~~diabetes~~to ~~further behind~~prescribe.

Our current ~~goal~~pump ishas been built to ~~commercialize~~test ~~our~~what ~~MODD1pump~~we ~~product~~believe ~~and~~to ~~successfully obtain~~be ~~all~~our ~~required~~novel ~~regulatory~~approach ~~approvals~~to ~~for~~insulin ~~our~~pumps. ~~Pivot~~By providing a pump ~~product.~~that ~~Our~~we ~~long-term~~believe ~~goal~~will establish isindustry tostandards ~~become~~in aterms ~~leading~~of ~~provider~~technology, simplicity to understand, ease of ~~insulin~~use and price, we believe our Pivot pump will ~~therapy~~offer bythe ~~focusing~~vast onmajority ~~both~~of ~~consumer~~benefits afforded by more expensive and ~~clinical~~complex ~~needs~~pumps, but it will remain accessible to a substantially greater percentage of diabetes sufferers requiring daily insulin therapy.

7We believe people generally will not use technology that intimidates them, especially for a life-sustaining therapy. In addition, we believe that physicians are hesitant to prescribe such technology due to the level of training and support required with the present pump product offerings. It is our belief that broadly-needed medical products, such as our Pivot pump, must be user-friendly and affordable. We believe this approach is fundamentally different from that applied to the existing pump market today, where most pumps are continuously adding complex features appealing to super users and leaving the other people with diabetes further behind.

ToOur ~~achieve~~current goal is to expand commercialization of our ~~above~~Pivot ~~stated~~pump ~~immediate~~product across metropolitan markets in the United States and ~~current goals,~~obtain weall ~~intend~~required regulatory approvals to ~~pursue~~offer the ~~following~~product ~~business~~for ~~strategies:~~sale in multiple international markets.

●Our long-term ~~Use~~goal is to become a leading provider of ~~innovative~~insulin ~~proprietary~~pump ~~technology~~therapy by focusing on both consumer and clinical needs.

Based on the substantial experience of Paul DiPerna, our President, Chief Financial Officer, Treasurer and Chairman of our board of directors, in engineering design and innovative technology in the medical device industry and, in particular, with the invention, market vision and technical development of insulin pumps, we have generated proprietary technology that has been incorporated into our proposed insulin pump. We believe this technology allowing for a two-part, yet small enough to wear, pump product, along with simplified mechanics for pumping, has greatly assisted us in creating a simpler, user-friendly pump. We believe the completed design, engineering and technology being incorporated into our pump will make it substantially simpler and more affordable than those currently available. These features, together with the safety and reliability of our proposed pump, are designed to create the next generation of insulin pumps that will feature important and well-differentiated attributes compared to those currently available and make it available to consumers across mostly all socioeconomic groups in the United States and around the world.8

●To achieve ~~Use~~our ofabove ~~go-~~stated immediate and current goals, we intend to ~~market~~pursue ~~commercialization~~the ~~technology.~~following business strategies:

We● ~~plan~~Use to commercialize our MODD1 product line using a highly differentiated go-to-market strategy. Generally, current pumps are marketed by a large, direct sales force to end users directly, and the manufacturer provides all training and support, as the current training reimbursement offered by insurance providers is inadequate to motivate clinicians to provide such training to patients. We intend to employ a different strategy and utilize i) distributors to target the daily insulin users who are still managed by a primary care physician and ii) a small direct sales force to directly engage with diabetes educator practices. Specifically, our direct sales force will engage with larger diabetes educator practices, which currently prescribe a high volume of ~~pumps~~innovative ~~and~~proprietary ~~deliver a consultative message focused on those users that indicate a desire to use a pump but have rejected all of the currently available options~~technology. We engaged Seagrove to conduct a survey of physicians and diabetes educators, and the resulting data suggested that approximately 25% of multiple daily injectors could be receptive to our offering. We believe that the modest 30-minute training requirement for our product, combined with the more limited feature set for our MODD1, will incentivize nurse practitioners to identify and train new users who have not been offered pumps before. This would also allow us to offer virtual or second level training support and not require us to be the primary training provider.

WeBased ~~plan~~on tothe ~~launch~~substantial ~~our~~experience ~~MODD1~~of ~~product~~Paul ~~during~~DiPerna, ~~the~~our President, ~~quarter~~Chief ~~ending~~Financial ~~September 30~~Officer, ~~2025~~Treasurer and Chairman of our board of directors, in aengineering ~~single~~design ~~region~~and innovative technology in the ~~United~~medical device ~~States~~industry and, in particular, with athe ~~select~~invention, ~~group~~market vision and technical development of ~~providers~~insulin topumps, ~~gain~~we ~~user~~have ~~experience.~~generated Byproprietary ~~October~~technology ~~31,~~that ~~2025,~~has webeen ~~plan~~incorporated tointo ~~submit~~our aPivot ~~510(k)~~insulin ~~premarket~~pump. ~~notification~~We tobelieve ~~the~~this ~~FDA~~technology allowing for a ~~new~~two-part, ~~and~~yet ~~improved~~small ~~version~~enough to ofwear, ~~the~~pump ~~MODD1~~product, ~~the~~along ~~Pivot, which~~with ~~will~~simplified ~~use~~mechanics ~~our~~for ~~proprietary~~pumping, ~~integrated~~has ~~insulin-delivery~~greatly ~~set~~assisted ~~manufactured~~us byin ~~us.~~creating a simpler, user-friendly pump. We believe the ~~new~~completed ~~integrated~~design, ~~insulin-delivery~~engineering ~~set~~ and technology being incorporated into our pump will ~~offer~~make ~~improved~~it ~~user~~substantially ~~experience,~~simpler ~~while~~and ~~reducing~~more affordable ~~our~~than ~~production~~those ~~costs~~currently available. ~~This~~These ~~new~~features, ~~version~~together with the safety and reliability of our ~~product~~Pivot pump, ~~the~~are ~~Pivot,~~designed isto create the ~~version~~next generation of insulin pumps that we ~~plan~~will tofeature ~~launch~~important ~~nationally~~and inwell-differentiated ~~the~~attributes ~~United~~compared ~~States~~to ~~after~~those wecurrently available ~~receive~~and ~~FDA~~make ~~clearance,~~it ~~which~~available weto ~~expect~~consumers ~~could~~across ~~occur~~mostly ~~sometime~~all socioeconomic groups in the ~~first~~United ~~quarter of~~States ~~2026~~and around the world.

We● ~~have~~Use ~~also begun the process~~ of ~~obtaining Conformite Europeenne, or CE, mark clearance for our Pivot design, which would allow us~~ go-to market ~~and~~commercialization ~~sell in European markets~~technology. We expect to obtain CE mark clearance in the first quarter of 2026. Our initial strategy to address European markets is to partner with distributors to bring the Pivot to market in those countries that accept the CE mark and have acceptable reimbursement. We believe that the combination of our patch pump form factor, lower cost at scale and lower training burden is well suited for European markets where there are very few physicians or nurses available to provide training. This would allow the Pivot to gain rapid adoption in areas where pump penetration is currently much lower than in the United States. We will target other select international markets using the same approach.

We plan ~~believe~~to ~~the~~commercialize ~~combination~~our ofPivot ~~these~~product line using a highly differentiated go-to-market strategy. Generally, current pumps are marketed ~~approaches~~by ~~will~~a ~~enable~~large, usdirect sales force to ~~take~~end ~~reasonable~~users ~~initial~~directly, ~~market~~and ~~share~~the manufacturer provides all training and support, ~~while~~as ~~not~~the ~~incurring~~current training reimbursement offered by insurance providers is inadequate to motivate clinicians to provide such training to patients. We intend to employ a different strategy and utilize i) distributors to target the ~~significant~~daily ~~overhead~~insulin ~~cost~~users who are still managed by a primary care physician and ii) a small direct sales force to directly engage with diabetes educator practices. Specifically, our direct sales force will engage with larger diabetes educator practices, which currently prescribe a high volume of ~~existing~~pumps ~~commercialization~~and deliver a consultative message focused ~~strategies~~on ~~employed~~those byusers that indicate a desire to use a pump but have rejected all of the ~~incumbents~~currently available options. We engaged Seagrove to conduct a survey of physicians and diabetes educators, ~~where~~and ~~competition~~the resulting data suggested that approximately 25% of multiple daily injectors could be receptive to our offering. We believe that the modest 30-minute training requirement for our product, combined with the more limited feature set for our Pivot pump, will incentivize nurse practitioners to identify and train new users iswho ~~intense~~have not been offered pumps before. This would also allow us to offer virtual or second level training support and not require us to be the primary training provider. In addition, in June 2026, we launched PivotPump.com, a patient-focused website designed to support individuals seeking a simpler path to insulin pump therapy. The PivotPump.com website provides accessible, educational content on insulin pump therapy and highlights our focus on real-world usability and supporting patients in evaluating and adopting pump-based diabetes care.

~~Manufacturing~~In June 2026, we announced commercial availability of our Pivot product in the United States and commenced initial patient shipments. We intend to expand commercial activities across metropolitan markets by late 2026.

~~Our~~We ~~pump~~have ~~product~~also ~~comprises~~begun the ~~pump,~~process aof ~~disposable~~obtaining Conformite Europeenne, ~~cartridge~~or ~~that~~CE, ~~holds~~mark ~~the~~clearance ~~insulin~~for ~~reservoir~~our Pivot product, awhich ~~baseplate~~would ~~that~~allow ~~affixes~~us to market and sell in European and certain other international markets. We expect to obtain clearance by the ~~pump~~second ~~product~~quarter of 2027. Our initial strategy to address European markets is to partner with distributors to bring the ~~user’s~~Pivot ~~body~~to ~~and~~market in those countries that accept the ~~infusion~~CE ~~set~~mark and have acceptable reimbursement. During fiscal 2026, ~~which includes~~we hired a ~~cannula~~head toof ~~infuse~~international ~~the~~operations in Switzerland, who has significant experience in launching competitive insulin ~~into~~pump ~~the~~systems ~~body.~~in Europe. We ~~intend~~believe tothat ~~manufacture~~ the combination of our patch pump form factor, ~~the~~lower ~~cartridge~~cost at scale and ~~the~~lower ~~baseplate~~training ~~and~~burden ~~purchase~~is well suited for European ~~the~~markets ~~infusion~~where ~~set~~there ~~from~~are ~~third~~very ~~parties~~few physicians or nurses available to provide training. ~~Prior~~This would allow the Pivot to ~~shipment,~~gain ~~our~~rapid adoption in areas where pump ~~product~~penetration ~~will~~is becurrently ~~packaged~~much ~~with~~lower anthan ~~infusion~~in ~~set~~the United States. InWe ~~connection~~will ~~therewith:~~target other select international markets using the same approach.

● We believe ~~have~~the ~~installed~~combination ~~automation~~of ~~machines~~these indifferentiated ~~our~~approaches ~~facility that~~ will beenable ~~capable~~us ofto ~~assembling~~take ~~the~~reasonable ~~cartridges~~initial atmarket ~~a rate sufficient to supply 6~~share,~~000~~ ~~patients~~while ~~(60,000~~not ~~cartridges~~incurring the ~~per~~significant ~~month),~~overhead ~~and~~cost weof ~~plan~~existing tocommercialization ~~have~~strategies ~~this~~employed ~~capacity~~by ~~moved to~~ the ~~Pivot~~incumbents, ~~product~~where incompetition ~~2026. We also have ordered production molding~~ for ~~more than three times this number of~~ users, sois ~~we can quickly scale up with demand~~intense.

● Product packaging will initially be performed manually by our personnel, while the cartridge automation is being refined. We expect to purchase and implement packaging automation equipment as the second phase of automation of the cartridge.9

We have engaged Phillips Medisize as our manufacturing partner, and we are in the final stages of validating our manufacturing at Phillips Medisize’s facilities. Once the validation is complete, Phillips Medisize will then perform all manufacturing operations to ensure compliance with FDA regulations.Manufacturing

8Our pump product comprises the pump, a disposable cartridge that holds the insulin reservoir, a baseplate that affixes the pump product to the user’s body and the infusion set, which includes a cannula to infuse the insulin into the body. We intend to manufacture the pump, the cartridge and the baseplate and purchase the infusion set from third parties. Prior to shipment, our pump product will be packaged with an infusion set. In connection therewith:

~~FDA~~● ~~Clearance~~We have installed automation machines in our facility that will be capable of assembling the cartridges at a rate sufficient to supply 6,000 patients (60,000 cartridges per month), and we plan to have this capacity moved to the Pivot product in 2026. We also have ordered production molding for more than three times this number of users, so we can quickly scale up with demand.

~~The~~● ~~FDA~~Product ~~requires~~packaging uswill toinitially ~~meet~~be ~~all~~performed ~~applicable~~manually ~~regulations for insulin pumps, a subcategory of infusion pumps, which are generally considered Class II devices~~ by ~~the~~our ~~FDA. In January 2024~~personnel, wewhile ~~submitted a 510(k) premarket notification to~~ the ~~FDA~~cartridge ~~for~~automation ~~our~~is ~~initial~~being ~~insulin~~refined. ~~pump~~We ~~product,~~expect ~~the MODD1, and, in September 2024, we received FDA clearance~~ to ~~market~~purchase and ~~sell~~implement ~~our~~packaging ~~MODD1~~automation ~~pump~~equipment inas the ~~United~~second ~~States.~~phase Weof ~~plan~~automation toof ~~submit our Pivot successor product to~~ the ~~FDA by October 31, 2025, and we expect to receive FDA clearance by March 31, 2026~~cartridge.

~~Commercialization~~Phillips Medisize, ~~Steps~~our manufacturing partner, performs all manufacturing operations to ensure compliance with FDA regulations.

~~To commercialize our product, we must successfully~~FDA ~~complete a number of material steps, including:~~Clearance

●The FDA ~~Continue~~requires us to ~~ensure~~meet itall ~~meets:~~applicable regulations for insulin pumps, a subcategory of infusion pumps, which are generally considered Class II devices by the FDA. As discussed above, we have obtained the required FDA clearance for our MODD1 and Pivot insulin pump products.

~~o FDA requirements for 510(k) clearance, including taking such actions, if any, as may be required by the FDA as a condition to granting approval and providing 510(k) clearance for our insulin pump;~~Commercialization Steps

oTo commercialize ~~the general needs and preferences of~~ our ~~Almost-Pumper~~product, ~~target~~we ~~market~~must ~~based~~successfully oncomplete ~~our~~a ~~knowledge~~number of ~~the~~material ~~diabetes industry~~steps, ~~information gathered from our soft launch and other information available and/or obtained by us from Almost Pumpers and their caregivers; and~~including:

o● ~~the~~Continue general guidelines of third-party payors, private and public insurance companies, preferred provider organizations and other managed care providers with particular focus on the guidelines established by the Center for Medicare and Medicaid Services, or CMS which administers the United States Medicare program, or Medicare. To assist us in making such modifications and refinements, we have retained independent consultants to ~~focus~~ensure onit ~~ensuring that our products and product candidates satisfy the existing coverage and reimbursement criteria of such third-party payors.~~meets:

● ~~Transfer~~FDA ~~our~~requirements ~~manufacturing~~for ~~equipment~~510(k) ~~and~~clearance, ~~process~~including totaking ~~Phillips~~such ~~Medisize~~actions, ~~prior~~if any, as may be required by the FDA as a condition to ~~product~~granting ~~launch;~~approval and providing 510(k) clearance for our insulin pump;

● ~~Hire~~the general needs and ~~retain~~preferences ~~appropriate~~of ~~sales~~our ~~and~~Almost-Pumper ~~marketing~~target ~~personnel~~market tobased ~~develop~~on our knowledge of the diabetes industry, ~~implement~~information ~~and~~gathered from our soft launch aand ~~promotional~~other ~~campaign~~information ~~for~~available ~~our~~and/or ~~insulin~~obtained ~~pump~~by ~~substantially~~us ~~focused~~from onAlmost ~~our~~Pumpers ~~target~~and ~~market.~~their caregivers; and

As● ~~with~~the ~~any~~general ~~medical~~guidelines ~~device~~of ~~attempting~~third-party topayors, ~~enter~~ private and ~~successfully~~public ~~compete~~insurance companies, preferred provider organizations and other managed care providers with ~~existing~~particular ~~products~~focus inon anthe guidelines established by the Center for Medicare and ~~competitive~~Medicaid ~~marketplace~~Services, or CMS which administers the United States Medicare program, or Medicare. To assist us in making such modifications and refinements, we ~~will~~have ~~face~~retained ~~significant~~independent ~~hurdles~~consultants to ~~accomplish~~ focus on ensuring that our products and product candidates satisfy the ~~above~~existing ~~steps~~coverage toand ~~commercialization~~reimbursement ~~including:~~criteria of third-party payors.

● ~~Obtaining~~Transfer ~~FDA~~our ~~510(k)~~manufacturing ~~clearance~~equipment ~~to market~~ and ~~sell~~process ~~our~~to ~~insulin~~Phillips ~~pump~~Medisize prior to ~~the~~product ~~public~~launch; and

● ~~Obtaining~~Hire ~~any~~and ~~other~~retain ~~FDA-required~~appropriate ~~authorizations~~sales ~~with~~and ~~regard~~marketing personnel to ~~our product~~develop, asimplement ~~required~~and bylaunch ~~the~~a ~~Federal~~promotional ~~Food,~~campaign ~~Drug,~~for ~~and~~our ~~Cosmetic~~insulin ~~Act,~~pump orsubstantially ~~FDCA,~~focused ~~which~~on isour ~~administered~~target ~~by the FDA;~~market.

●As with ~~Educating~~any ~~endocrinologists,~~medical ~~physician’s~~device ~~assistants,~~attempting ~~nurse~~to ~~practitioners~~enter and ~~nurse~~successfully ~~educators,~~compete ~~who~~with ~~typically~~existing ~~prescribe~~products ~~pump~~in ~~usage,~~an ~~and~~established ~~certified diabetes educators~~ and ~~dieticians,~~competitive ~~who provide education and guidance to diabetes patients~~marketplace, we aswill toface ~~what~~significant wehurdles ~~believe~~ to beaccomplish the ~~superior~~above ~~qualities~~steps ~~of our products. We expect~~ to ~~continue~~commercialization ~~to exhibit at the Association of Diabetes Care & Education Specialists, or ADCES, conference annually;~~including:

● ~~Demonstrating~~Obtaining any other FDA-required authorizations, in addition to ~~select~~FDA ~~general~~510(K) ~~practitioners~~clearance, ~~who~~with ~~have~~regard ~~historically~~to ~~been~~our ~~skeptical~~product, ofas required by the ~~heightened~~Federal ~~support~~Food, ~~inherent~~Drug, inand ~~insulin~~Cosmetic ~~pumps~~Act, ~~our~~or ~~product’s~~FDCA, ~~ease~~which ofis ~~use~~administered ~~and~~by ~~convenience~~the FDA;

~~● Ensuring that our products do, in fact, meet the needs of Almost Pumpers;~~10

● ~~Overcoming~~Educating ~~the~~endocrinologists, ~~historic~~physician’s ~~obstacles~~assistants, nurse practitioners and ~~reluctance~~nurse ofeducators, ~~Almost~~who ~~Pumpers~~typically prescribe pump usage, and certified diabetes educators and dieticians, who provide education and guidance to ~~using~~diabetes ~~insulin~~patients, ~~pumps~~as to ~~treat~~what ~~their~~we believe to be the superior qualities of our products. We attend and exhibit at multiple diabetes; industry conferences and trade shows;

● ~~Ensuring~~Demonstrating ~~that~~to ~~third-party~~select ~~payors~~general ~~agree~~practitioners, towho ~~cover~~have ~~all~~historically orbeen askeptical ~~substantial portion~~ of the ~~purchase~~heightened ~~price~~support ~~and~~inherent ~~recurring~~in ~~costs~~insulin ofpumps, ~~the~~our ~~use~~product’s ease of ~~our~~use ~~insulin~~and ~~pump products.~~convenience;

~~Looking~~● ~~Forward~~Ensuring that our products do, in fact, meet the needs of Almost Pumpers;

~~Going~~● ~~forward,~~Overcoming wethe ~~expect~~historic toobstacles ~~continue to evolve our MODD1 pump~~ and ~~its capabilities~~reluctance ~~and~~of ~~functionality~~Almost ~~both~~Pumpers ~~in response~~ to ~~patient~~using ~~needs~~insulin ~~and~~pumps asto ~~part~~treat oftheir ~~our~~diabetes; ~~current platform roadmap.~~and

● ~~With~~Ensuring ~~future~~that ~~Pivot products, we intend to seek to add phone~~third-~~based~~party ~~control~~payors ~~and~~agree ~~Alternative Controller Enabled (“ACE”) and Automated Insulin Deliver (“AID”) capability~~ to ~~allow~~cover ~~integration~~all ~~with~~or ~~popular~~a ~~continuous~~substantial ~~glucose~~portion ~~monitors.~~of ~~We believe this will expand our available market to include many existing pumpers. The new model has~~ the ~~same~~purchase ~~modular~~price ~~design~~ and ~~low-cost~~recurring ~~components~~costs asof ~~MODD1 and provides a much desired breakthrough for patients - two-factor command authentication that allows~~ the ~~wearer to~~ use anof ~~application~~our oninsulin ~~his/her~~pump ~~cell phone as the controller~~products.

~~● AID-control functionality is being developed and will be added via an ACE designation on the pump.~~Looking Forward

9Going forward, we expect to continue to evolve our Pivot pump and its capabilities and functionality both in response to patient needs and as part of our current platform roadmap.

● ~~Any~~With ~~approved~~future ~~AID~~Pivot ~~controller~~products, ~~can~~we ~~drive~~intend ~~insulin~~to ~~delivery~~seek into add phone-based control and Alternative Controller Enabled (“~~auto~~ACE”) ~~mode,~~and ~~when~~Automated ~~appropriate~~Insulin Deliver (“AID”) capability to allow integration with popular continuous glucose monitors. We believe this will expand our available market to include many existing pumpers. The new model has the same modular design and low-cost components as MODD1 and provides a much desired breakthrough for patients — two-factor command authentication that allows the wearer to use an application on his/her cell phone as the controller.

● ~~CGM~~AID-control ~~integration~~functionality ~~allows~~is ~~the~~being ~~controller~~developed toand ~~potentially~~will ~~adjust~~be ~~basal~~added ~~insulin~~via ~~rate~~an ~~for~~ACE ~~meals~~designation ~~and~~on ~~exercise~~the ~~with an approved algorithm~~pump.

● ~~With~~Any ~~our~~approved ~~future~~AID ~~Pivot~~controller ~~product,~~can wedrive ~~will seek to move to a full-featured, multi-chamber pump optimized for high time-in-range fully autonomous close loop~~ insulin delivery ~~utilizing~~in ~~the form factor and cost advantages of its pumping designs to create an affordable, easy to use drug delivery system to realize the aspiration of true~~ “~~artificial pancreas~~auto” ~~systems. We envision moving to a drug prefill model~~mode, ~~such~~when ~~that cartridges can be filled with insulin or other drugs and shipped cold chain to patients, further simplifying the use process~~appropriate.

~~Competition~~● CGM integration allows the controller to potentially adjust basal insulin rate for meals and exercise with an approved algorithm.

~~Today~~● With our future Pivot product, we will seek to move to a full-featured, multi-chamber pump optimized for high time-in-range fully autonomous close loop insulin delivery utilizing the ~~United~~form ~~States~~factor and cost advantages of its pumping designs to create an affordable, ~~only~~easy ~~three~~to ~~companies are~~use ~~commercializing~~drug ~~insulin~~delivery ~~pumps~~system to ~~T1D~~realize ~~patients~~the ~~and~~aspiration of true “artificial pancreas” systems. We envision moving to a drug prefill model, such that cartridges can be filled with insulin ~~treated~~or ~~T2D~~other ~~patients~~drugs and ~~have~~shipped ~~significant~~cold ~~market~~chain ~~share:~~to patients, further simplifying the use process.

~~● Medtronic - commercializes the durable Minimed 770G and also offers older durable pumps (670G, 630G etc.). In 2020, they held approximately 51% of the US insulin pump market.~~Competition

●Today, ~~Tandem~~in ~~- commercializes~~ the ~~durable~~United ~~t:slim~~States, X2five ~~pump~~companies ~~(with~~are orcommercializing ~~without~~insulin pumps ~~algorithms~~to -T1D ~~Basal-IQ~~patients and ~~Control-IQ).~~insulin Intreated ~~2020,~~T2D ~~they~~patients ~~held~~and ~~approximately~~only ~~28%~~three ofhave ~~the~~significant ~~US insulin pump~~ market. share:

● Insulet -— commercializes ~~the~~a disposable ~~Omnipod~~ patch pump, ~~with~~which held approximately 1943% of the US market in ~~2020~~2026.

Medtronic pump and infusion set Tandem pump and infusion set

	●	Tandem — commercializes a durable pump available with or without automated dosing algorithms. In 2026, they held approximately 34% of the US insulin pump market.

	●	Minimed — commercializes a durable insulin delivery pump and continues to offer a range of older durable pumps. In 2026, they held approximately 21% of the US insulin pump market.

These three insulin pump offerings are vying for the attention of the most motivated and well insured in hope of converting them away from their reliance on MDI. We believe the t:slim X2 and Minimed 770G pump products each receive in excess of $4,000 through durable medical equipment (DME) and daily consumable insurance coverage reimbursements. Daily consumable reimbursement would also cover on an ongoing basis cartridge, tubing and sets for each three-day period, as well. These products have controllers integrated into the pump, making them cumbersome and bulky, along with long (greater than 20 inch) tubing between the pump and the cannular site. The Omnipod is the third offering; a patch pump that attaches to your body for 72 hours and uses a separate controller to manage the insulin delivery process. Insurance coverage for Omnipod can be provided via DME but also via Pharmacy Benefit (PB). The Omnipod patch pump is more expensive per day and less accurate than other insulin pumps, according to a Mende 2022 study. Around 33% of people living with T1D are currently using insulin pumps; of these, the vast majority are using one of these three offerings, a statistic that has not changed significantly over the last five years.11

~~All~~These ofthree ~~these~~insulin pump ~~products~~offerings ~~require~~are ~~extensive~~vying ~~training~~for tothe ~~initiate~~attention of the most motivated and well insured in hope of converting them away from their reliance on MDI. We believe the each of the two toleading ~~four~~durable ~~hours~~pump ~~per~~products ~~day~~receive toin ~~use~~excess of $4,000 through durable medical equipment (DME) and ~~manage~~daily consumable insurance coverage reimbursements. Daily consumable reimbursement would also cover on an ongoing basis cartridge, tubing and sets for each three-day period, as well. WeThese ~~believe~~products ~~this~~have ~~level~~controllers integrated into the pump, making them cumbersome and bulky, along with long (greater than 20 inch) tubing between the pump and the cannular site. The third offering is a patch pump that attaches to the body for 72 hours and uses a separate controller to manage the insulin delivery process. Insurance coverage for patch pumps of ~~sophistication~~this type can be provided via DME but is primarily provided through the Pharmacy Benefit (PB). These patch pumps can be more expensive per day and ~~effort~~less ~~combined~~accurate than other insulin pumps, according to a Mende 2022 study. Around 38% of people living with T1D are currently using insulin pumps; of these, the ~~cost~~vast ~~and~~majority ~~awkwardness~~are using one of these ~~products~~three ~~contribute~~offerings, toa statistic that has not changed significantly over the ~~limited~~last ~~uptake~~five years.

~~Although~~All ~~there are purely mechanical pumps available to patients with a small percentage~~ of ~~T2D~~these ~~patients using the Mannkind V-Go patch~~ pump, aproducts ~~fixed~~require ~~basal~~extensive ~~rate and a button to deliver small~~training ~~boluses. This pump is simple~~ to ~~use,~~initiate ~~though~~and ~~gives~~two ~~little performance decision~~ to ~~the~~four ~~user~~hours ~~(e.g.,~~per noday ~~possibility~~ to ~~change~~use ~~the~~and ~~basal~~manage ~~rate, no~~on ~~possibility~~an toongoing ~~stop bolus doses, small reservoir, pump that needs to be changed every day, etc~~basis.). ~~The~~We ~~last~~believe ~~available~~this ~~patch~~level ~~pump~~of ~~is provided~~sophistication by Cequr, called Simplicity, a bolus only delivery option without basal delivery or any electronic reporting. Cequr recently disclosed it has slightly more than 6,000 users. Beta Bionics, Inc. launched its I-Let pump in October 2023 and ~~reported~~effort ~~approximately~~combined ~~15,000~~with ~~users at~~ the ~~end~~cost ~~of 2024. Deka Research~~ and ~~Development~~awkwardness ~~Corp.~~of ~~received~~these ~~clearance~~products ~~for~~contribute ~~its Sequel Twist pump in July of 2023, but,~~ to ~~our~~the ~~knowledge,~~limited ~~has not yet made its product available for sale~~uptake.

10There are purely mechanical pumps available to patients, and a modest percentage of T2D patients use Mannkind’s mechanical patch pump, which provides a fixed basal rate and a button to deliver small boluses. This pump is simple to use, though gives little performance decision to the user (e.g., no possibility to change the basal rate, no possibility to stop bolus doses, small reservoir, pump that needs to be changed every day, etc.). Lastly, Cequr offers another patch pump, providing a bolus only delivery option without basal delivery or any electronic reporting. Cequr recently disclosed it has slightly more than 15,000 users. Beta Bionics, Inc. launched its durable pump in October 2023 and reported approximately 35,000 users at the end of 2025. Deka Research and Development Corp. (Deka) received clearance for its durable pump in July of 2023. Deka has launched broadly with a large sales force in the United States, but it has not yet publicly disclosed the number of users.

~~Medtronic~~Minimed’s ~~has~~flagship ~~launched~~durable ~~a new version of its insulin~~ pump, ~~the~~is ~~Minimed 780G, already~~ available in some European countries with an advanced algorithm, but nothere has not been an obvious change in hardware. Tandem is now selling a small, no display pump ~~called~~with ~~Mobi. The Mobi has~~ a small 2mL reservoir ~~and~~that is controlled by a separate unit, similar in concept to ~~the~~existing ~~current~~patch ~~Omnipod~~pump ~~product~~controllers. Insulet has also launched ~~the~~a ~~Omnipod~~new 5,version aof ~~similar~~its patch pump ~~to its current offering,~~ that includes an AID algorithm and improved low-power Bluetooth.

Approximately 79% of the people who rely upon MDI therapy choose to not administer a shot outside of their house, which creates a poorly controlled group. Our pump products are designed to focus upon a segment of these people and mobilize them via a simple, easy to use, affordable product.

~~Intellectual Property~~12

~~Our success depends in part on our ability to~~Intellectual obtain patents and trademarks, maintain trade secret and know-how protection, enforce our proprietary rights against infringers, and operate without infringing on the proprietary rights of third parties. Because of the length of time and expense associated with developing new products and bringing them through the regulatory approval process, the health care industry places considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies, products, processes, know-how, and methods.Property

~~As of March 31, 2025, we held five U.S. utility~~Our ~~and~~success ~~two~~depends ~~foreign patents, and we also held 20 pending applications~~ in ~~the~~part ~~United~~on ~~States~~our ~~and~~ability ~~abroad.~~to ~~The~~obtain patents and ~~patent~~trademarks, ~~applications cover~~maintain ~~various~~trade ~~aspects~~secret ofand ~~our~~know-how ~~technology~~protection, ~~including~~enforce our proprietary rights ~~fluid~~against ~~movement~~infringers, ~~technology~~ and ~~associated~~operate ~~features~~without ofinfringing ~~our~~on ~~insulin~~the ~~delivery methodology.~~proprietary ~~There~~rights ~~can~~of bethird noparties. ~~assurance~~Because ~~that~~of the ~~pending~~length ~~patent applications will result in the issuance~~ of ~~patents,~~time ~~that patents issued~~and toexpense orassociated ~~licensed~~with bydeveloping usnew ~~will~~products ~~not~~and bebringing ~~challenged~~them orthrough ~~circumvented~~the byregulatory ~~competitors~~approval process, orthe ~~that~~health ~~these~~care ~~patents~~industry ~~will~~places considerable beemphasis ~~found~~on toobtaining bepatent ~~valid~~protection orand ~~sufficiently broad~~maintaining totrade ~~protect~~secret ~~our~~protection ~~technology~~for ornew ~~provide~~technologies, usproducts, ~~with~~processes, know-how, aand ~~competitive advantage~~methods.

~~Government~~As ~~Regulation~~of June 29, 2026, we held eight U.S. utility and six foreign patents, and we have numerous applications pending and in various stages of review by the USPTO and foreign patent agencies. The patents and patent applications cover various aspects of our technology, including our proprietary fluid movement technology and associated features of our insulin delivery methodology. There can be no assurance that the pending patent applications will result in the issuance of patents, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that these patents will be found to be valid or sufficiently broad to protect our technology or provide us with a competitive advantage.

~~Our operations are subject to comprehensive federal,~~Government state, and local laws and regulations in the jurisdictions in which we or our research and development partners do business. The laws and regulations governing our business and interpretations of those laws and regulations and are subject to frequent change. Our ability to operate profitably will depend in part upon our ability, and that of our research and development partners and affiliates, to operate in compliance with applicable laws and regulations. The laws and regulations relating to medical products and healthcare services that apply to our business and that of our partners and affiliates continue to evolve, and we must, therefore, devote significant resources to monitoring developments in legislation, enforcement, and regulation in such areas. As the applicable laws and regulations change, we are likely to make conforming modifications in our business processes from time to time. We cannot provide assurance that a review of our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations or that the regulatory environment will not change in a way that restricts our operations.Regulation

~~FDA~~Our operations ~~Regulation~~are subject to comprehensive federal, state, and local laws and regulations in the jurisdictions in which we or our research and development partners do business. The laws and regulations governing our business and interpretations of those laws and regulations and are subject to frequent change. Our ability to operate profitably will depend in part upon our ability, and that of our research and development partners and affiliates, to operate in compliance with applicable laws and regulations. The laws and regulations relating to medical products and healthcare services that apply to our business and that of our partners and affiliates continue to evolve, and we must, therefore, devote significant resources to monitoring developments in legislation, enforcement, and regulation in such areas. As the applicable laws and regulations change, we are likely to make conforming modifications in our business processes from time to time. We cannot provide assurance that a review of our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations or that the regulatory environment will not change in a way that restricts our operations.

~~In the United States, medical devices are strictly regulated by the~~ FDA~~. Under the FDCA, a medical device is defined as “an instrument, apparatus, implement, machine, contrivance,~~ implant, in vitro reagent, or other similar or related article, including a component, part or accessory which is, among other things: intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of a medical product is achieved through chemical action or by being metabolized by the body, the product is usually a drug or biologic. If not, it is generally a medical device.Regulation

WeIn the ~~have~~United ~~developed~~States, anmedical ~~insulin~~devices ~~pump~~are ~~delivery~~strictly ~~system, which is~~ regulated by the FDA. asUnder the FDCA, a medical device ~~under~~is ~~the~~defined ~~FDCA~~as “an instrument, apparatus, asimplement, ~~implemented~~machine, ~~and~~contrivance, ~~enforced~~implant, byin ~~the~~vitro ~~FDA.~~reagent, ~~The~~or ~~FDA~~other ~~regulates~~similar ~~the~~or ~~development, testing,~~related ~~manufacturing~~article, ~~labeling,~~including ~~packaging,~~a ~~storage~~component, ~~installation,~~part or ~~servicing,~~accessory ~~advertising~~which is, ~~promotion~~among other things: intended for use in the diagnosis of disease or other conditions, ~~marketing~~or in the cure, ~~distribution~~mitigation, treatment, ~~import~~or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man ~~export~~or other animals, and ~~market~~which ~~surveillance~~does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” This definition provides a clear distinction between a medical ~~devices~~device and other FDA regulated products such as drugs. If the primary intended use of a medical product is achieved through chemical action or by being metabolized by the body, the product is usually a drug or biologic. If not, it is generally a medical device.

11We have developed an insulin pump delivery system, which is regulated by the FDA as a medical device under the FDCA, as implemented and enforced by the FDA. The FDA regulates the development, testing, manufacturing, labeling, packaging, storage, installation, servicing, advertising, promotion, marketing, distribution, import, export, and market surveillance of medical devices.

Device Premarket Regulatory Requirements

Before being introduced into the U.S. market, each medical device must obtain marketing clearance or approval from the FDA through the premarket notification (or 510(k)) process, the de novo classification process, or the premarket approval, or PMA, process, unless they are determined to be Class I devices or to otherwise qualify for an exemption from one of these available forms of premarket review and authorization by the FDA. Under the FDCA, medical devices are classified into one of three classes - — Class I, Class II or Class III -— depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurance of safety and effectiveness. Classification of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA review required prior to marketing the device. Class I devices are those for which reasonable assurance of safety and effectiveness can be maintained through adherence to general controls which include compliance with the applicable portions of the FDA’s Quality System Regulation (the “QSR”), as well as regulations requiring facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials. The Class I designation also applies to devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable ~~assurance~~ assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but that are not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and that do not present a potential, unreasonable risk of illness or injury.

Class II devices are those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish “special controls.” These special controls can include performance standards, post-market surveillance requirements, patient registries and FDA guidance documents describing device-specific special controls. While most Class I devices are exempt from the premarket notification requirement, most Class II devices require a premarket notification prior to commercialization in the United States; however, the FDA has the authority to exempt Class II devices from the premarket notification requirement under certain circumstances. As a result, manufacturers of most Class II devices must submit premarket notifications to the FDA under Section 510(k) of the FDCA (21 U.S.C. § 360(k)) in order to obtain the necessary clearance to market or commercially distribute such devices. To obtain 510(k) clearance, manufacturers must submit to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate device” that is already on the market. A predicate device is a legally marketed device that is not subject to PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976 (“pre-amendments device”) and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class II or I or (iii) a device that was found substantially equivalent through the 510(k) process. If the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant in a premarket notification submission, the agency will grant 510(k) clearance for the new device, permitting the applicant to commercialize the device. Premarket notifications are subject to user fees, unless a specific exemption applies.13

IfClass II ~~there~~devices isare nothose ~~adequate~~for ~~predicate~~which general controls alone are insufficient to ~~which~~provide areasonable ~~manufacturer~~assurance of safety and effectiveness and there is sufficient information to establish “special controls.” These special controls can ~~compare~~include ~~its~~performance ~~proposed~~standards, post-market surveillance requirements, patient registries and FDA guidance documents describing device-specific special controls. While most Class I devices are exempt from the premarket notification requirement, most Class II devices require a premarket notification prior to commercialization in the ~~proposed~~United ~~device~~States; ishowever, ~~automatically~~the ~~classified~~FDA ashas the authority to exempt Class II devices from the premarket notification requirement under certain circumstances. As a result, manufacturers of most Class ~~III~~II ~~device~~devices must submit premarket notifications to the FDA under Section 510(k) of the FDCA (21 U.S.C. In§ 360(k)) in order to obtain the necessary clearance to market or commercially distribute such ~~cases~~devices. To obtain 510(k) clearance, manufacturers must submit to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate device” ~~manufacturer must~~that ~~then~~is ~~fulfill~~already on the ~~more~~market. ~~rigorous~~A predicate device is a legally marketed device that is not subject to PMA, ~~requirements~~meaning, (i) a device that was legally marketed prior to May 28, 1976 (“pre-amendments device”) and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class II or ~~can~~I ~~request~~or (iii) a ~~risk-based~~device ~~classification~~that ~~determination~~was ~~for~~found ~~its~~substantially equivalent through the 510(k) process. If the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant in ~~accordance~~a premarket notification submission, the agency will grant 510(k) clearance for ~~with~~the new device, permitting the deapplicant ~~novo~~to ~~classification~~commercialize ~~process~~the device. Premarket notifications are subject to user fees, unless a specific exemption applies.

