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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 2026

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

Commission File Number: 001-43275

MOBIA MEDICAL, INC.

(Exact name of registrant as specified in its charter)

     Delaware

     20-8573833

     (State or other jurisdiction of
incorporation or organization)

     (I.R.S. Employer
Identification No.)

2802 Flintrock Trace, Suite 226

Austin, TX

(Address of principal executive offices)

78738

(Zip Code)

(855) 628-9375

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

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


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, $0.01 par value per share	MOBI	The Nasdaq Stock Market LLC

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

As of June 1, 2026, there were 33,249,006 shares of the registrant’s common stock, par value $0.01 per share, outstanding.

Mobia Medical, Inc.

TABLE OF CONTENTS


		Page

PART I—FINANCIAL INFORMATION		6
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements		6
Item 1. Condensed Financial Statements
Condensed Balance Sheets (unaudited) as of March 31, 2026 and December 31, 2025		6

Condensed Statements of Operations (unaudited) for the three months ended March 31, 2026 and 2025		7


Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit (unaudited) for the three months ended March 31, 2026 and 2025		8

Condensed Statements of Cash Flows (unaudited) for the three months ended March 31, 2026 and 2025		9

Notes to Condensed Financial Statements		10
Notes to Condensed Financial Statements
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		27

Item 3. Quantitative and Qualitative Disclosures About Market Risk		37

Item 4. Controls and Procedures		37
Item 4. Controls and Procedures
PART II—OTHER INFORMATION		39
PART II—OTHER INFORMATION

	Item 1. Legal Proceedings	39

	Item 1A. Risk Factors	39

	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	89

	Item 3. Defaults Upon Senior Securities	90

	Item 4. Mine Safety Disclosures	90

	Item 5. Other Information	90

	Item 6. Exhibits	90

SIGNATURES		93

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our expectations of future results of operations and financial condition, business strategy, solutions, technology, R&D costs, regulatory approvals, potential market opportunity, anticipated trends in our business, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:

•

the expected growth of our business and our organization;

•

our ability to continue as a going concern;

•

our ability to retain and recruit key personnel, including the continued development of a sales and marketing infrastructure;

•

our expectations regarding the potential market size and size of the potential patient populations for treatment with our Vivistim Paired Vagus Nerve Stimulation System and any future products, if approved for commercial use;

•

the expected use of our products by physicians and patients;

•

our plans to conduct further clinical trials and patient registries;

•

our plans and expected timeline related to our products, or developing new products, to address additional indications or otherwise;

•

our ability to obtain, maintain and expand regulatory clearances for our products and any new products we create;

•

our expected uses of the net proceeds from the initial public offering and our existing cash and cash equivalents;

•

our expectations regarding government and third-party payer coverage and reimbursement;

•

our ability to purchase sufficient quantities from manufacturers of our products with sufficient quality and at an acceptable price;

•

our ability to obtain an adequate supply of materials and components for our products from our third-party suppliers;

•

our ability to obtain, maintain and enforce intellectual property protection for our products;

•

our ability to expand our business into new geographic markets;

•

our compliance with extensive exchange requirements and government laws, rules, and regulations both in the United States and internationally;

•

our estimates of our expenses, ongoing losses, future revenue, and capital requirements, as well as our need for, or ability to obtain, additional financing, and our future financial performance;

•

our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”);

•

our ability to identify and develop new and planned products or acquire new products;

•

developments and projections relating to our competitors or our industry; and

•

the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements.

These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described in the section titled “Risk Factors” and elsewhere in this Quarterly Report and in other filings we make with the U.S. Securities and Exchange Commission (the “SEC”) from time to time. Moreover, we operate in a competitive and rapidly changing environment.

New risks and uncertainties emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

Although we believe that the expectations reflected in our forward-looking statements are reasonable based on the information available to us when they are made, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these forward-looking statements. We undertake no obligation to update any forward-looking statements, which speak only as the date they are made, for any reason after the date of this Quarterly Report.

Regulation FD – Channel of Distribution

We periodically post information that may be important to investors on our investor relations website at https://ir.mobia.com. We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult our website regularly for important information, in addition to following our press releases, filings with the SEC and public conference calls and webcasts. The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this Quarterly Report.

Summary Risk Factors

The risk factors summarized and detailed below could materially harm our business, operating results and/or financial condition, impair our future prospects and/or cause the price of our common stock to decline. A summary of the material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, those relating to:

•

We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it.

•

If we fail to manage our growth effectively, our business could be materially and adversely affected.

•

The commercial success of treatment with our Vivistim Paired Vagus Nerve Stimulation (“Paired VNS”) System (“Vivistim Therapy”) depends upon attaining significant market acceptance of our products by hospitals, healthcare providers, therapists, patients, caregivers and payors.

•

Our success depends entirely on our currently marketed Vivistim Therapy. If we are unable to successfully market and sell Vivistim Therapy, our business prospects will be materially and adversely affected, and we may be unable to achieve revenue growth and to fund our operations.

•

If we fail to effectively hire, train, and retain our direct sales force, increase our sales capabilities, or develop broad brand awareness in a cost-effective manner, our growth will be materially and adversely affected, and our business will suffer.

•

Coverage and adequate reimbursement may not be available or may be subject to change for our Vivistim System, including any future products we commercialize, which could diminish our sales, increase our competition, or affect our ability to sell our currently marketed Vivistim Therapy and any future products profitably.

•

We depend on a small number of third-party contract manufacturers and suppliers, some of which are single source, to produce and package all elements comprising our Vivistim Paired VNS System (the “Vivistim System”) as well as certain implantation tools, and if these suppliers and manufacturers fail to supply our Vivistim System or its components or subcomponents in sufficient quantities or at all, it will have a material adverse effect on our business, financial condition, and results of operations.

•

The size of our market opportunity has not been established with precision and may be smaller than we estimate, possibly materially.