~~Devices that are intended to be life sustaining~~If orthere ~~life~~is ~~supporting,~~no ~~devices~~adequate ~~that~~predicate ~~are~~to ~~implantable,~~which ~~devices that present~~ a ~~potential~~manufacturer ~~unreasonable~~can ~~risk~~compare ofits ~~harm~~proposed ~~or are of substantial importance in preventing impairment of health~~device, ~~and~~the ~~devices~~proposed ~~that are not substantially equivalent to a predicate~~ device ~~and~~is ~~for~~automatically ~~which safety and effectiveness~~classified ~~cannot~~as bea ~~assured solely by the general controls and special controls are placed in~~ Class III device. ~~Such~~In ~~devices~~such ~~generally require FDA approval through the PMA process~~cases, ~~unless the device is~~ a ~~pre-amendments~~ device ~~not yet subject to a regulation requiring premarket approval. The PMA process is more demanding than the 510(k) process. For a PMA, the~~ manufacturer must ~~demonstrate~~then ~~through~~fulfill ~~extensive~~the ~~data, including data from preclinical studies and one or~~ more ~~clinical~~rigorous ~~trials, that the device is safe and effective for its proposed indication. The~~ PMA ~~must~~requirements ~~also~~or ~~contain~~can arequest ~~full description of the device and its components,~~ a ~~full description of the methods, facilities and controls~~risk-based ~~used~~classification ~~for~~determination manufacturing, and proposed labeling. Following receipt of a PMA submission, the FDA determines whether the application is sufficiently complete to permit a substantive review. If the FDA accepts the application for ~~review, it has 180 days under the FDCA to complete~~ its ~~review~~ ~~and determine whether the proposed~~ device ~~can be approved for commercialization, although~~ in ~~practice,~~accordance ~~PMA~~with ~~reviews often take significantly longer, and it can take up to several years for~~ the ~~FDA~~de tonovo ~~issue~~classification ~~a final decision~~process. ~~Before approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance with the QSR.~~

~~The de~~Devices that ~~novo classification~~are ~~process allows~~intended to be life sustaining or life supporting, devices that are implantable, devices that present a ~~manufacturer~~potential ~~whose~~unreasonable risk ~~novel~~of harm or are of substantial importance in preventing impairment of health, and devices that are not substantially equivalent to a predicate device isand ~~automatically~~for ~~classified~~which ~~into~~safety and effectiveness cannot be assured solely by the general controls and special controls are placed in Class III. toSuch ~~request~~devices ~~down-classification~~generally ofrequire ~~its~~FDA approval through the PMA process, unless the device is a pre-amendments device not yet subject to ~~Class~~a regulation requiring premarket approval. The PMA process is more demanding than the 510(k) process. For a PMA, the manufacturer Imust ordemonstrate ~~Class~~through IIextensive data, onincluding ~~the~~data ~~basis~~from preclinical studies and one or more clinical trials, that the device ~~presents~~is safe ~~low~~and oreffective ~~moderate~~for ~~risk,~~its asproposed anindication. ~~alternative~~The toPMA ~~following~~must ~~the~~also ~~typical~~contain ~~Class~~a ~~III~~full description of the device and its components, a full ~~pathway~~description ~~requiring~~of the ~~submission~~methods, facilities and ~~approval~~controls used for manufacturing, and proposed labeling. Following receipt of a PMA submission, the FDA determines whether the application is sufficiently complete to permit a substantive review. ~~The~~If the FDA accepts the application for review, it has ~~confirmed~~180 ~~our~~days ~~MODD1~~under ~~product~~the ~~qualifies~~FDCA asto acomplete ~~510(k)~~its ~~eligible~~ review and determine whether the proposed device can be approved for commercialization, although in practice, PMA reviews often take significantly longer, and ~~does~~it ~~not~~can ~~require~~take up to several years for the FDA to issue a definal ~~novo~~decision. Before ~~classification~~approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance with the QSR.

~~Clinical trials are almost always required to~~The ~~support PMAs and are sometimes required to support 510(k) and~~ de novo classification ~~submissions.~~process Inallows ~~our~~a ~~case,~~manufacturer ~~usability studies~~whose ofnovel ~~our~~device ~~intended~~is ~~users~~automatically ~~are~~classified ~~required~~into ~~and~~Class ~~have~~III ~~been completed. All clinical investigations of devices~~ to ~~determine safety and effectiveness~~request ~~must~~down-classification beof ~~conducted~~its indevice ~~accordance~~to ~~with~~Class ~~the~~I ~~FDA’s~~or ~~investigational~~Class ~~device exemption~~II, oron ~~IDE,~~the ~~regulations~~basis that govern investigational device labeling, prohibit promotion of investigational devices, and specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents alow ~~“significant~~or moderate risk,” as ~~defined~~an ~~by the FDA, the agency requires~~alternative ~~the study sponsor~~ to ~~submit~~following ~~an IDE application to~~ the ~~FDA,~~typical ~~which~~Class ~~must~~III ~~become~~device ~~effective~~pathway ~~prior~~requiring ~~to commencing human clinical trials. The IDE will automatically become effective 30 days after receipt by~~ the ~~FDA,~~submission ~~unless the FDA denies the application or notifies the sponsor that the investigation is on hold~~ and ~~may~~approval not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of ~~the study, the FDA may permit~~ a ~~clinical~~PMA ~~trial to proceed under a conditional approval~~application. The FDA ~~may~~has ~~also~~confirmed ~~notify the sponsor that the~~our ~~study~~MODD1 isproduct ~~approved~~qualifies as ~~proposed~~a or510(k) ~~approved~~eligible ~~with~~device ~~specific requested modification. Furthermore, the agency may withdraw approval of an IDE under certain circumstances. In addition, the study must be approved by,~~ and ~~conducted~~does ~~under~~not ~~the~~require ~~oversight of, an institutional review board, or IRB, for each clinical site. If the device presents~~ a ~~non-significant~~de ~~risk~~novo to the patient according to criteria established by the FDA as part of the IDE regulations, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate authorization from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirementsclassification.

12Clinical trials are almost always required to support PMAs and are sometimes required to support 510(k) and de novo classification submissions. In our case, usability studies of our intended users are required and have been completed. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations that govern investigational device labeling, prohibit promotion of investigational devices, and specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk,” as defined by the FDA, the agency requires the study sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the sponsor that the investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may permit a clinical trial to proceed under a conditional approval. The FDA may also notify the sponsor that the study is approved as proposed or approved with specific requested modification. Furthermore, the agency may withdraw approval of an IDE under certain circumstances. In addition, the study must be approved by, and conducted under the oversight of, an institutional review board, or IRB, for each clinical site. If the device presents a non-significant risk to the patient according to criteria established by the FDA as part of the IDE regulations, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate authorization from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

~~Post-Marketing Restrictions and Enforcement~~14

~~After a device is placed on the market, numerous~~Post-Marketing ~~regulatory~~Restrictions ~~requirements~~and ~~apply. These include, but are not limited to:~~Enforcement

●After a ~~submitting~~device ~~and~~is ~~updating~~placed ~~establishment~~on ~~registration~~the ~~and~~market, ~~device~~numerous ~~listings~~regulatory ~~with~~requirements ~~the~~apply. ~~FDA;~~These include, but are not limited to:

● ~~compliance~~submitting ~~with the QSR, which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint~~ and ~~related~~updating ~~investigation~~establishment ~~files,~~registration and ~~other~~device ~~quality~~listings ~~assurance~~with ~~controls during~~ the ~~manufacturing process~~FDA;

● ~~unannounced~~compliance ~~routine~~with orthe ~~for-cause~~QSR, ~~device~~which ~~facility~~requires ~~inspections~~manufacturers byto ~~the~~follow ~~FDA~~stringent design, ~~which~~testing, ~~may~~control, ~~include~~documentation, ~~our~~record ~~suppliers’~~maintenance, ~~facilities;~~including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;

● ~~labeling~~unannounced ~~regulations,~~routine ~~which~~or ~~prohibit the promotion of products~~ for-cause ~~uncleared~~device orfacility ~~unapproved~~inspections ~~(or~~by ~~“off-label”)~~the ~~uses~~FDA, ~~and~~which ~~impose~~may ~~other~~include ~~restrictions~~our ~~relating~~suppliers’ ~~to promotional activities~~facilities; and

● ~~corrections~~labeling ~~and removal reporting~~ regulations, which ~~require~~prohibit ~~that~~the ~~manufacturers~~promotion ~~report~~of toproducts ~~the~~for ~~FDA~~uncleared ~~field corrections~~ or ~~removals~~unapproved ~~if undertaken to reduce a risk to health posed by a device~~ (or to“off-label”) ~~remedy~~uses aand ~~violation~~impose ofother ~~the~~restrictions ~~FDCA~~relating ~~that may present a risk~~ to ~~health;~~promotional ~~and~~activities;

● ~~post-market~~corrections ~~surveillance~~and removal reporting regulations, which ~~apply~~require that manufacturers report to ~~certain~~the ~~Class~~FDA IIfield corrections or ~~III~~removals ~~devices~~if ~~when~~undertaken ~~necessary~~ to ~~protect~~reduce ~~the~~a ~~public~~risk to health posed by a device or to ~~provide~~remedy ~~additional~~a ~~safety~~violation ~~and~~of ~~effectiveness~~the ~~data~~FDCA ~~for~~that ~~the~~may ~~device.~~present a risk to health; and

In● ~~addition,~~post-market ~~under~~surveillance ~~the FDA medical device reporting, or MDR,~~ regulations, ~~medical~~which ~~device~~apply ~~manufacturers are required~~ to ~~report~~certain toClass ~~the~~II ~~FDA information that a device has~~ or ~~may~~III ~~have~~devices ~~caused~~when ~~or contributed~~necessary to aprotect ~~death~~the orpublic ~~serious~~health ~~injury~~ or ~~has malfunctioned in a way that would likely cause or contribute~~ to ~~death~~provide oradditional ~~serious~~safety ~~injury if~~and ~~the~~effectiveness ~~malfunction~~data offor the device ~~or a similar device of such manufacturer were to recur~~. ~~The decision to file an MDR involves a judgment by the manufacturer. If the FDA disagrees with the manufacturer’s determination, the FDA can take enforcement action.~~

~~The MDR requirements also extend to health-care~~In ~~facilities~~addition, ~~that~~under ~~use~~the FDA medical ~~devices~~device inreporting, ~~providing~~or ~~care~~MDR, ~~to patients~~regulations, ormedical “device ~~user~~manufacturers ~~facilities,”~~are ~~which~~required ~~include~~to ~~hospitals,~~report ~~ambulatory surgical~~to ~~facilities,~~the ~~nursing~~FDA information ~~homes,~~that ~~outpatient~~a ~~diagnostic~~device ~~facilities,~~has or ~~outpatient~~may ~~treatment~~have ~~facilities,~~caused ~~but~~or ~~not~~contributed ~~physician~~to ~~offices.~~a ~~A device~~death ~~user~~or ~~facility~~serious ~~must~~injury ~~report~~or ~~any~~has ~~device-related~~malfunctioned ~~death~~in toa ~~both~~way ~~the~~that ~~FDA~~would likely ~~and~~cause ~~the~~or ~~device~~contribute ~~manufacturer,~~to death or ~~any device-related~~ serious injury to ~~the manufacturer (or,~~ if the ~~manufacturer~~malfunction isof ~~unknown, to~~ the ~~FDA)~~device ~~within~~or 10a ~~days~~similar device of ~~the~~such ~~event.~~manufacturer ~~Device user facilities are not required~~were to ~~report~~recur. ~~device~~The ~~malfunctions~~decision ~~that~~to ~~would~~file ~~likely~~an ~~cause~~MDR orinvolves ~~contribute~~a tojudgment ~~death~~by orthe ~~serious~~manufacturer. ~~injury~~If if the ~~malfunction~~FDA ~~were~~disagrees towith ~~recur~~the ~~but~~manufacturer’s ~~may voluntarily report such malfunctions through MedWatch~~determination, the FDA’s ~~Safety~~can ~~Information~~take ~~and~~enforcement ~~Adverse Event Reporting Program~~action.

The MDR ~~FDA~~requirements also ~~has~~extend ~~the authority~~ to ~~require~~health-care ~~the recall~~facilities ofthat ~~commercialized~~use medical ~~device~~devices ~~products~~ in ~~the~~providing ~~event~~care ofto ~~material~~patients, ~~deficiencies~~ or ~~defects~~“device inuser facilities,” ~~design~~which orinclude ~~manufacture.~~hospitals, ~~The~~ambulatory ~~authority to~~surgical ~~require~~facilities, anursing ~~recall~~homes, ~~must~~outpatient bediagnostic ~~based~~facilities, onor anoutpatient treatment ~~FDA~~facilities, ~~finding~~but ~~that~~not ~~there~~physician isoffices. aA ~~reasonable~~device ~~probability~~user ~~that~~facility ~~the~~must ~~device~~report ~~would~~any ~~cause~~device-related ~~serious~~death ~~adverse health~~to ~~consequences~~both orthe ~~death.~~FDA ~~Manufacturers~~and ~~may~~the device manufacturer, ~~under~~or ~~their~~any ~~own~~device-related ~~initiative,~~serious ~~recall~~injury ato ~~product~~the manufacturer (or, if ~~any~~the ~~distributed~~manufacturer ~~devices~~is ~~fail~~unknown, to ~~meet~~the FDA) within ~~established~~10 ~~specifications,~~days ~~are~~of ~~otherwise~~the ~~misbranded~~event. orDevice ~~adulterated~~user ~~under~~facilities ~~the~~are ~~FDCA,~~not orrequired ifto ~~any~~report ~~other~~device ~~material~~malfunctions ~~deficiency~~that iswould ~~found.~~likely ~~The FDA~~cause ~~requires~~or ~~that~~contribute ~~certain~~to death ~~classifications~~or ofserious ~~recalls~~injury beif ~~reported~~the malfunction were to ~~the~~recur ~~FDA~~but ~~within~~may ~~ten~~voluntarily ~~working~~report ~~days~~such ~~after~~malfunctions through MedWatch, the ~~recall~~FDA’s Safety isInformation ~~initiated~~and Adverse Event Reporting Program.

The FDA ~~failure~~also has the authority to ~~comply~~require ~~with~~the ~~applicable~~recall ~~regulatory requirements~~of ~~can~~commercialized ~~result~~medical device products in ~~enforcement~~the ~~action~~event byof ~~the~~material deficiencies or defects in design or manufacture. The authority to require a recall must be based on an FDA, ~~which~~finding that there is a reasonable probability that the device would cause serious adverse health consequences or death. Manufacturers may, ~~include~~under their own initiative, recall a product if any distributed devices fail to meet established specifications, are otherwise misbranded or adulterated under the FDCA, or if any other material deficiency is found. The FDA requires that certain classifications of recalls be reported to the FDA ~~following~~within ~~sanctions:~~ten working days after the recall is initiated.

~~● warning letters, fines, injunctions or civil penalties;~~15

●The failure ~~recalls~~to comply with applicable regulatory requirements can result in enforcement action by the FDA, ~~detentions~~which ormay ~~seizures~~include any of ~~products;~~the following sanctions:

● ~~operating~~warning ~~restrictions~~letters, fines, injunctions or civil penalties;

● ~~delays~~recalls, indetentions ~~the~~or ~~introduction~~seizures of products ~~into the market~~;

● ~~total~~operating ~~or partial suspension of production~~restrictions;

● ~~delay~~delays orin ~~refusal of~~ the ~~FDA~~introduction orof ~~other~~products ~~regulators~~into tothe ~~grant 510(k) clearance, PMA approvals, or other marketing authorization to new products~~market;

● ~~withdrawals~~total ofor ~~marketing~~partial ~~authorizations;~~suspension orof production;

● indelay or refusal of the ~~most~~FDA ~~serious~~or ~~cases~~other regulators to grant 510(k) clearance, ~~criminal~~PMA ~~prosecution.~~approvals, or other marketing authorization to new products;

To● ~~ensure~~withdrawals ~~compliance~~of ~~with~~marketing ~~regulatory~~authorizations; requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of subcontractors.or

13● in the most serious cases, criminal prosecution.

~~Federal~~To ensure ~~Trade~~compliance ~~Commission~~with ~~Regulatory~~regulatory ~~Oversight~~requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of subcontractors.

~~Our advertising for our products and services will be subject to federal truth-in-advertising laws enforced by the~~ Federal ~~Trade Commission (the “FTC”) as well as comparable~~ ~~state consumer protection laws. Under the Federal~~ Trade Commission ~~Act~~Regulatory (the “FTC Act”), the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce; (b) seek monetary redress and other relief for conduct injurious to consumers; and (c) gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce. The FTC has very broad enforcement authority, and failure to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or judicial penalties, including civil penalties, injunctions affecting the manner in which we would be able to market services or products in the future, or criminal prosecution.Oversight

~~Healthcare~~Our advertising ~~Law~~for our products and ~~Regulation~~services will be subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (the “FTC”) as well as comparable state consumer protection laws. Under the Federal Trade Commission Act (the “FTC Act”), the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce; (b) seek monetary redress and other relief for conduct injurious to consumers; and (c) gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce. The FTC has very broad enforcement authority, and failure to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or judicial penalties, including civil penalties, injunctions affecting the manner in which we would be able to market services or products in the future, or criminal prosecution.

~~United~~Healthcare Law ~~States~~and Regulation

~~We will have to comply with various U.S. federal~~United and state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws, rules and regulations. Violations of the fraud and abuse laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid. These laws include the following:States

●We will ~~the~~have ~~federal~~to ~~Anti-Kickback~~comply ~~Statute~~with ~~prohibits,~~various ~~among~~U.S. ~~other~~federal ~~things,~~and ~~persons~~state ~~from~~laws, ~~knowingly~~rules and ~~willfully~~regulations ~~soliciting,~~pertaining ~~offering,~~to ~~receiving~~healthcare orfraud ~~providing~~and ~~remuneration~~abuse, ~~directly~~including anti-kickback orlaws ~~indirectly,~~and inphysician ~~cash~~self-referral ~~or in kind~~laws, torules ~~induce~~and orregulations. ~~reward~~Violations ~~either~~of the ~~referral~~fraud ofand anabuse ~~individual~~laws ~~for,~~are orpunishable ~~the~~by criminal ~~purchase,~~and ~~order~~civil ~~or recommendation of~~sanctions, ~~any good or service~~including, ~~for~~in ~~which~~some ~~payment may be made~~instances, inexclusion ~~whole~~from orparticipation in ~~part,~~federal ~~under~~and astate ~~federal~~ healthcare ~~program~~programs, ~~such as~~ including Medicare and Medicaid;. These laws include the following:

● the federal ~~False~~Anti-Kickback ~~Claims~~Statute ~~Act~~prohibits, ~~imposes~~among ~~civil~~other ~~penalties~~things, persons from knowingly and ~~provides~~willfully ~~for~~soliciting, ~~civil~~offering, ~~whistleblower~~receiving or ~~qui~~providing ~~tam actions~~remuneration, ~~against~~directly ~~individuals~~ or ~~entities~~indirectly, ~~for~~in ~~knowingly~~cash ~~presenting,~~ or ~~causing~~in kind, to beinduce ~~presented,~~or toreward either the ~~federal~~referral ~~government,~~of ~~claims~~an individual for, ~~payment~~or ~~that~~the ~~are~~purchase, ~~false~~order or ~~fraudulent~~recommendation of, any good or ~~making~~service, afor ~~false~~which ~~statement~~payment tomay ~~avoid~~be made, ~~decrease~~in whole or ~~conceal~~in anpart, ~~obligation~~under toa ~~pay~~federal ~~money~~healthcare toprogram ~~the~~such ~~federal~~as ~~government~~Medicare and Medicaid;

● the federal ~~Health~~False ~~Insurance~~Claims ~~Portability~~Act imposes civil penalties, and ~~Accountability~~provides ~~Act~~for ofcivil ~~1996,~~whistleblower or ~~HIPAA,~~qui ~~imposes~~tam ~~criminal~~actions, ~~and~~against ~~civil~~individuals ~~liability~~or entities for ~~executing~~knowingly apresenting, ~~scheme~~or causing to ~~defraud~~be ~~any~~presented, ~~healthcare~~to ~~benefit~~the ~~program~~federal government, claims for payment that are false or fraudulent or making a false ~~statements~~statement ~~relating~~to avoid, decrease or conceal an obligation to ~~healthcare~~pay ~~matters~~money to the federal government;

● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;16

● the federal ~~false~~Health ~~statements~~Insurance ~~statute~~Portability ~~prohibits~~and ~~knowingly~~Accountability ~~and~~Act ~~willfully~~of ~~falsifying~~1996, ~~concealing~~ or ~~covering~~HIPAA, upimposes acriminal ~~material~~and ~~fact~~civil orliability ~~making~~for ~~any~~executing ~~materially~~a ~~false~~scheme ~~statement~~to indefraud ~~connection~~any ~~with~~healthcare ~~the~~benefit ~~delivery~~program of or ~~payment~~making ~~for~~false ~~healthcare~~statements ~~benefits,~~relating ~~items~~to orhealthcare ~~services~~matters;

● ~~the~~HIPAA, ~~federal~~as ~~transparency~~amended ~~requirements~~by ~~under~~ the ~~Physician~~Health ~~Payments~~Information ~~Sunshine~~Technology ~~Act~~for ~~require~~Economic ~~manufacturers~~and ofClinical ~~FDA-approved~~Health ~~drugs,~~Act ~~devices, biologics~~ and ~~medical~~its ~~supplies~~implementing ~~covered~~regulations, byalso ~~Medicare~~imposes ~~or Medicaid to report~~obligations, onincluding anmandatory ~~annual~~contractual ~~basis~~terms, towith ~~the~~respect ~~Department of Health and Human Services information related~~ to ~~payments~~safeguarding ~~and~~the ~~other transfers of value to physicians~~privacy, ~~teaching~~security ~~hospitals,~~ and ~~certain~~transmission ~~advanced~~of ~~non-physician~~individually identifiable health ~~care practitioners and physician ownership and investment interests~~information; ~~and~~

● ~~analogous~~the ~~state~~federal ~~and~~false ~~foreign~~statements ~~laws~~statute prohibits knowingly and ~~regulations~~willfully falsifying, ~~such~~concealing asor ~~state~~covering ~~anti-kickback~~up ~~and~~a ~~false~~material ~~claims~~fact ~~laws,~~or ~~may~~making ~~apply~~any tomaterially ~~sales~~false orstatement ~~marketing~~in ~~arrangements~~connection ~~and~~with ~~claims~~the ~~involving~~delivery ~~healthcare~~of ~~items~~ or ~~services~~payment ~~reimbursed~~for byhealthcare ~~nongovernmental third-party payors~~benefits, ~~including~~items ~~private~~or ~~insurers.~~services;

~~Some~~● ~~state~~the ~~laws~~federal ~~require~~transparency ~~pharmaceutical~~requirements orunder ~~medical device~~the ~~companies~~Physician toPayments ~~comply~~Sunshine ~~with~~Act ~~the~~require ~~relevant~~manufacturers ~~industry’s~~of ~~voluntary~~FDA-approved ~~compliance~~drugs, ~~guidelines~~devices, biologics and ~~the~~medical ~~relevant~~supplies ~~compliance~~covered ~~guidance promulgated~~ by ~~the~~Medicare ~~federal~~or ~~government~~Medicaid into ~~addition~~report, on an annual basis, to ~~requiring~~the ~~drug~~Department ~~and~~of ~~device~~Health ~~manufacturers~~and toHuman ~~report~~Services information related to payments and other transfers of value to physicians , teaching hospitals, and ~~other~~certain advanced non-physician health care ~~providers~~practitioners orand ~~marketing~~physician ~~expenditures.~~ownership and investment interests; and

14● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.

~~State~~Some state ~~and foreign~~ laws ~~also~~require ~~govern~~pharmaceutical ~~the~~or ~~privacy and~~medical ~~security~~device ofcompanies ~~health~~to ~~information~~comply inwith ~~some~~the ~~circumstances,~~relevant ~~many~~industry’s ofvoluntary ~~which~~compliance ~~differ from each other in significant ways~~ guidelines and ~~often~~the ~~are~~relevant ~~not preempted by HIPAA, thus complicating~~ compliance ~~efforts.~~guidance Wepromulgated ~~also~~by ~~may~~the befederal ~~subject~~government ~~to, or may~~ in ~~the~~addition ~~future become subject~~ to, ~~U.S.~~requiring ~~federal~~drug and ~~state, and~~device ~~foreign~~manufacturers ~~laws~~to report ~~and regulations imposing obligations on how we collect, use, disclose, store and process personal~~ information. ~~Our~~related ~~actual or perceived failure~~ to ~~comply~~payments ~~with such obligations could result in liability or reputational harm and could harm our business. Ensuring compliance with such laws could also impair our efforts~~ to ~~maintain~~physicians and ~~expand~~other ~~our~~health ~~customer~~care ~~base~~providers ~~and~~or ~~thereby~~marketing ~~decrease our future revenues~~expenditures.

~~The~~State and ~~European~~foreign ~~Union~~laws ~~approves~~also govern the ~~use~~privacy and security of ~~medical devices~~health information in asome ~~very~~circumstances, ~~different~~many ~~way.~~of ~~They~~which ~~have~~differ ~~similar~~from ~~regulations~~each other in significant ways and ~~requirements~~often toare ~~adhere~~not ~~to,~~preempted ~~however~~by HIPAA, athus ~~Notified~~complicating ~~Body,~~compliance inefforts. ~~the~~We ~~form~~also ~~of a~~may ~~private~~be ~~company~~subject to, ~~will~~or ~~represent~~may ~~their~~in the ~~interests~~future ~~and~~become issubject ~~required~~ to, ~~have~~U.S. ~~sufficient~~federal ~~expertise~~and tostate, ~~review~~and ~~all~~foreign ~~applications~~laws and ~~the~~regulations ~~company’s internal~~imposing ~~processes~~obligations toon ~~ensure~~how ~~the~~we ~~safety~~collect, ofuse, ~~the~~disclose, store ~~product~~and ~~for~~process ~~which~~personal ~~approval~~information. isOur ~~being~~actual ~~requested.~~or Weperceived ~~have~~failure ~~identified~~to acomply ~~Notified~~with ~~Body~~such toobligations ~~represent~~could result in liability or ~~us,~~reputational harm and wecould ~~are~~harm ~~following~~ our ~~FDA~~business. ~~submission~~Ensuring ~~process~~compliance with ~~regard~~such tolaws ~~preparing~~could ~~the~~also ~~materials~~impair ~~and~~our ~~processes~~efforts ~~required~~ to ~~meet~~maintain ~~the~~and ~~regulations~~expand our customer base and ~~gain~~thereby ~~clearance~~decrease our future revenues.

The European Union approves the use of medical devices in a very different way. They have similar regulations and requirements to adhere to, however, a Notified Body, in the form of a private company, will represent their interests and is required to have sufficient expertise to review all applications and the company’s internal processes to ensure the safety of the product for which approval is being requested. We have identified a Notified Body to represent us, and we are following our FDA submission process with regard to preparing the materials and processes required to meet the regulations and gain clearance.

~~EEA~~European Union

~~In the European Economic Area, or~~ EEA, which is comprised of the 27 member states of the European Union plus Norway, Iceland and Liechtenstein, manufacturers of medical devices need to comply with the Essential Requirements laid out in Annex I to the EU Medical Devices Directive (Council Directive 93/42/EEC) or with the General Safety and Performance Requirements (GSPR) of the new EU Medical Devices Regulation (EU 2017/745). Compliance with these requirements is a prerequisite to be able to affix the CE mark to medical devices, without which they cannot be marketed or sold in the EEA. To demonstrate compliance with the Essential Requirements and the GSPR and obtain the right to affix the CE Mark, manufacturers of medical devices must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the Essential Requirements and the GSPR, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments. Depending on the relevant conformity assessment procedure, the Notified Body would audit and examine the Technical File and the quality system for the manufacture, design and final inspection of the devices. The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the Essential Requirements and GSPR. This Certificate entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. As a general rule, demonstration of conformity of medical devices and their manufacturers with the Essential Requirements and GSPR must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

~~All~~In the European Economic Area, or EEA, which is comprised of the 27 member states of the European Union plus Norway, Iceland and Liechtenstein, manufacturers ~~placing~~of medical devices ~~into~~need to comply with the ~~market~~Essential Requirements laid out in Annex I to the ~~EEA~~EU ~~must~~Medical ~~comply~~Devices Directive (Council Directive 93/42/EEC) or with the General Safety and Performance Requirements (GSPR) of the new EU Medical ~~Device~~Devices ~~Vigilance~~Regulation ~~System~~(EU 2017/745). ~~Under~~Compliance ~~this~~with ~~system,~~these ~~incidents~~requirements is ~~must~~a prerequisite to be ~~reported~~able to affix the ~~relevant~~CE mark to medical devices, without which they cannot be marketed or sold in the EEA. To demonstrate ~~authorities~~compliance ofwith the ~~member~~Essential ~~states~~Requirements ofand the ~~EEA,~~GSPR and ~~manufacturers~~obtain ~~are~~the ~~required~~right to ~~take~~affix ~~Field~~the ~~Safety~~CE ~~Corrective Actions~~mark, ormanufacturers ~~FSCAs,~~of tomedical ~~reduce~~devices must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer can issue an EC Declaration of Conformity ~~death~~based oron ~~serious~~a ~~deterioration~~self-assessment inof the ~~state~~conformity of ~~health~~its ~~associated~~products with the ~~use~~Essential Requirements and the GSPR, a conformity assessment procedure requires the intervention of a ~~medical~~Notified ~~device~~Body, ~~that~~which is ~~already~~an ~~placed~~organization ondesignated by a competent authority of an EEA country ~~the~~to ~~market~~conduct conformity assessments. AnDepending ~~incident~~on isthe ~~defined~~relevant asconformity ~~any~~assessment ~~malfunction~~procedure, orthe ~~deterioration~~Notified inBody would audit and examine the ~~characteristics~~Technical File and~~/or~~ ~~performance~~the ofquality asystem ~~device~~for the manufacture, asdesign ~~well as~~and ~~any~~final ~~inadequacy~~inspection inof the ~~labeling~~devices. orThe ~~the~~Notified ~~instructions~~Body ~~for~~issues ~~use~~a CE ~~which,~~Certificate ~~directly~~of orConformity ~~indirectly,~~following ~~might~~successful ~~lead~~completion toof ora ~~might~~conformity ~~have~~assessment ~~led~~procedure conducted in relation to the ~~death~~medical ofdevice aand ~~patient~~its ormanufacturer ~~user~~and ortheir ofconformity ~~other~~with ~~persons~~the orEssential Requirements and GSPR. This Certificate entitles the manufacturer to aaffix ~~serious~~the ~~deterioration~~CE inmark ~~their~~to ~~state~~its medical devices after having prepared and signed a related EC Declaration of ~~health~~Conformity. AnAs ~~FSCA~~a ~~may~~general ~~include~~rule, demonstration of conformity of medical devices and their manufacturers with the ~~recall,~~Essential ~~modification~~Requirements and GSPR must be based, among other ~~exchange~~things, ~~destruction~~on orthe ~~retrofitting~~evaluation of ~~the~~clinical ~~device.~~data ~~FSCAs~~supporting ~~must~~the besafety ~~communicated~~and byperformance of the ~~manufacturer~~products orduring ~~its~~normal ~~legal~~conditions ~~representative~~of touse. ~~its~~Specifically, ~~customers~~a ~~and/or~~manufacturer tomust demonstrate that the ~~end~~device ~~users~~achieves its intended performance during normal conditions of use, that the ~~device~~known ~~through~~and foreseeable ~~Field~~risks, ~~Safety~~and ~~Notices.~~any ~~Where~~adverse ~~appropriate~~events, ~~our~~are ~~products~~minimized ~~commercialized~~and inacceptable ~~Europe~~when weighed against the benefits of its intended performance, ~~are~~and CEthat ~~marked~~any claims made about the performance and ~~classified~~safety asof ~~either~~the ~~Class~~device Iare orsupported ~~Class~~by IIsuitable evidence.

1517

InAll manufacturers ~~2017,~~placing ~~the~~medical ~~European~~devices ~~Parliament~~into ~~passed~~ the ~~Medical Devices~~market ~~Regulation,~~in ~~which~~the ~~repeals~~EEA ~~and~~must ~~replaces~~comply with the EU Medical ~~Devices~~Device ~~Directive~~Vigilance System. ~~Unlike~~Under ~~directives~~this system, ~~which~~incidents must be ~~implemented~~reported ~~into~~to the ~~national~~ ~~laws~~relevant authorities of the ~~EEA~~ member states, of the ~~regulations~~EEA, ~~would~~and bemanufacturers ~~directly~~are ~~applicable~~required ~~(i.e.~~to take Field Safety Corrective Actions, ~~without~~or ~~the~~FSCAs, ~~need~~to ~~for~~reduce ~~adoption~~a risk of ~~EEA~~death ~~member~~or serious deterioration in the state of health associated with ~~State~~the ~~laws~~use ~~implementing~~of ~~them)~~a inmedical ~~all~~device ~~EEA~~that ~~member~~is ~~states~~already ~~and~~placed ~~are~~on ~~intended~~the tomarket. ~~eliminate~~An ~~current~~incident ~~differences~~is defined as any malfunction or deterioration in the ~~regulation~~characteristics and/or performance of ~~medical devices~~a ~~among~~device, ~~EEA~~as ~~member~~well ~~States.~~as ~~The~~any ~~Medical~~inadequacy ~~Devices~~in ~~Regulation~~the labeling or the instructions for use which, ~~among~~directly ~~other~~or ~~things~~indirectly, might islead ~~intended~~to or might have led to ~~establish~~the death of a ~~uniform~~patient or user or of other persons or to a serious deterioration in their state of health. An FSCA may include the recall, ~~transparent~~modification, ~~predictable~~ ~~and~~exchange, ~~sustainable~~destruction ~~regulatory~~or ~~framework~~retrofitting ~~across~~of the ~~EEA~~device. ~~for~~FSCAs ~~medical~~must ~~devices~~be ~~and~~communicated by inthe ~~vitro~~manufacturer ~~diagnostic~~or ~~devices~~its legal representative to its customers and/or ~~ensure~~to athe ~~high level~~end users of ~~safety~~the device through Field Safety Notices. Where appropriate, our products commercialized in Europe are CE marked and ~~health~~classified ~~while~~as ~~supporting~~either ~~innovation~~Class I or Class II.

~~The~~In 2017, the European Parliament passed the Medical ~~Device~~Devices Regulation, ~~became~~which ~~applicable on~~repeals ~~May~~and ~~26,~~replaces ~~2021.~~the EU Medical Devices ~~lawfully~~Directive. ~~placed~~Unlike directives, onwhich must be implemented into the ~~market~~national ~~pursuant~~laws toof the EUEEA ~~Medical~~member ~~Devices~~states, ~~Directive~~the ~~prior~~regulations towould ~~May~~be 26directly applicable (i.e., without ~~2021~~the ~~may~~need ~~generally continue~~for toadoption beof ~~made~~EEA ~~available~~member onState ~~the~~laws ~~market~~implementing orthem) ~~put~~in ~~into~~all ~~service~~EEA ~~until~~member ~~May~~states ~~26,~~and ~~2026~~are intended to eliminate current differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other things:, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and in vitro diagnostic devices and ensure a high level of safety and health while supporting innovation.

●The Medical ~~strengthens~~Device ~~the~~Regulation ~~rules~~became applicable on ~~placing~~May ~~devices~~26, 2021. Devices lawfully placed on the market ~~and~~pursuant ~~reinforces~~to ~~surveillance~~the ~~once~~EU ~~they~~Medical ~~are~~Devices Directive prior to May 26, 2021 may generally continue to be made available; on the market or put into service until May 26, 2026. The Medical Devices Regulation, among other things:

● ~~establishes~~strengthens ~~explicit~~the ~~provisions~~rules on ~~manufacturers’~~placing ~~responsibilities~~devices ~~for~~on the ~~follow-up~~market ~~of the quality, performance~~ and ~~safety~~reinforces ofsurveillance ~~devices~~once ~~placed~~they onare ~~the market~~available;

● ~~improves~~establishes ~~the~~explicit ~~traceability~~provisions ofon ~~medical~~manufacturers’ ~~devices~~responsibilities ~~throughout~~for the ~~supply~~follow-up ~~chain~~of to the ~~end-user~~quality, orperformance ~~patient~~and ~~through~~safety aof ~~unique~~devices ~~identification~~placed ~~number~~on the market;

● ~~sets~~improves upthe atraceability ~~central~~of ~~database~~medical todevices ~~provide~~throughout ~~patients,~~the ~~healthcare~~supply ~~professionals~~chain ~~and~~to the ~~public~~end-user ~~with~~or ~~comprehensive~~patient ~~information~~through ona ~~products~~unique ~~available~~identification ~~in the EU~~number; ~~and~~

● ~~strengthens~~sets ~~rules~~up ~~for~~a ~~the~~central ~~assessment~~database ofto ~~certain~~provide ~~high-risk devices~~patients, ~~such~~healthcare asprofessionals ~~implants,~~and ~~which~~the ~~may~~public ~~have~~with tocomprehensive ~~undergo~~information anon ~~additional~~products ~~check~~available byin ~~experts before they are placed on~~ the ~~market.~~EU; and

~~Available~~strengthens rules ~~Information~~for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

~~Our annual reports on Form 10-K, quarterly reports~~Available on Form 10-Q, current reports on Form 8-K and amendments to such reports filed or furnished pursuant to section 13(a) or 15(d) of the Securities Exchange Act of 1934, as well as section 16 reports on Form 3, 4, or 5, are available free of charge on our website at www.modular-medical.com. as soon as it is reasonably practicable after they are filed or furnished with the SEC. Our Code of Business Conduct and Ethics and the charters for the Audit Committee, Compensation Committee and Nominating and Governance Committee are also available on our website. The Code of Business Conduct and charters are also available in print to any stockholder upon request without charge. Requests for such documents should be directed to Modular Medical, Inc., 10740 Thornmint Road, San Diego CA 92127, Attn. CFO. Our Internet website and the information contained on it or connected to it are not part of, or incorporated by, reference into this Report. Our filings with the SEC are also available on the SEC’s website at http://www.sec.gov.Information

~~Corporate~~Our annual ~~Information~~reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to such reports filed or furnished pursuant to section 13(a) or 15(d) of the Securities Exchange Act of 1934, as well as section 16 reports on Form 3, 4, or 5, are available free of charge on our website at www.modular-medical.com. as soon as it is reasonably practicable after they are filed or furnished with the SEC. Our Code of Business Conduct and Ethics and the charters for the Audit Committee, Compensation Committee and Nominating and Governance Committee are also available on our website. The Code of Business Conduct and charters are also available in print to any stockholder upon request without charge. Requests for such documents should be directed to Modular Medical, Inc., 10740 Thornmint Road, San Diego CA 92127, Attn. CFO. Our Internet website and the information contained on it or connected to it are not part of, or incorporated by, reference into this Report. Our filings with the SEC are also available on the SEC’s website at http://www.sec.gov.

~~We are a Nevada corporation, and Quasuras, Inc.,~~Corporate a Delaware corporation, is our only subsidiary. Our corporate headquarters and operating facilities are located at 10740 Thornmint Road, San Diego, CA 92127. Our telephone number is (858) 800-3500. We maintain a website at www.modular-medical.com.Information

~~Employees~~We are a Nevada corporation, and Quasuras, Inc., a Delaware corporation, is our only subsidiary. Our corporate headquarters and operating facilities are located at 10740 Thornmint Road, San Diego, CA 92127. Our telephone number is (858) 800-3500. We maintain a website at www.modular-medical.com.

As of March 31, 2025, we had 54 employees, all of whom are located in the United States and 53 of whom are full-time, consisting of 49 in research and development and manufacturing operations and 5 in general and administrative functions.Employees

16As of March 31, 2026, we had 51 employees, all located in the United States of which 50 of are full-time, consisting of 42 in research and development and manufacturing operations, six in general and administrative functions and three in sales and marketing.

~~ITEM 1A. RISK FACTORS~~18

~~This Annual Report on Form 10-K contains~~ITEM ~~forward-looking statements that involve risks and uncertainties, such as statements of our objectives, expectations and intentions~~1A. ~~The cautionary~~RISK statements made in this Annual Report on Form 10-K should be read as applicable to all forward-looking statements wherever they appear in this report. Our actual results could differ materially from those discussed herein. Factors that could cause or contribute to such differences include those discussed below, as well as those discussed elsewhere in this Annual Report on Form 10-K.FACTORS

~~Summary~~This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties, such as statements of ~~Risk~~our objectives, expectations and intentions. The cautionary statements made in this Annual Report on Form 10-K should be read as applicable to all forward-looking statements wherever they appear in this report. Our actual results could differ materially from those discussed herein. Factors that could cause or contribute to such differences include those discussed below, as well as those discussed elsewhere in this Annual Report on Form 10-K.

~~The following summarizes the risks and~~Summary ~~uncertainties that could materially adversely affect our business, financial condition, results~~ of ~~operation~~Risk ~~and stock price. You should read this summary together with the more detailed description of each risk factor contained below.~~Factors

~~Risks~~The following ~~Related~~summarizes tothe ~~Our~~risks ~~Business~~and uncertainties that could materially adversely affect our business, financial condition, results of ~~Operations~~operation and ~~Industry~~stock price. You should read this summary together with the more detailed description of each risk factor contained below.

●Risks Related ~~We might not be able~~ to ~~continue~~Our asBusiness, aOperations ~~going~~and ~~concern.~~Industry

● We ~~are~~might anot ~~pre-revenue~~be ~~medical~~able ~~device company and have a history of significant operating losses; we expect~~ to continue toas ~~incur~~a ~~operating~~going ~~losses, and we may never achieve or maintain profitability~~concern.

● We ~~will~~are ~~need~~an ~~substantial~~early ~~additional~~commercial-stage ~~funding~~medical todevice ~~complete~~company ~~subsequent~~and ~~phases~~have ofa ~~the~~history ~~development~~ of ~~our~~significant ~~insulin~~operating ~~pump~~losses; ~~products~~we ~~and~~expect to ~~operate~~continue ~~our~~to ~~business~~incur ~~and~~operating ~~such~~losses, ~~funding~~and we may ~~not~~never beachieve ~~available~~ or, ifmaintain ~~it is available, such financing is likely to substantially dilute our existing stockholders~~profitability.

● We ~~have~~will aneed ~~limited~~substantial ~~operating~~additional ~~history~~funding to complete subsequent phases of the development of our insulin pump products and ~~historical~~to ~~financial~~operate ~~information~~our ~~upon~~business ~~which~~and ~~you~~such funding may ~~evaluate~~not be available or, if it is available, such financing is likely to substantially dilute our ~~performance~~existing stockholders.

● ~~The~~We ~~amount~~have ~~of financing we require will depend on~~ a ~~number~~limited ofoperating ~~factors,~~history ~~many~~and ofhistorical ~~which are beyond our control. Our results of operations,~~ financial ~~condition~~information ~~and~~upon ~~stock~~which ~~price~~you ~~are~~may ~~likely~~evaluate ~~to be adversely affected if~~ our ~~funding requirements increase or are otherwise greater than we expect~~performance.

● The amount of financing we require will depend on a number of factors, many of which are beyond our control. Our ~~future~~results ~~cash~~of ~~requirements~~operations, ~~may~~financial ~~differ~~condition ~~significantly~~and ~~from~~stock price are likely to be adversely affected if our ~~current~~funding ~~estimates~~requirements increase or are otherwise greater than we expect.

● WeOur ~~may~~future ~~not~~cash berequirements ~~able~~may todiffer ~~utilize~~significantly afrom ~~significant portion of~~ our ~~net~~current ~~operating losses and tax credits~~estimates.

● ~~Technological~~We ~~breakthroughs~~may innot ~~diabetes~~be ~~monitoring,~~able ~~treatment~~to orutilize ~~prevention~~a ~~could~~significant ~~render~~portion of our ~~insulin~~net ~~pump~~operating ~~products~~losses ~~obsolete~~and tax credits.

● ~~Any~~Technological ~~failure~~breakthroughs toin ~~attract~~diabetes ~~and retain skilled directors~~monitoring, ~~executives,~~treatment ~~employees~~or ~~and~~prevention ~~consultants~~ could ~~impair~~render our ~~product~~insulin ~~development~~pump ~~and~~products ~~commercialization activities~~obsolete.

● ~~Our~~Any ~~operations~~failure ~~are~~to ~~substantially~~attract ~~dependent~~and ~~upon~~retain ~~key~~skilled ~~personnel~~directors, executives, employees and consultants could impair our product development and commercialization activities.

● WeOur ~~have~~operations ~~and~~are ~~will~~substantially need to outsource and rely on third parties for various aspects relating to the development, manufacture, sales and marketing of our insulin pump products, as well as in connection with assisting us in the preparation and filing of our regulatory submissions, and our future success will be dependent onupon ~~the~~key ~~timeliness and effectiveness of the efforts of these third parties~~personnel.

● We ~~may~~have ~~not~~and bewill ~~able~~need to ~~identify,~~outsource ~~negotiate~~ and ~~maintain~~rely ~~the~~on ~~strategic~~third ~~alliances~~parties ~~necessary~~for various aspects relating to ~~develop~~the development, manufacture, sales and ~~commercialize~~marketing of our insulin pump products, as well as in connection with assisting us in the preparation and ~~technologies~~filing of our regulatory submissions, and weour future success will be dependent on ~~our~~the ~~corporate~~timeliness ~~partners~~and ifeffectiveness weof dothe efforts of these third parties.

17● We may not be able to identify, negotiate and maintain the strategic alliances necessary to develop and commercialize our products and technologies, and we will be dependent on our corporate partners if we do.

●

We may not receive the necessary regulatory clearance or approvals for our insulin pump products, and failure to timely obtain necessary clearances and/or approvals could harm our then operations, including our ability to commercialize our products.

● ~~Obtaining~~We ~~marketing~~have ~~authorization~~a inlimited ~~the~~operating ~~United~~history ~~States~~upon ~~will~~which ~~not obviate the need~~ to ~~obtain~~evaluate ~~marketing~~our ~~authorization~~business ~~in other jurisdictions. We must obtain approval from foreign regulatory authorities before we can market~~ and ~~sell~~forecast ~~any of~~ our ~~product~~future ~~candidates~~sales inand ~~countries~~operating ~~outside~~results ~~the~~and ~~United~~may ~~States.~~face Wedifficulties ~~will~~frequently ~~incur~~encountered ~~additional~~by ~~costs~~companies in ~~seeking~~competitive ~~such approvals, may experience delays in obtaining such approvals~~ and ~~cannot~~rapidly-evolving ~~be certain that such approvals will be granted~~markets.

● ~~Our~~We ~~competitors~~have ~~may~~a ~~develop~~limited commercial history and limited experience marketing and selling our products. ~~that~~We ~~are~~only ~~more~~recently ~~effective~~launched our commercial product, ~~safer~~which may make it difficult to evaluate the prospects for our future viability and ~~less~~predict ~~expensive~~our ~~than~~future ~~ours~~performance.

~~● We expect to rely on third-party manufacturers and will be dependent on their quality and effectiveness.~~19

● WeObtaining ~~may~~marketing authorization in the United States will not beobviate ~~able~~the need to ~~successfully~~obtain ~~scale-up~~marketing ~~manufacturing~~authorization in other jurisdictions. We must obtain approval from foreign regulatory authorities before we can market and sell any of our ~~products~~product candidates in ~~sufficient~~countries ~~quality~~outside ~~and~~the ~~quantity,~~United ~~which~~States. ~~would~~We ~~delay~~will orincur ~~prevent~~additional uscosts ~~from~~in ~~developing~~seeking ~~and~~such ~~commercializing~~approvals, ~~our~~may ~~products~~experience delays in obtaining such approvals and ~~product~~cannot ~~candidates~~be certain that such approvals will be granted.

● WeOur ~~are~~competitors ~~dependent~~may ~~upon~~develop ~~third-party~~products ~~suppliers~~that toare ~~manufacture~~more ~~our products~~effective, ~~and~~safer ~~this makes us vulnerable to supply shortages~~ and ~~price~~less ~~increases;~~expensive wethan ~~may not be able to obtain an adequate supply of components on a timely basis or at all~~ours.

● We ~~may~~expect ~~be subject~~ to ~~potential~~rely ~~product~~on ~~liability~~third-party manufacturers and ~~other~~will ~~claims~~be ~~that~~dependent ~~could~~on ~~materially~~their ~~impact~~quality ~~our business~~ and ~~financial condition~~effectiveness.

● ~~Legislative,~~We ~~regulatory~~may not be able to successfully scale-up manufacturing of our products in sufficient quality and quantity, orwhich ~~medical~~would ~~cost~~delay ~~reimbursement~~or ~~changes~~prevent ~~may~~us ~~adversely~~from ~~impact~~developing and commercializing our ~~business~~products and product candidates.

● We are ~~subject~~dependent toupon ~~extensive~~third-party ~~regulation~~suppliers byto ~~the~~manufacture ~~FDA, which could restrict the sales and marketing of~~ our ~~insulin pump~~ products, and ~~could~~this ~~cause~~makes us tovulnerable ~~incur significant costs. ● Although our insulin pump products do not presently require clinical trials~~ to ~~apply~~supply toshortages ~~the FDA for clearance,~~ and ~~even~~price ifincreases; awe ~~clinical trial is completed, the results of our clinical testing~~ may not ~~demonstrate the safety and efficacy of the device or may~~ be ~~equivocal~~able orto ~~otherwise~~obtain ~~not~~an beadequate ~~sufficient~~supply ~~for~~of uscomponents toon ~~obtain~~a ~~approval~~timely ofbasis ~~our~~or ~~product~~at ~~candidates~~all.

● ~~Our~~We ~~success~~may ~~depends~~be ~~substantially~~subject ~~upon~~to ~~our~~potential ~~ability~~product toliability ~~obtain~~ and ~~maintain~~other ~~intellectual~~claims ~~property~~that ~~protection~~could ~~relating~~materially toimpact our ~~insulin~~business ~~pump products~~ and ~~research~~financial ~~technologies~~condition.

● ~~If we are sued for infringing on third-party intellectual property rights~~Legislative, ~~it will be costly and time-consuming~~regulatory, ~~and~~or anmedical ~~unfavorable~~cost ~~outcome~~reimbursement ~~would~~changes ~~have~~may aadversely ~~significant~~impact ~~adverse effect on~~ our business.

● IfWe we are ~~unable~~subject to ~~protect~~extensive ~~the~~regulation ~~confidentiality~~by ofthe ~~our~~FDA, ~~proprietary~~which ~~information,~~could restrict the ~~value~~sales and marketing of our ~~technology~~insulin ~~and~~pump products and could because ~~adversely~~us ~~affected~~to incur significant costs.

● ~~Intellectual~~Although ~~property~~our ~~rights~~insulin pump products do not ~~necessarily~~presently ~~address~~require ~~all~~clinical ~~potential~~trials ~~threats~~to apply to the FDA for clearance, and even if a clinical trial is completed, the results of our ~~competitive~~clinical ~~advantage~~testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidates.

● ~~Healthcare~~Our ~~reform~~success depends substantially upon our ability to obtain and ~~drug-pricing~~maintain ~~reform~~intellectual ~~laws~~property ~~could~~protection ~~adversely~~relating ~~affect~~to our insulin pump products and ~~financial~~research ~~condition~~technologies.

● ~~Even~~If if we are ~~able~~sued tofor ~~obtain~~infringing ~~all~~on ~~regulatory~~third-party ~~approvals~~intellectual ~~and~~property ~~have~~rights, ~~completed~~it ~~all~~will ~~other steps needed to~~ be ~~taken~~costly toand ~~commercialize our insulin pump products~~time-consuming, ifand wean orunfavorable ~~any~~outcome ~~contract~~would ~~manufacturers~~have wea ~~select~~significant ~~fail~~adverse toeffect ~~comply~~on ~~with the FDA’s quality system regulations, the manufacturing and distribution of~~ our ~~products could be interrupted, and our product sales and operating results could suffer~~business.

18● If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.

● WeIntellectual ~~may become involved in disputes with our present or future contract partners over intellectual~~ property ~~ownership~~rights ordo ~~other~~not ~~matters,~~necessarily ~~which~~address ~~would~~all ~~have~~potential athreats ~~significant~~to ~~effect on~~ our ~~business~~competitive advantage.

● ~~Our~~Healthcare ~~insulin~~reform ~~pump~~and ~~products~~drug-pricing ~~will~~reform belaws ~~subject~~could toadversely ~~recalls,~~affect ~~which would harm~~ our ~~reputation,~~products ~~business operations~~ and financial ~~results~~condition.

● ~~Our~~Even ~~current~~if ~~insulin~~we ~~pump~~are ~~product~~able ~~does~~to ~~not~~obtain ~~yet~~all ~~have~~regulatory ~~reimbursement~~approvals and ishave ~~not~~completed ~~approved~~all ~~for~~other ~~insurance~~steps ~~coverage.~~needed Ifto inbe ~~the~~taken ~~future we are otherwise able~~ to commercialize our insulin pump products, ~~but~~if ~~are~~we ~~unable~~or toany ~~obtain~~contract ~~adequate~~manufacturers ~~reimbursement~~we orselect ~~insurance~~fail ~~coverage~~to ~~for~~comply ~~such~~with ~~product~~the ~~from~~FDA’s ~~third-party~~quality ~~payors~~system regulations, wethe ~~will~~manufacturing and distribution of our products could be ~~unable~~interrupted, toand ~~generate~~our ~~significant~~product ~~revenue~~sales and operating results could suffer.

~~Risks~~● ~~Related~~We tomay ~~Our~~become ~~Securities~~involved in disputes with our present or future contract partners over intellectual property ownership or other matters, which would have a significant effect on our business.

● WeOur ~~are~~insulin ~~subject~~pump toproducts ~~oversight~~will bybe ~~the~~subject ~~SEC~~to ~~and~~recalls, ~~other~~which ~~regulatory~~would ~~agencies.~~harm ~~Investigations~~our byreputation, ~~those~~business ~~agencies~~operations ~~could divert management’s focus~~ and ~~could have a material adverse effect on our reputation and~~ financial ~~condition~~results.

● Our current insulin pump product does not yet have reimbursement and is not approved for insurance coverage. If in the future we are ~~unable~~otherwise able to ~~satisfy~~commercialize ~~the~~our ~~continued~~insulin ~~listing~~pump, ~~requirements~~but ofare ~~the~~unable ~~Nasdaq,~~to ~~our~~obtain ~~common~~adequate ~~stock~~reimbursement ~~could~~or beinsurance ~~delisted~~coverage ~~and~~for ~~the~~such ~~price~~product ~~and~~from ~~liquidity~~third-party ofpayors, ~~our~~we ~~common~~will ~~stock~~be ~~may~~unable beto ~~adversely~~generate ~~affected~~significant revenue.

● We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.20

●Risks Related ~~We do not expect any cash dividends~~ to beOur ~~paid on our shares of common stock for the foreseeable future.~~Securities

● IfWe are subject to oversight by the ~~beneficial~~SEC ~~ownership~~and ofother ~~our~~regulatory ~~common~~agencies. ~~stock~~Investigations ~~continues~~by tothose beagencies ~~concentrated,~~could itdivert ~~may~~management’s ~~prevent~~focus ~~our~~and ~~stockholders~~could ~~from~~have ~~influencing~~a ~~significant~~material ~~corporate~~adverse ~~decisions~~effect on our reputation and financial condition.

● ~~Future~~If ~~sales~~we ofare ~~our~~unable ~~securities~~to ~~could~~satisfy ~~adversely affect~~ the ~~market~~continued ~~price~~listing requirements of the Nasdaq, our common stock ~~and our future capital-raising activities~~ could ~~involve~~be ~~the~~delisted ~~issuance of equity securities, which would dilute your investment~~ and ~~could result in a decline in~~ the ~~trading~~ price and liquidity of our common stock may be adversely affected.

● ~~Our~~We ~~articles~~are ofa ~~incorporation~~“smaller ~~allow~~reporting ~~for~~company” ~~our~~and, ~~board~~as ofa ~~directors~~result toof ~~create~~the ~~new~~reduced ~~series~~disclosure ofand ~~preferred~~governance ~~stock~~requirements ~~without~~applicable ~~further~~to ~~approval~~smaller byreporting ~~our stockholders~~companies, ~~which~~our ~~could~~common ~~adversely~~stock ~~affect~~may ~~the~~be ~~rights~~less ofattractive ~~the~~to ~~holders of our common stock~~investors.

● IfWe wedo ~~fail to establish and maintain an effective system of internal controls, we may~~ not beexpect ~~able~~any tocash ~~report~~dividends ~~our financial results accurately or prevent fraud. Any inability~~ to ~~report~~be ~~and~~paid ~~file~~on our ~~financial~~shares ~~results~~of ~~accurately~~common ~~and~~stock ~~timely~~for ~~could harm our reputation and adversely affect~~ the ~~trading~~foreseeable ~~price of our common stock~~future.

● ~~Sustained~~If ~~inflation~~the ~~could~~beneficial ~~have~~ownership aof ~~material~~our ~~adverse~~common ~~effect~~stock oncontinues ~~our~~to ~~business~~be concentrated, ~~financial~~it ~~condition,~~may ~~results~~prevent ofour ~~operations~~stockholders ~~and~~from ~~liquidity~~influencing significant corporate decisions.

● ~~Our~~Future ~~board~~sales of ~~directors~~our issecurities ~~able~~could toadversely ~~adopt~~affect ~~recapitalizations~~the ~~through~~market ~~forward~~price orof ~~reverse~~our ~~splits~~common ofstock and our ~~outstanding~~future ~~shares~~capital-raising activities could involve the issuance of ~~common~~equity ~~stock~~securities, ~~without~~which ~~stockholder~~would ~~approval~~dilute your investment and could result in a decline in the trading price of our common stock.

● IfThe effective increase in the ~~beneficial~~number ~~ownership~~of shares of our common stock ~~continues~~available tofor beissuance ~~concentrated,~~as ita ~~may~~result ~~prevent~~of our ~~stockholders~~reverse ~~from~~stock ~~influencing~~split ~~significant~~could ~~corporate~~result ~~decisions~~in further dilution to our existing stockholders and have antitakeover implications.

● ~~Future~~Our ~~sales~~articles of ~~our~~incorporation ~~securities~~allow ~~could~~for ~~adversely~~our ~~affect~~board ~~the market price~~ of ~~our~~directors ~~common~~to ~~stock~~create ~~and~~new ~~our~~series ~~future~~of ~~capital-raising~~preferred ~~activities~~stock ~~could~~without ~~involve~~further ~~the~~approval ~~issuance~~by ofour ~~equity securities~~stockholders, which ~~would dilute your investment and~~ could ~~result~~adversely inaffect athe ~~decline~~rights inof the ~~trading~~holders ~~price~~ of our common stock.

19● If we fail to establish and maintain an effective system of internal controls, we may not be able to report our financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely affect the trading price of our common stock.

~~Risks~~● ~~Related~~Sustained toinflation ~~Our~~could ~~Business~~have a material adverse effect on our business, ~~Operations~~ financial condition, results of operations and ~~Industry~~liquidity.

We● ~~might~~Our ~~not~~board beof directors is able to ~~continue as~~adopt arecapitalizations ~~going~~through ~~concern~~forward or reverse splits of our outstanding shares of common stock without stockholder approval.

~~Our consolidated~~Risks ~~financial~~Related statements as of March 31, 2025 have been prepared under the assumption that we will continue as a going concern twelve months from the date of issuance of this Report. At March 31, 2025, we had cash and cash equivalents of $13.1 million and an accumulated deficit of $84.8 million. In March 2025, we completed a private placement of common stock and warrants for net proceeds to usOur ~~of approximately $11.4 million. In addition~~Business, inOperations ~~November 2024, we completed a public offering of common stock for net proceeds to us of approximately $7.3 million. Even with these offering proceeds, we do not believe that our cash~~ and cash equivalents will be sufficient to fund our operations for the period of 12 months from the date of issuance of this report, and we would need to raise additional capital. As a result of our expected operating losses and cash burn for the foreseeable future and recurring losses from operations, if we are unable to raise sufficient capital through additional debt or equity arrangements, there will be uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt as to our ability to continue as a going concern. If we cannot continue as a viable entity, our stockholders would likely lose most or all of their investment in us.Industry

~~If we are unable to generate sustainable operating profit and sufficient cash flows, then our future success will depend on our ability to raise capital.~~ We ~~intend to seek additional~~ ~~financing~~might ~~and~~not ~~evaluate~~be ~~financing~~able ~~alternatives in order~~ to ~~meet~~continue ~~our~~as ~~cash requirements for the foreseeable future. We cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining~~ a ~~line~~going ~~of credit or other loan, will be available to us or, if available, will be on terms acceptable to us~~concern. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.

WeOur ~~are~~consolidated financial statements as of March 31, 2026 have been prepared under the assumption that we will continue as a ~~pre-revenue~~going ~~medical~~concern twelve months from the date of issuance of this Report. At March 31, 2026, ~~device~~we ~~company~~had cash and ~~have~~cash equivalents of $6.9 million and an accumulated deficit of $113.0 million. Subsequent to March 31, 2026, in April 2026, we closed a ~~history~~public offering for net proceeds of ~~significant~~approximately $3.0 million. Even with these proceeds, we do not believe that our cash and cash equivalents will be sufficient to fund our operations for the next 12 months, and we will need to raise additional capital. As a result of our expected operating losses; and cash burn for the foreseeable future and recurring losses from operations, if we ~~expect~~are unable to raise sufficient capital through additional debt or equity arrangements, there will be uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt as to our ability to continue as a going concern. If we cannot continue as a viable entity, our shareholders would likely lose most or all of their investment in us. If we are unable to ~~incur~~generate sustainable operating ~~losses~~profit and sufficient cash flows, then our future success will depend on our ability to raise capital. We intend to seek additional financing and evaluate financing alternatives in order to meet our cash requirements for the foreseeable future. We cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may ~~never~~have ~~achieve~~rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution. If we are unable to obtain funds when needed or ~~maintain~~on ~~profitability~~acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.

We do not currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses in each year due to costs incurred in connection with research and development activities and general and administrative expenses associated with our operations. For the years ended March 31, 2025 and, 2024, we incurred net losses of approximately $18.9 million and $17.5 million, respectively. As a result, we will need to raise additional capital in the future, which may or may not be available to us at all or only on unfavorable terms.21

We ~~expect~~are toan ~~incur~~early ~~losses~~commercial-stage ~~for the foreseeable~~medical ~~future~~device ascompany weand ~~continue~~have ~~the~~a ~~development~~history of, ~~and~~significant ~~seek~~operating ~~regulatory~~losses; ~~clearance and approvals for, our insulin pump. Our MODD1 insulin pump is currently our only product, if it fails to gain market acceptance,~~ we ~~will~~expect ~~not be able~~ to ~~generate~~continue ~~any revenue, or explore other opportunities~~ to ~~enhance~~incur ~~stockholder~~operating ~~value~~losses, ~~such as through a sale. If we fail to generate revenue~~ and ~~eventually become profitable, or if~~ we ~~are~~may ~~unable~~never toachieve ~~fund our continuing losses, our stockholders could lose all~~ or amaintain ~~substantial part of their investment~~profitability.

20We do not currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses each year due to costs incurred in connection with research and development activities and general and administrative expenses associated with our operations. For the years ended March 31, 2026 and 2025, we incurred net losses of approximately $28.2 million and $18.8 million, respectively. As a result, we will need to raise additional capital in the future, which may or may not be available to us at all or only on unfavorable terms.

We ~~will~~expect ~~need~~to ~~substantial~~incur ~~additional~~losses ~~funding~~for the foreseeable future as we continue to ~~complete~~commercialize ~~subsequent phases~~and ofseek ~~the~~to ~~development~~expand market acceptance of our insulin pump products. ~~and~~Our toPivot ~~operate~~insulin pump is currently our ~~business~~only commercial product, and, ~~such~~if ~~funding~~it fails to gain market acceptance, we may not be ~~available~~able ~~or,~~to ifgenerate itsufficient isrevenue, or explore ~~available~~other opportunities to enhance stockholder value, such ~~financing~~as isthrough ~~likely~~a sale. If we fail to ~~substantially~~generate ~~dilute~~sufficient revenue and eventually become profitable, or if we are unable to fund our ~~existing~~continuing losses, our stockholders could lose all or a substantial part of their investment.

~~The discovery, development, and commercialization~~We ofwill ~~new~~need ~~medical~~substantial ~~devices,~~additional ~~such~~funding asto ~~our~~complete ~~insulin~~subsequent ~~pump,~~phases ~~entails~~of ~~significant costs. We have completed~~ the ~~engineering and mechanical~~ development of our insulin pump ~~and~~products ~~cartridge,~~ and ~~obtained~~to ~~FDA clearance. In addition, we have also implemented a production-level manufacturing~~operate ~~process,~~our ~~including~~business ~~purchasing~~and ~~required~~such ~~equipment~~funding ~~for~~may ~~low-level~~not ~~manufacturing.~~be Weavailable ~~have developed a follow-on product~~or, ~~our~~if ~~Pivot~~it ~~pump,~~is toavailable, ~~among~~ ~~other~~such ~~things,~~financing ~~meet~~is ~~the~~likely ~~general needs and preferences of the Almost Pumper marketplace and the guidelines of third-party payors. To enable us~~ to ~~accomplish~~substantially ~~these~~dilute ~~and other related items and continue to operate~~ our ~~business, we will need to raise substantial additional~~existing ~~capital and/or enter into strategic partnerships or joint ventures to enable us to:~~stockholders.

●The ~~seek~~discovery, ~~European~~development, ~~regulatory~~and ~~approvals~~commercialization of new medical devices, such as our insulin pump, entails significant costs. We have completed the engineering and mechanical development of our insulin pump and cartridge, and obtained FDA clearance for our Pivot product. In addition, we have also implemented a production-level manufacturing process with ~~appropriate~~a ~~clinical~~tier-one ~~studies;~~manufacturing partner. In June 2026, we announced commercial availability of our Pivot product and commenced initial shipments. To enable us to expand commercial activities and continue to operate our business, we will need to raise substantial additional capital and/or enter into strategic partnerships or joint ventures to enable us to:

● ~~expand~~seek ~~and~~European ~~continue~~regulatory toapprovals ~~improve~~with ~~our~~appropriate ~~manufacturing~~clinical ~~and~~studies, ~~commercialization~~as ~~capabilities~~required;

● ~~develop,~~expand ~~test,~~ and, ifcontinue ~~approved,~~to ~~market~~improve our ~~future~~manufacturing ~~product~~and ~~candidates~~commercialization capabilities;

● ~~acquire~~develop, ortest, ~~license~~and, ~~additional~~if ~~internal~~approved, ~~systems~~market ~~and~~our ~~other~~future ~~infrastructure;~~product ~~and~~candidates;

● ~~hire~~acquire ~~and~~or ~~support~~license additional ~~management,~~internal ~~administrative,~~systems ~~sales~~ and ~~marketing,~~other ~~and~~infrastructure; ~~technical personnel.~~and

~~Until~~● wehire ~~can~~and ~~generate~~support a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through the establishment of possible strategic alliances. We may in the future seek additional ~~capital from public or private offerings of our capital stock or borrow additional amounts under new credit lines or from other sources. If we issue equity or debt securities to raise additional funds~~management, ~~our existing stockholders may experience dilution~~administrative, ~~we may~~sales ~~incur significant financing costs,~~ and ~~the new equity or debt securities may have rights~~marketing, ~~preferences~~ and ~~privileges~~technical ~~senior to those of our existing stockholders~~personnel. In addition, if we raise additional funds through collaborations, licensing, joint ventures, strategic alliances, partnership arrangements or other similar arrangements, it may be necessary to relinquish valuable rights to the MODD1 pump or our potential future products or proprietary technologies or grant licenses on terms that are not favorable to us.

WeUntil we ~~cannot~~can begenerate ~~certain~~a ~~that~~sufficient ~~additional~~amount ~~funding will~~of beproduct ~~available~~revenue onto ~~acceptable~~finance ~~terms,~~our orcash atrequirements, ~~all.~~which If we ~~are~~may ~~not~~never ~~able to secure additional equity funding when needed~~achieve, we ~~may~~expect ~~have~~ to ~~delay,~~finance ~~reduce~~our ~~the~~cash ~~scope~~needs ~~of,~~primarily orthrough ~~eliminate~~public ~~one~~ or ~~more~~private ofequity ~~our post-market clinical studies~~offerings, ~~development~~debt ~~programs~~financings or ~~future~~through ~~commercialization initiatives. In addition, any additional equity funding that we do obtain will dilute~~ the ~~ownership~~establishment ~~held~~of bypossible ~~our existing equity holders~~strategic alliances. ~~The~~We ~~amount of~~may ~~this~~in ~~dilution~~the ~~may~~future beseek ~~substantially~~additional ~~increased~~capital iffrom ~~the~~public ~~trading~~or ~~price~~private offerings of our ~~common~~capital stock isor ~~lower~~borrow atadditional ~~the~~amounts under ~~time~~new ofcredit ~~any~~lines ~~financing.~~or ~~Regardless, the~~from ~~economic~~other ~~dilution~~sources. toIf ~~stockholders~~we ~~will~~issue beequity ~~significant~~or ifdebt ~~our~~securities ~~stock~~to ~~price~~raise ~~does~~additional ~~not increase significantly~~funds, orour ifexisting ~~the effective price~~stockholders ofmay ~~any~~experience ~~sale~~dilution, iswe ~~below~~may ~~the~~incur ~~price~~significant ~~paid by a particular stockholder. Any debt~~ financing ~~that~~costs, weand ~~obtain~~the innew ~~the~~equity ~~future~~or ~~could~~debt ~~involve~~securities ~~substantial restrictions~~may onhave ~~activities~~rights, preferences and ~~creditors~~privileges ~~could~~senior ~~seek~~to athose ~~pledge~~ of ~~some~~our orexisting ~~all~~stockholders. ofIn ~~our~~addition, ~~assets.~~if Wewe ~~have~~raise ~~not~~additional ~~identified~~funds ~~potential~~through ~~sources~~collaborations, ~~for~~licensing, ~~such~~joint ~~financing~~ventures, ~~that~~strategic ~~we will require~~alliances, ~~and~~partnership wearrangements door ~~not~~other ~~have~~similar ~~commitments~~arrangements, ~~from~~it ~~any~~may ~~third~~be ~~parties~~necessary to ~~provide~~relinquish ~~any future debt financing. If we~~valuable ~~fail~~rights to ~~obtain~~our ~~funding~~pump asproducts ~~needed,~~or weour ~~may~~potential befuture ~~forced~~products ~~to cease~~ or ~~scale~~proprietary ~~back~~technologies ~~operations,~~or ~~and~~grant ~~our~~licenses ~~business,~~on ~~prospects,~~terms ~~results~~that ofare ~~operations,~~not favorable ~~financial~~to ~~condition and stock price would be adversely affected~~us.

~~We have a limited operating history and historical financial information upon which you may evaluate our performance.~~22

~~You~~We cannot ~~should~~be ~~consider,~~certain ~~among~~that ~~other~~additional ~~factors, our~~funding ~~prospects~~will ~~for~~be ~~success~~available inon ~~light~~acceptable ofterms, ~~the~~or ~~risks~~at ~~and~~all. ~~uncertainties~~If ~~encountered~~we byare ~~companies~~not ~~that,~~able ~~like~~to ~~us,~~secure ~~are~~additional inequity funding ~~their~~when ~~early~~needed, ~~stages~~we ~~of development.~~may Wehave ~~may~~to ~~not~~delay, ~~successfully~~reduce ~~address~~the ~~these~~scope ~~risks~~of, ~~and~~or ~~uncertainties~~eliminate one or ~~successfully~~more ~~complete~~of our post-market clinical studies, ~~and/~~development programs or ~~implement~~future ~~our~~commercialization ~~existing and~~initiatives. ~~new~~In ~~products.~~addition, Ifany weadditional ~~fail~~equity tofunding that we do ~~so,~~obtain itwill ~~could~~dilute ~~materially~~the ~~harm~~ownership held by our ~~business~~existing ~~and~~equity ~~impair~~holders. The amount of this dilution may be substantially increased if the ~~value~~trading price of our common stock. is ~~Unanticipated~~lower ~~problems~~at the time of any financing. Regardless, ~~expenses~~ ~~and~~the ~~delays~~economic ~~are~~dilution ~~frequently~~to ~~encountered~~stockholders inwill ~~establishing~~be asignificant ~~new~~if ~~business,~~our ~~conducting~~stock ~~research~~price does not increase significantly, ~~and~~or ~~developing~~if ~~new~~the ~~products~~effective price of any sale is below the price paid by a particular stockholder. ~~These~~Any debt financing ~~include,~~that ~~but~~we ~~are~~obtain ~~not~~in ~~limited~~the ~~to,~~future ~~inadequate~~could ~~funding,~~involve ~~failure~~substantial torestrictions ~~obtain~~on ~~regulatory~~activities ~~approval,~~and ~~unforeseen~~creditors ~~research~~could ~~issues,~~seek ~~lack~~a pledge of ~~consumer, physician~~some or ~~third-party~~all ~~payor~~of our ~~acceptance,~~assets. ~~competition,~~We ~~sluggish~~have ~~product~~not ~~development~~identified potential sources for such financing that we will require, and ~~inadequate~~we ~~sales~~do ~~and~~not ~~marketing.~~have ~~The~~commitments ~~failure by~~from usany third parties to ~~meet~~provide any offuture debt ~~these~~financing. ~~conditions~~If ~~would~~we ~~have~~fail ato ~~materially~~obtain ~~adverse~~funding ~~effect~~as ~~upon~~needed, uswe ~~and~~ may ~~force~~be usforced to ~~reduce~~cease or ~~curtail~~scale back operations~~. No~~, ~~assurance~~and ~~can~~our bebusiness, ~~given~~prospects, results ~~that~~of weoperations, ~~can~~financial orcondition ~~will~~and ~~ever~~stock ~~operate~~price ~~profitably~~would be adversely affected.

21We have a limited operating history and historical financial information upon which you may evaluate our performance.

~~The~~You should ~~amount~~consider, ofamong ~~financing~~other ~~we require~~factors, ~~will~~our ~~depend~~prospects onfor asuccess ~~number~~in light of ~~factors~~the risks and uncertainties encountered by companies that, like ~~many~~us, are in their early stages of ~~which~~development. ~~are~~We ~~beyond~~may not successfully address these risks and uncertainties or successfully complete our ~~control~~studies and/or implement our existing and new products. ~~Our~~If ~~results~~we offail ~~operations~~to do so, ~~financial~~it ~~condition~~could materially harm our business and impair the value of our common stock. Unanticipated problems, expenses and delays are frequently encountered in establishing a new business, conducting ~~price~~research, and developing new products. These include, but are ~~likely~~not limited to, beinadequate ~~adversely~~funding, ~~affected~~failure ifto ~~our~~obtain ~~funding~~regulatory ~~requirements~~approval, unforeseen ~~increase~~research issues, lack of consumer, physician or ~~are~~third-party ~~otherwise~~payor ~~greater~~acceptance, ~~than~~competition, sluggish product development, and inadequate sales and marketing. The failure by us to meet any of these conditions would have a materially adverse effect upon us and may force us to reduce or curtail operations. No assurance can be given that we ~~expect~~can or will ever operate profitably.

~~Our~~The amount ~~future~~of ~~funding~~financing ~~requirements~~we require will depend on ~~many~~a number of factors, ~~including~~many of which are beyond our control. Our results of operations, ~~but~~financial condition ~~not~~and ~~limited~~stock price are likely to: be adversely affected if our funding requirements increase or are otherwise greater than we expect.

●Our future ~~the~~funding ~~testing~~requirements ~~costs~~will ~~for~~depend ~~our~~on ~~insulin~~many ~~pump~~factors, ~~product candidates and other development activities conducted by us directly~~including, ~~and~~but ~~our~~not ~~ability~~limited to: ~~successfully conclude the studies and activities and achieve favorable results;~~

● the testing costs for our ~~ability~~insulin topump ~~attract~~product ~~future~~candidates ~~strategic~~and ~~partners~~other todevelopment ~~pay~~activities ~~for~~conducted orby ~~share~~us ~~costs~~directly, ~~related~~and our ability to ~~our~~successfully ~~product~~conclude ~~development~~the ~~efforts~~studies and activities and achieve favorable results;

● ~~the~~our ~~costs~~ability ~~and~~to ~~timing~~attract offuture ~~seeking~~strategic ~~and~~partners ~~obtaining~~to ~~regulatory~~pay ~~clearance~~for ~~and~~or ~~approvals~~share ~~for~~costs related to our product ~~candidates~~development efforts;

● the costs ~~of filing, prosecuting, maintaining~~ and ~~enforcing~~timing ~~any~~of ~~patents~~seeking and ~~other~~obtaining ~~intellectual~~regulatory ~~property~~clearance ~~rights that we may have~~ and ~~defending~~approvals ~~against~~for ~~potential~~our ~~claims~~product ~~of infringement~~candidates;

● ~~decisions~~the tocosts ~~hire~~of ~~additional~~filing, ~~scientific~~prosecuting, ~~engineering~~maintaining orand ~~administrative~~enforcing ~~personnel~~any orpatents ~~consultants~~and other intellectual property rights that we may have and defending against potential claims of infringement;

● ~~our~~decisions ~~ability~~ to ~~manage~~hire ~~administrative~~additional ~~and~~scientific, ~~other~~engineering ~~costs~~or ofadministrative ~~our~~personnel ~~operations;~~or ~~and~~consultants;

● ~~the~~our ~~presence~~ability orto ~~absence~~manage ofadministrative ~~adverse~~and ~~developments~~other incosts of our ~~research~~operations; ~~program.~~and

If● ~~any~~the ofpresence ~~these~~or ~~factors~~absence ~~cause~~of ~~our~~adverse ~~funding needs~~developments toin ~~be greater than expected,~~ our ~~operations,~~research ~~financial condition, ability to continue operations and stock price may be adversely affected~~program.