•

Adverse events, product recalls, or other complications or customer satisfaction issues associated with Vivistim Therapy, including regarding the finite implanted pulse generator (“IPG”) battery life, could limit its adoption.

•

We have limited clinical data, evidence and experience regarding the safety and efficacy of Vivistim Therapy.

•

If we are unable to maintain existing, and obtain additional, patent and other intellectual property protection for our technology and products, or if the scope of the patent protection we obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

•

Our products and operations are subject to extensive government regulation and oversight in the United States, and our failure to comply with applicable requirements could materially and adversely affect our business.

•

Failure to maintain marketing authorizations for our products, or to timely obtain necessary marketing authorizations for our future products, may have a material and adverse effect on our business, financial condition and results of operations.

•

We have identified a material weakness in our internal control over financial reporting.

The risks described above should be read together with the text of the full risk factors described below in the section entitled “Risk Factors” and the other information set forth in this Quarterly Report, including our condensed financial statements and the related notes, as well as in other documents that we file with the SEC. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not precisely known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects.

PART I—FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

Mobia Medical, Inc.

Condensed Balance Sheets

(Unaudited)

(in thousands, except share and per share data)


	March 31,			December 31,
	2026			2025
Assets
Current assets
Cash and cash equivalents	$	55,725		$	33,587
Accounts receivable		4,854			4,435
Inventory		6,049			5,457
Deferred offering costs		3,496			935
Other current assets		1,590			1,943
Total current assets		71,714			46,357
Property and equipment, net		738			669
Right-of-use assets — operating leases		1,001			1,068
Other assets		143			55
Total assets	$	73,596		$	48,149
Liabilities, redeemable convertible preferred stock, and stockholders’ deficit
Current liabilities
Accounts payable	$	3,033		$	2,223
Operating lease liabilities, current		358			358
Product warranty liability		1,029			844
Accrued payroll, commissions, and bonuses		3,113			4,854
Accrued offering costs		2,641			935
Accrued and other current liabilities		1,660			992
Total current liabilities		11,834			10,206
Warrant liabilities		882			865
Notes payable, net of discount and deferred financing costs		7,257			7,130
Convertible notes payable		14,359			—
Convertible notes payable due to related parties		26,369			—
Operating lease liabilities, non-current		870			948
Total liabilities		61,571			19,149
Commitments and contingencies (Note 13)
Redeemable convertible preferred issuable in series, stock, $0.01 par value, 67,174,403 shares authorized as of March 31, 2026 and December 31, 2025, respectively; 65,591,701 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively; aggregate liquidation value of $182,255 as of March 31, 2026 and December 31, 2025, respectively		179,773			179,773
Stockholders’ deficit
Common stock, $0.01 par value, 86,600,000 shares authorized as of March 31, 2026 and December 31, 2025; 1,003,256 and 884,030 shares outstanding as of March 31, 2026 and December 31, 2025, respectively		10			9
Additional paid-in capital		7,771			7,007
Accumulated deficit		(175,529	)		(157,789	)
Total stockholders’ deficit		(167,748	)		(150,773	)
Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit	$	73,596		$	48,149

The accompanying notes are an integral part of these condensed financial statements.

Mobia Medical, Inc.

Condensed Statements of Operations

(Unaudited)

(in thousands, except share and per share data)


	Three Months Ended
	March 31,
	2026			2025
Revenue	$	12,074		$	5,661
Cost of goods sold		2,133			1,015
Gross profit		9,941			4,646
Operating expenses
Research and development costs		1,692			1,354
Selling, general and administrative expenses		25,186			13,596
Total operating expenses		26,878			14,950
Loss from operations		(16,937	)		(10,304	)
Other income (expense)
Change in fair value of convertible notes payable		(728	)		—
Interest expense		(357	)		(239	)
Other income (expense), net		282			(109	)
Total other expense, net		(803	)		(348	)
Loss before provision for income tax		(17,740	)		(10,652	)
Provision for income tax		—			(1	)
Net loss attributable to common stockholders	$	(17,740	)	$	(10,653	)
Net loss per share attributable to common stockholders
Basic	$	(19.30	)	$	(12.97	)
Diluted	$	(19.30	)	$	(12.97	)
Weighted average shares used to compute net loss per share attributable to common stockholders
Basic		918,935			821,160
Diluted		918,935			821,160

The accompanying notes are an integral part of these condensed financial statements.

Mobia Medical, Inc.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit

(Unaudited)

(in thousands, except share and per share data)

For the three months ended March 31, 2026


									Additional					Total
	Redeemable Convertible Preferred Stock				Common Stock				Paid-In		Accumulated			Stockholders'
	Shares		Amount		Shares		Amount		Capital		Deficit			Deficit
Balance, December 31, 2025		65,591,701	$	179,773		884,030	$	9	$	7,007	$	(157,789	)	$	(150,773	)
Net loss		—		—		—		—		—		(17,740	)		(17,740	)
Exercise of common stock options		—		—		119,226		1		357		—			358
Share-based compensation		—		—		—		—		407		—			407
Balance, March 31, 2026		65,591,701	$	179,773		1,003,256	$	10	$	7,771	$	(175,529	)	$	(167,748	)

For the three months ended March 31, 2025


									Additional					Total
	Redeemable Convertible Preferred Stock				Common Stock				Paid-In		Accumulated			Stockholders'
	Shares		Amount		Shares		Amount		Capital		Deficit			Deficit
Balance, December 31, 2024		40,892,855	$	114,826		776,701	$	8	$	5,247	$	(111,291	)	$	(106,036	)
Net loss		—		—		—		—		—		(10,653	)		(10,653	)
Issuance of Series F redeemable convertible preferred stock, net of tranche liability of $625,628 and issuance costs of $264,065		11,351,970		28,985		—		—		—		—			—
Related Party Issuance of Series F redeemable convertible preferred stock, net of tranche liability of $54,972 and issuance costs of $23,202		997,453		2,547		—		—		—		—			—
Exercise of common stock options		—		—		65,105		1		210		—			211
Share-based compensation		—		—		—		—		201		—			201
Balance, March 31, 2025		53,242,278	$	146,358		841,806	$	9	$	5,658	$	(121,944	)	$	(116,277	)

The accompanying notes are an integral part of these condensed financial statements.