~~Our~~If any ~~future~~of ~~cash~~these ~~requirements may~~factors ~~differ~~cause ~~significantly~~our ~~from~~funding needs to be greater than expected, our ~~current~~operations, ~~estimates~~financial condition, ability to continue operations and stock price may be adversely affected.

Our future cash requirements may differ significantly from our ~~estimates~~current ~~from time to time, depending on a number of factors, including:~~estimates.

●Our cash ~~the~~requirements ~~costs~~may ~~and~~differ ~~results~~significantly offrom our ~~clinical~~estimates ~~studies~~from ~~regarding~~time ~~our~~to ~~insulin~~time, ~~pump~~depending ~~product~~on ~~candidates;~~a number of factors, including:

● the ~~time~~costs and ~~costs~~results ~~involved~~of inour ~~obtaining~~clinical ~~regulatory~~studies ~~clearance~~regarding ~~and~~our ~~approvals~~insulin pump product candidates;

● ~~whether~~the wetime ~~are~~and ~~able~~costs toinvolved ~~obtain~~in ~~funding~~obtaining ~~under~~regulatory ~~future~~clearance ~~licensing~~and ~~agreements, strategic partnerships, or other collaborative relationships, if any~~approvals;

● ~~the~~whether ~~costs~~we ofare ~~compliance~~able ~~with~~to ~~laws~~obtain funding under future licensing agreements, ~~regulations~~strategic partnerships, or ~~judicial~~other ~~decisions~~collaborative ~~applicable~~relationships, toif usany; ~~and~~

~~● the costs of general and administrative infrastructure required to manage our business and protect corporate assets and stockholder interests.~~23

If● wethe ~~fail~~costs toof ~~raise~~compliance ~~additional~~with ~~funds on a timely basis~~laws, ~~we will need to scale back our business plans~~regulations, ~~which~~or ~~would~~judicial ~~adversely~~decisions ~~affect~~applicable ~~our business, prospects, results of operations, financial condition, and stock price, and we may even be forced~~ to ~~discontinue~~us; ~~our operations~~ and ~~liquidate our assets.~~

22● the costs of general and administrative infrastructure required to manage our business and protect corporate assets and stockholder interests.

WeIf we ~~may~~fail ~~not~~to beraise ~~able~~additional tofunds ~~utilize~~on a ~~significant~~timely ~~portion~~basis, ofwe will need to scale back our ~~net~~business plans, which would adversely affect our ~~operating~~business, ~~losses~~prospects, results of operations, financial condition, and ~~tax~~stock ~~credits~~price, and we may even be forced to discontinue our operations and liquidate our assets.

~~As of March 31, 2025, our federal net operating~~We ~~loss~~may ~~carryforwards totaled $45.6 million, of which $0.7 million will expire in 2037 and 2038 and $44.9 million will~~ not ~~expire.~~be Weable ~~have federal~~to ~~R&D~~utilize ~~tax~~a ~~credit~~significant ~~carryforwards~~portion of ~~$2.6~~our ~~million which will expire in various years between 2038 through 2045. U.S. federal~~ net operating losses ~~arising~~and in tax ~~years beginning after December 31, 2017 can be carried forward indefinitely, but for taxable years beginning after December 31, 2020, the deductibility of such U~~credits.S. federal NOLs is limited to 80% of current year taxable income. Additionally, we have state net operating loss carryforwards of $68.0 million which will expire in various years between 2038 through 2045.

~~Under~~As ~~Sections 382 and 383~~ of ~~the~~March ~~Internal Revenue Code of 1986~~31, ~~as amended~~2026, aour ~~corporation~~federal ~~that~~and ~~undergoes~~state ~~an “ownership change” is subject to limitations on its ability to utilize its pre-change~~ net operating ~~losses~~loss ~~and~~carryforwards ~~other tax attributes to offset future taxable income or income tax. In general, an~~ (“~~ownership change~~NOLs” ~~occurs if there is a greater than 50 percentage point change (by value~~) intotaled ~~a corporation’s equity ownership by certain stockholders over a rolling three year period~~$74.6 Wemillion ~~may have experienced ownership changes in the past~~ and ~~may experience ownership changes in the future as a result of subsequent shifts in our stock ownership (many of which are outside our control)~~$93.6 ~~If it is determined that we have in the past experienced an ownership change~~million, orrespectively. ifThese weNOLs ~~undergo~~are ~~one~~available orto ~~more ownership changes as a result of~~ reduce future ~~transactions in~~taxable ~~our~~income ~~stock~~and ~~then~~will weexpire ~~may~~at ~~not~~various betimes ~~able~~from to2037 ~~utilize~~through a2046, ~~material~~except ~~portion~~federal ofNOLs ~~our~~from ~~net~~fiscal ~~operating~~2018 ~~losses~~and ~~prior to their expiration~~later, ~~even~~which ~~if we were~~will tonever ~~achieve profitability~~expire. ToIn ~~the~~addition, ~~extent~~ we ~~are~~had ~~not~~federal ~~able~~R&D totax ~~offset~~credit ~~future~~carryforwards ~~taxable~~of ~~income~~$3.2 ~~with~~million ~~our~~which ~~net~~will ~~operating~~expire ~~losses,~~in ~~our~~various ~~net~~years ~~income~~between ~~and~~2038 ~~cash~~through ~~flows may be adversely affected~~2045.

~~Technological~~Under Sections ~~breakthroughs~~382 and 383 of the Internal Revenue Code of 1986, as amended, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses and other tax attributes to offset future taxable income or income tax. In general, an “ownership change” occurs if there is a greater than 50 percentage point change (by value) in a corporation’s equity ownership by certain stockholders over a rolling three year period. We may have experienced ownership ~~diabetes~~changes ~~monitoring~~in the past and may experience ownership changes in the future as a result of subsequent shifts in our stock ownership (many of which are outside our control). If it is determined that we have in the past experienced an ownership change, ~~treatment~~or if we undergo one or ~~prevention~~more ~~could~~ownership ~~render~~changes as a result of future transactions in our ~~insulin~~stock ~~pump~~then ~~products~~we ~~obsolete~~may not be able to utilize a material portion of our net operating losses prior to their expiration, even if we were to achieve profitability. To the extent we are not able to offset future taxable income with our net operating losses, our net income and cash flows may be adversely affected.

~~The diabetes treatment market is subject~~Technological to rapid technological change and product innovation. Our insulin pump products are based on our proprietary technology, but a number of companies, medical researchers and existing pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapeutics for the monitoring, treatment and/or prevention of insulin-dependent diabetes. Any technological breakthroughs in diabetes monitoring, treatment or prevention could render our ~~products~~insulin ~~obsolete,~~pump ~~which~~products ~~would have a material adverse effect on our business, prospects, results of operations and financial condition and could result in stockholders losing their entire investment~~obsolete.

~~Any~~The diabetes ~~failure~~treatment market is subject to ~~attract~~rapid technological change and product innovation. Our insulin pump products are based on our ~~retain~~proprietary ~~skilled~~technology, ~~directors~~but a number of companies, ~~executives~~medical researchers and existing pharmaceutical companies are pursuing new delivery devices, ~~employees~~delivery technologies, sensing technologies, procedures, drugs and ~~consultants~~other therapeutics for the monitoring, treatment and/or prevention of insulin-dependent diabetes. Any technological breakthroughs in diabetes monitoring, treatment or prevention could ~~impair~~render our ~~product~~products obsolete, ~~development~~which would have a material adverse effect on our business, prospects, results of operations and ~~commercialization~~financial ~~activities~~condition and could result in stockholders losing their entire investment.

~~Our business depends on the skills, performance,~~Any ~~and~~failure dedication of our directors, executive officers and key engineering, scientific and technical advisors. Many of our current engineering or scientific advisors are independent contractors and are either self- employed or employed by other organizations. As a result, they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, which may affect their ability to ~~provide~~attract ~~services to us in a timely manner. We will need to recruit additional directors, executive management employees,~~ and ~~advisers,~~retain ~~particularly engineering, scientific and technical personnel, which will require additional financial resources. In addition, there is currently intense competition for~~ skilled directors, executives, ~~and~~ employees ~~with relevant engineering, scientific~~ and ~~technical expertise,~~consultants ~~and~~could ~~this~~impair ~~competition is likely to continue. If we are unable to attract and retain persons with sufficient engineering, scientific, technical and managerial experience, we may be forced to limit or delay~~ our product development ~~activities or may experience difficulties in successfully conducting our business, which would adversely affect our business, prospects, results of operations~~ and ~~financial condition~~commercialization activities.

Our business ~~operations~~depends on the skills, performance, and dedication of our directors, executive officers and key engineering, scientific and technical advisors. Many of our current engineering or scientific advisors are ~~substantially~~independent contractors and are either self employed or ~~dependent~~employed ~~upon~~by ~~key~~other organizations. As a result, they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, which may affect their ability to provide services to us in a timely manner. We will need to recruit additional directors, executive management employees, and advisers, particularly engineering, scientific and technical personnel, which will require additional financial resources. In addition, there is currently intense competition for skilled directors, executives and employees with relevant engineering, scientific and technical expertise, and this competition is likely to continue. If we are unable to attract and retain persons with sufficient engineering, scientific, technical and managerial experience, we may be forced to limit or delay our product development activities or may experience difficulties in successfully conducting our business, which would adversely affect our business, prospects, results of operations and financial condition.

Our performance is substantially dependent on the continued services and performance of our senior management and certain other key personnel. In particular, we are dependent on the performance and continued engagement of Paul DiPerna, our chairman, president and principal financial officer. Although we believe we will be able to engage qualified personnel for such purposes, an inability to do so could materially adversely affect our ability to market, sell, and enhance our products. While Mr. DiPerna is currently devoting his full-time working efforts to us, other employees and consultants may only be available to us on a part-time basis. The loss of services of one or more of our executive officers, especially Mr. DiPerna, or other key employees or our inability to hire and retain other qualified employees, including but not limited to research and development, sales, manufacturing, and administrative support staff, could have a material adverse effect on our business, prospects, results of operations and financial condition.24

~~We have and will need to outsource~~Our ~~and~~operations ~~rely~~are onsubstantially third parties for various aspects relating to the development, manufacture, sales and marketing of our insulin pump products, as well as in connection with assisting us in the preparation and filing of our regulatory submissions, and our future success will be dependent onupon ~~the~~key ~~timeliness and effectiveness of the efforts of these third parties~~personnel.

WeOur performance ~~are~~is substantially dependent on ~~third~~the ~~parties~~continued ~~for~~services ~~important~~and ~~aspects~~performance of our ~~business strategy.~~senior Wemanagement doand ~~not~~certain ~~have~~other ~~the~~key ~~required~~personnel. In ~~financial~~particular, ~~resources~~we ~~and~~are ~~personnel~~dependent toon ~~carry~~the ~~out~~performance ~~independently~~and ~~all~~continued ~~aspects~~engagement of ~~the~~Paul ~~development~~DiPerna, of our ~~products,~~ ~~and have limited resources to manufacture~~chairman, ~~market~~president and ~~sell~~principal ~~our current product candidate~~financial officer. AsAlthough awe ~~result,~~believe we ~~contract~~will ~~with~~be ~~and rely~~able onto ~~third~~engage ~~parties~~qualified personnel for ~~important~~such ~~functions~~purposes, ~~including~~an ininability ~~connection~~to ~~with~~do ~~certain~~so ~~aspects~~could ofmaterially adversely ~~the~~affect ~~development~~our ~~and~~ability ~~finalization~~to ofmarket, ~~our products~~sell, ~~the preparation~~ and ~~filing~~enhance of our ~~regulatory~~products. ~~submissions~~While ~~and~~Mr. ~~manufacturing~~DiPerna ~~and~~is ~~commercialization~~currently ofdevoting ~~our~~his ~~pump~~full-time ~~products.~~working efforts Weto ~~have in~~us, ~~the~~other ~~past~~employees and ~~will~~consultants ~~continue~~may toonly ~~enter~~be ~~into~~available ~~multiple~~to ~~agreements~~us ~~with~~on ~~third~~a ~~parties~~part-time ~~for~~basis. ~~such~~The loss of services. Ifof ~~problems~~one ~~develop~~or inmore of our ~~relationships with~~executive ~~third~~officers, ~~parties~~especially Mr. DiPerna, or ifother ~~such~~key ~~parties~~employees ~~fail~~or our inability to ~~perform~~hire asand ~~expected~~retain other qualified employees, including itbut ~~could~~not ~~lead~~limited to ~~delays~~research orand ~~lack~~development, ofsales, ~~progress~~manufacturing, inand ~~obtaining~~administrative ~~regulatory clearance~~support staff, ~~significant~~could ~~cost~~have ~~increases,~~a ~~changes~~material adverse ineffect on our ~~strategies~~business, ~~and~~prospects, ~~even~~results ~~failure~~ of ~~our~~operations ~~product~~and ~~initiatives~~financial condition.

23We have and will need to outsource and rely on third parties for various aspects relating to the development, manufacture, sales and marketing of our insulin pump products, as well as in connection with assisting us in the preparation and filing of our regulatory submissions, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We are ~~may~~dependent on third parties for important aspects of our business strategy. We do not behave ~~able~~the required financial resources and personnel to ~~identify~~carry out independently all aspects of the development of our products, and have limited resources to manufacture, market and sell ~~negotiate~~our current product candidate. As a result, we contract with and ~~maintain~~rely ~~the~~on ~~strategic~~third ~~alliances~~parties ~~necessary~~for toimportant ~~develop~~functions, including in connection with certain aspects of the development and ~~commercialize~~finalization of our products, the preparation and ~~technologies,~~filing of our regulatory submissions and manufacturing weand commercialization of our pump products. We have in the past and will becontinue ~~dependent~~to enter into multiple agreements with onthird parties for such services. If problems develop in our ~~corporate~~relationships ~~partners~~with third parties, or if wesuch doparties fail to perform as expected, it could lead to delays or lack of progress in obtaining regulatory clearance, significant cost increases, changes in our strategies, and even failure of our product initiatives.

We may ~~seek to enter into a strategic alliance with a diabetes-related service providing company for the further development and approval of our insulin pump product candidate. At this time, we have~~ not ~~entered~~be ~~into~~able ~~any~~to ~~such strategic alliance. Strategic alliances~~identify, ifnegotiate ~~entered into, could potentially provide us with additional funds, expertise, access,~~ and ~~other~~maintain ~~resources in exchange for exclusive or non-exclusive licenses or other rights to~~ the ~~product~~ ~~that~~strategic wealliances ~~are~~necessary ~~currently developing or a product we may explore in the future. We cannot give any assurance that we will be able~~ to ~~enter~~develop ~~into~~and ~~strategic~~commercialize ~~relationships~~our ~~with~~products aand ~~diabetes-related service providing company or others in the near future or at all. In addition~~technologies, weand ~~cannot assure you that any agreements that~~ we ~~do reach~~ will ~~allow us to achieve our goals or that such grants will~~ be ~~on terms that prove to be economically beneficial to us. When we do enter into strategic or contractual relationships, we become~~ dependent on ~~the successful performance of~~ our corporate partners orif ~~counter-parties.~~we ~~If they fail to perform as expected, such failure could adversely affect our financial condition, lead to increases in our capital needs, or hinder or delay our development efforts~~do. ~~See “Our Business -Employees” below.~~

We may ~~not~~seek ~~receive~~to ~~the~~enter ~~necessary~~into ~~regulatory~~a ~~clearance~~strategic oralliance ~~approvals~~ with a diabetes-related service providing company for the further development and approval of our insulin pump ~~products~~product candidate. At this time, we have not entered into any such strategic alliance. Strategic alliances, if entered into, could potentially provide us with additional funds, expertise, access, and ~~failure~~other resources in exchange for exclusive or non-exclusive licenses or other rights to ~~timely~~the ~~obtain~~product ~~necessary~~that ~~clearances~~we ~~and/~~are currently developing or ~~approvals~~a ~~could~~product ~~harm~~we may explore in the future. We cannot give any assurance that we will be able to enter into strategic relationships with a diabetes-related service providing company or others in the near future or at all. In addition, we cannot assure you that any agreements that we do reach will allow us to achieve our ~~then~~goals ~~operations~~or that such grants will be on terms that prove to be economically beneficial to us. When we do enter into strategic or contractual relationships, we ~~including~~become dependent on the successful performance of our partners or counter-parties. If they fail to perform as expected, such failure could adversely affect our ~~ability~~financial condition, lead to ~~commercialize~~increases in our ~~products~~capital needs, or hinder or delay our development efforts. See “Our Business-Employees” below.

~~Before we can market a new medical device,~~We ~~such~~may asnot ~~our insulin pump, we must first~~ receive ~~clearance under Section 510(k) of~~ the ~~Federal~~necessary ~~Food,~~regulatory ~~Drug, and Cosmetic Act, or the “FDCA.” In the 510(k)~~ clearance process, before a device may be marketed, the FDA must determine that such proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre- amendments device), a device that was originally on the U.S. market pursuant to a premarket approval (PMA) and later down- classified, or aapprovals ~~510(k)-exempt~~for ~~device.~~our Toinsulin bepump ~~“substantially equivalent~~products,” ~~the proposed device must have the same intended use as the predicate device,~~ and ~~either~~failure ~~have~~to ~~the~~timely ~~same~~obtain ~~technological~~necessary ~~characteristics~~clearances ~~as the predicate device or have different technological characteristics~~ and ~~not raise different questions of safety~~ /or ~~effectiveness~~ ~~than~~approvals ~~the~~could ~~predicate~~harm ~~device.~~our Inthen ~~September 2024~~operations, weincluding ~~received~~our ~~FDA~~ability ~~clearance~~ to ~~market~~commercialize ~~and sell~~ our ~~initial pump product, our MODD1, in the United States~~products.

~~Our~~Before we ~~Pivot~~can ~~product,~~market ~~which~~a ~~will~~new bemedical ~~our~~device, ~~second~~such ~~product~~as ~~after~~ our ~~MODD1 product~~insulin pump, ~~will~~we ~~require~~must afirst ~~new~~receive ~~510(k)~~ clearance. ~~The~~under Section 510(k) ~~clearance~~of ~~process~~the ~~can~~Federal beFood, Drug, ~~expensive~~and Cosmetic Act, ~~lengthy~~or ~~and~~the ~~uncertain~~“FDCA.” ~~The~~In ~~FDA’s~~the 510(k) clearance process, ~~usually~~before ~~takes~~a ~~less~~device ~~than~~may 12be ~~months~~marketed, ~~but~~the itFDA ~~can~~must ~~last~~determine that ~~longer.~~such ~~Despite~~proposed ~~the~~device ~~time,~~is ~~effort~~“substantially ~~and~~equivalent” ~~cost~~to a legally-marketed “predicate” device, which includes a device ~~may~~that ~~not~~has bebeen ~~approved or~~previously cleared bythrough the ~~FDA.~~510(k) ~~Any~~process, ~~delay~~a ordevice ~~failure~~that towas ~~obtain~~legally ~~necessary~~marketed ~~regulatory~~prior ~~authorizations~~to ~~could~~May ~~harm~~28, ~~our~~1976 ~~business~~(preamendments device), ~~including~~a ~~our~~device ~~ability to~~that ~~commercialize~~was ~~our~~originally ~~future~~on ~~product~~the ~~candidates~~U.S. ~~and~~market ~~our~~pursuant ~~stockholders~~to ~~could~~a ~~lose~~premarket ~~their~~approval ~~entire~~(PMA) ~~investment.~~and ~~Furthermore,~~later ~~even~~down ifclassified, weor ~~are~~a ~~granted~~510(k)-exempt ~~the~~device. ~~required~~To ~~regulatory~~be ~~authorizations~~“substantially equivalent,” ~~such~~the ~~authorizations~~proposed ~~may~~device bemust ~~subject~~have tothe ~~significant~~same ~~limitations~~intended onuse as the ~~indicated~~predicate ~~uses~~device, ~~for~~and either have the same technological characteristics as the predicate device, or have different technological characteristics and not raise ~~which~~different ~~may~~questions ~~limit~~of safety or effectiveness than the predicate device. We have received FDA clearance to market ~~for~~and sell our ~~future~~initial pump products, our MODD1 and Pivot, in the United States. Our Pivot product ~~candidates~~is the product that we intend to commercialize in the fall of 2026.

IfWe expect that future versions of our pump products will require FDA 510(k) approvals. The 510(k) clearance process can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually takes less than 12 months, but it can last longer. Despite the time, effort and cost, a device may not be approved or cleared by the FDA. ~~requires~~Any usdelay or failure to goobtain ~~through~~necessary aregulatory ~~lengthier~~authorizations could harm our business, ~~more~~including ~~rigorous~~our ~~examination for~~ability to commercialize our future product candidates ~~than~~and weour ~~had~~stockholders ~~expected~~could lose their entire investment. Furthermore, ~~product~~even ~~introductions~~if orwe ~~modifications~~are ~~could~~granted bethe ~~delayed~~required orregulatory ~~canceled~~authorizations, ~~which~~such ~~could adversely~~authorizations ~~affect~~may ~~our~~be ~~ability~~subject to ~~grow~~significant limitations on the indicated uses for the device, which may limit the market for our ~~business~~future product candidates.

~~The FDA can delay, limit or deny clearance or approval for our product candidates for many reasons, including, for example:~~25

●If the ~~our~~FDA ~~inability~~requires us to ~~demonstrate~~go tothrough ~~the~~a ~~satisfaction~~lengthier, ofmore ~~the~~rigorous ~~FDA~~examination ~~that~~for aour future product ~~candidate~~candidates isthan ~~substantially~~we ~~equivalent~~had expected, product introductions or modifications could be delayed or canceled, which could adversely affect our ability to ~~the~~grow ~~proposed~~our ~~predicate~~business. ~~device;~~

●The FDA ~~the~~can ~~disagreement~~delay, oflimit ~~the~~or ~~FDA~~deny ~~with~~clearance ~~the design~~ or ~~implementation~~approval offor our ~~performance~~product ~~testing~~candidates ~~protocols~~for ormany ~~the~~reasons, ~~interpretation~~including, offor ~~data~~example: ~~from our performance testing;~~

● ~~the~~our ~~data~~inability ~~from~~to ~~performance~~demonstrate ~~testing may be insufficient~~ to ~~support~~the asatisfaction ~~determination~~ of ~~substantial~~the ~~equivalence~~FDA or that ~~our~~a ~~device~~product ~~meets~~candidate ~~required~~is ~~special~~substantially ~~controls~~equivalent orto ~~applicable~~the ~~performance~~proposed ~~standards~~predicate device;

● ~~our~~the ~~inability~~disagreement toof ~~demonstrate~~the ~~that~~FDA with the ~~benefits~~design or implementation of our ~~pump~~performance ~~outweigh~~testing protocols or the ~~risks~~interpretation of data from our performance testing;

● the ~~manufacturing~~data ~~process~~from orperformance ~~facilities~~testing ~~we intend to use~~ may ~~not~~be ~~meet~~insufficient ~~applicable~~to ~~requirements;~~support ~~for~~a ~~example,~~determination ~~we experienced issues maintaining insulin stability on an initial version~~ of ~~our~~substantial ~~MODD1~~equivalence ~~product,~~or ~~and~~that ~~we attributed this issue to the materials used in the initial production process; we made the necessary changes to~~ our ~~materials~~device ~~and~~meets ~~process~~required tospecial ~~address~~controls ~~this~~or ~~issue~~applicable toperformance ~~obtain FDA clearance for the MODD1 product~~standards; ~~and~~

● ~~the~~our ~~potential~~inability ~~for~~to ~~approval~~demonstrate ~~policies~~that orthe ~~regulations~~benefits of ~~the FDA to change significantly in a manner rendering~~ our ~~data~~pump oroutweigh ~~regulatory~~the ~~filings insufficient for clearance or approval.~~risks;

24● the manufacturing process or facilities we intend to use may not meet applicable requirements; for example, we experienced issues maintaining insulin stability on an initial version of our MODD1 product, and we attributed this issue to the materials used in the initial production process; we made the necessary changes to our materials and process to address this issue to obtain FDA clearance for the MODD1 product; and

In● ~~addition,~~ the ~~FDA~~potential ~~may~~for ~~change its clearance and~~ approval policies~~, adopt~~ ~~additional regulations~~ or ~~revise existing~~ regulations, ~~or take other actions, which may prevent or delay approval or clearance~~ of ~~our~~ ~~future~~the ~~product~~FDA ~~candidates or impact our ability~~ to ~~modify~~change ~~our~~significantly ~~future~~in ~~product candidate after clearance on~~ a ~~timely~~manner ~~basis.~~rendering ~~Such~~our ~~policy~~ data or regulatory ~~changes~~filings ~~could~~insufficient ~~impose~~for ~~additional requirements upon us that could delay our ability to obtain~~ clearance ~~for our proposed future pump products, increase the costs of compliance~~ or ~~restrict our ability to maintain our current~~ approval.

~~As a general rule~~In addition, ~~demonstration~~the ofFDA ~~conformity of~~may ~~medical~~change ~~devices~~its clearance and ~~their~~approval ~~manufacturers~~policies, ~~with~~adopt ~~the~~additional ~~essential~~regulations ~~requirements~~or ~~must~~revise beexisting ~~based~~regulations, ~~among~~or take other ~~things~~actions, onwhich ~~the~~may ~~evaluation~~prevent ofor ~~data supporting~~delay ~~the~~approval ~~safety~~or ~~and~~clearance ~~performance~~ of ~~the~~our future product candidates ~~during~~or ~~normal~~impact ~~conditions~~our ofability ~~use.~~to ~~Specifically,~~modify ~~a manufacturer must demonstrate~~our ~~that~~future ~~the~~product ~~device~~candidate ~~achieves~~after ~~its~~clearance ~~intended~~on ~~performance~~a ~~during~~timely ~~normal~~basis. ~~conditions~~Such ofpolicy ~~use,~~or ~~that~~regulatory ~~the~~changes ~~known~~could ~~and~~impose ~~foreseeable~~additional ~~risks,~~requirements ~~and any adverse~~upon ~~events,~~us ~~are~~that ~~minimized~~could ~~and~~delay ~~acceptable~~our ~~when~~ability ~~weighed~~to ~~against~~obtain ~~the~~clearance ~~benefits~~for ofour ~~its~~proposed ~~intended~~future ~~performance~~pump products, ~~and~~increase ~~that~~the ~~any~~costs ~~claims~~of ~~made~~compliance ~~about~~or ~~the~~restrict ~~performance~~our ~~and~~ability ~~safety~~to ofmaintain ~~the~~our ~~device~~current ~~are supported by suitable evidence~~approval.

~~Obtaining~~As a ~~marketing~~general ~~authorization in~~rule, ~~the~~demonstration ~~United~~of ~~States~~conformity ~~will~~of ~~not~~medical ~~obviate~~devices ~~the~~and ~~need~~their tomanufacturers ~~obtain~~with ~~marketing~~the ~~authorization~~essential inrequirements ~~other~~must ~~jurisdictions~~be Webased, among ~~must~~other ~~obtain~~things, ~~approval~~on ~~from~~the ~~foreign regulatory~~evaluation ~~authorities~~of ~~before~~data wesupporting ~~can~~the ~~market~~safety and ~~sell~~performance ~~any~~ of ~~our~~the product candidates induring ~~countries~~normal ~~outside~~conditions of use. Specifically, a manufacturer must demonstrate that the ~~United~~device ~~States.~~achieves Weits ~~will~~intended ~~incur additional~~performance ~~costs~~during innormal ~~seeking~~conditions ~~such~~of ~~approvals~~use, that ~~may~~the ~~experience~~known ~~delays~~and inforeseeable ~~obtaining~~risks, ~~such~~and ~~approvals~~any adverse events, are minimized and ~~cannot~~acceptable bewhen ~~certain~~weighed ~~that~~against ~~such~~the ~~approvals~~benefits of its intended ~~will~~performance, beand ~~granted~~that any claims made about the performance and safety of the device are supported by suitable evidence.

~~The~~We ~~development,~~have manufacture, and marketing of our product candidates outside the United States is subject to government regulation. In most foreign countries, we must complete rigorous pre-clinical testing and extensive human clinical trials that demonstrate the safety and efficacy of a ~~product in order to apply for regulatory approval to market the product. If foreign regulatory authorities grant regulatory approval of a product, the approval may be~~ limited to ~~specific~~operating ~~indications~~history ~~or limited with respect to its distribution. Expanded or additional indications for approved devices may not be~~upon ~~approved,~~ which ~~could~~to ~~limit~~evaluate our ~~potential~~business ~~revenues.~~and ~~Foreign~~forecast ~~regulatory~~our ~~authorities~~future ~~may~~sales ~~refuse~~and tooperating ~~grant~~results ~~any approval. Consequently, even if we believe that pre- clinical~~ and ~~clinical~~may ~~data~~face ~~are~~difficulties ~~sufficient~~frequently toencountered ~~support regulatory approval for our products, foreign regulatory~~by ~~authorities~~companies ~~may not ultimately grant approval for commercial sale~~ in ~~any~~competitive ~~jurisdiction. If our product candidates are not approved in such jurisdictions, our ability to generate revenues will be limited~~ and ~~our~~rapidly-evolving ~~business will be adversely affected~~markets.

~~Our~~We ~~competitors~~have ~~may~~a ~~develop~~limited operating history upon ~~products~~which ~~that~~to ~~are~~evaluate ~~more~~our ~~effective~~business and forecast our future sales and operating results. In June 2026, ~~safer~~we announced commercial availability of, and ~~less~~commenced ~~expensive~~initial ~~than~~shipments ~~ours~~of, our Pivot insulin delivery system in the United States, and we intend to expand commercial activities across metropolitan markets by late 2026. This is our first commercial product launch. We previously received FDA clearance for our MODD1 pump in September 2024, but we do not intend to commercialize the MODD1 product. In assessing our business prospects, you should consider these factors as well as the various risks and difficulties frequently encountered by companies in competitive and rapidly evolving markets, particularly those facing emerging growth companies that manufacture and sell medical devices.

~~Existing~~These ~~insulin~~risks ~~pumps~~include ~~are~~our ~~expensive,~~ability with the more popular models receiving reimbursement exceeding $4,000 under durable medical equipment or pharmacy benefit coverage from individuals without health insurance and often requiring significant patient copays. Others have daily use costs that exceed the reimbursement rates of many health insurance plans, forcing some users to ~~spend thousands of dollars a year in copays. We believe this makes insurers hesitant to pay for any pumps and places pumps out of reach for many patients who cannot afford such out of pocket expenses.~~:

We● ~~are~~implement ~~engaged in the diabetes treatment sector of the healthcare marketplace, which is intensely competitive. There are current products that are quite effective at addressing the effects of diabetes,~~ and weexecute expect that new developments by other companies and academic institutions in the areas of diabetes treatment will continue. If approved for marketing by the FDA, depending on the approved clinical indication, our ~~product~~business ~~will be competing with existing and future products related to treatments for diabetes.~~strategy;

~~Our~~● ~~competitors~~manage ~~may:~~and improve the productivity of our sales, clinical and marketing infrastructure to grow sales of our Pivot insulin pump and any future products;

~~● develop product candidates and market products that increase the levels of safety or efficacy that our product candidates will need to show in order to obtain regulatory approval;~~26

● ~~develop~~gain ~~product~~acceptance ~~candidates~~of our Pivot pump among people with insulin-dependent diabetes, their caregivers and ~~market~~healthcare ~~products~~providers, ~~that~~particularly ~~are~~the ~~less~~“Almost ~~expensive~~Pumpers,” orwho ~~more~~are ~~effective~~our ~~than~~primary ~~ours~~target market;

● ~~commercialize~~comply ~~competing~~with ~~products~~a ~~before~~broad werange ~~can~~of ~~launch~~regulatory ~~any~~requirements ~~products~~within wea ~~are~~highly ~~working~~regulated ~~to develop~~industry;

● ~~hold~~enhance orour ~~obtain~~manufacturing ~~proprietary~~capabilities ~~rights~~with ~~that~~our ~~could~~manufacturing ~~prevent~~partner, usPhillips ~~from~~Medisize, ~~commercializing~~increase production of our Pivot pump efficiently while maintaining quality standards, and adapt our manufacturing facilities to the production of new products; or

● ~~introduce~~respond ~~therapies~~effectively orto ~~market~~competitive ~~medical~~pressures ~~products~~from ~~that~~established ~~render~~insulin ~~our~~pump ~~current~~manufacturers ~~MODD1~~such ~~product~~as ~~and~~Medtronic, ~~future~~Tandem ~~product~~and ~~candidates obsolete.~~Insulet;

We● ~~expect~~enhance toour ~~compete~~Pivot ~~against~~pump ~~large medical device companies, such as Medtronic, Inc., Tandem Diabetes Care, Inc.~~ and ~~Insulet~~develop ~~Corporation,~~future smaller companies that are collaborating with larger medical device companies, new companies, academic institutions, government agencies and other public and private research organizations. These competitors, in nearly all cases, produce similar products ~~relative to the treatment of diabetes and have substantially greater financial resources than we do. Some of our competitors also have significantly greater experience in:~~;

● ~~developing~~obtain ~~medical~~and ~~device~~maintain regulatory clearance or approval to enhance our existing products and ~~other~~commercialize ~~product~~proposed ~~candidates~~products;

● ~~undertaking~~perform ~~testing~~any ~~and~~required clinical ~~studies~~trials with respect to our existing products and proposed products; and

● ~~building~~attract, ~~relationships~~retain ~~with~~and ~~key~~motivate ~~customers~~qualified ~~and~~personnel ~~opinion-leading~~in ~~physicians;~~various areas of our business.

●Due ~~obtaining~~to our limited operating history, we may not have the institutional knowledge or experience to be able to effectively address these and ~~maintaining~~other ~~FDA~~risks that may face our business. In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends. As a result of these or other ~~regulatory~~risks, ~~approvals;~~we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.

25We have a limited commercial history and limited experience marketing and selling our products. We only recently launched our commercial product, which may make it difficult to evaluate the prospects for our future viability and predict our future performance.

●We ~~formulating~~are ~~and~~a ~~manufacturing~~commercial-stage medical ~~devices;~~device company with limited commercial history and may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown obstacles. We announced commercial availability of our Pivot insulin delivery system in June 2026 and therefore do not have a long history operating as a commercial company. Our limited commercial history and limited number of cleared products makes it difficult to evaluate our current business and predict our future performance. These factors also make it difficult for us to forecast our future financial performance and growth. Although we intend to expand commercial activities across metropolitan markets by late 2026, any assessment of our future revenue, profitability or prediction about our future success or viability is subject to significant uncertainty. We have encountered in the past, and will encounter in the future, risks and uncertainties frequently experienced by growing companies in emerging and rapidly changing industries, including scaling up our infrastructure and headcount, developing relationships with distributors and diabetes educator practices, and building brand awareness among Almost Pumpers and healthcare providers. If our assumptions regarding these risks and uncertainties, which we use to plan and operate our business, are incorrect or change, or if we do not address these risks successfully, our results of operations could differ materially from our expectations, and our business, financial condition and results of operations could be materially and adversely affected.

●Obtaining marketing ~~launching,~~authorization in the United States will not obviate the need to obtain marketing authorization in other jurisdictions We must obtain approval from foreign regulatory authorities before we can market and ~~selling~~sell ~~medical~~any ~~devices;~~of our product candidates in countries outside the United States. We will incur additional costs in seeking such approvals, may experience delays in obtaining such approvals and cannot be certain that such approvals will be granted.

●The development, ~~providing~~manufacture, ~~management~~and ~~oversight~~marketing of our product candidates outside the United States is subject to government regulation. In most foreign countries, we must complete rigorous pre-clinical testing and extensive human clinical trials that demonstrate the safety and efficacy of a product in order to apply for ~~all~~regulatory approval to market the product. If foreign regulatory authorities grant regulatory approval of a product, the ~~above-listed~~approval ~~operational~~may ~~functions;~~be limited to specific indications or limited with respect to its distribution. Expanded or additional indications for approved devices may not be approved, which could limit our potential revenues. Foreign regulatory authorities may refuse to grant any approval. Consequently, even if we believe that preclinical and clinical data are sufficient to support regulatory approval for our products, foreign regulatory authorities may not ultimately grant approval for commercial sale in any jurisdiction. If our product candidates are not approved in such jurisdictions, our ability to generate revenues will be limited and our business will be adversely affected.

~~● obtaining insurance coverage and reimbursement for their competitive products.~~27

~~If we fail to achieve acceptance over other existing or newly developed~~Our ~~products,~~competitors we may bedevelop ~~unable~~products ~~to obtain regulatory approval or successfully commercialize our future insulin pump product candidates. If our competitors’ market medical devices~~ that are ~~less expensive, safer or~~ more effective ~~than our insulin pump~~, orsafer ~~that gain or maintain greater market acceptance, we may not be able to compete effectively, which would adversely affect our business, prospects, results of operations~~ and ~~financial~~less ~~condition.~~expensive ~~See~~than ~~“Business - Competition~~ours.”

WeExisting insulin ~~expect~~pumps toare ~~rely~~expensive, onwith ~~third-party~~the more popular models receiving reimbursement exceeding $4,000 under durable medical equipment or ~~manufacturers~~pharmacy benefit coverage from individuals without health insurance and ~~will~~often berequiring ~~dependent~~significant onpatient ~~their~~copays. ~~quality~~Others have daily use costs that exceed the reimbursement rates of many health insurance plans, forcing some users to spend thousands of dollars a year in copays. We believe this makes insurers hesitant to pay for any pumps and ~~effectiveness~~places pumps out of reach for many patients who cannot afford such out of pocket expenses.

~~Our insulin pump requires precise, high-quality~~We ~~manufacturing.~~are ~~The~~engaged ~~failure~~in tothe ~~achieve~~diabetes ~~and~~treatment ~~maintain~~sector ~~high~~of ~~manufacturing standards, including failure to detect or control anticipated or unanticipated manufacturing errors or~~ the ~~frequent~~healthcare ~~occurrence of such errors~~marketplace, ~~could~~which ~~result~~is inintensely ~~patient~~competitive. ~~injury~~There orare ~~death,~~current ~~discontinuance~~products orthat ~~delay~~are ofquite ~~ongoing~~effective orat ~~planned~~addressing ~~clinical~~the ~~studies,~~effects ~~delays~~of ~~or failures in product testing or delivery~~diabetes, ~~cost overruns, product recalls or withdrawals~~ and ~~other~~we ~~problems~~expect that ~~could~~new ~~seriously~~developments ~~hurt~~by ~~our~~other ~~business.~~companies ~~Contract~~and ~~medical~~academic ~~device manufacturers often encounter difficulties~~institutions ~~involving~~in ~~production~~the ~~yields,~~areas ~~quality~~of ~~control~~diabetes ~~and~~treatment ~~quality~~will ~~assurance and shortages of qualified personnel~~continue. ~~These~~If ~~manufacturers~~approved ~~are~~for ~~subject to~~marketing ~~stringent~~by ~~regulatory requirements, including~~ the FDA’s, ~~current~~depending ~~good-manufacturing-practices~~on ~~regulations. If our contract manufacturers fail to maintain ongoing compliance at any time,~~ the ~~production~~approved ofclinical indication, our product ~~could~~will be ~~interrupted,~~competing ~~resulting~~with inexisting ~~delays~~and orfuture ~~discontinuance of~~products ~~our~~related ~~clinical~~to ~~studies,~~treatments ~~additional~~for ~~costs and loss of potential revenues~~diabetes.

WeOur competitors may: ~~not be able to successfully scale-up manufacturing of our products in sufficient quality and quantity, which would delay or prevent us from commercializing our products.~~

In● ~~order~~develop toproduct ~~conduct~~candidates ~~larger-scale or late-stage clinical studies~~ and ~~for~~ ~~commercialization~~market ~~of our insulin pump~~ products, ifthat ~~510(k) clearance is granted for any product, we will need to manufacture it in larger quantities. We may not be able to successfully~~ increase the ~~manufacturing~~levels ~~capacity~~of ~~for~~safety ~~our~~or ~~MODD~~efficacy 1that ~~product~~our ~~or future~~ product candidates in awill ~~timely~~need ~~or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities. If we are unable~~ to ~~successfully~~ ~~scale~~show ~~up the manufacture of our product candidate~~ in ~~sufficient~~order ~~quality~~to ~~and~~obtain ~~quantity, the development and testing of our product candidates and~~ regulatory approval ~~or commercial launch may be delayed, which could significantly harm our business.~~;

We● ~~are~~develop ~~dependent upon third-party suppliers to manufacture our~~ product, ~~and~~candidates ~~this makes us vulnerable to supply shortages~~ and ~~price~~market ~~increases;~~products wethat ~~may~~are ~~not~~less beexpensive ~~able~~or tomore ~~obtain an~~effective ~~adequate~~than ~~supply of components on a timely basis or at all.~~ours;

~~The~~● ~~future~~commercialize ~~manufacture~~competing ofproducts ~~our~~before product will require the timely delivery of sufficient amounts of components from multiple suppliers in various countries. We intend to work closely with our suppliers to ensure continuity of supply, but we ~~cannot~~can ~~guarantee~~launch these efforts will be successful. Due to the supply chain issues experienced by the semiconductor industry, at times, we have experienced delays obtaining integrated circuits from certain suppliers. We may need to enter into “take or pay” contracts with suppliers. We have also seen price increases for various components. We do not have supply agreements with any ofproducts ~~our suppliers, and~~ we ~~make~~are ~~purchases~~working ~~based on individual purchase orders. An interruption, delay, or inability~~ to obtain components from our third-party suppliers at acceptable prices in a timely manner, could hinder our ability to manufacture our products and have a material adverse effect on our business, prospects, financial condition and results of operations.develop;

We● ~~may~~hold beor ~~subject~~obtain toproprietary ~~potential product~~rights ~~liability and other claims~~ that could ~~materially~~prevent ~~impact~~us ~~our~~from ~~business~~commercializing ~~and~~our ~~financial~~products; ~~condition.~~or

~~The~~● ~~marketing~~introduce ~~and~~therapies ~~sale~~or ofmarket ~~our~~medical ~~insulin pump~~products ~~exposes~~that usrender toour ~~the~~current ~~risk of significant damages from~~ product ~~liability~~ and ~~other~~future ~~claims, and the use of our~~ product incandidates ~~clinical studies may result in adverse effects from liability claims~~obsolete. We cannot predict all the possible harms or adverse effects that may result. We intend to obtain product liability insurance to provide some protection from claims. Nonetheless, we may not have sufficient resources to pay for any liabilities resulting from a personal injury or other claim, even if it is partially covered by insurance. In addition to the possibility of direct claims, we may be required to indemnify third parties against damages and other liabilities arising out of our development, commercialization and other business activities, which would increase our liability exposure. If third parties that have agreed to indemnify us fail to do so, we may be held responsible for those damages and other liabilities as well.

26We expect to compete against large medical device companies, such as Medtronic, Inc., Tandem Diabetes Care, Inc. and Insulet Corporation, smaller companies that are collaborating with larger medical device companies, new companies, academic institutions, government agencies and other public and private research organizations. These competitors, in nearly all cases, produce similar products relative to the treatment of diabetes and have substantially greater financial resources than we do. Some of our competitors also have significantly greater experience in:

~~Legislative,~~● ~~regulatory,~~developing or medical ~~cost~~device ~~reimbursement~~and ~~changes~~other ~~may~~product ~~adversely impact our business.~~candidates;

~~New~~● ~~laws,~~undertaking regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to the health care system in the U.S. and in other jurisdictions may change the nature of and regulatory requirements relating to innovations in medical devices, testing and ~~regulatory~~clinical approvals, limit or eliminate payments for medical procedures and treatments, or subject the pricing of medical devices to government control. In addition, third-party payors in the U.S. are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement of new products. Consequently, significant uncertainty exists as to the reimbursement status of newly approved health care products. Significant changes in the health care system in the U.S. or elsewhere, including changes resulting from adverse trends in third-party reimbursement programs, could have a material adverse effect on our projected future operating results and our ability to raise capital, commercialize products, and remain in business.studies;

We● ~~are~~building ~~subject~~relationships towith ~~extensive~~key ~~regulation~~customers ~~by the FDA, which could restrict the sales~~ and ~~marketing~~opinion-leading ~~of our insulin pump products and could cause us to incur significant costs.~~physicians;

~~Our~~● ~~insulin~~obtaining ~~pump products are subject to extensive regulation by the FDA. These regulations relate to manufacturing, labeling, sale, promotion, distribution~~ and ~~shipping.~~maintaining ~~Before a new medical device, or a new intended use of a legally marketed device, can be marketed in the United States, it must be cleared or approved by the~~ FDA through the applicable premarket review process (510(k), PMA, or de novo classification), unless an exemption applies. While we have received 510(k) clearance for our initial insulin pump product, the MODD1, we may be required to obtain new 510(k) clearances for significant post-market modifications to the pump. For example, our Pivot product, which we expect over time to replace the MODD1 product, will require 510(k) clearance. Each premarket submission and ~~review~~other ~~process~~regulatory ~~can be expensive and lengthy, and entail significant user fees, unless exempt.~~approvals;

~~Medical~~● ~~devices~~formulating ~~may~~and bemanufacturing ~~marketed~~medical ~~only for the indications for which they are approved or cleared. Further, 510(k) clearance can be revoked if safety or effectiveness problems develop once the device is on the market.~~devices;

~~The~~● current regulatory requirements to which we are subject may change in the future in a way that adversely affects us. If we fail to comply with present or future regulatory requirements that are applicable to uslaunching, wemarketing ~~may~~and beselling ~~subject~~medical ~~to enforcement action by the FDA, which may include any of the following sanctions:~~devices;

● ~~untitled~~providing ~~letters,~~management ~~warning~~oversight ~~letters,~~for ~~fines,~~all ~~injunctions,~~of ~~consent~~the ~~decrees~~above-listed ~~and~~operational ~~civil penalties~~functions; and

● ~~customer~~obtaining ~~notification,~~insurance orcoverage ~~orders~~and reimbursement for ~~repair,~~their ~~replacement~~competitive ~~or refunds;~~products.

●If we ~~voluntary~~fail to achieve acceptance over other existing or ~~mandatory~~newly ~~recall~~developed products, we may be unable to obtain regulatory approval or ~~seizure~~successfully commercialize ofour future insulin pump product candidates. If our ~~current~~competitors’ market medical devices that are less expensive, safer or ~~future~~more ~~products;~~effective than our insulin pump, or that gain or maintain greater market acceptance, we may not be able to compete effectively, which would adversely affect our business, prospects, results of operations and financial condition. See “Business - Competition.”

~~● administrative detention by the FDA of medical devices believed to be adulterated or misbranded;~~28

●We expect ~~imposing~~to ~~operating~~rely ~~restrictions,~~on ~~suspension~~third-party ormanufacturers ~~shutdown~~and ofwill ~~production;~~be dependent on their quality and effectiveness.

●Our insulin ~~refusing~~pump ~~our~~requires ~~requests~~precise, ~~for~~high-quality ~~510(k)~~manufacturing. ~~clearance~~The failure to achieve and maintain high manufacturing standards, ~~PMA~~including failure to detect or ~~de-novo~~control ~~classification~~anticipated or unanticipated manufacturing errors or the frequent occurrence of ~~any~~such ~~new~~errors, ~~products~~could result in patient injury or death, ~~new~~discontinuance ~~intended~~or ~~uses~~delay of ongoing or ~~modifications~~planned clinical studies, delays or failures in product testing or delivery, cost overruns, product recalls or withdrawals and other problems that could seriously hurt our business. Contract medical device manufacturers often encounter difficulties involving production yields, quality control and quality assurance and shortages of qualified personnel. These manufacturers are subject to stringent regulatory requirements, including the FDA’s current good-manufacturing-practices regulations. If our ~~insulin~~contract ~~pump;~~manufacturers fail to maintain ongoing compliance at any time, the production of our product could be interrupted, resulting in delays or discontinuance of our clinical studies, additional costs and loss of potential revenues.

●We may ~~rescinding~~not ~~510(k)~~be ~~clearance~~able ~~that~~to ~~has~~successfully ~~already~~scale-up ~~been~~manufacturing ~~granted;~~of our products in sufficient quality and quantity, which would delay or prevent us from commercializing our products.

●In order ~~criminal~~to ~~prosecution~~conduct larger-scale or late-stage clinical studies and for commercialization of our insulin pump products, we will need to manufacture it in larger quantities. We may not be able to successfully increase the manufacturing capacity for our Pivot product or future product candidates in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities. If we are unable to successfully scale up the manufacture of our product candidates in sufficient quality and quantity, the development and testing of our product candidates and regulatory approval or commercial launch may be delayed, which could significantly harm our business.

~~The~~We are ~~occurrence~~dependent ofupon ~~any~~third-party ofsuppliers ~~these~~to ~~events would~~manufacture ~~have~~our aproduct, ~~material~~and ~~adverse~~this ~~effect~~makes onus ~~our~~vulnerable ~~business,~~to ~~financial~~supply ~~condition~~shortages and ~~results~~price ofincreases; we ~~operations~~may ~~and~~not ~~could~~be ~~result~~able into ~~stockholders~~obtain ~~losing their~~an ~~entire~~adequate ~~investment~~supply of components on a timely basis or at all.

27The manufacture of our product will require the timely delivery of sufficient amounts of components from multiple suppliers in various countries. We have been working closely with our suppliers to ensure continuity of supply, but we cannot guarantee these efforts will be successful. Due to the supply chain issues experienced by the semiconductor industry, at times, we have experienced delays obtaining integrated circuits from certain suppliers. We may need to enter into “take or pay” contracts with suppliers. We have also seen price increases for various components. We do not have supply agreements with any of our suppliers, and we make purchases based on individual purchase orders. An interruption, delay, or inability to obtain components from our third-party suppliers at acceptable prices in a timely manner, could hinder our ability to manufacture our products and have a material adverse effect on our business, prospects, financial condition and results of operations.

~~Although our insulin pump products do not presently require clinical~~We ~~trials~~may tobe ~~apply~~subject to ~~the~~potential ~~FDA~~product ~~for~~liability ~~clearance,~~ and ~~even~~other ifclaims athat ~~clinical~~could ~~trial~~materially isimpact ~~completed, the results of~~ our ~~clinical~~business ~~testing may not demonstrate the safety~~ and ~~efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidates~~financial condition.

~~Clinical trials are almost always required~~The tomarketing ~~support a PMA application~~ and ~~may~~sale ~~also~~of ~~be required to support 510(k) submissions, although at this time~~ our ~~products~~insulin dopump ~~not~~exposes ~~require a~~us ~~PMA.~~to If the ~~device~~risk ~~presents~~of ~~a “~~significant ~~risk”~~damages tofrom ~~human~~product ~~health~~liability asand ~~defined~~other ~~by the FDA~~claims, ~~the~~and ~~FDA requires~~ the ~~study sponsor~~ touse ~~submit~~of anour ~~investigational~~product ~~device~~in ~~exemption, or IDE, application and obtain IDE approval prior to commencing human~~ clinical ~~trials. The~~studies ~~IDE~~may ~~must~~result ~~be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device~~ in ~~humans~~adverse ~~and~~effects ~~that~~from ~~the~~liability ~~testing protocol is scientifically sound~~claims. AnWe ~~IDE~~cannot ~~will~~predict ~~automatically~~all ~~become effective 30 days after receipt by~~ the ~~FDA,~~ ~~unless~~possible ~~the FDA denies the application~~ harms or ~~notifies~~adverse ~~the~~effects ~~sponsor~~ that ~~the investigation is on hold and~~ may ~~not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns~~result. ~~The~~We ~~FDA~~have ~~may~~obtained ~~also~~product ~~notify~~liability ~~the~~insurance ~~sponsor that~~to ~~the~~provide ~~study~~some isprotection ~~approved~~from aspotential ~~proposed~~claims. ~~If the FDA determines that there are deficiencies or other concerns with an IDE that require modification~~Nonetheless, ofwe ~~the study, the FDA~~ may ~~permit~~not ahave ~~clinical~~sufficient ~~trial~~resources to ~~proceed~~pay ~~under~~for ~~conditional~~any ~~approval.~~liabilities ~~Furthermore,~~resulting ~~the~~from ~~agency may withdraw approval of an IDE under certain circumstances. Clinical trials for~~ a ~~significant~~personal ~~risk~~injury ~~device~~or ~~may~~other ~~begin~~claim, ~~once~~even anif ~~IDE~~it is ~~approved~~partially covered by ~~the~~insurance. ~~FDA~~In ~~and the~~addition ~~appropriate~~to ~~Institutional Review Board, or IRB, at each clinical trial site. If~~ the ~~product~~possibility isof ~~deemed~~direct ~~a “non-significant risk” device~~claims, ~~IDE~~we ~~approval~~may ~~from the FDA would not~~ be required, ~~but the clinical trial would need~~ to ~~meet~~indemnify ~~other~~third ~~requirements~~parties ~~including~~against ~~IRB approval.~~damages ~~Our clinical trials must be conducted in accordance with FDA regulations~~ and ~~federal~~other ~~and~~liabilities ~~state~~arising ~~regulations~~out ~~concerning~~of ~~human~~our ~~subject protection~~development, ~~including~~ ~~informed~~commercialization ~~consent~~ and ~~healthcare~~other ~~privacy.~~business Aactivities, ~~clinical~~which ~~trial~~would ~~may~~increase beour ~~suspended by the FDA or at a specific site by the relevant~~liability ~~IRB~~exposure. atIf ~~any~~third ~~time~~parties ~~for various reasons, including a determination~~ that ~~the~~have ~~risks~~agreed to ~~the~~indemnify ~~trial~~us ~~participants~~fail ~~outweigh~~to ~~the~~do ~~benefits of participation in the clinical trial. Even if a clinical trial is completed~~so, ~~the~~we ~~results of our clinical testing~~ may ~~not demonstrate the safety and efficacy of the device or may~~ be ~~equivocal~~held orresponsible ~~otherwise not be sufficient~~ for usthose todamages ~~obtain~~and ~~approval~~other ofliabilities as ~~our product~~well.

~~Our~~Legislative, regulatory, ~~success~~or ~~depends~~medical ~~substantially~~cost ~~upon~~reimbursement ~~our~~changes ~~ability~~may toadversely ~~obtain~~impact ~~and maintain intellectual property protection relating to~~ our ~~insulin pump products and research technologies~~business.

WeNew laws, ~~have~~regulations ~~applied~~and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to the health care system in the U.S. ~~Patent~~ and ~~Trademark~~ ~~Office,~~in orother jurisdictions may change the ~~USPTO,~~nature of and ~~various~~regulatory ~~foreign~~requirements ~~patent~~relating ~~agencies~~to ~~for~~innovations ~~patents~~in onmedical devices, ~~our~~testing ~~proprietary~~and ~~fluid~~regulatory ~~movement~~approvals, ~~technology~~limit ~~and~~or ~~our~~eliminate ~~insulin delivery~~payments ~~methodology.~~for Tomedical ~~date~~procedures and treatments, ~~the~~or ~~USPTO~~subject ~~has~~the ~~granted~~pricing of ~~five~~medical ~~patents~~devices to usgovernment control. In addition, ~~and~~third-party wepayors ~~have~~in ~~been~~the ~~awarded~~U.S. ~~two~~are ~~patents~~increasingly byattempting ~~foreign~~to ~~jurisdictions.~~contain health care Wecosts ~~have~~by ~~additional~~limiting ~~applications~~both ~~pending~~coverage and inthe ~~various~~level ~~stages~~of reimbursement of ~~review~~new byproducts. ~~the~~Consequently, ~~USPTO~~significant ~~and~~uncertainty ~~foreign~~exists ~~patent~~as ~~agencies.~~to ~~There~~the reimbursement ~~can~~status beof nonewly ~~assurance that~~approved wehealth ~~will~~care beproducts. ~~issued~~Significant ~~additional~~changes ~~patents~~in bythe health care system in the ~~USPTO~~U.S. or ~~foreign~~elsewhere, including ~~patent~~changes ~~agencies~~resulting ~~and~~from ~~that~~adverse ~~any~~trends ofin ~~our~~third-party ~~patents~~reimbursement ~~will~~programs, ~~prevent~~could ~~other~~have ~~companies from~~a ~~competing~~material ~~with~~adverse ~~us.~~effect Weon ~~will~~our ~~continue~~projected future tooperating ~~attempt~~results toand ~~patent~~ our ~~innovations,~~ability asto ~~appropriate~~raise capital, tocommercialize ~~help~~products, ~~ensure~~and aremain ~~sustainable~~in ~~competitive advantage~~business.

Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering health care product inventions, our ability to enforce our existing patents and to obtain and enforce patents that may issue from any pending or future patent applications is uncertain and involves complex legal, scientific and factual questions. To date, no consistent policy has emerged regarding the breadth of claims allowed in medical device patents. Thus, we cannot be sure that any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents do issue, we cannot be sure that the claims of these patents will be held valid or enforceable by a court of law, will provide us with any significant protection against competing products, or will afford us a commercial advantage over competitive products. If, at some point in the future, one or more products resulting from our product candidates is approved for sale by the FDA and we do not have adequate intellectual property protection for those products, competitors could duplicate them for approval and sale in the United States without repeating the extensive testing required of us to obtain FDA approval.29

~~If we~~ We are ~~sued~~subject ~~for~~to ~~infringing on~~extensive ~~third-party~~regulation ~~intellectual~~by ~~property~~the ~~rights~~FDA, itwhich ~~will~~could berestrict ~~costly~~the sales and ~~time-consuming,~~marketing ~~and~~of anour ~~unfavorable~~insulin ~~outcome~~pump ~~would~~products ~~have~~and acould ~~significant~~cause ~~adverse~~us ~~effect~~to onincur ~~our~~significant ~~business~~costs.

Our insulin ~~ability~~pump products are subject to ~~commercialize~~extensive ~~our~~regulation ~~pump~~by ~~products~~the ~~depends~~FDA. onThese ~~our~~regulations ~~ability~~ relate to ~~use~~manufacturing, ~~manufacture~~labeling, sale, promotion, distribution and ~~sell~~shipping. ~~our~~Before ~~product~~a ~~current~~new ~~and~~medical ~~future~~device, ~~product~~or ~~candidates~~a ~~without~~new ~~infringing~~intended ~~the~~use ~~patents~~of ora ~~other~~legally ~~proprietary~~marketed ~~rights~~device, can be marketed in the United ofStates, ~~third~~it ~~parties.~~must ~~Numerous~~be ~~U.S.~~cleared ~~and~~or ~~foreign~~approved ~~issued~~by ~~patents~~the ~~and~~FDA ~~pending~~through ~~patent~~the ~~applications~~applicable ~~owned~~premarket byreview ~~third~~process ~~parties~~(510(k), ~~exist~~PMA, inor ~~the~~de ~~diabetes~~novo classification), ~~medical~~unless ~~device~~an ~~area~~exemption applies. ~~There~~While ~~may~~we behave ~~existing~~received ~~patents~~510(k) clearance for our initial insulin pump products, ~~unknown~~the toMODD1 usand Pivot, onwe ~~which~~may be ~~our~~required ~~activities~~to ~~with~~obtain ~~our~~new ~~insulin~~510(k) clearances for significant, post-market modifications to our pump products. ~~could~~Each ~~infringe~~premarket submission and review process can be expensive and lengthy, and entail significant user fees, unless exempt.

IfMedical devices amay ~~third~~be ~~party~~marketed ~~claims~~only ~~that~~for ~~our~~the ~~actions infringe~~indications onfor ~~its~~which ~~patents~~they orare ~~other~~approved ~~proprietary~~or ~~rights~~cleared. Further, we510(k) ~~could~~clearance ~~face~~can abe ~~number~~revoked ofif safety ~~issues~~or ~~that~~effectiveness ~~could~~problems ~~materially~~develop ~~harm~~once ~~our~~the ~~competitive~~device ~~position, including,~~is ~~but~~on ~~not~~the ~~limited~~market. ~~to:~~

●The current ~~infringement~~regulatory ~~and~~requirements ~~other~~to ~~intellectual~~which ~~property~~we ~~claims~~are subject may change in the future in a way that, ~~even~~adversely ifaffects ~~meritless,~~us. ~~can~~If bewe ~~costly~~fail ~~and~~to ~~time-consuming,~~comply with ~~delay~~present ~~the~~or future regulatory ~~approval~~requirements ~~process~~that ~~and~~are ~~divert~~applicable ~~management’s~~to ~~attention~~us, ~~from~~we ~~our~~may ~~core~~be ~~business~~subject ~~operations;~~to enforcement action by the FDA, which may include any of the following sanctions:

● anuntitled ~~order~~letters, ~~that~~warning weletters, ~~pay substantial damages for infringement~~fines, ~~including consequential damages for lost of profits or market share~~injunctions, ifconsent adecrees ~~court~~and ~~determines~~civil ~~that our products or technologies infringe on a third party’s patent or other proprietary rights~~penalties;

● acustomer ~~court~~notification, ~~prohibiting us from selling~~ or ~~licensing~~orders ~~our~~for ~~products~~repair, orreplacement ~~technologies unless the holder licenses the patent~~ or ~~other proprietary rights to us, which it is not required to do~~refunds; ~~and~~

● ~~even~~voluntary ifor amandatory ~~license~~recall ~~is available from a holder, we may have to pay substantial royalties~~ or ~~grant~~seizure ~~cross-licenses~~of to our ~~patents~~current or ~~other~~future ~~proprietary rights.~~products;

If● ~~any~~administrative ofdetention ~~these~~by ~~events~~the ~~occur,~~FDA itof ~~could significantly~~medical ~~harm~~devices ~~our~~believed ~~operations~~to ~~and~~be ~~financial~~adulterated ~~condition~~or ~~and negatively affect our stock price.~~misbranded;

28● imposing operating restrictions, suspension or shutdown of production;

If● werefusing ~~are~~our ~~unable~~requests tofor ~~protect the~~510(k) ~~confidentiality~~clearance, ofPMA ~~our~~or ~~proprietary~~de-novo ~~information,~~classification ~~the~~of ~~value~~any ofnew ~~our~~products, ~~technology~~new ~~and~~intended ~~products~~uses ~~could~~or bemodifications ~~adversely~~to ~~affected.~~our insulin pump;

In● ~~addition~~rescinding to510(k) ~~patented~~clearance technology and technology for which patent protection is being sought, we rely on our unpatented technology, trade secrets and know-how. We generally seek to protect this information by confidentiality, non-disclosure and assignment of invention agreements with our officers, employees, contractors and other service providers and with parties with which we do business. These agreements may be breached, which breach may result in the misappropriation of such information, and we may not have adequate remedies for any such breach. We cannot be certain that ~~the~~ ~~steps~~has wealready ~~have~~been ~~taken~~granted; ~~will prevent unauthorized use or reverse engineering of our technology.~~and

~~Moreover,~~● ~~our~~criminal ~~trade secrets may be disclosed to or otherwise become known or be independently developed by competitors~~prosecution. To the extent that our officers, employees, contractors, other service providers, or other third parties with whom we do business use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. If, for any of the above reasons, our intellectual property is disclosed or misappropriated, it would harm our ability to protect our rights and have a material adverse effect on our business, financial condition, and results of operations.

~~Intellectual~~The occurrence ~~property~~of ~~rights do~~any ~~not~~of ~~necessarily~~these ~~address~~events ~~all~~would ~~potential~~have ~~threats~~a tomaterial adverse effect on our ~~competitive~~business, ~~advantage~~financial condition and results of operations and could result in stockholders losing their entire investment.

~~The~~Although our ~~degree~~insulin ofpump ~~future~~products ~~protection~~do ~~afforded by~~not ~~our~~presently ~~intellectual~~require ~~property~~clinical ~~rights~~trials isto ~~uncertain~~apply ~~because~~to ~~intellectual~~the ~~property~~FDA ~~rights~~for ~~have limitations~~clearance, and ~~may~~even ~~not~~if ~~adequately~~a ~~protect~~clinical trial is completed, the results of our ~~business,~~clinical ortesting ~~permit~~may usnot todemonstrate ~~gain~~the safety and ~~maintain~~efficacy aof ~~competitive~~the ~~advantage.~~device ~~The~~or ~~following~~may ~~examples~~be ~~are~~equivocal ~~illustrative:~~or otherwise not be sufficient for us to obtain approval of our product candidates.

●Clinical trials ~~others~~are almost always required to support a PMA application and may also be ~~able~~required to ~~make~~support ~~devices~~510(k) submissions, although at this time our products do not require a PMA. If the device presents a “significant risk” to human health as defined by the FDA, the FDA requires the study sponsor to submit an investigational device exemption, or IDE, application and obtain IDE approval prior to commencing human clinical trials. The IDE must be supported by appropriate data, such as animal and laboratory testing results, showing that ~~are~~it ~~similar~~is safe to ~~our~~test ~~insulin~~the ~~pump~~device ~~but~~in humans and that the testing protocol is scientifically sound. An IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the sponsor that the investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns. The FDA may also notify the sponsor that the study is approved as proposed. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may permit a clinical trial to proceed under conditional approval. Furthermore, the agency may withdraw approval of an IDE under certain circumstances. Clinical trials for a significant risk device may begin once an IDE is approved by the FDA and the appropriate Institutional Review Board, or IRB, at each clinical trial site. If the product is deemed a “non-significant risk” device, IDE approval from the FDA would not ~~covered~~be required, but the clinical trial would need to meet other requirements including IRB approval. Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and healthcare privacy. A clinical trial may be suspended by the ~~claims~~FDA ofor at a specific site by the ~~patents~~relevant IRB at any time for various reasons, including a determination that wethe ~~own;~~risks to the trial participants outweigh the benefits of participation in the clinical trial. Even if a clinical trial is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product.

~~● we or any collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own;~~30

●Our success wedepends ~~might~~substantially ~~not~~upon ~~have~~our ~~been~~ability ~~the~~to ~~first~~obtain toand ~~file~~maintain ~~patent~~intellectual ~~applications~~property ~~covering~~protection ~~certain~~relating ofto our ~~inventions;~~insulin pump products and research technologies.

●We have ~~others~~applied ~~may~~to ~~independently~~the ~~develop~~U.S. ~~similar~~Patent and Trademark Office, or ~~alternative~~the ~~technologies~~USPTO, and various foreign patent agencies for patents on our proprietary fluid movement technology and our insulin delivery methodology. To date, the USPTO has granted six patents to us, and we have been awarded four patents by foreign jurisdictions. We have additional applications pending and in various stages of review by the USPTO and foreign patent agencies. There can be no assurance that we will be issued additional patents by the USPTO or ~~duplicate~~foreign patent agencies and that any of our ~~technologies~~patents ~~without~~will ~~infringing~~prevent other companies from competing with us. We will continue to attempt to patent our ~~intellectual~~innovations, ~~property~~as ~~rights;~~appropriate, to help ensure a sustainable competitive advantage.

●Due to itevolving legal standards relating to the patentability, validity and enforceability of patents covering health care product inventions, our ability to enforce our existing patents and to obtain and enforce patents that may issue from any pending or future patent applications is ~~possible~~uncertain and involves complex legal, scientific and factual questions. To date, no consistent policy has emerged regarding the breadth of claims allowed in medical device patents. Thus, we cannot be sure that ~~our~~any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents do issue, we cannot be sure that the claims of these patents will be held valid or enforceable by a court of law, will provide us with any significant protection against competing products, or will afford us a commercial advantage over competitive products. If, at some point in the future, one or more products resulting from our product candidates is approved for sale by the FDA and we do not ~~lead~~have adequate intellectual property protection for those products, competitors could duplicate them for approval and sale in the United States without repeating the extensive testing required of us to ~~issued~~obtain ~~patents;~~FDA approval.

~~● issued patents that~~ If we ~~own~~are ~~may~~sued ~~not~~for ~~provide~~infringing uson ~~with~~third-party ~~any~~intellectual ~~competitive~~property ~~advantages~~rights, orit ~~may~~will be ~~held~~costly ~~invalid~~and ortime-consuming, ~~unenforceable~~and asan unfavorable outcome would have a ~~result~~significant ofadverse ~~legal~~effect ~~challenges;~~on our business.

●Our ability ~~our~~to ~~competitors~~commercialize ~~might~~our ~~conduct~~pump ~~research~~products ~~and~~depends ~~development~~on ~~activities~~our inability ~~the~~to ~~U.S.~~use, manufacture and ~~other~~sell ~~countries~~our ~~that~~product ~~provide~~current aand ~~safe~~future ~~harbor~~product candidates ~~from~~without ~~patent~~infringing ~~infringement~~the ~~claims~~patents ~~for~~or ~~certain~~other ~~research~~proprietary ~~and~~rights ~~development~~of ~~activities,~~third asparties. ~~well~~Numerous asU.S. inand ~~countries~~foreign ~~where~~issued wepatents doand pending ~~not~~patent ~~have~~applications ~~patent~~owned ~~rights,~~by ~~and~~third ~~then~~parties ~~use~~exist in the ~~information~~diabetes ~~learned~~medical ~~from~~device ~~such~~area. ~~activities~~There may be existing patents, unknown to ~~develop~~us, ~~competitive~~on ~~products~~which ~~for~~our ~~sale~~activities inwith our ~~major~~insulin ~~commercial~~pump ~~markets;~~products ~~and~~could infringe.

●If a wethird ~~may~~party ~~not~~claims ~~develop~~that ~~additional~~our actions infringe on its patents or other proprietary ~~technologies~~rights, we could face a number of issues that ~~are~~could materially ~~patentable.~~harm our competitive position, including, but not limited to:

29● infringement and other intellectual property claims that, even if meritless, can be costly and time-consuming, delay the regulatory approval process and divert management’s attention from our core business operations;

~~Healthcare~~● ~~reform~~an ~~and~~order ~~drug-pricing~~that ~~reform~~we ~~laws~~pay ~~could~~substantial ~~adversely~~damages ~~affect~~ for infringement, including consequential damages for lost of profits or market share, if a court determines that our products ~~and~~or ~~financial~~technologies ~~condition.~~infringe on a third party’s patent or other proprietary rights;

In● ~~the United States, there have been, and continue to be,~~ a ~~number~~court ofprohibiting ~~legislative~~us ~~initiatives~~from toselling contain healthcare costs. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (ACA), was enacted in the United States, which made a number of substantial changes in the way healthcare is financed by both governmental and private insurers. Among other ways in which it may affect our business, the ACA implemented payment system reforms, including a national pilot program on payment bundling to encourage hospitals, physicians, and other providers to improve the coordination, quality, and efficiency of certain healthcare services through bundled payment models and expanded the eligibility criteria for Medicaid programs. Since its enactment, there have been judicial, executive, and Congressional challenges to certain aspects of the ACA. It is unclear how the ACA and its implementation, as well as efforts to repeal or ~~replace,~~licensing ~~or invalidate, the ACA, or portions thereof, will affect~~ our ~~insulin~~products ~~pump~~ or ~~our~~technologies ~~business.~~unless ~~Additional legislative changes, regulatory changes, and judicial challenges related to~~ the ~~ACA~~holder ~~remain~~licenses ~~possible. It is possible that~~ the ~~ACA,~~patent ~~as currently enacted~~ or ~~as it may be amended in the future, and~~ other ~~healthcare~~proprietary ~~reform~~rights ~~measures~~to ~~that may be adopted in the future~~us, ~~could~~which ~~have~~it ~~an adverse effect on our industry generally and on our ability to commercialize our insulin pump products and achieve profitability. We have assumed in all of our financial projections that there~~ is not anrequired ~~increase~~to indo; ~~the reimbursement for our products through the pharmacy or durable medical equipment routes.~~and

~~Drug~~● ~~pricing~~even ~~continues~~if ~~to be~~ a ~~subject of~~license ~~debate~~is atavailable ~~the~~from ~~executive~~a ~~and legislative levels of U.S. government. The American Rescue Plan Act of 2021 eliminated the statutory cap on rebates that drug manufacturers pay to Medicaid beginning January 1~~holder, ~~2024.~~we ~~With the elimination of the rebate cap, manufacturers~~ may be ~~required~~have to ~~compensate states in an amount greater than what the state Medicaid programs~~ pay ~~for the drug. Additionally, the Inflation Reduction Act of 2022 contains~~ substantial ~~drug~~royalties pricing reforms, including the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or ~~pay~~grant ancross-licenses ~~excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable under Medicare Parts B and D~~ to penalize price increases that outpace inflation, and requires manufacturers to provide discounts on Part D drugs. Substantial penalties can be assessed for noncompliance with the drug pricing provisions in the Inflation Reduction Act of 2022. The Inflation Reduction Act of 2022 could have the effect of reducing the prices we can charge and reimbursement we receive for our ~~products,~~patents ifor ~~approved,~~other ~~thereby~~proprietary ~~reducing our profitability, and could have a material adverse effect on our financial condition, results of operations and growth prospects~~rights. ~~The effect of Inflation Reduction Act of 2022 on our business and the pharmaceutical industry in general is not yet known.~~

~~At the state level, legislatures have~~If increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. We expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of ~~which~~these ~~could~~events ~~limit the amounts that federal and state governments will pay for healthcare products and services~~occur, ~~which~~it could ~~result~~significantly inharm ~~limited~~our ~~coverage~~operations and ~~reimbursement~~financial condition and ~~reduced~~negatively ~~demand~~affect ~~for~~ our ~~products, once~~stock ~~approved, or additional pricing pressures~~price.

~~These and other healthcare reform measures~~If ~~that~~we ~~may~~are beunable ~~adopted~~to inprotect the ~~future~~confidentiality may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any current product or future product candidate. Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors. The implementation of ~~cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize~~ our ~~products.~~proprietary Legislative and regulatory proposals have been made to expand post- approval requirements and restrict sales and promotional activities for drugs. We cannot be sure whether additional legislative changes will be enactedinformation, ~~or whether~~ the ~~FDA~~value ~~regulations, guidance or interpretations will be changed, or what the impact~~ of ~~such~~our ~~changes~~technology onand ~~the~~products ~~marketing~~could ~~approvals of any current or future product candidates, if any, may~~ be. ~~In addition, increased~~adversely Congressional scrutiny of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirementsaffected.

30In addition to patented technology and technology for which patent protection is being sought, we rely on our unpatented technology, trade secrets and know-how. We generally seek to protect this information by confidentiality, non-disclosure and assignment of invention agreements with our officers, employees, contractors and other service providers and with parties with which we do business. These agreements may be breached, which breach may result in the misappropriation of such information, and we may not have adequate remedies for any such breach. We cannot be certain that the steps we have taken will prevent unauthorized use or reverse engineering of our technology.

Even if we are able to obtain all regulatory approvals and have completed all other steps needed to be taken to commercialize our insulin pump, if we or any contract manufacturers we select fail to comply with the FDA’s quality system regulations, the manufacturing and distribution of our products could be interrupted, and our sales and operating results could suffer.31

~~We have established initial~~Moreover, ~~low-volume manufacturing capability in~~ our ~~facility~~trade ~~and~~secrets ~~with~~may ~~a tier one medical device contract manufacturer. We and the contract manufacturer of our insulin pump products will~~ be ~~required~~disclosed to ~~comply~~or ~~with~~otherwise ~~the~~become ~~FDA’s~~known ~~quality~~or ~~system~~be ~~regulations,~~independently ~~which~~developed ~~impose~~by acompetitors. ~~complex~~To ~~regulatory~~the ~~framework~~extent that ~~covers the procedures~~our ~~and documentation of the design~~officers, ~~testing~~employees, ~~production~~contractors, ~~control,~~other ~~quality~~service ~~assurance~~providers, ~~labeling,~~or ~~packaging,~~other ~~sterilization,~~third ~~storage~~parties ~~and~~with ~~shipping of~~whom ~~medical~~we ~~devices.~~do ~~The~~business ~~FDA~~use ~~enforces~~intellectual ~~its quality system regulations through periodic unannounced inspections. We cannot assure you that,~~property ~~in the future, any manufacturing facilities~~ owned by usothers orin ~~any~~their ~~contract~~work ~~manufacturer~~for ~~will~~us, ~~pass~~disputes ~~any~~may ~~quality~~arise ~~system~~as ~~inspection.~~to In the ~~event that~~rights ~~our~~in orrelated ~~any contract manufacturer’s facilities fails a quality system inspection, the manufacturing~~ or ~~distribution~~resulting ofknow-how ~~our products could be interrupted~~ and ~~our operations disrupted~~inventions. ~~Failure~~If, tofor ~~take adequate and timely corrective action in response to an adverse quality~~any ~~system inspection could force a suspension or shutdown~~ of ~~any~~the ~~packaging~~above ~~and labeling operations or then manufacturing operations of any contract manufacturers~~reasons, ~~or a recall of~~ our ~~insulin~~intellectual ~~pump~~property ~~products.~~is Ifdisclosed ~~any~~or ~~of these events were to occur~~misappropriated, weit ~~at such time~~ would ~~not~~harm ~~be able to provide~~ our ~~customers~~ability ~~with~~to ~~the~~protect ~~quantity of insulin pumps that they require on a timely basis,~~ our ~~reputation~~rights ~~could be harmed~~ and we ~~could lose any customers we then~~ have, ~~any or all of which could have~~ a material adverse effect on our business, financial condition, and results of operations.

WeIntellectual ~~may~~property ~~bring~~rights ~~infringement~~do not ~~claims~~necessarily oraddress ~~other~~all ~~legal~~potential ~~proceedings~~threats ~~against third parties, causing us~~ to ~~spend substantial resources on litigation and exposing~~ our ~~own intellectual~~competitive ~~property portfolio to challenge~~advantage.