Mobia Medical, Inc.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)


	Three Months Ended
	March 31,
	2026			2025
Cash flows from operating activities
Net loss	$	(17,740	)	$	(10,653	)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization		56			31
Share-based compensation		407			201
Change in fair value of convertible notes payable		728			—
Change in fair value of warrant liabilities		16			265
Amortization of debt discount and debt issuance costs		127			9
Changes in operating assets and liabilities
Accounts receivable		(419	)		409
Inventory		(593	)		(486	)
Other assets		(139	)		(104	)
Accounts payable		727			1,521
Accrued liabilities and other		(898	)		(916	)
Net cash used in operating activities		(17,728	)		(9,723	)
Cash flows from investing activities
Purchases of property and equipment		(42	)		(23	)
Net cash used in investing activities		(42	)		(23	)
Cash flows from financing activities
Exercise of common stock options		358			211
Proceeds from issuance of convertible notes payable		14,102			—
Proceeds from the related party issuance of convertible notes payable		25,898			—
Proceeds from issuance of Series F redeemable convertible preferred stock, net of issuance costs		—			29,611
Proceeds from the related party issuance of Series F redeemable convertible preferred stock, net of issuance costs		—			2,602
Payment of deferred offering costs		(450	)		—
Net cash provided by financing activities		39,908			32,424
Net change in cash and cash equivalents		22,138			22,678
Cash and cash equivalents, beginning of period		33,587			14,620
Cash and cash equivalents, end of period	$	55,725		$	37,298
Supplemental disclosures of cash flows information
Cash paid for interest	$	230		$	230

The accompanying notes are an integral part of these condensed financial statements.

Mobia Medical, Inc.

Notes to Condensed Unaudited Interim Financial Statements

Note 1 – Description of Business

Mobia Medical, Inc. (the “Company”) was incorporated in Delaware in March 2007. Effective February 23, 2026, the Company amended its articles of incorporation to change its name from MicroTransponder, Inc. to Mobia Medical, Inc. The change was solely a corporate name change and had no impact on the Company’s financial statements.

The Company develops, markets, and sells devices for the treatment of medical conditions. The first device brought to market, the Vivistim Paired VNS System (“Vivistim System”), received U.S. Food and Drug Administration premarket approval in 2021 and is intended to be used by chronic ischemic stroke survivors with moderate to severe upper extremity impairments to reduce upper extremity motor deficits and improve motor function. The Vivistim System was first brought to market in 2022, with the first commercial implant in May 2022, and commenced full commercial launch in 2023.

Initial Public Offering – In May 2026, the Company completed its initial public offering (“IPO”) in which it sold 10,000,000 shares of its common stock at a public offering price of $15.00 per share, for net proceeds of approximately $134.5 million, after deducting the underwriters’ discounts and commissions, and estimated offering costs paid by the Company. In addition, immediately prior to the completion of the IPO, all the outstanding shares of the Company’s redeemable convertible preferred stock were converted into an aggregate of 18,831,868 shares of common stock, and the Company's convertible promissory notes issued during the three months ended March 31, 2026 were converted into an aggregate of 3,333,324 shares of common stock.

Risks and Uncertainties – The Company’s activities are subject to significant risks and uncertainties, including, but not limited to, failure to manage growth effectively, reliance on the success of the Vivistim System, new technological innovations, dependence upon third-party payers to provide adequate coverage and reimbursement to our customers, the absence of a national coverage determination or local coverage determinations applicable to its device administered by the Centers for Medicare and Medicaid Services (CMS), dependence on key personnel, dependence on key suppliers, protection of proprietary technology, product liability, and compliance with government regulations. The Company is also subject to risks relating to cybersecurity and the protection of confidential information and personal information, as well as risks relating to evolving regulatory requirements (including potential additional clinical evidence requirements) that could affect commercialization of existing or future products. These risks and uncertainties, as well as failure to secure additional funding, if needed, can adversely affect the Company’s future financial results, financial position, and cash flow.

In addition, economic conditions in the United States, including any economic disruptions, inflationary, or supply chain pressures, may adversely impact the Company’s future financial results. The Company uses contract manufacturers in Uruguay to supply key products. Political instability or the deterioration of trade relations, including implementation of new tariffs and trade restrictions, could adversely impact the Company’s business.

Concentration of credit risk – The Company maintains its cash deposits with high credit quality financial institutions. At times, such deposits may be in excess of the Federal Deposit Insurance Corporation insured limits; however, management does not believe it is exposed to any significant credit risk. All such accounts are monitored by management to mitigate risk and cash equivalents are invested in highly rated money market funds.

Supplier concentration risk – The Company depends on a small number of third-party contract manufacturers and suppliers, some of which are single source, to produce and package all elements comprising our Vivistim System as well as certain implantation tools, and if these suppliers and manufacturers fail to supply the Vivistim System or its components or subcomponents in sufficient quantities or at all, it will have a material adverse effect on our business, financial condition, and results of operations.

Note 2 – Liquidity and Going Concern

These condensed unaudited interim financial statements were prepared on a going concern basis. The going concern basis assumes that the Company will continue in operation for the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.

The Company has incurred operating losses and negative cash flows from operations since its inception. For the three months ended March 31, 2026, the Company had a net loss of $17.7 million and had an accumulated deficit of $175.5 million as of March 31, 2026. Additionally, the Company has generated negative cash flows from operations for the three months ended March 31, 2026.