WeThe degree ~~may~~of ~~come~~future toprotection ~~believe~~afforded ~~that~~by ~~third parties are infringing on~~ our ~~patents~~intellectual orproperty ~~other proprietary~~ rights. Tois ~~prevent~~uncertain ~~infringement~~because orintellectual ~~unauthorized~~property ~~use,~~rights wehave ~~may need to file infringement~~limitations, and~~/or~~ misappropriation suits, which are very expensive and time-consuming, could result in meritorious counterclaims against us and would distract management’s attention. Also, in an infringement or misappropriation proceeding, a court may ~~decide~~not ~~that~~adequately ~~one~~protect ~~or more of~~ our ~~patents is invalid~~business, ~~unenforceable,~~ or ~~both,~~permit inus ~~which case third parties may be able~~ to ~~use~~gain ~~our~~and ~~technology~~maintain ~~without~~a ~~paying~~competitive ~~license fees or royalties~~advantage. ~~Even~~The iffollowing ~~the~~examples ~~validity of our patents is upheld, a court may refuse to stop the other party from using the technology at issue on the grounds that the other party’s activities~~ are ~~not covered by our patents. See “Business - Patents,” below.~~illustrative:

We● others may ~~become~~be ~~involved~~able ~~in disputes~~to ~~with~~make ~~our~~devices ~~present~~that orare ~~future~~similar ~~contract~~to ~~partners~~our ~~over~~insulin ~~intellectual~~pump ~~property~~but ~~ownership~~that orare ~~other~~not ~~matters,~~covered ~~which~~by ~~would~~the ~~have~~claims aof ~~significant effect~~the onpatents ~~our~~that ~~business.~~we own;

~~Inventions~~● ~~discovered~~we ~~in the course of performance of contracts with third parties~~ or ~~contractors~~any ~~may~~collaborators ~~become~~might ~~jointly~~not ~~owned~~have bybeen ~~such third-party contractors and us, in some cases, and~~ the ~~exclusive~~first ~~property of one of us, in other cases. Under some circumstances, it may be difficult~~ to ~~determine~~make ~~who~~the ~~owns a particular invention or whether it is jointly owned, and disputes could arise regarding ownership or use of those~~ inventions orcovered ~~jointly~~by ~~developed improvements thereto. Other disputes may also arise relating to~~ the ~~performance~~issued patents or ~~alleged~~pending ~~breach~~patent ofapplications ~~our~~that ~~agreements~~we ~~with third parties. Any disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business.~~own;

~~Our~~● ~~insulin~~we ~~pump~~might ~~products will~~not behave ~~subject~~been tothe ~~recalls,~~first ~~which~~to ~~would~~file ~~harm~~patent ~~our~~applications ~~reputation,~~covering ~~business~~certain ~~operations~~of ~~and~~our ~~financial results.~~inventions;

~~The~~● ~~FDA~~others ~~has~~may ~~the~~independently ~~authority~~develop tosimilar ~~require the recall of our pump products, if we commence manufacturing of our insulin pumps, and we,~~ or ~~any~~alternative ~~contract~~technologies ~~manufacturers we retain, fail to comply with relevant regulations pertaining to manufacturing practices, labeling, advertising~~ or ~~promotional~~duplicate ~~activities,~~any ~~or if new information is obtained concerning the safety or efficacy~~ of ~~the device. A government-mandated recall could occur if the FDA finds that there is a reasonable probability that~~ our ~~device~~technologies ~~would~~without ~~cause~~infringing serious, adverse health consequences or death. A voluntary recall by us could occur as a result of manufacturing defects, labeling deficiencies, packaging defects or other failures to comply with applicable regulations. Any recall would divert management’s attention and financial resources and harm our ~~reputation~~intellectual ~~with~~property ~~customers. A recall involving our insulin pump products would be particularly harmful to our business, financial condition and results of operations because these are currently our only products.~~rights;

~~Our~~● ~~current~~it ~~insulin pump product does not yet have reimbursement and~~ is ~~not~~possible ~~approved~~that ~~for insurance coverage. If in the future we are otherwise able to commercialize~~ our ~~insulin pump~~pending ~~products,~~patent ~~but~~applications ~~are unable to obtain adequate reimbursement or insurance coverage for such product from third-party payors, we~~ will be ~~unable~~not lead to ~~generate~~issued ~~significant revenue.~~patents;

~~Our~~● ~~current~~issued ~~insulin~~patents ~~pump~~that iswe ~~not~~own ~~yet~~may ~~eligible for reimbursement and is~~ not ~~approved~~provide ~~for~~us ~~insurance~~with ~~coverage.~~any ~~The~~competitive ~~future availability of insurance coverage and reimbursement for newly approved medical devices is highly uncertain. In the United States~~advantages, ~~patients using insulin pumps are generally reimbursed for all~~ or ~~part~~may ofbe ~~the~~held ~~product~~invalid ~~cost by Medicare~~ or ~~other~~unenforceable third-party payors. Any future commercial success of our insulin pump products will be substantially dependent on whether third-party coverage and reimbursement is available for future customers. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new medical devices, and, as a result, they may not cover or provide adequate reimbursement for our insulin pump, assuming we are able to fully develop and obtain all regulatory approval to market it in the United States. In addition, in certain countries, no uniform policy of ~~coverage~~legal and reimbursement for medical device products and services exists among third- party payors. Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor. In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained, if obtained. Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. Accordingly, unless government and other third-party payors provide coverage and reimbursement for our insulin pump products, patients may not use it, which would cause investors to lose their entire investment.challenges;

31● our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and

~~Risks~~● ~~Related~~we tomay ~~Our~~not ~~Securities~~develop additional proprietary technologies that are patentable.

~~Any~~Healthcare ~~disruption~~reform and~~/or~~ ~~instability~~drug-pricing inreform ~~economic~~laws ~~conditions and capital markets~~ could adversely affect our ~~ability~~products ~~to access the capital markets,~~ and ~~thus~~financial ~~adversely affect our business and liquidity~~condition.

~~Negative~~In the ~~economic~~United ~~conditions~~States, ~~and~~there ~~instability or~~have ~~uncertainty~~been, inand ~~the~~continue ~~financial~~to ~~markets~~be, ~~could~~a ~~have~~number aof ~~negative~~legislative ~~impact~~initiatives onto ~~our~~contain ~~ability~~healthcare tocosts. ~~access~~In March 2010, the ~~capital~~Patient ~~markets,~~Protection and ~~thus~~Affordable ~~have~~Care aAct, ~~negative impact~~as onamended ~~our~~by ~~then~~the ~~operations~~Health Care and ~~liquidity.~~Education WeAffordability ~~face~~Reconciliation ~~certain~~Act ~~risks~~(ACA), was enacted in the ~~event~~United ofStates, awhich ~~sustained~~made ~~deterioration~~a number of ~~financial~~substantial ~~market~~changes ~~liquidity, as~~in ~~well~~the asway inhealthcare ~~the~~is ~~event~~financed ofby ~~sustained~~both ~~deterioration~~governmental inand ~~the~~private insurers. ~~liquidity,~~Among orother ~~failure,~~ways ofin which it may affect our ~~banking~~business, ~~cash~~the ~~management~~ACA ~~and~~implemented ~~custodial~~payment ~~financial~~system reforms, including a national pilot ~~institutions.~~program Aon ~~general~~payment ~~shortage~~bundling ofto ~~liquidity~~encourage hospitals, physicians, and ~~credit~~other ~~combined~~providers ~~with~~to improve the ~~substantial~~coordination, ~~losses~~quality, inand ~~worldwide~~efficiency of ~~equity~~certain ~~markets~~healthcare ~~could~~services ~~lead~~through ~~to an~~bundled ~~extended~~payment ~~worldwide~~models ~~recession~~and inexpanded the ~~future.~~eligibility Ifcriteria ~~such~~for ~~occurred~~Medicaid programs. Since its enactment, wethere ~~would~~have ~~face~~been ~~significant~~judicial, executive, and Congressional challenges ifto ~~conditions~~certain inaspects of the ~~capital~~ACA. ~~markets~~It is unclear how the ACA ~~did~~and ~~not~~its ~~improve.~~implementation, ~~Our~~as ~~ability~~well as efforts to ~~access~~repeal ~~the~~or ~~capital~~replace, ~~markets~~or ~~under~~invalidate, ~~such~~the ~~circumstances~~ACA, ~~could~~or beportions ~~severely~~thereof, ~~restricted~~will ataffect aour ~~time~~insulin pump ~~when~~or weour ~~need to~~business. ~~access~~Additional ~~such~~legislative ~~markets~~changes, ~~which~~regulatory ~~could~~changes, ~~have~~and ajudicial ~~negative~~challenges ~~impact~~related onto ~~our~~the ~~business~~ACA ~~plans~~remain possible. It ~~Even~~is ifpossible wethat ~~are~~the ~~able~~ACA, toas ~~raise~~currently ~~capital~~enacted ~~under~~or ~~such~~as ~~circumstances,~~ it may ~~not~~be amended in the future, and other healthcare reform measures that may be atadopted ain ~~price~~the orfuture, could have an adverse effect on ~~terms~~our ~~that~~industry ~~are~~generally ~~favorable~~and on our ability to uscommercialize our insulin pump products and achieve profitability. We ~~cannot~~have ~~predict~~assumed ~~the~~in ~~occurrence~~all of ~~future~~our ~~disruptions~~financial orprojections ~~how~~that ~~long~~there ~~such~~is not an increase in the reimbursement ~~negative~~for ~~conditions~~our ~~might~~products ~~continue~~through the pharmacy or durable medical equipment routes.

~~International trade policies, including protectionist trade policies, such as tariffs and sanctions, could adversely affect our business, results of operations and financial condition.~~32

~~Due~~Drug pricing continues to ~~the~~be ~~interconnectedness~~a subject of debate at the ~~global~~executive and legislative levels of U.S. government. The American Rescue Plan Act ~~economy,~~of ~~policy~~2021 ~~changes~~eliminated inthe ~~one~~statutory ~~area~~cap on rebates that drug manufacturers pay to Medicaid beginning January 1, 2024. With the elimination of the ~~world~~rebate ~~can~~cap, ~~have~~manufacturers may be required to compensate states in an ~~immediate~~amount ~~and~~greater ~~material~~than ~~adverse~~what ~~impact~~the onstate ~~markets~~Medicaid ~~around~~programs pay for the ~~world~~drug. ~~Changes in~~Additionally, ~~international~~the ~~trade~~Inflation ~~policies~~Reduction Act of 2022 contains substantial drug pricing reforms, including: ~~(i)~~the ~~changes~~establishment of a drug price negotiation program within the U.S. Department of Health and Human Services that would require manufacturers to ~~existing~~charge a ~~trade~~negotiated ~~agreements;~~“maximum ~~(ii)~~fair ~~greater~~price” ~~restrictions~~for oncertain ~~free~~selected ~~trade~~drugs ~~generally;~~or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable under Medicare Parts B and ~~(iii)~~D ~~significant~~to ~~increases~~penalize inprice ~~customs~~increases ~~duties~~that outpace inflation, and ~~tariffs~~requires manufacturers to provide discounts on ~~goods~~Part ~~imported~~D ~~into~~drugs. Substantial penalties can be assessed for noncompliance with the ~~United~~drug ~~States~~pricing ~~and~~provisions ~~reciprocal~~in ~~actions~~the byInflation ~~other~~Reduction Act of 2022. The Inflation Reduction Act of 2022 could have the effect of reducing ~~countries~~the prices we can charge and reimbursement we receive for our products, if approved, thereby reducing our profitability, and could ~~adversely~~have a ~~affect~~material adverse effect on our ~~business~~financial condition, results of operations and ~~financial~~growth ~~condition~~prospects. The effect of Inflation Reduction Act of 2022 on our business and the pharmaceutical industry in general is not yet known.

~~Current~~At the orstate ~~future~~level, ~~tariffs~~legislatures orhave ~~other~~increasingly ~~restrictive trade~~passed ~~measures~~legislation ~~may~~and ~~raise~~implemented ~~the~~regulations ~~costs~~designed ofto ~~raw~~control ~~materials~~pharmaceutical product pricing, ~~components~~including price or ~~finished~~patient ~~goods~~reimbursement constraints, ~~which~~discounts, ~~may~~restrictions ~~adversely~~on ~~impact~~certain ~~both~~product ~~our~~access ~~product~~and ~~offerings~~marketing cost disclosure and ~~our~~transparency ~~operational~~measures, ~~expenses.~~and, ~~Such~~in ~~cost~~some ~~increases~~cases, ~~may~~designed ~~reduce~~to ~~our~~encourage ~~margins~~importation from other countries and ~~require~~bulk uspurchasing. toWe ~~increase~~expect that ~~prices~~additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which could ~~harm~~limit ~~our~~the ~~competitive~~amounts ~~position~~that federal and state governments will pay for healthcare products and services, ~~reduce~~which ~~customer~~could ~~demand~~result in limited coverage and ~~damage~~reimbursement and ~~customer~~reduced ~~relationships~~demand for our products, once approved, or additional pricing pressures.

~~Trade~~These and ~~disputes,~~other ~~trade~~healthcare ~~restrictions,~~reform ~~tariffs~~ measures that may be adopted in the future may result in more rigorous coverage criteria and ~~other~~in ~~political~~additional downward ~~tensions~~pressure ~~between~~on the Uprice that we receive for any current product or future product candidate.S. ~~and~~Any reduction in reimbursement from Medicare or other ~~countries~~government healthcare programs may ~~also~~result ~~exacerbate~~in ~~unfavorable~~a ~~macroeconomic~~similar ~~conditions~~reduction ~~including~~in ~~inflationary~~payments from private payors. The implementation ~~pressures,~~of ~~foreign~~cost ~~exchange~~containment ~~volatility,~~measures ~~financial~~or ~~market~~other ~~instability~~healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products. Legislative and ~~economic~~regulatory ~~recessions~~proposals orhave ~~downturns,~~been ~~which~~made ~~may~~to ~~also~~expand ~~negatively~~post approval requirements and restrict sales ~~impact~~and ~~customer~~promotional ~~demand~~activities for ~~our~~drugs. ~~products~~We orcannot ~~services,~~be ~~delay~~sure ~~purchases~~whether oradditional ~~renewals~~legislative changes will be enacted, ~~limit~~or ~~expansion~~whether ~~opportunities~~the ~~with~~FDA ~~customers~~regulations, ~~limit~~ ~~our~~guidance ~~access~~or tointerpretations ~~capital~~will be changed, or ~~otherwise~~what ~~negatively~~the impact ~~our~~of ~~business~~such ~~and~~changes ~~operations~~on the marketing approvals of any current or future product candidates, if any, may be. ~~Ongoing~~In ~~tariff~~addition, ~~trade~~increased ~~restrictions~~Congressional ~~and~~scrutiny ~~macroeconomic uncertainty~~of ~~has~~the ~~and~~FDA’s approval process may ~~continue~~significantly todelay or ~~contribute~~prevent marketing approval, as well as subject us to ~~volatility~~more instringent ~~the~~product ~~price~~labeling ofand ~~our~~post-marketing ~~common~~testing ~~stock~~and other requirements.

~~Ongoing~~Even ~~uncertainty~~if ~~regarding~~we ~~trade~~are ~~policies may~~able ~~also~~to ~~complicate~~obtain ~~our~~all ~~short-~~regulatory approvals and ~~long-term~~have ~~strategic~~completed ~~planning,~~all ~~and~~other ~~that~~steps ofneeded ~~our~~to ~~partners~~be ~~and~~taken ~~customers~~to commercialize our insulin pump, ~~including~~if ~~decisions~~we ~~regarding~~or any contract manufacturers ~~hiring,~~we ~~product~~select ~~strategy~~fail to comply with the FDA’s quality system regulations, ~~capital~~the ~~investment~~manufacturing and distribution of our products could be interrupted, ~~supply~~and ~~chain~~our ~~design~~sales and ~~geographic~~operating ~~expansion~~results could suffer.

~~While~~We have weestablished ~~continue~~initial, low-volume manufacturing capability in our facility and with a tier one medical device contract manufacturer. We and the contract manufacturer of our insulin pump products will be required to ~~monitor~~comply ~~trade~~with ~~developments~~the FDA’s quality system regulations, which impose a complex regulatory framework that covers the ~~ultimate~~procedures ~~impact~~and documentation of ~~these~~the ~~risks~~design, ~~remains~~testing, ~~uncertain~~production, ~~and~~control, quality ~~any~~assurance, ~~prolonged~~labeling, ~~economic~~packaging, ~~downturn~~sterilization, ~~escalation~~storage and shipping of medical devices. The FDA enforces its quality system regulations through periodic unannounced inspections. We cannot assure that, in ~~trade~~the ~~tensions~~future, any manufacturing facilities owned by us or ~~deterioration~~any contract inmanufacturer ~~international~~will ~~perception~~pass any quality system inspection. In the event that our or any contract manufacturer’s facilities fails a quality system inspection, the manufacturing or distribution of Uour products could be interrupted and our operations disrupted.~~S.-based~~ ~~companies~~Failure to take adequate and timely corrective action in response to an adverse quality system inspection could ~~materially~~force a suspension or shutdown of any packaging and ~~adversely~~labeling ~~affect~~operations ~~our~~or ~~supply~~then ~~chain~~manufacturing operations of any contract manufacturers, asor ~~well~~a asrecall of our ~~business,~~insulin ~~results~~pump products. If any of ~~operations~~these ~~and~~events ~~financial~~were ~~condition.~~to Inoccur, ~~addition~~we at such time would not be able to provide our customers with the quantity of insulin pumps that they require on a timely basis, ~~tariffs~~our reputation could be harmed and ~~other~~we ~~trade~~could ~~developments~~lose ~~have~~any ~~and~~customers ~~may~~we ~~continue~~then tohave, ~~heighten~~any ~~the~~or ~~risks~~all ~~related~~of which could tohave ~~the~~a ~~other~~material ~~risk~~adverse ~~factors~~effect ~~described~~on inour ~~this~~business, ~~Report~~financial condition and results of operations.

~~Third parties might attempt to gain unauthorized access to our network or seek to compromise our products.~~33

~~Our~~We ~~business~~may isbring ~~dependent~~infringement onclaims ~~the security~~or ~~and~~other ~~efficacy~~legal ofproceedings ~~our~~against ~~networks~~third ~~and~~parties, ~~computer~~causing ~~and~~us ~~data~~to ~~management~~spend ~~systems,~~substantial ~~and~~resources ~~we rely~~ on ~~our~~litigation ~~internal~~and ~~computer~~exposing ~~networks for many of the systems we use to operate~~ our ~~business~~own ~~generally. From time to time, we may face attempts by others to gain unauthorized access through the Internet~~intellectual orproperty ~~otherwise~~portfolio or to ~~introduce malicious software to our information technology systems~~challenge. ~~We or our products may be a target of computer hackers, organizations or malicious attackers who attempt to:~~

●We may ~~gain~~come ~~access~~to believe that third parties are infringing on our patents or other proprietary rights. To prevent infringement or unauthorized use, we may need to file infringement and/or misappropriation suits, which are very expensive and time-consuming, could result in meritorious counterclaims against us and would distract management’s attention. Also, in an infringement or misappropriation proceeding, a court may decide that one or more of our ~~network;~~patents is invalid, unenforceable, or both, in which case third parties may be able to use our technology without paying license fees or royalties. Even if the validity of our patents is upheld, a court may refuse to stop the other party from using the technology at issue on the grounds that the other party’s activities are not covered by our patents. See “Business - Patents,” below.

●We ~~steal~~may ~~proprietary~~become ~~information~~involved ~~related~~in todisputes with our ~~business,~~present ~~products~~or ~~and~~future ~~employees;~~contract partners over intellectual property ownership or other matters, which would have a significant effect on our business.

●Inventions discovered ~~interrupt~~in the course of performance of contracts with third parties or contractors may become jointly owned by such third-party contractors and us, in some cases, and the exclusive property of one of us, in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention or whether it is jointly owned, and disputes could arise regarding ownership or use of those inventions or jointly developed improvements thereto. Other disputes may also arise relating to the performance or alleged breach of our ~~systems~~agreements with third parties. Any disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business.

32Our insulin pump products may be subject to recalls, which would harm our reputation, business operations and financial results.

~~From time to time, we may encounter attempts at gaining unauthorized~~The ~~access~~FDA tohas ~~our~~the ~~network,~~authority ~~and we periodically run security checks. While we seek~~ to ~~detect~~require ~~and~~the ~~investigate~~recall ~~unauthorized~~of ~~attempts and attacks against~~ our ~~network~~pump ~~and~~ products, ofif ~~which~~ we ~~become~~commence ~~aware,~~manufacturing ~~and~~of ~~to prevent their recurrence where practicable through changes to~~ our ~~internal processes~~insulin ~~and~~pumps, ~~tools~~ and~~/or~~ ~~changes to our products~~we, ~~we remain potentially vulnerable to additional known~~ or ~~unknown~~any ~~threats. In addition~~contract tomanufacturers ~~intentional~~we ~~security breaches~~retain, ~~the~~fail ~~integrity~~to ~~and~~comply ~~confidentiality~~with ofrelevant ~~Company~~regulations ~~and~~pertaining ~~customer~~to ~~data~~manufacturing ~~and our intellectual property may be compromised as a result of human error~~practices, ~~product defects~~labeling, advertising or ~~technological failures. Different geographic markets may have different regulations~~promotional ~~regarding data protection~~activities, ~~raising~~or ~~potential~~if ~~compliance~~new ~~risks.~~information ~~Further,~~is ~~retaliatory~~obtained ~~acts~~concerning bythe ~~foreign~~safety ~~governments~~ or ~~terrorist~~efficacy ~~organizations in response to policies~~ of the ~~United~~device. ~~States~~A government-mandated ~~could~~recall ~~include cyber attacks that~~ could ~~disrupt~~occur if the ~~economy~~FDA ~~more~~finds ~~generally or~~ that ~~could~~ ~~also~~there ~~impact~~is ~~our~~a ~~operations~~reasonable ~~directly~~probability orthat ~~indirectly. Any failure or perceived failure by us or~~ our ~~service~~device ~~providers~~would tocause ~~prevent information security breaches or other incidents or system disruptions~~serious, oradverse ~~any~~health ~~compromise~~consequences ~~of security that results in~~ or isdeath. ~~perceived or reported~~A tovoluntary ~~result~~recall inby ~~unauthorized~~us ~~access~~could ~~to,~~occur oras ~~loss,~~a ~~theft,~~result ~~alteration, release or transfer~~ of, ~~our~~manufacturing ~~information~~defects, orlabeling ~~any personal information~~deficiencies, ~~confidential~~ ~~information,~~packaging defects or other ~~data~~failures ~~could result in loss or theft of proprietary or sensitive data and intellectual property, could harm our reputation and competitive position and could expose us~~ to ~~legal claims, regulatory investigations and proceedings, and fines,~~ ~~penalties,~~comply ~~and~~with ~~other~~applicable ~~liability~~regulations. Any ~~such~~recall ~~actual~~would ~~or perceived security breach, incident or system disruption could also~~ divert ~~the~~management’s ~~efforts of~~attention ~~our personnel,~~ and ~~could~~financial ~~require~~resources ~~us to incur significant costs~~ and ~~operational~~harm consequences in connection with investigating, remediating, eliminating and putting in place additional tools, devices, policies, and other measures designed to prevent actual or perceived security breaches and other incidents and system disruptions, and in, for example, rebuilding internal systems, reduced inventory value, providing modifications to our ~~products and services, defending against claims and litigation, responding to regulatory inquiries or actions, paying~~reputation ~~damages, or taking other remedial steps~~ with ~~respect to third parties~~customers. ~~Moreover,~~A werecall ~~could~~involving beour ~~required~~insulin orpump ~~otherwise~~products ~~find~~would itbe ~~appropriate to~~particularly ~~expend~~harmful ~~significant capital and other resources~~ to ~~respond~~our tobusiness, ~~notify~~financial ~~third~~condition ~~parties of,~~ and ~~otherwise address the incident or breach~~results ~~and its root cause, and to notify individuals, regulatory authorities and others~~ of ~~security~~operations ~~breaches~~because ~~involving~~these ~~certain~~are ~~types~~currently ofour ~~data~~only products.

~~Further,~~Our ~~we cannot assure that any limitations of liability provisions in our~~ current orinsulin ~~future~~pump ~~contracts~~product ~~that may be applicable would be enforceable or adequate or would otherwise~~does ~~protect~~not usyet ~~from~~have ~~any~~reimbursement ~~liabilities~~and oris ~~damages~~not ~~with~~approved ~~respect~~for ~~to any particular claim relating to a security breach or other security-related matter. We also cannot be sure that any~~ insurance coverage. ~~will~~If, ~~continue to be available on acceptable terms or will be available~~ in ~~sufficient amounts to cover claims related to a security breach or incident, or that~~ the ~~insurer will not deny coverage as to any~~ future ~~claim. The successful assertion of claims against us that exceed available insurance coverage~~, orwe ~~the~~are ~~occurrence~~otherwise ofable ~~changes~~to incommercialize our insulin ~~insurance~~pump ~~policies~~products, ~~including~~ ~~premium~~but ~~increases~~are orunable ~~the~~to ~~imposition~~obtain ofadequate ~~large~~reimbursement ~~deductible~~ or ~~co-~~insurance ~~requirements,~~coverage ~~could~~for ~~have~~such aproduct ~~material~~from ~~adverse~~third-party ~~effect on~~payors, ~~our~~we ~~business,~~will ~~including~~be ~~our~~unable ~~financial~~to ~~condition,~~generate ~~operating~~significant ~~results, and reputation~~revenue.

~~Risks~~Our Pivot ~~Related~~insulin pump is not yet eligible for reimbursement and is not approved for insurance coverage. The future availability of insurance coverage and reimbursement for newly approved medical devices is highly uncertain. In the United States, patients using insulin pumps are generally reimbursed for all or part of the product cost by Medicare or other third-party payors. Any future commercial success of our insulin pump products will be substantially dependent on whether third-party coverage and reimbursement is available for future customers. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to ~~Our~~contain ~~Securities~~healthcare costs by limiting both coverage and the level of reimbursement of new medical devices, and, as a result, they may not cover or provide adequate reimbursement for our insulin pump, assuming we are able to fully develop and obtain all regulatory approval to market it in the United States. In addition, in certain countries, no uniform policy of coverage and reimbursement for medical device products and services exists among third- party payors. Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor. In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained, if obtained. Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. Accordingly, unless government and other third-party payors provide coverage and reimbursement for our insulin pump products, patients may not use it, which would cause investors to lose their entire investment.

We are subject to oversight by the SEC and other regulatory agencies. Investigations by those agencies could divert management’s focus and could have a material adverse effect on our reputation and financial condition.34

WeRisks ~~are~~Related ~~subject~~ to ~~the~~Our regulation and oversight of the SEC and state regulatory agencies, in addition to the FDA. As a result, we may face legal or administrative proceedings by these agencies. We are unable to predict the effect of any investigations on our business, financial condition or reputation. In addition, publicity surrounding any investigation, even if ultimately resolved in our favor, could have a material adverse effect on our business.Securities

IfAny wedisruption ~~are~~and/or ~~unable~~instability toin economic ~~satisfy~~conditions ~~the continued~~and ~~listing~~capital ~~requirements~~markets ofcould ~~the~~adversely ~~Nasdaq,~~affect our ~~common~~ability ~~stock~~to ~~could~~access ~~be delisted and~~ the ~~price~~capital markets, and ~~liquidity~~thus ofadversely ~~our~~affect ~~common stock may be~~our ~~adversely~~business ~~affected~~and liquidity.

~~Our~~Negative economic ~~common~~conditions ~~stock~~and ~~may~~instability ~~lose~~or ~~value~~uncertainty ~~and~~in the financial markets could be ~~delisted~~have ~~from~~a ~~Nasdaq~~negative ~~due~~impact on our ability to ~~several~~access ~~factors~~the capital ormarkets, and thus have a ~~combination~~negative ofimpact ~~such~~on ~~factors~~our then operations and liquidity. ~~While~~We ~~our~~face ~~common~~certain ~~stock~~risks isin ~~currently~~the ~~listed~~event onof ~~Nasdaq,~~a sustained wedeterioration ~~can~~of ~~give~~financial nomarket ~~assurance~~liquidity, ~~that~~as wewell ~~will~~as bein ~~able~~the toevent ~~maintain~~of ~~compliance~~sustained ~~with~~deterioration in the ~~continued~~liquidity, ~~listing~~or ~~requirements~~failure, of ~~Nasdaq~~our banking, ~~including,~~cash ~~but~~management and custodial financial institutions. A general shortage of liquidity and credit combined with the substantial ~~not~~losses ~~limited~~in worldwide equity markets could lead to, an extended worldwide recession in the ~~corporate~~future. ~~governance~~If ~~requirements~~such occurred, ~~the~~we ~~minimum~~would ~~closing~~face ~~bid~~significant challenges ~~price~~if ~~requirement~~conditions orin the ~~minimum~~capital ~~equity~~markets ~~requirement~~did not improve. ~~If we~~Our ~~fail~~ability to ~~maintain~~access ~~compliance~~the ~~with~~capital ~~any~~markets under such ~~continued~~circumstances ~~listing~~could be ~~requirement~~severely restricted at a time when we need to access such markets, ~~there~~which ~~can~~could ~~also~~have bea nonegative ~~assurance~~impact ~~that~~on weour ~~will~~business beplans. Even if we are able to ~~regain compliance~~raise ~~with~~capital ~~any~~under such ~~continued~~circumstances, ~~listing~~it ~~requirement~~may innot ~~the~~be ~~future~~at a price or ~~that~~on ~~our~~terms ~~common~~that ~~stock~~are ~~will~~favorable ~~not~~to beus. ~~delisted~~We incannot predict the occurrence of future disruptions or how long such negative conditions might continue.

IfInternational wetrade ~~were to be delisted~~policies, ~~we would expect~~including ~~our~~protectionist ~~common~~trade ~~stock~~policies, tosuch beas ~~traded~~tariffs inand ~~the~~sanctions, ~~over-the-counter market which~~ could adversely affect ~~the liquidity of~~ our ~~common stock. Additionally~~business, we ~~could~~results ~~face~~of ~~significant~~operations ~~material~~and ~~adverse consequences, including:~~financial condition.

●Due to athe ~~limited~~interconnectedness ~~availability~~of the global economy, policy changes in one area of ~~market~~the ~~quotations~~world ~~for~~can ~~our~~have ~~common~~an ~~stock~~immediate and material adverse impact on markets around the world. Changes in international trade policies, including: (i) changes to existing trade agreements; (ii) greater restrictions on free trade generally; and (iii) significant increases in customs duties and tariffs on goods imported into the United States and reciprocal actions by other countries, could adversely affect our business, results of operations and financial condition.

●Current or afuture ~~decreased~~tariffs ~~ability~~or toother ~~issue~~restrictive ~~additional~~trade ~~securities~~measures may raise the costs of raw materials, components or ~~obtain~~finished ~~additional~~goods, ~~financing~~which inmay ~~the~~adversely impact ~~future;~~both our product offerings and our operational expenses. Such cost increases may reduce our margins and require us to increase prices, which could harm our competitive position, reduce customer demand and damage customer relationships.

●Trade disputes, ~~reduced~~trade ~~liquidity~~restrictions, tariffs and other political tensions between the U.S. and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns, which may also negatively impact customer demand for our ~~stockholders;~~products or services, delay purchases or renewals, limit expansion opportunities with customers, limit our access to capital, or otherwise negatively impact our business and operations. Ongoing tariff, trade restrictions and macroeconomic uncertainty has and may continue to contribute to volatility in the price of our common stock.

●Ongoing uncertainty ~~potential~~regarding ~~loss~~trade ofpolicies ~~confidence~~may byalso ~~customers~~complicate our short- and long-term strategic planning, ~~collaboration~~and that of our partners and ~~employees;~~customers, including decisions regarding hiring, product strategy, capital investment, supply chain design and geographic expansion.

●While we ~~loss~~continue to monitor trade developments, the ultimate impact of ~~institutional~~these ~~investor~~risks ~~interest~~remains uncertain and any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our supply chain, as well as our business, results of operations and financial condition. In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described in this Report.

InThird ~~the~~parties ~~event~~might ofattempt ato ~~delisting, we can provide~~gain nounauthorized ~~assurance~~access ~~that any action taken by us~~ to ~~restore compliance with listing requirements would allow~~ our ~~common~~network ~~stock to become listed again, stabilize the market price~~ or ~~improve~~seek ~~the~~to ~~liquidity~~compromise of our ~~common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements~~products.

33Our business is dependent on the security and efficacy of our networks and computer and data management systems, and we rely on our internal computer networks for many of the systems we use to operate our business generally. From time to time, we may face attempts by others to gain unauthorized access through the Internet or otherwise or to introduce malicious software to our information technology systems. We or our products may be a target of computer hackers, organizations or malicious attackers who attempt to:

We● ~~are~~gain aaccess ~~“smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable~~ to ~~smaller reporting companies,~~ our ~~common stock may be less attractive to investors.~~network;

We● ~~are~~steal aproprietary ~~“smaller~~information ~~reporting~~related ~~company,” and are subject~~ to ~~lesser disclosure obligations in~~ our ~~SEC filings compared to other issuers. Specifically~~business, ~~“smaller~~products reporting companies” are able to provide simplified executive compensation disclosures in their filings, are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting and ~~have~~employees; certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our operating results and financial prospects.or

We● dointerrupt ~~not expect any cash dividends to be paid on~~ our ~~shares of common stock for the foreseeable future~~systems.

We have never declared or paid a cash dividend and we do not anticipate declaring or paying dividends on our common stock for the foreseeable future. We expect to use future financing proceeds and earnings, if any, to fund operating expenses. Consequently, stockholders’ only opportunity to achieve a return on their investment is if the price of our stock appreciates and they sell their shares at a profit. We cannot assure stockholders of a positive return on their investment when they sell their shares or that stockholders will not lose the entire amount of their investment.35

IfFrom time ~~the~~to ~~beneficial~~time, ~~ownership~~we may encounter attempts at gaining unauthorized access to our network, and we periodically run security checks. While we seek to detect and investigate unauthorized attempts and attacks against our network and products of which we become aware, and to prevent their recurrence where practicable through changes to our ~~common~~internal ~~stock~~processes ~~continues~~and tools and/or changes to our products, we remain potentially vulnerable to additional known or unknown threats. In addition to intentional security breaches, the integrity and confidentiality of Company and customer data and our intellectual property may be ~~concentrated~~compromised as a result of human error, itproduct defects, or technological failures. Different geographic markets may have different regulations regarding data protection, raising potential compliance risks. Further, retaliatory acts by foreign governments or terrorist organizations in response to policies of the United States government could include cyber-attacks that could disrupt the economy more generally or that could also impact our operations directly or indirectly. Any failure or perceived failure by us or our service providers to prevent information security breaches or other incidents or system disruptions, or any compromise of security that results in or is perceived or reported to result in unauthorized access to, or loss, theft, alteration, release or transfer of, our ~~stockholders~~information, ~~from~~or ~~influencing~~any personal information, confidential information, or other data could result in loss or theft of proprietary or sensitive data and intellectual property, could harm our reputation and competitive position and could expose us to legal claims, regulatory investigations and proceedings, and fines, penalties, and other liability. Any such actual or perceived security breach, incident or system disruption could also divert the efforts of our personnel, and could require us to incur significant ~~corporate~~costs ~~decisions~~and operational consequences in connection with investigating, remediating, eliminating and putting in place additional tools, devices, policies, and other measures designed to prevent actual or perceived security breaches and other incidents and system disruptions, and in, for example, rebuilding internal systems, reduced inventory value, providing modifications to our products and services, defending against claims and litigation, responding to regulatory inquiries or actions, paying damages, or taking other remedial steps with respect to third parties. Moreover, we could be required or otherwise find it appropriate to expend significant capital and other resources to respond to, notify third parties of, and otherwise address the incident or breach and its root cause, and to notify individuals, regulatory authorities and others of security breaches involving certain types of data.

~~As of March 31~~Further, ~~2025, our executive officers, directors and certain~~ ~~persons,~~we ~~who~~cannot ~~may~~assure bethat ~~deemed~~any ~~affiliates,~~limitations ~~beneficially owned approximately 14%~~ of ~~our~~liability ~~issued~~provisions ~~and~~in ~~outstanding common stock. Specifically, James Besser,~~ our ~~chief~~current ~~executive~~or ~~officer,~~future ~~and~~contracts ~~Morgan~~that ~~Frank,~~may abe ~~member~~applicable ofwould ~~our~~be ~~board of directors, are the principals of Manchester Explorer,~~enforceable ~~L.P.,~~or ~~our~~adequate ~~largest~~or ~~stockholder.~~would Asotherwise ofprotect ~~March~~us ~~31,~~from ~~2025,~~any inliabilities ~~the~~or ~~aggregate,~~damages ~~Messrs.~~with ~~Besser~~respect ~~and~~to ~~Frank~~any ~~were~~particular ~~the~~claim ~~beneficial~~relating ~~owners~~to ~~of approximately 9% of our outstanding common stock. As~~ a ~~result, such persons may exercise substantial influence over the outcome of corporate actions~~security ~~requiring~~breach ~~stockholder approval including, without limitation, the election of directors, certain mergers, consolidations and sales of all~~ or ~~substantially all of our assets or any~~ other ~~significant~~security-related ~~corporate transactions~~matter. ~~Such~~We ~~persons may~~ also ~~vote~~cannot ~~against~~be asure ~~change~~that ~~of control,~~any ~~even~~insurance ifcoverage ~~such~~will acontinue ~~change~~to ofbe ~~control~~available ~~would~~on ~~benefit~~acceptable terms ~~our~~or ~~other~~will ~~stockholders.~~be ~~Thus,~~available ~~investors~~ in ~~our~~sufficient ~~common~~amounts ~~stock cannot reasonably expect~~ to ~~have~~cover ~~any~~claims ~~influence~~related ~~over the election of our directors or other matters submitted~~ to a ~~vote~~security ofbreach ~~our~~or ~~stockholders. Instead~~incident, ~~our existing~~or ~~significant~~that ~~stockholders may exert a substantial influence on~~ the ~~election~~insurer ofwill ~~our~~not deny ~~directors~~coverage ~~and~~as ~~any actions requiring or otherwise put~~ to aany ~~stockholder~~future ~~vote, potentially in a manner that you do not support~~claim. The ~~concentrated~~successful ~~amount~~assertion of ~~control~~claims ~~over~~against ~~our~~us ~~affairs~~that ~~held~~exceed ~~by a~~available ~~relatively~~insurance ~~few~~coverage, ~~significant investors could serve to reduce the attractiveness~~ or ~~liquidity of our common stock, and thereby depress~~the ~~its~~occurrence ~~trading price. Additionally, conflicts~~ of ~~interest~~changes ~~may~~in ~~arise between these executive officers, directors and other affiliates, on the one hand, and us and~~ our ~~other~~insurance ~~stockholders~~policies, onincluding ~~the~~premium ~~other~~increases ~~hand.~~or ~~In resolving these conflicts of interests, these investors may favor their own interests and~~ the ~~interests~~imposition of ~~their~~large ~~affiliates,~~deductible ~~over~~or ~~the~~co-insurance ~~interests of our other stockholders~~requirements, ~~which~~ could ~~cause~~have a material adverse effect on our business, ~~prospects,~~including our financial condition, ~~and~~operating results, ofand ~~operations~~reputation.

~~Future~~We ~~sales~~are ofsubject ~~our~~to ~~securities could~~oversight ~~adversely~~by ~~affect~~ the SEC ~~market~~and ~~price~~other ofregulatory ~~our~~agencies. ~~common~~Investigations ~~stock~~by ~~and~~those ~~our~~agencies ~~future capital-raising activities~~ could ~~involve~~divert ~~the~~management’s ~~issuance~~focus ~~of equity securities, which would dilute your investment~~ and could ~~result~~have in a ~~decline~~material inadverse effect ~~the~~on ~~trading~~our ~~price~~reputation ofand ~~our~~financial ~~common stock~~condition.

We are ~~may~~subject ~~sell~~to ~~securities in~~ the ~~public~~regulation ~~or private~~and ~~equity~~oversight ~~markets~~of ~~at prices per share below~~ the ~~current~~SEC ~~market~~and ~~price~~state ofregulatory ~~our common stock~~agencies, ~~even~~in ifaddition weto dothe ~~not have an immediate need for additional capital at that time~~FDA. ~~Sales~~As ofa ~~substantial~~result, ~~amounts~~we ofmay ~~shares~~face legal ~~of our common stock,~~ or ~~the~~administrative ~~perception~~proceedings ~~that~~by ~~such~~these ~~sales~~agencies. ~~could occur,~~We ~~could~~are ~~adversely~~unable ~~affect~~to predict the ~~prevailing~~effect ~~market price~~ of ~~our~~any ~~shares~~investigations ~~and~~on our ~~ability~~business, ~~to raise capital. We may issue additional shares~~financial ofcondition ~~common stock in future financing transactions~~ or asreputation. ~~incentive~~In ~~compensation for our executive management and other key personnel~~addition, ~~consultants and~~publicity ~~advisors.~~surrounding ~~Issuing~~ any ~~equity securities would be dilutive to the equity interests represented by our then-outstanding shares of common stock. Moreover~~investigation, ~~sales~~even ofif ~~substantial~~ultimately ~~amounts~~resolved ~~of shares~~ in ~~the~~our ~~public market~~favor, ~~or the perception that such sales~~ could ~~occur,~~have ~~may adversely~~a ~~affect~~material ~~the~~adverse ~~prevailing~~effect ~~market price of our common stock and make it more difficult for us to raise additional capital. Such resulting significant downward pressure~~ on ~~the price of~~ our ~~common stock could also encourage short sales by third parties~~business. ~~Such an event could place further downward pressure on the price of our common stock.~~

~~Our~~If ~~articles~~we ofare ~~incorporation allow~~unable ~~for our board of directors~~ to ~~create~~satisfy ~~new~~the ~~series~~continued listing requirements of ~~preferred~~Nasdaq, ~~stock without further approval by~~ our ~~stockholders,~~common ~~which~~stock could ~~adversely affect~~be ~~the~~delisted ~~rights~~and of the ~~holders~~price and liquidity of our common stock may be adversely affected.

Our ~~board~~common ofstock ~~directors~~may ~~has~~lose ~~the~~value ~~authority to fix~~ and ~~determine~~could ~~the~~be ~~relative~~delisted from ~~rights~~Nasdaq ~~and~~due ~~preferences~~to ofseveral ~~preferred~~factors ~~stock.~~or ~~Currently,~~a ~~our~~combination ~~board~~ of ~~directors~~such ~~has~~factors. ~~the~~While ~~authority to designate and issue up to 5,000,000 shares of~~ our ~~preferred~~common stock ~~without~~is ~~further~~currently ~~stockholder~~listed ~~approval.~~on ~~In the future~~Nasdaq, ~~our~~we ~~board~~can ofgive no ~~directors~~assurance ~~could authorize~~that ~~the~~we ~~issuance~~will ofbe ~~one~~able orto ~~more~~maintain ~~series~~compliance ofwith ~~preferred~~the ~~stock~~continued ~~that~~listing ~~would~~requirements ~~grant~~of toNasdaq, ~~holders~~including, ~~among~~but ~~other~~not ~~rights~~limited to, the ~~preferred~~corporate ~~right~~governance ~~to our assets upon liquidation~~requirements, the ~~right~~minimum toclosing ~~receive~~bid ~~dividend~~price ~~payments~~requirement ~~before~~or ~~dividends are distributed to~~ the ~~holders~~minimum ofequity ~~common~~requirement. ~~stock~~If ~~and the~~we ~~right~~fail to maintain ~~the~~compliance ~~redemption~~with ofany ~~our preferred shares acquired by~~ such ~~persons,~~continued ~~together~~listing ~~with a premium~~requirement, ~~prior~~there tocan ~~the~~also ~~redemption~~be ofno ~~our common~~assurance ~~stock.~~that Inwe ~~addition,~~will ~~our~~be ~~board~~able ofto ~~directors~~regain ~~could~~compliance with ~~authorize~~any ~~the~~such ~~issuance~~continued oflisting arequirement ~~series~~in ofthe ~~preferred~~future ~~stock that has greater voting power than our common stock~~ or that ~~is convertible into~~ our common stock, ~~which~~will ~~could~~not ~~decrease~~be ~~the~~delisted ~~relative voting power of our common stock or result~~ in ~~dilution~~the ~~to our existing stockholders~~future.

34If we were to be delisted, we would expect our common stock to be traded in the over-the-counter market which could adversely affect the liquidity of our common stock. Additionally, we could face significant material adverse consequences, including:

If● wea ~~fail~~limited toavailability ~~establish and maintain an effective system~~ of ~~internal~~market ~~controls,~~quotations wefor ~~may not be able to report~~ our ~~financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely affect the trading price of our~~ common stock.;

~~Effective~~● internal controls are necessary for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be harmed. If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a ~~public~~decreased ~~company,~~ability ~~including the requirements of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act). In addition, we may be unable~~ to ~~accurately~~issue ~~report~~additional ~~our~~securities ~~financial results in future periods~~ or ~~report them~~obtain within the timeframes required by the requirements of the SEC or the Sarbanes-Oxley Act. Failure to comply with the Sarbanes-Oxley Act, when and as applicable, could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could result in identification of additional ~~material~~financing ~~weaknesses or significant deficiencies, cause us to fail to meet our reporting obligations or result~~ in ~~material~~the ~~misstatements in our financial statements.~~future;

~~Furthermore,~~● ~~Section~~reduced ~~404~~liquidity offor ~~the Sarbanes-Oxley Act and related regulations require~~ our management to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. Based on its evaluation, our management concluded that our internal controls over financial reporting were effective as of March 31, 2025. We cannot provide assurance that, in the future, a material weakness or significant deficiency will not exist or otherwise be discovered. If that were to happen, it could harm our operating results and cause stockholders ~~to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price of our securities.~~;

~~Sustained~~● ~~inflation~~potential ~~could have~~loss aof ~~material~~confidence ~~adverse~~by ~~effect on our business~~customers, ~~financial~~collaboration ~~condition,~~partners ~~results~~and ofemployees; ~~operations~~ and ~~liquidity.~~

~~Inflation~~● ~~rates~~loss in the United States have remained elevated and may continue to rise. Inflation over the last several months has led us to experience higher costs, including, among others, labor and transportation. Some of ~~our~~institutional ~~suppliers~~investor have raised their prices and may continue to raise prices, and, assuming we achieve FDA clearance and commence commercialization of our product, in the future, we may not be able to make corresponding price increases to obtain adequate gross margins and achieve profitabilityinterest. If inflation rates continue to rise or remain elevated for a sustained period of time, they could have a material adverse effect on our business, financial condition, results of operations and liquidity.

~~Our board of directors is able to adopt recapitalizations through forward or reverse splits of our outstanding shares of common stock without stockholder approval.~~36

~~Pursuant~~In tothe ~~our~~event ~~amended and restated articles~~ of ~~incorporation~~a delisting, ~~our~~we ~~board~~can ofprovide ~~directors~~no assurance ~~has~~that ~~the~~any ~~power,~~action ~~without~~taken ~~obtaining~~by ~~stockholder~~us ~~approval,~~ to ~~effectuate~~restore ~~recapitalizations~~compliance ofwith ~~us through~~listing ~~forward~~requirements orwould ~~reverse~~allow ~~splits of~~ our ~~outstanding~~ common stock. Asto abecome ~~result~~listed ~~of such provision~~again, ~~our board of directors can implement~~ ~~recapitalizations~~stabilize ofthe usmarket byprice ~~effectuating a forward~~ or ~~reverse~~improve ~~stock~~the ~~split~~liquidity of our ~~outstanding~~ common stock, ~~which~~prevent ~~would~~our ~~increase~~common orstock ~~decrease each~~from ofdropping ~~our~~below ~~stockholder’s~~the ~~number~~Nasdaq ofminimum bid ~~shares~~price ~~owned~~requirement, ~~and our stockholders will have no right to approve~~ or ~~disapprove~~prevent ~~any~~future ~~such~~non-compliance ~~action even~~with ifNasdaq’s ~~such~~listing ~~actions have a material adverse effect on them~~requirements.

35We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.

~~ITEM~~We are 1Ba “smaller reporting company,” and are subject to lesser disclosure obligations in our SEC filings compared to other issuers. ~~UNRESOLVED~~Specifically, ~~STAFF~~“smaller ~~COMMENTS~~reporting companies” are able to provide simplified executive compensation disclosures in their filings, are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our operating results and financial prospects.

~~None~~We do not expect any cash dividends to be paid on our shares of common stock for the foreseeable future.

~~Item~~We have 1Cnever declared or paid a cash dividend and we do not anticipate declaring or paying dividends on our common stock for the foreseeable future. ~~CYBERSECURITY~~We expect to use future financing proceeds and earnings, if any, to fund operating expenses. Consequently, stockholders’ only opportunity to achieve a return on their investment is if the price of our stock appreciates and they sell their shares at a profit. We cannot assure stockholders of a positive return on their investment when they sell their shares or that stockholders will not lose the entire amount of their investment.

WeIf ~~believe~~the abeneficial ~~robust~~ownership ~~and~~of ~~proactive approach~~our tocommon ~~cybersecurity~~stock ~~risks~~continues ~~and threats is essential~~ to ~~achieving~~be ~~our strategic business objectives and protecting our business. We may face a wide range of cybersecurity threats~~concentrated, ~~such~~it ~~as ransomware and denial-of- service attacks. Our customers, suppliers and other business partners~~ may ~~also~~prevent ~~face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these third parties could have a material adverse effect on~~ our ~~business~~stockholders and results of operations. Due to the risks that cybersecurity threats can pose to our business, we intend to continually evaluate best practices and methods, including cyber defense systems and training programs, to protect our business from ainfluencing ~~wide~~significant ~~range~~corporate ~~of potential threats~~decisions.

WeAs of ~~continue~~March to31, ~~evaluate~~2026, our ~~cybersecurity~~executive ~~control~~officers, ~~processes~~directors and ~~procedures to~~certain ~~address~~persons, ~~the~~who ~~evolving~~may ~~cybersecurity~~be ~~risks~~deemed ~~that~~affiliates, weowned ~~may~~approximately ~~face~~5.4% inof anour issued ~~increasingly~~and ~~technically~~outstanding ~~capable~~common ~~environment~~stock. WeSpecifically, ~~have~~James ~~implemented~~Besser, ~~practices and~~our ~~intend~~chief toexecutive ~~implement~~officer, ~~policies~~and toMorgan ~~educate~~Frank, ~~and~~a ~~provide~~member ~~guidance~~of to our ~~personnel~~board of directors, ~~including~~are ~~awareness~~the ~~programs~~principals ~~and~~of ~~other~~Manchester ~~related~~Explorer, ~~cybersecurity best practices~~L.P., Weour ~~plan~~largest tostockholder. ~~conduct~~As ~~technical~~of ~~risk~~March ~~assessments~~31, to2026, ~~identify~~in ~~cybersecurity~~the ~~threats~~aggregate, asMessrs. Besser ~~well~~and asFrank ~~assessments~~were in the ~~event~~owners of a ~~material~~approximately ~~change~~3.4% inof our ~~business~~outstanding ~~practices~~common ~~that~~stock. ~~may~~As ~~affect~~a ~~information~~result, ~~systems~~such ~~that~~persons ~~are~~may ~~vulnerable~~exercise tosubstantial influence ~~such~~over ~~cybersecurity~~the ~~threats.~~outcome ~~We also~~of ~~plan~~corporate toactions ~~conduct~~requiring ~~programmatic~~stockholder ~~risk~~approval ~~assessments~~including, ~~including~~without ~~identification~~limitation, ofthe ~~reasonably~~election ~~foreseeable~~of ~~internal~~directors, certain ~~and external risks~~mergers, ~~the likelihood~~consolidations and ~~potential~~sales ~~damage~~of ~~that~~all ~~could~~or ~~result~~substantially ~~from~~all ~~such~~of ~~risks,~~our ~~and~~assets ~~the~~or ~~sufficiency~~any ofother ~~existing~~significant ~~policies,~~corporate ~~procedures, systems, and~~transactions. ~~safeguards~~Such inpersons ~~place~~may toalso ~~manage~~vote ~~such~~against ~~risks.~~a ~~Following~~change ~~these~~of ~~risk assessments~~control, weeven ~~will~~if ~~evaluate:~~such i)a ~~whether~~change ~~and~~of ~~how~~control towould ~~implement,~~benefit ~~and~~our ~~maintain~~other stockholders. Thus, ~~reasonable~~investors ~~safeguards~~in toour ~~minimize~~common ~~identified~~stock ~~risks,~~cannot ~~ii)~~reasonably ~~how~~expect to ~~reasonably~~have ~~address~~ any ~~identified~~influence ~~gaps~~over ~~in existing safeguards; and how to regularly monitor~~ the ~~effectiveness~~election of our ~~safeguards.~~directors Asor weother ~~are~~matters submitted to a ~~small~~vote ~~pre-revenue~~of ~~company,~~our westockholders. ~~currently~~Instead, ~~outsource~~ our ~~information technology~~existing ~~(IT)~~significant ~~functions~~stockholders tomay exert a ~~third~~substantial ~~party.~~influence ~~Working~~on ~~with~~ the ~~outsourced~~election ITof ~~firm,~~ our directors ~~president~~and ~~will~~any ~~manage~~actions ~~the~~requiring ~~risk~~or ~~assessment~~otherwise ~~and~~put ~~mitigation process.~~to ~~Third~~a ~~parties~~stockholder ~~will~~vote, ~~play~~potentially anin ~~important~~a ~~role~~manner inthat ~~our~~you ~~cybersecurity~~do ~~program~~not support. WeThe ~~intend~~concentrated amount toof ~~engage~~control ~~third-party~~over ~~service~~our ~~providers~~affairs ~~to conduct~~held ~~evaluations~~by ofa ~~our~~relatively ~~security~~few ~~controls,~~significant ~~including~~investors ~~penetration~~could ~~testing~~serve ~~and~~to ~~consulting~~reduce onthe ~~best~~attractiveness ~~practices.~~or ~~The third-party services~~liquidity ~~include~~of ~~testing~~our ~~both~~common ~~the~~stock, ~~design~~ and ~~operational~~thereby ~~effectiveness~~depress ofits ~~security~~trading ~~controls~~price. ~~This~~Additionally, ~~dependence~~conflicts ~~exposes~~of ~~us,~~interest ~~along~~may ~~with~~arise ~~others~~between ~~who~~these executive officers, ~~use~~directors ~~such~~and ~~service~~other ~~providers~~affiliates, toon the ~~impact~~one ofhand, aand ~~cyber-attack~~us onand ~~their~~our ~~service~~other ~~providers.~~stockholders, Iton isthe ~~possible~~other ~~for~~hand. aIn ~~cyber-attack~~resolving atthese aconflicts ~~third-~~of ~~party~~interests, ~~service~~these ~~provider~~investors tomay ~~have~~favor atheir ~~significant~~own ~~financial,~~interests ~~operational,~~and orthe ~~reputational~~interests ~~impact~~of totheir ~~us.~~affiliates, Toover ~~reduce~~ the ~~effective~~interests ~~impact to us~~ of aour ~~cyber-attack~~other ~~on a third-party service provider~~stockholders, which wecould ~~intend~~cause toa ~~monitor~~material ~~the~~adverse ~~risks~~effect ~~associated~~on ~~with~~ our ~~service~~business, ~~providers~~prospects, ~~through~~financial ~~periodic review~~condition ofand ~~these~~results ~~providers’~~of ~~cybersecurity programs~~operations.

~~Our~~Future ~~board~~sales of ~~directors, through its audit committee, oversees~~ our ~~processes~~securities ~~for identifying and mitigating risks, including cybersecurity risks. Management will periodically brief~~could ~~the~~adversely ~~audit~~affect ~~committee and/or~~ the ~~board~~market price of ~~directors on~~ our ~~cybersecurity~~common ~~and~~stock ~~information security policies~~ and ~~plans.~~our ~~Our~~future ~~board~~capital-raising ofactivities ~~directors will~~could beinvolve ~~apprised~~the issuance of ~~cybersecurity incidents deemed to have a moderate or higher business impact~~equity securities, ~~and~~which wewould ~~will~~dilute ~~provide~~your ~~updates~~investment ~~on management’s incident response plan for addressing~~ and ~~mitigating~~could ~~any~~result ~~impacts~~in ~~and risks associated with such an incident. We intend to develop~~ a ~~formal incident~~decline ~~response~~in ~~plan, which sets forth~~ the ~~steps~~trading toprice beof ~~followed from incident detection and assessment to mitigation, recovery and notification and reporting within~~ our ~~organization~~common ~~and to our board of directors~~stock.

~~For~~We may ~~additional~~sell ~~information~~securities ~~regarding~~in ~~whether any~~the ~~risks~~public ~~from~~or ~~cybersecurity~~private ~~threats~~equity markets at prices per share below the current market price of our common stock, even if we do not have ~~materially~~an ~~affected~~immediate need for additional capital at that time. Sales of substantial amounts of shares of our common stock, or ~~are~~the ~~reasonably~~perception ~~likely~~that tosuch ~~materially~~sales ~~affect~~could usoccur, ~~including~~could adversely affect the prevailing market price of our ~~business~~shares and our ability to raise ~~strategy,~~capital. ~~results~~We may issue additional shares of ~~operations,~~common stock in future financing transactions or ~~financial~~as ~~condition~~incentive compensation for our executive management and other key personnel, ~~please~~consultants ~~refer~~and advisors. Issuing any equity securities would be dilutive to ~~Item~~the ~~1A,~~equity ~~“Risk~~interests represented ~~Factors~~by our then-outstanding shares of common stock. Moreover,” sales of substantial amounts of shares in ~~this~~the ~~Report~~public market, ~~including~~or the ~~risk~~perception ~~factor~~that ~~entitled~~such ~~“Third~~sales ~~parties~~could ~~might~~occur, ~~attempt~~may toadversely ~~gain~~affect ~~unauthorized~~the ~~access~~prevailing tomarket price of our ~~network~~common orstock ~~seek~~and make it more difficult for us to ~~compromise~~raise additional capital. Such resulting significant downward pressure on the price of our ~~insulin~~common stock could also encourage ~~pump~~short ~~product~~sales by third parties.” Such an event could place further downward pressure on the price of our common stock.

~~ITEM 2. PROPERTIES~~37

~~Our~~The ~~principal~~effective ~~administrative,~~increase ~~operations, and research and development functions are located~~ in athe ~~leased facility in San Diego, California. We currently occupy approximately 24,000~~number ~~square~~of ~~feet~~shares of ~~space~~our incommon ~~the~~stock ~~San~~available ~~Diego~~for ~~facility,~~issuance ~~and~~as ~~the~~a ~~lease~~result ~~extends~~of ~~through~~our ~~January~~reverse ~~2027.~~stock ~~Under~~split ~~the~~could ~~lease,~~result in ~~addition~~further dilution to ~~the minimum lease payments, we are responsible for property taxes, insurance and certain other operating costs. We believe that~~ our existing ~~facility~~ isstockholders ~~adequate~~and tohave ~~meet~~antitakeover ~~our current needs~~implications.

~~ITEM~~The reverse 3stock split effected in March 2026 alone had no effect on our authorized capital stock, and the total number of authorized shares remains the same as before the reverse stock split. ~~LEGAL~~The ~~PROCEEDINGS~~reverse stock split of our issued and outstanding shares increased the number of shares of our common stock (or securities convertible or exchangeable for our common stock) available for issuance by decreasing the number of shares of our common stock issued and outstanding. The additional available shares are available for issuance from time to time at the discretion of our board of directors when opportunities arise, without further stockholder action or the related delays and expenses, except as may be required for a particular transaction by law, the rules of any exchange on which our securities may then be listed, or other agreements or restrictions. Any issuance of additional shares of our common stock would increase the number of outstanding shares of our common stock and (unless such issuance was pro-rata among existing stockholders) the percentage ownership of existing stockholders would be diluted accordingly. In addition, any such issuance of additional shares of our common stock could have the effect of diluting the earnings per share and book value per share of outstanding shares of our common stock.

WeAdditionally, the ~~are~~effective ~~not~~increase ain ~~party~~the tonumber ~~any~~of ~~material~~shares ~~legal proceeding~~available ~~that~~for weissuance ~~believe~~could, isunder ~~likely~~certain tocircumstances, have aanti-takeover ~~material~~implications. For ~~adverse~~example, ~~effect~~the onadditional ~~our~~shares ~~consolidated~~of ~~financial~~common ~~position~~stock orthat ~~results~~have ofbecome ~~operations. From~~available ~~time~~for toissuance ~~time,~~could webe ~~may~~used beby ~~subject~~us to ~~legal~~oppose ~~proceedings~~a ~~and~~hostile ~~claims~~takeover attempt inor ~~the~~to ~~ordinary~~delay ~~course~~or ofprevent ~~business.~~changes ~~These~~in ~~claims,~~control ~~even~~or ifour ~~not~~management. ~~meritorious, could~~Although ~~result~~our inreverse ~~the~~stock ~~expenditure~~split ofis ~~significant~~prompted ~~financial~~by ~~resources~~other considerations and ~~diversion~~not ofby ~~management efforts. to any pending legal proceeding. To~~ the ~~knowledge~~threat of ~~our~~any ~~management,~~hostile notakeover ~~federal~~attempt, ~~state~~stockholders orshould ~~local~~be ~~governmental~~aware ~~agency~~that isour ~~presently~~reverse ~~contemplating~~stock ~~any~~split ~~proceeding~~could ~~against~~facilitate ~~us.~~future Noefforts ~~director,~~by ~~executive~~us ~~officer~~to ordeter ~~affiliate of ours~~ or ~~owner~~prevent ofchanges ~~record~~in orcontrol, ~~beneficially~~including oftransactions ~~more~~in ~~than~~which ~~five percent of~~ our ~~common~~stockholders ~~stock~~might ~~is a~~otherwise ~~party~~receive ~~adverse to us or has~~ a ~~material~~premium for ~~interest~~their ~~adverse~~shares toover usthen-current inmarket ~~any proceeding~~prices.

~~ITEM~~Our 4.articles ~~MINE~~of ~~SAFETY~~incorporation ~~DISCLOSURES~~allow for our board of directors to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.

~~Not~~Our board ~~applicable~~of directors has the authority to fix and determine the relative rights and preferences of preferred stock. Currently, our board of directors has the authority to designate and issue up to 5,000,000 shares of our preferred stock without further stockholder approval. In the future, our board of directors could authorize the issuance of one or more series of preferred stock that would grant to holders, among other rights, the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of our preferred shares acquired by such persons, together with a premium, prior to the redemption of our common stock. In addition, our board of directors could authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our existing stockholders.

36If we fail to establish and maintain an effective system of internal controls, we may not be able to report our financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely affect the trading price of our common stock.

~~PART~~Effective IIinternal controls are necessary for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be harmed. If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company, including the requirements of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act). In addition, we may be unable to accurately report our financial results in future periods or report them within the timeframes required by the requirements of the SEC or the Sarbanes-Oxley Act. Failure to comply with the Sarbanes-Oxley Act, when and as applicable, could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could result in identification of material weaknesses or significant deficiencies, cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. As previously reported in our Form 10-Q for the period ended December 31, 2025, we identified a material weaknesses in our internal control over financial reporting. We did not design and maintain effective controls related to the accounting for the warrants issued in the public offering completed in December 2025. In response to this identified material weakness, our management, with the oversight of the Audit Committee of our board of directors, has been actively engaged in remediating the above material weakness. During the quarter ended March 31, 2026, we implemented remediation measures designed to remediate this material weakness. Furthermore, Section 404 of the Sarbanes-Oxley Act and related regulations require our management to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. Based on its evaluation, our management concluded that our internal controls over financial reporting were effective as of March 31, 2026. We cannot provide assurance that, in the future, a material weakness or significant deficiency will not exist or otherwise be discovered. If that were to happen, it could harm our operating results and cause stockholders to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price of our securities.

~~ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES~~38

~~Market~~Furthermore, Section ~~Information~~404 ~~for~~of ~~Common~~the ~~Stock~~Sarbanes-Oxley Act and related regulations require our management to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. Based on its evaluation, our management concluded that our internal controls over financial reporting were effective as of March 31, 2026. We cannot provide assurance that, in the future, a material weakness or significant deficiency will not exist or otherwise be discovered. If that were to happen, it could harm our operating results and cause stockholders to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price of our securities.

~~Our~~Sustained ~~common~~inflation ~~stock~~could ishave ~~currently~~a ~~listed~~material adverse effect on ~~the~~our ~~Nasdaq~~business, ~~Capital Market~~financial ~~under~~condition, ~~the~~results ~~symbol~~of ~~“MODD~~operations and liquidity.”

~~Authorized~~Inflation ~~Capital~~rates in the United States have remained elevated and may continue to rise. Inflation over the last several months has led us to experience higher costs, including, among others, labor and transportation. Some of our suppliers have raised their prices and may continue to raise prices, and, as we expand commercialization of our product, in the future, we may not be able to make corresponding price increases to obtain adequate gross margins and achieve profitability. If inflation rates continue to rise or remain elevated for a sustained period of time, they could have a material adverse effect on our business, financial condition, results of operations and liquidity.

WeOur ~~are~~board ~~authorized by our Certificate~~ of ~~Incorporation to~~directors ~~issue~~is anable ~~aggregate of up~~ to ~~5,000,000 shares of preferred stock, $0.001 par value per share, and 100,000,000 shares of common stock,~~adopt ~~$0.001~~recapitalizations ~~par~~through ~~value~~forward ~~per~~or ~~share.~~reverse Assplits of ~~March~~our ~~31,~~outstanding ~~2025, zero and 53,706,074~~ shares of ~~preferred stock and~~ common stock, ~~respectively,~~without ~~were~~stockholder ~~issued and outstanding~~approval.

~~Holders~~Pursuant to our amended and restated articles of ~~Record~~incorporation, our board of directors has the power, without obtaining stockholder approval, to effectuate recapitalizations of us through forward or reverse splits of our outstanding common stock. As a result of such provision, our board of directors can implement recapitalizations of us by effectuating a forward or reverse stock split of our outstanding common stock, which would increase or decrease each of our stockholder’s number of shares owned, and our stockholders will have no right to approve or disapprove any such action even if such actions have a material adverse effect on them.

AsITEM ~~of March 31, 2025, we had 169 stockholders of record~~1B. ~~The~~UNRESOLVED ~~actual~~STAFF number of stockholders is greater than this number of stockholders of record and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. This number of stockholders of record also does not include stockholders whose shares may be held in trust by other entities.COMMENTS

~~Securities Authorized for Issuance under Equity Compensation Plan~~None

~~For~~ITEM information regarding securities authorized for issuance under equity compensation plans, please refer to Item 12, Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters1C. CYBERSECURITY

~~Dividend~~We ~~Policy~~believe a robust and proactive approach to cybersecurity risks and threats is essential to achieving our strategic business objectives and protecting our business. We may face a wide range of cybersecurity threats, such as ransomware and denial-of-service attacks. Our customers, suppliers and other business partners may also face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these third parties could have a material adverse effect on our business and results of operations. Due to the risks that cybersecurity threats can pose to our business, we continually evaluate best practices and methods, including cyber defense systems and training programs, to protect our business from a wide range of potential threats.

We ~~have~~continue ~~never~~to ~~declared~~evaluate orour ~~paid~~cybersecurity ~~any~~control ~~cash dividend~~processes onand ~~our~~procedures ~~capital~~to ~~stock~~address the evolving cybersecurity risks that we may face in an increasingly technically capable environment. We dohave ~~not~~implemented ~~anticipate~~practices ~~paying~~and ~~any~~intend ~~cash~~to ~~dividends~~implement inpolicies ~~the~~to ~~foreseeable~~educate ~~future~~and provide guidance to our personnel, including a security awareness training program and other related cybersecurity best practices. Through our outsourced information technology (“IT”) provider, we ~~intend~~are toimplementing ~~retain~~an ongoing security awareness training program for all ~~of our~~personnel ~~earnings~~that includes annual and onboarding training, ifperiodic ~~any~~simulated phishing campaigns, toand ~~finance~~continuous ~~our~~reinforcement, ~~growth~~with participation tracked and ~~operations~~reported. Safeguards currently in place include enforced multi-factor authentication for email and cloud services, managed endpoint detection and response, monitored data backup, and access controls, which are reviewed on an ongoing basis. We conduct technical risk assessments to ~~fund~~identify cybersecurity threats, as well as assessments in the ~~expansion~~event of a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats. ~~Payment~~We also plan to conduct programmatic risk assessments, including identification of ~~any~~reasonably ~~dividends~~foreseeable internal and external risks, the likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems, and safeguards in place to manage such risks. Following these risk assessments, we will ~~be made~~evaluate: i) whether and how to implement, and maintain reasonable safeguards to minimize identified risks, ii) how to reasonably address any identified gaps in existing safeguards; and how to regularly monitor the ~~discretion~~effectiveness of our ~~board~~safeguards. ofAs ~~directors,~~we ~~after~~are ~~taking~~a ~~into~~small ~~account~~early ~~various~~commercial-stage ~~factors~~company, ~~including~~we currently outsource our ~~financial~~IT ~~condition,~~functions ~~operating results~~to a third party. Working with the outsourced IT firm, ~~current~~our ~~and~~president ~~anticipated~~manages ~~cash~~the ~~needs~~risk assessment and ~~plans~~mitigation ~~for~~process. ~~expansion~~Third parties will play an important role in our cybersecurity program. ~~Any~~We ~~dividends~~intend ~~that~~to ~~may~~engage bethird-party ~~declared~~service orproviders ~~paid~~to onconduct evaluations of our ~~common~~security ~~stock~~controls, ~~must also~~including bepenetration ~~paid~~testing inand consulting on best practices. The third-party services include testing both the ~~same~~design ~~consideration~~and oroperational ~~manner~~effectiveness of security controls. This dependence exposes us, asalong with others who use such service providers, to the ~~case~~impact ~~may~~of bea cyber-attack on their service providers. It is possible for a cyber-attack at a third-party service provider to have a significant financial, operational, or reputational impact to us. To reduce the effective impact to us of a cyber-attack on a third-party service provider, we intend to monitor the risks associated with our ~~shares~~service providers through periodic review of ~~preferred~~these ~~stock,~~providers’ ifcybersecurity ~~any~~programs.

~~Recent Sales of Unregistered Securities~~39

~~Set~~ ~~forth~~Our ~~below~~board isof ~~information~~directors, ~~regarding securities~~through ~~issued~~its byaudit uscommittee, ~~within~~oversees ~~the~~our ~~past~~processes ~~two~~for ~~years~~identifying ~~that~~and ~~were~~mitigating ~~not~~risks, ~~registered~~including ~~under~~cybersecurity risks. Management periodically briefs the ~~Securities~~audit ~~Act~~committee and/or the board of directors on our cybersecurity and information security policies and plans. ~~Also~~Our ~~included~~board of directors is ~~the~~apprised ~~consideration, if~~of ~~any~~cybersecurity incidents deemed to have a moderate or higher business impact, ~~received~~and bywe uswill provide updates on management’s incident response plan for ~~such~~addressing ~~issuances,~~and mitigating any impacts and risks associated with such an incident. Our outsourced information ~~relating~~technology toprovider ~~the~~maintains ~~section~~incident ofresponse ~~the~~procedures, ~~Securities~~and ~~Act~~we are formalizing a documented incident response plan, orwhich ~~rule~~sets offorth the ~~Securities~~steps to be followed from incident detection and ~~Exchange~~ ~~Commission~~assessment to mitigation, ~~under~~recovery ~~which~~and ~~exemption~~notification ~~from~~and ~~registration~~reporting ~~was~~within ~~claimed~~our organization and to our board of directors.

~~Director~~ ~~Compensation~~For additional information regarding whether any risks from cybersecurity threats have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition, please refer to Item 1A, “Risk Factors,” in this Report, including the risk factor entitled “Third parties might attempt to gain unauthorized access to our network or seek to compromise our insulin pump product.”

~~During~~ ~~the~~ITEM ~~years ended March 31, 2025 and 2024, we issued a total of 83,331 and 83,333 shares of our common stock, respectively, to a non-employee director upon vesting of restricted stock units~~2. PROPERTIES

OnOur ~~each~~principal ~~of March 31~~administrative, ~~2024~~operations, ~~December~~and ~~30, 2023,~~ research and ~~June~~development ~~30,~~functions ~~2023~~are ~~we issued~~located in a ~~total~~leased offacility ~~6,375~~in ~~shares~~San ofDiego, ~~our~~California. ~~common~~We ~~stock~~currently tooccupy aapproximately ~~total~~24,000 ofsquare feet ~~four~~ of ~~our~~space ~~non-employee~~in ~~directors~~the inSan ~~accordance~~Diego ~~with~~facility, ~~our~~and ~~Outside~~the ~~Director Compensation~~lease ~~Plan~~extends ~~(the~~through ~~“Director~~January ~~Plan”)~~2027. OnUnder ~~September~~the 30lease, ~~2023~~in addition to the minimum lease payments, we ~~issued~~are aresponsible ~~total~~for ofproperty 6taxes,~~265~~ ~~shares~~insurance ofand ~~our~~certain ~~common~~other ~~stock~~operating tocosts. ~~a total~~We ofbelieve ~~four~~that of our ~~non-employee~~existing ~~directors~~facility inis adequate ~~accordance~~to ~~with~~meet ~~the~~our ~~Director~~current ~~Plan~~needs.

~~March~~ITEM ~~2025~~3. ~~Placement~~LEGAL PROCEEDINGS

OnWe ~~March~~are ~~20,~~not ~~2025,~~a weparty ~~entered~~to ~~into~~any ~~Securities~~material legal proceeding that we believe ~~Purchase~~is ~~Agreements~~likely ~~(the~~to ~~“Purchase~~have ~~Agreements”)~~a ~~with~~material ~~investors~~adverse ~~(the~~effect ~~“Investors”)~~on ~~for~~our ~~the private~~consolidated ~~placement (the “Private~~financial ~~Placement”)~~position or results of ~~6,247,656 units (each~~operations. aFrom ~~“Unit”)~~time to time, ~~with~~we ~~each~~may be ~~Unit~~subject ~~consisting~~to legal proceedings and claims in the ordinary course of ~~(A)~~business. ~~two~~These ~~shares~~claims, even if not meritorious, could result in the expenditure of ~~our~~significant ~~common~~financial ~~stock~~resources and ~~(B)~~diversion ~~one~~of ~~warrant~~management (efforts. To the knowledge of our management, we are not a ~~“Warrant”)~~party to ~~purchase~~any ~~one~~pending ~~share~~legal proceeding. To the knowledge of our ~~common~~management, ~~stock~~no federal, atstate anor ~~offering~~local ~~price~~governmental ofagency ~~$1.92~~is presently ~~per~~contemplating ~~Unit~~any proceeding against us. ~~The~~No ~~common~~director, ~~stock~~executive ~~and~~officer ~~the~~or ~~Warrants~~affiliate ~~included~~of inours ~~the Units and~~or ~~the~~owner of record or beneficially of more than five percent of our common stock ~~underlying~~is ~~the~~a ~~Warrants~~party ~~are~~adverse ~~collectively referred~~ to ~~herein~~us asor ~~the~~has ~~“Securities.”~~a ~~The~~material ~~Private~~interest ~~Placement~~adverse ~~closed~~to onus ~~March~~in ~~26,~~any ~~2025~~proceeding.

~~Concurrently with~~ITEM the Private Placement, on March 20, 2025, we entered into a subscription agreement (the “Subscription Agreement”) with a foreign investor, pursuant to which we completed a direct private placement of 260,417 Units for additional aggregate gross proceeds of approximately $04.5 ~~million~~MINE onSAFETY ~~the same terms as the Private Placement (the “Concurrent Direct Placement”). The Concurrent Direct Placement closed on March 25, 2025.~~DISCLOSURES

~~The~~Not Securities being sold pursuant to the Purchase Agreements and the Subscription Agreement were sold and issued without registration under the Securities Act, in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as a transaction not involving a public offering and/or Rule 506 promulgated thereunder, and in reliance on similar exemptions under applicable ~~state laws~~. For the Securities being sold pursuant to the Subscription Agreement, we relied upon the exemption from the registration requirements of the Securities Act provided by Regulation S promulgated under the Securities Act.

3740

~~Service~~PART ~~Providers~~ II

On ~~August~~ITEM ~~26, 2024, we issued 20,000 shares of our common stock to a service provider~~5. OnMARKET ~~April~~FOR 9,REGISTRANT’S ~~2024~~COMMON ~~we issued 10~~EQUITY,~~000~~ ~~shares~~RELATED ofSTOCKHOLDER ~~our~~MATTERS ~~common~~AND ~~stock~~ISSUER toPURCHASES aOF ~~service~~EQUITY provider. In August 2023, we issued 1,429 shares of our common stock to a service provider. In March 2023, we issued 10,000 shares of our common stock to a service provider. The aforementioned issuances were made pursuant to exemptions from registration pursuant to Section 4(2) and/or Rule 506 of Regulation D of the Securities Act.SECURITIES

~~ITEM~~Market 6.Information ~~RESERVED~~for Common Stock

~~ITEM~~Our 7.common ~~MANAGEMENT’S~~stock ~~DISCUSSION~~is ~~AND~~currently ~~ANALYSIS~~listed OFon ~~FINANCIAL~~the ~~CONDITION~~Nasdaq Capital ~~AND~~Market ~~RESULTS~~under OFthe ~~OPERATIONS~~symbol “MODD.”

~~The~~Authorized following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and related notes included in this Annual Report on Form 10-K, or the Report. Management’s Discussion and Analysis of Financial Condition and Results of Operations may contain statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties and other factors. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue,” and similar expressions or variations. Actual results could differ materially because of the factors discussed in Part I, Item 1A, These risks and uncertainties may cause actual results to differ materially from those discussed in the forward-looking statements.Capital

~~Our~~We ~~fiscal~~are ~~year~~authorized ~~ends~~by onour ~~March~~Certificate 31 of ~~each~~ ~~calendar~~Incorporation ~~year. Each reference~~ to aissue ~~fiscal~~an ~~year~~aggregate inof ~~this~~up ~~Report~~to 5,000,000 ~~refers~~shares toof ~~the~~preferred ~~fiscal~~stock, ~~year~~$0.001 ~~ended~~par ~~March~~value 31per ofshare, ~~the~~and ~~calendar~~250,000,000 ~~year indicated~~shares ~~(for~~of ~~example~~common stock, ~~fiscal~~$0.001 ~~2025~~par ~~refers~~value toper ~~the~~share. ~~fiscal~~As ~~year~~of ~~ending~~ March 31, ~~2025). Unless the context requires otherwise~~2026, ~~references~~zero toand ~~“we~~4,~~” “us~~661,”160 ~~“our,”~~shares ~~and~~of ~~the~~preferred ~~“Company”~~stock ~~refer~~and tocommon ~~Modular Medical~~stock, respectively, ~~Inc.~~were issued and ~~its consolidated subsidiary~~outstanding.