Since inception, the Company has financed its activities principally from the issuance of preferred stock, debt financing arrangements, revenue from sales of the Vivistim System and, subsequent to March 31, 2026, net proceeds from the IPO completed in May 2026. The Company believes that its operating losses and negative operating cash flows will continue into the foreseeable future. There can be no assurance that the Company’s products will generate sufficient revenue for the Company to achieve profitable operations.

Based on its current operating plan, the Company plans significant increases in marketing expenditures to facilitate further awareness and adoption of the Vivistim System, spending on research and development, including regulatory affairs and clinical studies, and costs related to scaling the Company’s commercial operations and infrastructure. In addition, general and administrative expenses are expected to increase following the Company’s IPO due to the additional costs associated with being a public company. As discussed in previous filings (including the Company’s annual financial statements for the periods ended December 31, 2024 and 2025 included in the prospectus), the Company had previously concluded that the aforementioned factors raised substantial doubt about its ability to continue as a going concern. In May 2026, the Company completed its IPO and received net proceeds of approximately $134.5 million. As a result, the Company’s cash on hand, together with the net proceeds received from the IPO, is now expected to be sufficient to fund the Company’s operations for at least one year from the date these condensed unaudited interim financial statements are issued.

If future revenue is not sufficient or if sufficient funds on acceptable terms are not available when needed, the Company may be required to curtail planned activities to significantly reduce its operating expenses. Failure to manage discretionary spending or raise additional financing, as needed, may have a material adverse effect on the Company’s future viability and results of operations.

Note 3 – Summary of Significant Accounting and Reporting Policies

Basis of Presentation – The condensed unaudited interim financial statements do not include all disclosures, including certain notes required by accounting principles generally accepted in the United States of America (“GAAP”) on an annual reporting basis. The condensed unaudited interim financial statements have been prepared on the same basis as the annual financial statements. In management’s opinion, the condensed unaudited interim financial statements reflect all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the condensed balance sheets, condensed statements of operations, condensed statements of redeemable convertible preferred stock and stockholders’ deficit, and condensed statements of cash flows for the interim periods, but are not necessarily indicative of the results of operations to be anticipated for the full fiscal year or any future period. The condensed unaudited interim financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2025 included in the Company’s prospectus dated May 7, 2026 filed pursuant to Rule 424(b)(4) with the U.S. Securities and Exchange Commission (the “SEC”) on May 8, 2026.

The financial statements are presented in thousands, except for share and per share amounts. Certain prior period amounts presented in the Company’s Registration Statement on Form S-1 have been rounded to the nearest thousand to conform to the current period’s presentation. Accordingly, certain prior period figures may differ slightly from previously filed reports presented in whole dollars.

Reverse Stock Split – In connection with the IPO, on May 1, 2026 the Company effected a 1-for-3.483 reverse stock split of its issued and outstanding common stock. All references to common stock issued and outstanding, stock options, loss per share and per share amounts presented in the accompanying financial statements and notes thereto have been retroactively adjusted for all periods presented to reflect the reverse stock split. The per share par value, authorized numbers of shares of the Company’s common stock and redeemable convertible preferred stock, issued and outstanding number of shares of redeemable convertible preferred stock, and redeemable convertible preferred stock warrants were not adjusted as a result of the reverse stock split. Instead, the conversion ratio was updated whereby each share of each series of Preferred Stock was convertible into shares of common stock on a 1-for-3.483 basis.

Use of Estimates – The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions include, but are not limited to, stock compensation, valuation of common and preferred stock, valuation of warrant liability, product warranty liability, and redeemable convertible preferred stock tranche liability. Actual results could differ from those estimates.

Emerging Growth Company Status – The Company is an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”), enacted in 2012. Under the JOBS Act, EGCs can delay adopting new or revised accounting standards issued after the enactment of the JOBS Act until those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an EGC or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act.

Segment Reporting – The Company operates and manages its business as a single reportable and operating segment. Operating segments are defined as components of an enterprise where separate financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance. The Company’s CODM is the Chief Executive Officer, who reviews financial information on a company-wide basis for purposes of allocating resources and assessing financial performance and does not regularly review expenses or financial results on a more granular level. For additional segment reporting information, refer to Note 14.

Significant Accounting Policies – There have been no material changes to the Company’s significant accounting policies as described in the Company’s audited financial statements for the year ended December 31, 2025.

Deferred Offering Costs – Deferred offering costs consisted of legal and accounting fees incurred directly related to the Company's IPO. Upon completion of the IPO, these costs were recorded as a reduction of the offering proceeds included within additional paid-in capital. Unpaid offering costs during the three months ended March 31, 2026 were $2.2 million.

Inventory – Inventory costs are comprised primarily of finished goods and raw materials and include the acquisition costs of raw materials and components, in addition to direct labor and overhead. All inventory is stated at the lower of cost or net realizable value and is accounted for on a first in, first out (FIFO) basis.

The balance of inventory is as follows (in thousands):


	March 31,		December 31,
	2026		2025
Raw materials	$	1,188	$	1,192
Finished goods		4,861		4,265
Total inventories	$	6,049	$	5,457

The Company performs an assessment of the recoverability of inventory during each reporting period, and, if applicable, writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first

identified. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. There were no expenses recorded for excess inventory or other impairments for each of the three months ended March 31, 2026 and March 31, 2025.

Related Party Transactions – The Company’s Chief Financial Officer held an indirect ownership interest in Exceller Hunt MicroTransponder 2017, LP (“Exceller Hunt”) and the Curnes Fund 2001 (“Curnes Fund”), both of which are stockholders of the Company. Jordan Curnes, the Company’s Co-founder and a former member of the Board of Directors, also held an indirect ownership interest in the Curnes Fund. Entities affiliated with U.S. Venture Partners, GPG Healthcare Opportunities Fund, LLC, and Osage University Partners are principal stockholders of the Company. Casey Tansey is a member of the Board of Directors.