~~Company~~Holders ~~Overview~~of Record

WeAs ~~are a pre-revenue medical device company focused on the design, development and commercialization~~ of ~~innovative~~March ~~insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump~~31, ~~our initial product~~2026, ~~the MODD1,~~ we ~~seek~~had to76 ~~fundamentally~~stockholders ~~alter the trade-offs between cost and complexity and access to the higher standards~~ of ~~care that presently-available insulin pumps provide. By simplifying and streamlining~~ the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass marketrecord. The ~~product seeks~~actual tonumber ~~serve~~of ~~both~~stockholders ~~the~~is ~~type~~greater 1than ~~and~~this ~~the~~number ~~rapidly~~of ~~growing,~~stockholders ~~especially in terms~~ of ~~device~~record ~~adoption,~~and ~~type~~includes 2stockholders ~~diabetes~~who ~~markets.~~are ~~In January 2024,~~beneficial weowners ~~submitted~~but awhose ~~510(k)~~shares ~~premarket~~are ~~notification~~held ~~to the United States Food and Drug Administration (the “FDA”) for our MODD1 insulin pump, and,~~ in ~~September~~street ~~2024,~~name weby ~~received~~brokers ~~FDA clearance to market~~ and ~~sell~~other ~~our MODD1 pump in the United States~~nominees. WeThis ~~are~~number ~~actively~~of ~~working to~~stockholders i)of ~~commercialize~~record ~~our~~also ~~MODD1~~does ~~product~~not ~~and commence initial shipments in the quarter ending September 30, 2025, ii) obtain regulatory clearance~~include tostockholders ~~market~~whose ~~and~~shares ~~sell~~may ~~our~~be ~~Pivot~~held ~~Product~~ in ~~2026,~~trust ~~iii)~~by ~~obtain~~other ~~regulatory clearance to market and sell our pump products in foreign jurisdictions, iv) improve the manufacturability and usability of our pump products and v) develop new pump products~~entities.

InSecurities ~~March~~Authorized ~~2025,~~for weIssuance ~~completed~~under ~~a private placement (the “Private~~Equity ~~Placement”)~~Compensation of 6,247,656 units (each a “Unit”), with each Unit consisting of (A) two shares of our common stock and (B) one warrant to purchase one share of common stock, at an offering price of $1.92 per Unit. The Private Placement provided us with aggregate gross proceeds totaling approximately $12 million, before deducting placement agent fees and other expenses. Concurrently with the Private Placement, we entered into a subscription agreement with a foreign investor pursuant to which we completed a direct private placement of 260,417 Units for additional aggregate gross proceeds of approximately $0.5 million on the same terms as the Private Placement.Plan

~~Historically,~~For weinformation ~~have~~regarding ~~financed our operations~~securities ~~principally~~authorized ~~through~~for ~~private~~issuance ~~placements~~under ~~and~~equity ~~public~~compensation ~~offerings of our common stock and warrants and sales of convertible promissory notes. Based on our current operating plan~~plans, ~~substantial~~please ~~doubt~~refer ~~about our ability~~ to ~~continue as a going concern for a period of at least one year from the date that the financial statements included in~~ Item ~~8 of this Report are issued exists. Our ability to continue as a going concern depends on our ability to raise additional capital~~12, ~~through~~Security ~~the~~Ownership ~~sale~~ of ~~equity~~Certain orBeneficial ~~debt securities, to support our future operations. If~~Owners ~~we are unable to secure additional capital, we will be required to curtail our research~~ and ~~development~~Management ~~initiatives~~ and ~~take~~Related ~~additional measures~~Stockholder ~~to reduce costs~~Matters. ~~We have provided additional disclosure in Note 1 to the consolidated financial statements in Item 1 of this Report and under Liquidity below.~~

38Dividend Policy

~~World~~We ~~Unrest~~ have never declared or paid any cash dividends on our capital stock. We do not anticipate paying any cash dividends in the foreseeable future and we intend to retain all of our earnings, if any, to finance our growth and operations and to fund the expansion of our business. Payment of any dividends will be made in the discretion of our board of directors, after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and plans for expansion. Any dividends that may be declared or paid on our common stock, must also be paid in the same consideration or manner, as the case may be, on our shares of preferred stock, if any.

~~World~~Recent ~~unrest~~Sales ~~due~~of toUnregistered wars and terrorist attacks have led to economic disruptions. Mounting inflationary cost pressures and recessionary fears have negatively impacted the global economy. Since mid-2022, at times, the U.S. Federal Reserve has addressed elevated inflation by increasing interest rates. Market conditions may prevent us from accessing the capital markets, and additional capital may only be available to us on terms that could be significantly detrimental to our existing stockholders and to our business.Securities

~~Results~~Except ofas ~~Operations~~disclosed below, during the period covered by this Annual Report on Form 10-K, we have not sold any equity securities that were not registered under the Securities Act that were not previously reported in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K.

~~The~~Director ~~following discussion should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Report.~~Compensation

~~Research~~During the years ended March 31, 2026 and ~~Development~~2025, we issued a total of 2,777 and 2,778 shares of our common stock, respectively, to a non-employee director upon vesting of restricted stock units.

	Years ended March 31,				Year-over-Year Change
	2025		2024		2024 to 2025
Research and development	$	14,697	$	12,880	$	1,817	14.1	%

On each of March 31, 2024, December 30, 2023, and June 30, 2023 we issued a total of 213 shares of our common stock to a total of four of our non-employee directors in accordance with our Outside Director Compensation Plan (the “Director Plan”). On September 30, 2023, we issued a total of 208 shares of our common stock to a total of four of our non-employee directors in accordance with the Director Plan.

~~Our~~Service research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with the production of our insulin pump products. We expense R&D costs as they are incurred.Providers

~~R&D~~On ~~expenses~~August ~~increased~~26, ~~in fiscal 2025 compared with fiscal~~ 2024 ~~primarily due to increases in engineering and operations personnel costs of $1.6 million~~, ~~depreciation~~we ~~and~~issued ~~amortization of~~666 ~~$0.7~~shares ~~million and travel-related and other costs~~ of ~~approximately~~our ~~$0.3~~common ~~million.~~stock ~~The increase in personnel costs was attributable~~ to ~~increased~~ ~~average~~a ~~headcount year over year, salary increases effected during fiscal 2025, payment of bonuses in fiscal 2025 and higher~~service ~~payroll taxes~~provider. ~~Our~~On ~~R&D~~April ~~employee headcount increased to 48 at March 31~~9, ~~2025 from 36 at March 31,~~ 2024. ~~The~~we ~~increase~~issued in333 ~~depreciation and~~shares ~~amortization~~of ~~expenses~~our ~~was~~common ~~primarily~~stock ~~due~~ to ana ~~increase in machinery and equipment purchased and placed in~~ service ~~to further develop and expand our manufacturing capabilities~~provider. ~~The~~In ~~increases~~August ~~in R&D expense were partially offset by decreases in consulting costs of $0.6~~2023, ~~materials~~we ~~and~~issued ~~supplies~~47 ~~expenditures~~shares of ~~$0.1~~our common ~~million and~~ stock~~-based~~ ~~compensation~~to ofa ~~$0.1~~service ~~million~~provider. The ~~decrease~~aforementioned inissuances ~~consulting~~were ~~expenditures was~~made ~~primarily~~pursuant ~~due~~ to aexemptions ~~reduction~~from inregistration ~~utilization~~pursuant ofto ~~consultants, as we increased our employee headcount, and a decrease in utilization~~Section of4(2) ~~outside testing~~ and/or ~~other~~Rule ~~third~~506 ~~parties in support~~ of ~~our~~Regulation ~~FDA submission in the fourth quarter of 2024. R&~~D ~~expenses included stock-based compensation expenses~~ of ~~approximately~~the ~~$1.8~~Securities ~~million and $1~~Act.~~9 million for fiscal 2025 and fiscal 2024, respectively.~~

We expect R&D expenses will increase in fiscal 2026, as we continue to hire additional engineering, quality assurance, and operations personnel, bring-up our manufacturing process at our medical device contract manufacturer and continue the development and prepare for the submission of our Pivot product, as we expect to transition our MODD1 product to the new Pivot product in 2026.41

39ITEM 6. RESERVED

~~General~~ ~~and~~ITEM ~~Administrative~~7. MANAGEMENT’S DISCUSSIONANDANALYSIS OF FINANCIAL CONDITIONAND RESULTS OF OPERATIONS

	Year ended March 31,				Year-over-Year Change
	2025		2024		2024 to 2025
General and administrative	$	4,351	$	4,649	$	(298	)	(6.4	)%

The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and related notes included in this Annual Report on Form 10-K, or the Report. Management’s Discussion and Analysis of Financial Condition and Results of Operations may contain statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties and other factors. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue,” and similar expressions or variations. Actual results could differ materially because of the factors discussed in Part I, Item 1A, These risks and uncertainties may cause actual results to differ materially from those discussed in the forward-looking statements.

~~General~~Our ~~and~~fiscal ~~administrative,~~year orends ~~G&A, expenses~~on ~~consist~~March ~~primarily~~31 of ~~personnel~~each ~~and~~calendar year. ~~related~~Each ~~overhead~~reference ~~costs~~to a fiscal year in this Report, refers to the fiscal year ended March 31 of the calendar year indicated (for ~~facilities~~example, fiscal ~~finance~~2026 refers to the fiscal year ending March 31, ~~human~~2026). ~~resources~~Unless the context requires otherwise, ~~general~~references ~~management~~to “we,” “us,” “our,” and ~~marketing~~the “Company” refer to Modular Medical, Inc. and its consolidated subsidiary.

~~G&A~~Overview expenses decreased in fiscal 2025 compared with fiscal 2024 primarily as a result of reductions in stock-based compensation expense of $0.2 million, marketing expense of $0.1 million (due to a participant study for our product performed in fiscal 2024), travel-related expenses of $0.1 million and shipping expenses of $0.1 million. The decreases were partially offset by increased consulting fees of $0.1 million and personnel costs of $0.1 million. G&A expenses included stock-based compensation expenses of approximately $0.6 million and $0.8 million for fiscal 2025 and fiscal 2024, respectively. We expect G&A expenses to increase in fiscal 2026, as we expect to increase headcount, as we develop a limited sales and marketing organization, add finance and administration personnel and implement systems to support our anticipated growth and commercialization of our product during fiscal 2026.

~~Liquidity~~We are a commercial-stage medical device company focused on the design, development and ~~Capital~~commercialization ~~Resources;~~of ~~Changes~~innovative insulin pumps using modernized technology to increase pump adoption in ~~Financial~~the diabetes marketplace. ~~Condition~~Through the creation of a novel two part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for our initial product, our MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. In August 2025, we announced the first human use of our MODD1 pump delivering insulin to a human patient. In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot. We submitted a 510(k) premarket notification to the FDA for our Pivot product on November 13, 2025, and we received regulatory approval on April 9, 2026. In June 2026, we announced commercial availability of our Pivot product and commenced initial shipments. We are actively working to i) expand commercial activities for our Pivot product across metropolitan markets, ii) obtain regulatory clearance to market and sell our Pivot product in foreign jurisdictions, iii) improve the manufacturability and usability of our Pivot product and iv) develop new pump products.

~~Going~~On ~~Concern~~April 19, 2026, we entered into a placement agency agreement with Maxim Group LLC (“Maxim”), relating to a registered direct offering (the “April 2026 Offering”) of 750,000 shares of our common stock, par value $0.001 per share. The gross proceeds to us from the April 2026 Offering were approximately $3.375 million, before deducting offering expenses. The April 2026 Offering closed on April 21, 2026.

Historically, we have financed our operations principally through private placements and public offerings of our common stock and warrants and sales of convertible promissory notes. Based on our current operating plan, there is substantial doubt about our ability to continue as a going concern for a period of at least one year from June 29, 2026. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities, to support our future operations. If we are unable to secure additional capital, we will be required to curtail our research and development initiatives and take additional measures to reduce costs. We do not currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses and negative cash flows in each year due to ~~costs~~operating expenses and capital expenditures incurred ~~associated~~to ~~with~~conduct our operations. ~~For~~We ~~the years ended March 31, 2025 and 2024, we~~ incurred net losses of approximately $1828.82 million and $1718.58 million, ~~respectively.~~for Atthe years ended March 31, 2026 and 2025, respectively, and we had ~~a cash balance of $13.1 million and~~ an accumulated deficit of approximately $84113.80 million. ~~When~~as ~~considered~~of ~~with~~March ~~our current operating plan~~31, ~~these~~2026. ~~conditions raise substantial doubt about our ability~~These toand ~~continue~~prior asyear alosses ~~going~~have ~~concern~~resulted ~~for~~in asignificant ~~period~~negative ofcash atflows ~~least~~and ~~one~~have ~~year~~necessitated ~~from the date~~ that ~~the~~we ~~financial~~raise ~~statements~~substantial ~~included~~amounts ~~in Item 8~~ of ~~this~~additional ~~Report~~capital ~~are~~during ~~issued~~this period. ~~Our~~This ~~financial~~raises ~~statements~~significant dodoubt ~~not~~about ~~include~~our ~~adjustments~~ability to ~~the amounts and classification of assets and liabilities that may be necessary should we be unable to~~ continue as a going concern., ~~Our~~which ~~operating~~was ~~needs~~also ~~include~~expressed ~~the~~by our ~~planned~~independent ~~costs~~registered topublic ~~operate~~accounting ~~our~~firm ~~business, including~~in ~~amounts~~its ~~required~~report toon ~~fund~~our ~~continued~~consolidated ~~research~~financial ~~and~~statements ~~development~~for ~~activities,~~the ~~working~~year ~~capital~~ended ~~and~~March ~~capital expenditures~~31, 2026. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities to support our future operations.

~~Recently,~~World in March 2025, we entered into securities purchase agreements with investors, with respect to the issuance and sale in a firm commitment underwritten offering for the private placement (the “2025 Private Placement”) of 6,508,073 units of its securities. Upon closing of the 2025 Placement, we sold 13,016,146 shares of common stock and warrants to purchase 6,508,073 shares of its common stock for net proceeds of approximately $11.4 million. The securities were sold as a unit with each unit consisting of two shares of common stock and one warrant (the “2025 Private Placement Warrants”) to purchase one share of common stock, at a public offering price of $1.92 per unit. In November 2024, we completed a firm commitment underwritten offering for net proceeds of $7.3 million. In November 2023, we entered into a Sales Agreement (the “ATM Agreement”) with Leerink Partners LLC (“Leerink”) under which we may offer and sell, from time to time at our sole discretion, shares of our common stock (subject to and based on current availability on our shelf registration statement) through an “at the market offering” program under which Leerink will act as sales agent or principal. Currently, we have approximately $7.2 million available for issuance under the ATM Agreement. In fiscal 2025, we received gross proceeds of approximately $2.2 million from sales under the ATM Agreement. Further, in fiscal year 2025, we received a total of approximately $1.1 million of proceeds from the exercise of common stock purchase warrants issued in a public offering we completed in May 2023. Our future capital requirements and the adequacy of our available funds will depend on many factors, including, without limitation, our ability to successfully commercialize our product, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product offerings. If we are unable to secure additional capital timely, we may be required to curtail R&D initiatives, reduce headcount and take additional measures to reduce costs in order to conserve our cash.Unrest

~~Purchase~~World ~~Obligations~~unrest due to wars and terrorist attacks have led to economic disruptions. Mounting inflationary cost pressures and recessionary fears have negatively impacted the global economy. Since mid-2022, at times, the U.S. Federal Reserve has addressed elevated inflation by increasing interest rates. Market conditions may prevent us from accessing the capital markets, and additional capital may only be available to us on terms that could be significantly detrimental to our existing stockholders and to our business.

Our primary purchase obligations include purchase orders for machinery and equipment. At March 31, 2025, we had outstanding purchase orders for machinery and equipment and related expenditures of approximately $1.5 million. In December 2023, we signed a device integration agreement with a provider of connected-care and remote monitoring diabetes technology solutions. As of March 31, 2025, we had a remaining obligation under the device integration agreement of approximately $400,000 over three years for technology license fees.42

40Results of Operations

~~Liquidity~~The following discussion should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this Report.

InResearch ~~fiscal 2025, we used approximately $15.7 million in operating activities, which primarily resulted from our net loss of approximately $18.8 million, as increased by changes to operating assets~~ and liabilities of approximately $0.4 million, and as adjusted for non-cash charges and gains, which included approximately $2.4 million of stock-based compensation expenses, depreciation and amortization expenses of approximately $1.1 million, and other immaterial adjustments. The changes in operating assets and liabilities primarily related to the timing of payments to vendors.Development

In fiscal 2024, we used approximately $14.0 million in operating activities, which primarily resulted from our net loss of approximately $17.5 million, less changes to operating assets and liabilities of approximately $0.4 million, as adjusted for non-cash charges and gains, which included stock-based compensation expenses of approximately $2.7 million, depreciation and amortization of approximately $0.4 million and other immaterial adjustments. The changes in operating assets and liabilities primarily related to the timing of payments to vendors.

	Year ended March 31,				Year-over-Year Change
	2026		2025		2025 to 2026
Research and development	$	19,973	$	14,697	$	5,276	35.9	%

~~For~~Our research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with the production of our insulin pump products. We expense R&D costs as they are incurred. R&D expenses increased in fiscal 2026 compared with fiscal 2025 primarily due to increases in engineering and ~~fiscal~~operations ~~2024~~personnel costs of $2.9 million, ~~cash~~consulting expenses ~~used~~of in$1.2 ~~investing~~million, ~~activities~~depreciation and amortization of ~~approximately~~$0.6 million, shipping expenses $20.5 million and materials and supply expenditures of approximately $10.74 million,. ~~respectively~~The increase in personnel costs was attributable to increased average headcount year over year, salary increases effected during fiscal 2026 and higher payroll taxes. The increase in consulting expenditures and material and supply expenditures was primarily ~~for~~due ~~the~~to ~~purchase~~an increase in utilization of ~~property~~consultants and material and job supplies, in support of our FDA submission of our new Pivot product in fiscal year 2026. The increase in depreciation and amortization expenses was primarily due to an increase in machinery and equipment purchased and placed in service to further develop and expand our manufacturing capabilities. The increases in R&D expense were partially offset by a decrease in stock-based compensation expenses of $0.5 million. R&D expenses included stock-based compensation expenses of approximately $1.3 million and $1.8 million for fiscal 2026 and fiscal 2025, respectively.

~~Cash~~We ~~provided~~expect byR&D ~~financing~~expenses ~~activities~~will ~~for~~increase ~~fiscal~~in ~~2025 totaled approximately~~fiscal ~~$22.1~~2027, ~~million~~as ~~and~~we ~~was~~continue ~~primarily attributable~~ to ~~net~~hire ~~proceeds~~additional ~~of approximately $11.4 million from a private placement of common stock and warrants~~engineering, ~~which~~quality ~~closed in March 2025~~assurance, ~~net proceeds of approximately $7.3 million from the issuance of common stock~~ and ~~warrants~~operations ~~in a public offering~~personnel, ~~which~~optimize ~~closed~~our inmanufacturing ~~November~~process ~~2024,~~at our ~~proceeds~~medical ofdevice ~~approximately~~contract ~~$1.3~~manufacturer ~~million for the exercise of common stock purchase warrants~~ and ~~proceeds~~ ofcontinue ~~approximately~~to ~~$2.1~~advance ~~million from~~ the ~~sale~~product ofdevelopment ~~shares~~roadmap ~~under~~for ~~the~~our ~~ATM~~pump ~~Agreement~~products.

~~Cash~~General ~~provided by financing activities for fiscal 2024 totaled approximately $21.1 million~~ and was primarily attributable to proceeds of approximately $20.1 million from the sale of shares of common stock in a registered direct offering and issuance of warrants to purchase common stock in private placements that closed in May 2023 and February 2024, net of underwriter fees and issuance costs, proceeds of approximately $0.7 million for the exercise of common stock purchase warrants and proceeds of approximately $0.3 from the sale of shares under the ATM Agreement.Administrative

Critical Accounting Policies and Estimates

	Year ended March 31,				Year-over-Year Change
	2026		2025		2025 to 2026
General and administrative	$	7,587	$	4,351	$	3,236	74.4	%

~~Our~~General consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Note 1 to the consolidated financial statements in Item 8 of this Report describes the significant accounting policies and ~~methods~~administrative, ~~used~~or inG&A, ~~the preparation of our consolidated financial~~expenses ~~statements.~~consist Weprimarily ~~have identified the accounting policies below as some~~ of ~~the~~personnel ~~more critical to our business~~ and ~~the~~related ~~understanding~~overhead ofcosts ~~our results~~for ~~of operations. These policies may involve estimates and judgments that affect the reported amounts of assets~~facilities, ~~liabilities~~finance, ~~revenues and~~human ~~expenses. Although we believe our judgments and estimates are appropriate~~resources, ~~actual~~general ~~future~~management ~~results may differ from our estimates,~~ and if ~~different assumptions or conditions were to prevail, the results could be materially different from our reported results~~marketing.

~~Use~~G&A expenses increased in fiscal 2026 compared with fiscal 2025 primarily due to increases in general and administrative personnel costs of ~~estimates~~$1.5 million, consulting expenses of $1.3 million, sales and marketing activities of $0.5 million, The increase in personnel costs was attributable to increased average headcount year over year, salary increases effected during fiscal 2026 and higher payroll taxes. The increases in G&A expense were partially offset by a decrease in stock-based compensation expenses of $0.2 million. G&A expenses included stock-based compensation expenses of approximately $0.4 million and $0.6 million for fiscal 2026 and fiscal 2025, respectively. We expect G&A expenses to increase in fiscal 2027, as we expect to increase headcount, as we continue to expand our limited sales and marketing organization, add finance and administration personnel and implement additional systems to support our anticipated growth and commercialization of our product during fiscal 2027.

~~The~~Liquidity ~~preparation of financial statements in conformity with GAAP requires us to make estimates~~ and ~~assumptions~~Capital ~~that~~Resources; ~~affect~~Changes ~~the reported amounts of assets and liabilities and disclosure~~in ofFinancial contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Estimates may include those pertaining to accruals, stock-based compensation and income taxes. Actual results could materially differ from those estimates.Condition

~~Stock-based~~Going ~~compensation~~Concern

We ~~periodically~~do ~~issue~~not ~~stock~~currently ~~options,~~have ~~restricted~~revenues ~~stock~~to ~~units~~generate ~~and~~cash ~~stock awards~~flows to ~~employees~~cover ~~and non-employees~~operating expenses. WeSince ~~account~~our ~~for~~inception, ~~such~~we ~~awards~~have ~~based~~incurred onoperating ~~Financial~~losses ~~Accounting~~and ~~Standards~~negative ~~Board~~cash ~~Accounting~~flows ~~Standards~~in ~~Codification~~each year due to costs incurred associated ~~(“ASC”)~~with ~~718,~~our ~~whereby~~operations. For the ~~value~~years ofended ~~the~~March ~~award~~31, is2026 ~~measured~~and on2025, ~~the~~we ~~date~~incurred net losses of ~~grant~~approximately $28.2 million and ~~recognized~~$18.8 asmillion, respectively. ~~compensation~~At ~~expense~~March on31, 2026, we had a ~~straight-line basis~~cash ~~over~~balance ~~the~~of ~~requisite~~$6.9 ~~service~~million ~~period,~~and ~~usually~~an ~~the~~accumulated ~~vesting~~deficit ~~period~~of approximately $113.0 ~~With~~million. ~~respect~~When considered towith ~~performance-based~~our ~~awards~~current operating plan, wethese ~~assess~~conditions ~~the~~raise ~~probability~~substantial doubt about our ability to continue as a going concern offor ~~achieving~~a ~~the~~period ~~requisite~~of ~~performance~~at ~~criteria~~least ~~before~~one ~~recognizing~~year ~~compensation~~from ~~expense.~~the Wedate ~~estimate~~that the ~~fair~~financial ~~value~~statements included in Item 8 of ~~stock~~this ~~options~~Report onare issued. Our financial ~~the~~statements ~~date~~do ofnot ~~grant~~include ~~using~~adjustments to the ~~Black-Scholes-Merton~~amounts ~~Option~~and ~~Pricing~~classification ~~(“Black~~of ~~Scholes”)~~assets ~~model~~and ~~which~~liabilities ~~uses~~that ~~certain~~may ~~assumptions~~be ~~related~~necessary should we be unable to ~~risk-free~~continue ~~interest~~as ~~rates,~~a ~~expected~~going ~~volatility,~~concern. ~~expected~~Our ~~life~~operating ofneeds include the ~~options~~planned costs to operate our business, including amounts required to fund continued research and ~~future~~development ~~dividends~~activities, working capital and capital expenditures. ~~Compensation~~Our ~~expense~~ability isto ~~recorded based~~continue ~~upon~~as ~~the~~a ~~value~~going ~~derived~~concern ~~from~~depends on ~~the~~our ~~Black-Scholes~~ability ~~model.~~to ~~The~~raise ~~assumptions~~additional ~~used~~capital, inthrough the ~~Black-Scholes~~sale ~~model~~of ~~could~~equity ~~materially~~or ~~affect~~debt ~~compensation expense~~securities ~~recorded~~to insupport our future ~~periods~~operations.

~~Income taxes~~43

WeIn ~~determine~~March ~~deferred~~2026, ~~tax~~the ~~assets~~Company ~~and~~completed ~~liabilities~~a ~~based~~securities ~~upon~~purchase ~~the~~agreement ~~differences~~public ~~between~~offering ~~the~~of ~~financial~~its ~~statement~~common stock and ~~tax~~pre-funded ~~bases~~warrants offor ~~our~~gross ~~assets~~proceeds ~~and~~of ~~liabilities~~approximately ~~using~~$12.0 million. ~~tax~~Our ~~rates~~future incapital ~~effect~~requirements ~~for~~and the ~~year~~ inadequacy ~~which~~of weour ~~expect~~available ~~the~~funds ~~differences~~will todepend ~~affect~~on ~~taxable~~many ~~income.~~factors, Aincluding, ~~valuation~~without limitation, ~~allowance~~our isability ~~established~~to ~~for~~successfully ~~any~~commercialize ~~deferred~~our ~~tax~~product, ~~assets~~competing ~~for which~~technological itand ismarket ~~more~~developments, ~~likely~~and ~~than~~the ~~not~~need ~~that~~to enter ~~all~~into orcollaborations awith ~~portion~~other ofcompanies ~~the~~or ~~deferred~~acquire ~~tax~~other ~~assets~~companies ~~will~~or ~~not~~technologies beto ~~realized.~~enhance ~~Based~~or oncomplement ~~the~~our ~~available information~~product ~~and~~offerings. ~~other~~If ~~factors,~~we ~~management~~are ~~believes~~unable itto issecure ~~more~~additional ~~likely~~capital ~~than~~timely, ~~not~~we ~~that~~may ~~our~~be ~~federal~~required ~~and~~to ~~state~~curtail ~~net~~R&D ~~deferred~~initiatives, ~~tax~~reduce ~~assets~~headcount and ~~will~~take ~~not~~additional bemeasures ~~fully realized,~~to ~~and~~reduce wecosts ~~have~~in ~~recorded~~order ato ~~full~~conserve ~~valuation~~our ~~allowance~~cash.

41Purchase Obligations

WeOur ~~account~~primary ~~for~~purchase ~~uncertain~~obligations ~~tax~~include ~~positions~~purchase inorders ~~accordance~~for ~~with~~machinery ~~ASC~~and ~~Topic 740, Income Taxes~~equipment. ~~When~~At ~~tax~~March ~~returns are filed~~31, ~~it is likely that some positions taken would be sustained upon examination by the taxing authorities~~2026, ~~while~~we ~~others~~had ~~are~~outstanding ~~subject~~purchase toorders ~~uncertainty~~for ~~about~~machinery ~~the~~and ~~merits~~equipment ofand ~~the~~related ~~position taken or the amount~~expenditures of ~~the~~approximately ~~position~~$1.6 ~~that would be ultimately sustained~~million. ~~The~~At ~~benefit~~March ~~of a tax position is recognized in the consolidated financial statements in the period during which~~31, ~~based on all available evidence~~2026, ~~management~~we ~~believes~~had itoutstanding ispurchase ~~more~~orders likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more- likely-than-not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for ~~unrecognized~~ ~~tax~~supplies ~~benefits in the accompanying consolidated balance sheets along with any associated interest~~ and ~~penalties~~inventory ~~that~~components would be payable to the taxing authorities upon examination. Interest associated with unrecognized tax benefits is classified as interest expense and penalties are classified in general and administrative expenses in the consolidated statements of ~~operations~~approximately $431,000.

~~Leases~~Liquidity

WeIn ~~account~~fiscal ~~for~~2026, ~~our~~we ~~leases~~used ~~under~~approximately ~~ASC~~$23.8 ~~842,~~million ~~Leases~~in ~~(“ASC 842”)~~operating activities, which ~~and~~primarily ~~related~~resulted ~~ASUs,~~from ~~which~~our ~~provide~~net ~~supplementary~~loss ~~guidance~~of ~~and~~approximately ~~clarifications~~$28.2 ~~Under~~million, ~~ASC~~as ~~842,~~increased ~~all~~by ~~significant~~changes ~~lease~~to ~~arrangements are~~operating ~~generally~~assets ~~recognized~~and atliabilities of ~~lease~~approximately ~~commencement~~$0.2 ~~Operating~~million, ~~lease~~and ~~right-of-use~~as ~~(“ROU”)~~adjusted ~~assets~~for ~~and~~non-cash ~~lease~~charges ~~liabilities~~and ~~are~~gains, ~~recognized at~~which ~~the~~included ~~commencement~~approximately ~~date~~$1.8 ~~ROU~~million ~~assets~~of ~~and~~stock-based compensation ~~corresponding~~expenses, ~~lease~~depreciation ~~liabilities~~and ~~are~~amortization ~~not~~expenses ~~recorded~~of ~~for~~approximately ~~leases~~$1.7 ~~with~~million, anchange ~~initial~~in ~~term~~fair value of 12warrant ~~months~~liabilities orof ~~less~~approximately ~~(short-term~~$0.8 ~~leases),~~million and weother ~~recognize~~immaterial ~~lease~~adjustments. ~~expense~~The ~~for~~changes ~~these~~in ~~leases~~operating asassets ~~incurred~~and ~~over~~liabilities primarily related to the timing ~~lease~~of ~~term~~payments to vendors.

~~ROU~~In ~~assets~~fiscal ~~represent~~2025, ~~our~~we ~~right~~used toapproximately ~~use~~$15.7 million anin ~~underlying~~operating ~~asset during the reasonably certain lease terms~~activities, ~~and~~which ~~lease~~primarily ~~liabilities~~resulted ~~represent~~from our ~~obligation~~net toloss ~~make~~of ~~lease~~approximately ~~payments arising from the lease~~$18.8 ~~Our~~million, ~~lease~~less ~~terms~~changes ~~may include options~~ to ~~extend~~operating orassets and ~~terminate~~liabilities ~~the~~of ~~lease~~approximately ~~when~~$0.4 itmillion, isas ~~reasonably~~adjusted ~~certain~~for ~~that~~non-cash wecharges ~~will exercise that option. Operating lease ROU assets~~ and ~~liabilities~~gains, ~~are~~which ~~recognized~~included ~~at the lease commencement date~~ stock-based oncompensation ~~the present value~~ expenses of ~~lease payments~~approximately ~~over the lease term~~$2.4 ~~We use our incremental borrowing rate~~million, ~~based~~depreciation onand ~~the~~amortization ~~information~~of ~~available~~approximately at$1.1 ~~commencement~~million ~~date~~and inother ~~determining the~~immaterial ~~present value of lease payments~~adjustments. The changes in operating ~~lease~~assets ~~ROU~~and ~~asset~~liabilities ~~also~~primarily ~~includes any lease payments~~ related to ~~initial~~the ~~direct~~timing ~~cost~~of ~~and prepayments~~payments ~~and~~to ~~excludes lease incentives~~vendors. ~~Lease expense is recognized on a straight-line basis over the lease term.~~

~~Off-Balance~~For ~~Sheet~~fiscal ~~Arrangements~~2026 and fiscal 2025, cash used in investing activities of approximately $3.9 million and $2.5 million, respectively, was for the purchase of property and equipment.

WeCash doprovided ~~not~~by ~~maintain~~financing ~~any~~activities ~~off-balance~~for ~~sheet~~fiscal ~~arrangements~~2026 ortotaled ~~obligations~~approximately ~~that~~$21.5 ~~are~~million ~~reasonably~~and ~~likely~~was primarily attributable to ~~have~~net proceeds of approximately $15.7 million from a ~~material~~public ~~current~~offering of orcommon ~~future~~stock ~~effect~~and onwarrants, ~~our~~which ~~financial~~closed ~~condition~~in March 2026, ~~results~~ net proceeds of ~~operations,~~approximately ~~liquidity~~$4.0 ormillion ~~capital~~from ~~resources~~the issuance of common stock and warrants in a warrant inducement offering in September 2025 and proceeds of approximately $1.9 million from the sale of shares under the ATM Agreement

~~Contractual~~Cash ~~Obligations~~provided by financing activities for fiscal 2025 totaled approximately $22.1 million and was primarily attributable to proceeds of approximately $11.4 million from a private placement of common stock and warrants, which closed in March 2025, net proceeds of approximately $7.3 million from the issuance of common stock and warrants in a public offering, which closed in November 2024, proceeds of approximately $1.3 million for the exercise of common stock purchase warrants and approximately $2.1 million from the sale of shares under the ATM Agreement.

AsCritical aAccounting ~~“smaller~~Policies ~~reporting~~and ~~company,” as defined by Item 10 of Regulation S-K, we are not required to provide the information requested by paragraph (a)(5) of this Item.~~Estimates

~~Recent~~Our ~~Accounting~~consolidated ~~Pronouncements~~financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Note 1 to the consolidated financial statements in Item 8 of this Report describes the significant accounting policies and methods used in the preparation of our consolidated financial statements. We have identified the accounting policies below as some of the more critical to our business and the understanding of our results of operations. These policies may involve estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. Although we believe our judgments and estimates are appropriate, actual future results may differ from our estimates, and if different assumptions or conditions were to prevail, the results could be materially different from our reported results.

~~See~~Use ~~Note 1 to the consolidated financial statements in Item 8~~ of ~~this Report for a full description of relevant recent accounting pronouncements.~~estimates

~~ITEM~~The 7Apreparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. ~~QUANTITATIVE~~Estimates ~~AND~~may ~~QUALITATIVE~~include ~~DISCLOSURES~~those ~~ABOUT~~pertaining to accruals, stock-based compensation and income taxes. Actual results could ~~MARKET~~materially ~~RISK~~differ from those estimates.

~~Not applicable.~~44

42Stock-based compensation

~~ITEM~~We 8:periodically ~~FINANCIAL~~issue ~~STATEMENTS~~stock ~~AND~~options, ~~SUPPLEMENTARY~~restricted ~~DATA~~stock units and stock awards to employees and non-employees. We account for such awards based on Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 718, whereby the value of the award is measured on the date of grant and recognized as compensation expense on a straight-line basis over the requisite service period, usually the vesting period. With respect to performance-based awards, we assess the probability of achieving the requisite performance criteria before recognizing compensation expense. We estimate the fair value of stock options on the date of grant using the Black-Scholes-Merton Option Pricing (“Black Scholes”) model which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the options, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes model. The assumptions used in the Black-Scholes model could materially affect compensation expense recorded in future periods.

~~INDEX~~Income ~~TO CONSOLIDATED FINANCIAL STATEMENTS~~taxes

Report of Independent Registered Accounting Firm – Farber Hass Hurley LLP	F-2
Consolidated Balance Sheets	F-4
Consolidated Statements of Operations	F-5
Consolidated Statements of Stockholders’ Equity	F-6
Consolidated Statements of Cash Flows	F-7
Notes to Consolidated Financial Statements	F-8

We determine deferred tax assets and liabilities based upon the differences between the financial statement and tax bases of our assets and liabilities using tax rates in effect for the year in which we expect the differences to affect taxable income. A valuation allowance is established for any deferred tax assets for which it is more likely than not that all or a portion of the deferred tax assets will not be realized. Based on the available information and other factors, management believes it is more likely than not that our federal and state net deferred tax assets will not be fully realized, and we have recorded a full valuation allowance.

FWe account for uncertain tax positions in accordance with ASC Topic 740, Income Taxes. When tax returns are filed, it is likely that some positions taken would be sustained upon examination by the taxing authorities, while others are subject to uncertainty about the merits of the position taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the consolidated financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more-1likely-than-not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for unrecognized tax benefits in the accompanying consolidated balance sheets along with any associated interest and penalties that would be payable to the taxing authorities upon examination. Interest associated with unrecognized tax benefits is classified as interest expense and penalties are classified in general and administrative expenses in the consolidated statements of operations.

~~REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM~~ Leases

ToWe account for our leases under ASC 842, Leases (“ASC 842”), and related ASUs, which provide supplementary guidance and clarifications. Under ASC 842, all significant lease arrangements are generally recognized at lease commencement. Operating lease right-of-use (“ROU”) assets and lease liabilities are recognized at the ~~Audit~~commencement ~~Committee~~date. ROU assets and corresponding lease liabilities are not recorded for leases with ~~Stockholders~~an initial term of ~~Modular~~12 ~~Medical~~months or less (short-term leases), and we recognize lease expense for these leases as incurred over the lease ~~Inc~~term.

~~Opinion~~ROU assets represent our right to use an underlying asset during the reasonably certain lease terms, and lease liabilities represent our obligation to make lease payments arising from the lease. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the ~~Financial~~present ~~Statements~~value of lease payments over the lease term. We use our incremental borrowing rate, based on the information available at commencement date in determining the present value of lease payments. The operating lease ROU asset also includes any lease payments related to initial direct cost and prepayments and excludes lease incentives. Lease expense is recognized on a straight-line basis over the lease term.

We have audited the accompanying consolidated balance sheets of Modular Medical, Inc. (the “Company”) as of March 31, 2025 and 2024, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the twoOff-~~year~~Balance ~~period~~Sheet ended March 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the two-year period ended March 31, 2025, in conformity with accounting principles generally accepted in the United States of America.Arrangements

~~Substantial~~We ~~Doubt~~do ~~about~~not ~~the~~maintain ~~Company's~~any ~~Ability~~off-balance sheet arrangements toor ~~Continue~~obligations asthat are reasonably likely to have a ~~Going~~material ~~Concern~~current or future effect on our financial condition, results of operations, liquidity or capital resources.

~~The~~Contractual accompanying consolidated financial statements have been prepared to assume the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred losses from operations and will need to raise additional funds to sustain its operations and meet future obligations until profitability is achieved. These circumstances raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.Obligations

~~Basis~~As ~~for~~a ~~Opinion~~“smaller reporting company,” as defined by Item 10 of Regulation S-K, we are

Filing Compare · Modular Medical, Inc.