During the three months ended March 31, 2026, Exceller Hunt and the Curnes Fund participated in the Company’s issuance of convertible promissory notes discussed in Note 6 and purchased approximately $4.0 million and $2.1 million of such notes, respectively. Entities affiliated with U.S. Venture Partners, GPG Healthcare Opportunities Fund, LLC, Osage University Partners, and Casey Tansey also participated in the Company's issuance of convertible promissory notes discussed in Note 6 and purchased approximately $3.8 million, $7.4 million, $6.6 million and $2.0 million of such notes, respectively. The convertible promissory notes were issued on the same terms and conditions as those offered to other investors in the financing. Other transactions with related parties in the three months ended March 31, 2026 were immaterial.

During the three months ended March 31, 2025, Exceller Hunt and the Curnes Fund acquired 569,973 and 427,480 shares of the Company's Series F redeemable convertible preferred stock, respectively, at a price of $2.6317 per share. Entities affiliated with U.S. Venture Partners, GPG Healthcare Opportunities Fund, LLC, and Osage University Partners also participated in the Company's Series E and Series F redeemable convertible preferred stock financings on the same terms and conditions as other investors.

Recently Issued Accounting Standards – On December 14, 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. This guidance is effective for annual periods beginning after December 15, 2024; however, as an EGC, the Company has elected to use the extended transition period for adopting new or revised accounting standards, and therefore the guidance will be effective for the Company for the year ended December 31, 2026. The adoption of ASU 2023-09 is expected to have a disclosure-only impact on the Company’s financial statements for the year ended December 31, 2026. The Company is currently evaluating the impact of this pronouncement on the disclosures in its financial statements.

On November 4, 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The amendments may be applied either (i) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (ii) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact of this pronouncement on the disclosures in its financial statements.

On November 26, 2024, the FASB issued ASU 2024-04, Debt – Debt with Conversion and Other Options (Subtopic 470-20), which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion rather than as extinguishment of debt. The amendments may be applied on either a prospective or a retrospective basis. This ASU is effective for fiscal years beginning after December 15, 2025, and interim periods within those annual reporting periods. The Company adopted ASU 2024-04 as of January 1, 2026, on a prospective basis and it did not have a material impact on its financial statements.

On December 8, 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270) Narrow-Scope Improvements, which is intended to improve the navigability of interim disclosures, clarifies when Topic 270 applies, and provides additional interim disclosure guidance, including a principle to disclose material events since the most recent annual reporting period. The amendments do not change the underlying objectives of interim reporting but are designed to enhance clarity in application. This ASU is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027; however, as an EGC, the Company has elected to use the extended transition period for adopting new or revised accounting standards, and therefore the guidance will be effective for the Company for interim periods within annual periods beginning after December 15, 2028. The Company is currently evaluating the impact of this pronouncement on its financial statements.

Note 4 – Fair Value Measurements

ASC 820, Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC 820 are described below:

Level 1 – This level consists of quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2 – This level consists of directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument.

Level 3 – This level consists of unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions.

In determining the fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the unobservable inputs to the extent possible, as well as considers counterparty credit risk in its assessments of fair value.

Fair Value of Liabilities – The following tables represent the Company’s financial liabilities according to the fair value hierarchy, measured at fair value (in thousands):


March 31, 2026	Level 1		Level 2		Level 3		Total
Liabilities
Warrant liabilities	$	—	$	—	$	882	$	882
Convertible notes payable		—		—		40,728		40,728
Total liabilities, at fair value	$	—	$	—	$	41,610	$	41,610


December 31, 2025	Level 1		Level 2		Level 3		Total
Liabilities
Warrant liabilities	$	—	$	—	$	865	$	865
Total liabilities, at fair value	$	—	$	—	$	865	$	865

The value of the warrants to purchase the Company’s redeemable convertible preferred stock is dependent on inputs for which there is little or no market data, in particular the value of the Company’s stock. As a result, the valuation of the warrants to purchase the Company’s redeemable convertible preferred stock is categorized as Level 3. When a determination is made to classify a financial instrument within Level 3, the determination is based upon the lowest level of significance of the unobservable inputs to the overall fair value measurement. However, Level 3 financial instruments typically include, in addition to the unobservable inputs, observable inputs (that is, components that are actively quoted and can be validated to external sources). The fair values could change significantly based on future market conditions.

The fair value of the warrant liability is estimated using the option-pricing model based on the Black-Scholes-Merton model with the following inputs:


	Preferred Warrants
March 31, 2026	Series B	Series D	Series E2 and F
Strike price	$3.73744	$4.20700	$2.54430
Expected dividend yield	— %	— %	— %
Expected term (years)	6.8	7.2	7.8
Volatility	75%	75%	75%
Risk-free interest rate	3.465%	3.465%	3.465%


	Preferred Warrants
December 31, 2025	Series B	Series D	Series E2 and F
Strike price	$3.73744	$4.20700	$2.54430
Expected dividend yield	— %	— %	— %
Expected term (years)	7.0	7.4	8.0
Volatility	80%	80%	80%
Risk-free interest rate	3.445%	3.445%	3.445%

The Company estimates volatility based upon analysis of the historical volatility of peer public companies as well as factors specific to the Company, including, but not limited to, size, expected growth and relative risk. The expected life assumption is based on the remaining contractual terms of the warrants. The risk-free rate as of March 31, 2026 and December 31, 2025 is based on the 1.5 year U.S. treasury bond yield. The expected dividend yield used is zero, because the Company has no present intention to pay cash dividends. The fair value of the warrant liability as of March 31, 2026 and December 31, 2025, was $0.9 million and $0.9 million, respectively. The change in fair value of the warrant liabilities was recorded within Other income (expense), net in the condensed statements of operations.

In January and February 2026, the Company issued convertible promissory notes in an aggregate principal amount of $40.0 million (the “Convertible Notes”). The Company elected the fair value option under ASC 825 for the Convertible Notes. At issuance, the fair value of the Convertible Notes was determined based on the transaction price, which the Company concluded represented an orderly transaction between market participants. Subsequent fair value measurements are determined using a scenario-based valuation model that incorporates probability-weighted outcomes across multiple potential scenarios, including an initial public offering, financing, change of control, maturity, and default. The model incorporates discounted cash flow techniques and option-pricing methodologies to reflect the embedded conversion features and is calibrated to the transaction price at issuance and updated at each reporting date. Significant unobservable inputs used in the valuation include discount rate (including a company-specific credit spread), equity volatility, and the probability and timing of potential liquidity events. The Convertible Notes are recurring Level 3 liabilities measured under the ASC 825 fair value option.

As of issuance, key assumptions included a discount rate of approximately 21.2%, equity volatility of approximately 85%, and expected term of 1.0 – 2.0 years. As of March 31, 2026, key assumptions included a discount rate of approximately 21.5%, equity volatility of approximately 80% and expected timing of liquidity events of 0.8 – 1.5 years. For each measurement date, the estimated probability of an initial public offering was 40% and a change of control was 20%.

The following table summarizes the change in the fair market value of the Convertible Notes (in thousands):


	Three Months Ended
	March 31,
	2026
Beginning balance	$	—
Issuance of convertible notes payable		40,000
Change in fair value		728
Ending balance	$	40,728

As of March 31, 2026, the aggregate principal amount of the Convertible Notes outstanding was $40.0 million and the estimated fair value of the Convertible Notes was $40.7 million.

Note 5 – Product Warranties

The Company provides an assurance-type warranty that its products will conform to agreed-upon technical and quality specifications. The warranty provides for repair or replacement of products that fail to meet specifications or become unusable during this period, which generally ranges from one to two years, depending on the product.

The Company maintains a warranty reserve for implanted pulse generators (“IPGs”) and leads and began recording a warranty liability in 2024 based on historical product replacement experience. A warranty liability is recorded at the time revenue is recognized for all periods presented and is separately presented as product warranty liability on the face of the balance sheets. The warranty reserve is estimated based on historical product replacement experience. The Company establishes product replacement rates separately for IPGs and leads using historical replacement data beginning with the first full period of commercial shipments. The replacement rate represents the average historical rate of product replacement and is applied to units sold during each reporting period to estimate expected warranty obligations.

In developing its replacement rate assumptions, the Company evaluates historical replacement patterns over the expected product life cycle. The warranty accrual is calculated quarterly. The Company evaluates and updates its replacement rate assumptions annually, or more frequently if actual experience or product performance trends indicate that revisions are necessary. A reconciliation of the changes in the product warranty liability is as follows (in thousands):


	Three Months Ended
	March 31,
	2026			2025
Beginning balance	$	844		$	437
Accruals for warranties issued		328			133
Claims settled		(143	)		(78	)
Ending balance	$	1,029		$	492

Note 6 – Convertible Notes and Notes Payable

Convertible Notes

In January and February 2026, the Company issued Convertible Notes in an aggregate principal amount of $40.0 million. The Convertible Notes bear payment-in-kind (“PIK”) interest at a rate of 7.0% per annum and mature two years from issuance unless earlier converted or repaid. The Convertible Notes are convertible into equity upon the occurrence of specified events, including a qualified financing, non-qualified financing, change of control, or initial public offering. The Convertible Notes bear no interest for the first six months following the date of issuance (the “Interest Free Period”), and in connection with an initial public offering, all accrued PIK interest is contractually waived immediately prior to conversion.

The Company elected the fair value option under ASC 825 for the Convertible Notes in order to account for the instrument as a single unit of account, which reflects the combined effect of the debt host and the embedded features within the overall fair value measurement. Accordingly, the Convertible Notes are initially recorded at fair value and subsequently remeasured at fair value at each reporting date, with changes in fair value recognized in the statement of operations within “Change in fair value of convertible notes

payable.” This amount includes the impact of accrued PIK interest, and therefore no separate interest expense is presented for the Convertible Notes. The portion of the change in fair value attributable to changes in instrument-specific credit risk is recorded in other comprehensive income. There were no material changes in the fair value of the Convertible Notes during the period.

The Convertible Notes are presented as a separate line item on the balance sheet titled “Convertible notes payable”. At issuance, the Company determined that the transaction price represented the best evidence of fair value and recorded the Convertible Notes at the proceeds received. As of March 31, 2026, the aggregate principal amount of Convertible Notes outstanding was $40.0 million and the estimated fair value was $40.7 million. See Note 4 – Fair Value Measurements for the discussion on the methodology and assumptions used in assessing the fair value of the Convertible Notes.

Immediately prior to the completion of the IPO, the Convertible Notes issued during the three months ended March 31, 2026 were converted into an aggregate of 3,333,324 shares of common stock.

Notes

On December 29, 2023, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Horizon Technology Finance Corporation. On June 1, 2024, Horizon Technology Finance Corporation assigned all of its right, title and interest in and to the loans outstanding under the Loan and Security Agreement and related warrants to Horizon Funding II, LLC, its wholly-owned subsidiary (together with Horizon Technology Finance Corporation, “Horizon”). The Loan and Security Agreement provides for term loans of up to an aggregate principal amount of $30.0 million, available in four equal tranches of $7.5 million. Each tranche comprises two equal loans of $3,750,000. As of December 31, 2025, the Company had $7.5 million in principal outstanding under the Loan and Security Agreement (the “Notes”).

Borrowing under the Loan and Security Agreement accrue interest at an annual rate equal to the greater of (i) the Wall Street Journal (or any successor thereto) prime rate (subject to a floor of 8.50%) plus 3.75% and (ii) 12.25%. The Company is required to make monthly payment of interest through January 1, 2028, followed by amortizing principal and interest payments through the maturity date of January 1, 2029. The unpaid balance of principal and accrued interest is due at maturity. The borrowings are secured by substantially all of the Company’s assets, excluding intellectual property.

In connection with the Company’s draw down of the first tranche under the Loan and Security Agreement, the Company issued warrants to purchase such number of securities representing an aggregate of $262,500 to the lender. The warrants are exercisable at the election of the holder for (i) shares of Series E-2 redeemable convertible preferred stock at an exercise price of $2.5443 per share or, (ii) shares of Series F redeemable convertible preferred stock at an exercise price of $2.6317 per share, and expire ten years from the date of issuance. The warrants allow for settlement in shares and are transferable at the holder’s discretion. The value of the warrants is capped at $2.5443 per share, a total of $262,500, but the number of shares is not limited. Immediately prior to the completion of the IPO, the warrants automatically converted into warrants to purchase 29,622 shares of common stock with an average exercise price of $8.8618 per share.

As of March 31, 2026 and December 31, 2025, the carrying value of the borrowings under the Loan and Security Agreement was $7.3 million and $7.1 million, net of unamortized debt discount and deferred financing costs. The Company amortizes deferred financing costs associated with the Notes to interest expense over the term of the Notes. The amortization of debt discount was not material for each of the three months ended March 31, 2026 and March 2025. The amortization of deferred financing costs was $0.1 million and immaterial for the three months ended March 31, 2026 and March 31, 2025, respectively.

There were no additional borrowings, repayments, or material modifications regarding the Loan and Security Agreement during the three months ended March 31, 2026 and March 31, 2025. Total interest expense was $0.2 million for each of the three months ended March 31, 2026 and March 31, 2025.

Note 7 – Leases

On March 7, 2023, the Company entered into a noncancellable operating lease for office space and warehouse space. The commencement date of this lease was July 1, 2023, with an end date of July 31, 2028. Leases for all prior years were month to month. The lease contains a renewal option to extend the term for a period of five years. Because the Company is reasonably certain to exercise its renewal option, the optional period is included in determining the lease term, and associated payments under these renewal options are included in lease payments. The Company’s lease does not include termination options for either party to the lease or restrictive financial or other covenants. Payments due under the lease contract include fixed payments plus variable payments. The Company’s office space lease requires it to make variable payments for the Company’s proportionate share of the building’s property taxes, and common area operating expenses. These variable lease payments are not included in lease payments used to determine lease liability and are recognized as variable costs when incurred.

On March 20, 2025 the Company entered into a modification of its existing operating lease. The modification extended the lease term to April 30, 2030, expanded the office space and revised the future lease payments. Although the modification grants the Company an additional right of use at a stand-alone price, the modification also changes the scope of the original lease by extending it two additional years while also removing the renewal option. As such, the modification has been accounted for as a single contract.

On August 8, 2025, the Company entered into an additional non-cancellable operating lease for office space. The commencement date of the lease was September 1, 2025, with an end date of August 31, 2028. Payments due under the lease contract include fixed payments plus variable payments. The Company’s office space lease requires it to make variable payments for the Company’s proportionate share of the building’s property taxes, and common area operating expenses. These variable lease payments are not included in lease payments used to determine lease liability and are recognized as variable costs when incurred in accordance with ASC 842.

Supplemental lease cost information are as follows (in thousands):


	Three Months Ended
	March 31,
	2026		2025
Operating lease cost	$	102	$	25
Short-term lease cost	$	6	$	10
Variable lease cost	$	16	$	11
Total lease cost	$	124	$	46

The following table presents the lease balances within the balance sheet (in thousands):


	March 31, 2026		December 31, 2025
Operating Leases:
Right-of-use asset	$	1,001	$	1,068

Operating lease liabilities, current	$	358	$	358
Operating lease liabilities, non-current		870		948
Total operating lease liabilities	$	1,228	$	1,306

The following table presents undiscounted future minimum lease payments as of March 31, 2026, which reconcile to the total lease liability as follows (in thousands):


Years Ending December 31
2026, remaining months	$	341
2027		467
2028		387
2029		206
2030		70
Total undiscounted future minimum lease payments		1,471
Less: Amounts representing interest		(243	)
Total lease liabilities	$	1,228

The weighted average lease terms and discounts rates are as follows:


Operating Lease Term and Discount Rate	March 31, 2026	December 31, 2025
Weighted-average remaining lease term	3.28 years	3.54 years
Weighted-average discount rate	10.82%	10.82%

Supplemental cash flow information related to leases was as follows (in thousands):


	Three Months Ended
	March 31,
Cash paid for amounts included in the measurement of lease liabilities:	2026		2025
Operating cash flow from operating leases	$	112	$	25

Note 8 – Income Taxes

The Company accounts for income taxes in accordance with ASC 740, Income Taxes. The income tax provision for interim periods is determined using an estimate of the Company’s annual effective tax rate, adjusted for discrete items recognized in the period. The Company had an effective tax rate of 0% for each of the three months ended March 31, 2026 and March 31, 2025. The Company continues to incur operating losses.

For periods ended March 31, 2026 and 2025, the Company continued to maintain a full valuation allowance against its deferred tax assets as management believes it is more likely than not that these assets will not be realized based on the Company’s history of operating losses. The Company’s tax provision for interim periods primarily reflects state income taxes and other minimum taxes.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted, introducing various federal tax changes, including extensions of certain 2017 Tax Cuts and Jobs Act (“TCJA”) provisions and updates to individual and business tax rules. Management evaluated the provisions applicable to the Company and determined that OBBBA did not have a significant impact on the Company’s condensed unaudited interim financial statements for the as of and for the three months ended March 31, 2026.

Note 9 – Redeemable Convertible Preferred Stock

The Company has issued Series A redeemable convertible preferred stock (“Series A”), Series B redeemable convertible preferred stock (“Series B”), Series C redeemable convertible preferred stock (“Series C”), Series D redeemable convertible preferred stock (“Series D”), Series E-1 redeemable convertible preferred stock (“Series E-1”), Series E-2 redeemable convertible preferred stock (“Series E-2”), and Series F redeemable convertible preferred stock (“Series F”), collectively the (“Preferred Stock”).

In March 2025, the Company entered into a Series F preferred stock purchase agreement (the “Series F Agreement”) pursuant to which the Company issued 12,349,423 shares of Series F redeemable convertible preferred stock at a price of $2.6317 per share for gross cash proceeds of $32,499,977. The Series F Agreement also required the Company to issue, and the investors to purchase, an additional 12,349,423 shares of Series F redeemable convertible preferred stock at the same price per share on or around October 15, 2025 for additional gross cash proceeds of $32,499,977 (the “Series F preferred stock tranche obligation”).

The Company classified the Series F preferred stock tranche obligation as a liability on its balance sheets as it represents a freestanding financial instrument that may require the Company to transfer assets to settle its obligation (upon events that are outside of its control). The Series F preferred stock tranche obligations were initially recorded at fair value upon the date of issuance and was subsequently remeasured to fair value at each reporting date until settlement. Changes in the fair value of the Series F preferred stock tranche obligation was recognized as a component of other income, net in the statements of operations.

The Series F preferred stock tranche obligation had an initial fair value of $680,600. As a result of the initial issuance of Series F in March 2025, 12,349,423 shares of Series F were recorded at their fair value of $31,532,110, net of issuance costs of $287,267. The Series F preferred stock tranche obligation was subsequently remeasured to a fair value of $797,908 as of June 30, 2025, and $915,216 as of September 30, 2025, with changes in fair value of $117,308 for the three months ended June 30, 2025 and $117,308 for the three months ended September 30, 2025 recognized as a component of other income, net in the statements of operations.

The Series F preferred stock tranche obligation was settled in October 2025, with the issuance of 12,349,423 shares of Series F at a price of $2.6317 per share for gross cash proceeds of $32,499,977. The fair value of the Series F preferred stock tranche obligation at settlement was $915,216. As a result of the October 2025 issuance of Series F, as well as the settlement of the Series F preferred stock obligation, 12,349,423 shares of Series F were recorded at their fair value of $33,415,193. Issuance costs related to the October 2025 Series F issuance were immaterial.

Preferred Stock consists of the following (in thousands, except for share and per share amounts):


	March 31, 2026
	Number of Shares Authorized		Number of Shares Issued and Outstanding		Original Issue Price		Carrying Value		Liquidation Value
Series A		1,401,000		1,401,000	$	1.91259	$	2,694	$	3,215
Series B		4,229,000		3,321,000		3.73744		10,849		14,894
Series C		1,362,000		1,362,000		4.20700		5,744		5,730
Series D		5,127,000		4,865,000		4.20700		19,989		20,467
Series E-1		6,361,753		6,361,753		2.03540		15,841		12,949
Series E-2		23,994,804		23,582,102		2.54430		59,709		60,000
Series F		24,698,846		24,698,846		2.63170		64,947		65,000
Total		67,174,403		65,591,701			$	179,773	$	182,255


	December 31, 2025
	Number of Shares Authorized		Number of Shares Issued and Outstanding		Original Issue Price		Carrying Value		Liquidation Value
Series A		1,401,000		1,401,000	$	1.91259	$	2,694	$	3,215
Series B		4,229,000		3,321,000		3.73744		10,849		14,894
Series C		1,362,000		1,362,000		4.20700		5,744		5,730
Series D		5,127,000		4,865,000		4.20700		19,989		20,467
Series E-1		6,361,753		6,361,753		2.03540		15,841		12,949
Series E-2		23,994,804		23,582,102		2.54430		59,709		60,000
Series F		24,698,846		24,698,846		2.63170		64,947		65,000
Total		67,174,403		65,591,701			$	179,773	$	182,255

Dividends

In the event dividends are declared by the Board of Directors on the common stock (except dividends on common stock payable in additional shares of common stock), the holders of the Preferred Stock shall be entitled to receive a dividend per share on the Preferred Stock, as applicable, pro rata with the shares of common stock, as if such shares of Preferred Stock had been converted to shares of common stock, assuming for this purpose only that shares of redeemable convertible preferred stock are convertible into

fractional shares, at the record date for the determination of stockholders entitled to such dividends. The right to receive dividends on shares of redeemable convertible preferred stock is non-cumulative, and no right to such dividends accrues to holders of redeemable convertible preferred stock by reason of the fact that dividends on such shares are not declared or paid in any years. No dividends have been declared or paid as of March 31, 2026 or December 31, 2025.

Liquidation Rights

In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, or in the event of a deemed liquidation event (as defined below) the holders of Preferred Stock are entitled to liquidation preferences.

Payment of liquidation preferences rights to preferred stockholders are in the order of: first, the Series F redeemable convertible preferred stock, then the Series E-2 and Series E-1 redeemable convertible preferred stock, then the Series D redeemable convertible preferred stock, then the Series C redeemable convertible preferred stock, then the Series B and A redeemable convertible preferred stock. The liquidation values for the Series F, Series E-2, Series E-1, Series D, and Series C redeemable convertible preferred stock are equivalent to an amount equal to the respective original issue price per share, adjusted for any recapitalization, stock split and the like, plus any dividends declared but unpaid thereon. The liquidation values for the Series B and Series A redeemable convertible preferred stock are equivalent the greater of (i) an amount equal to 1.2 multiplied by the respective original issue price per share, adjusted for any recapitalization, stock split and the like, plus any dividends declared but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series B and Series A redeemable convertible preferred stock been converted into common stock immediately prior to such liquidation, dissolution or winding up. The remaining assets, if any, shall be distributed among the holders of the shares of common stock, Series C Preferred Stock, Series D Preferred Stock, Series E-1 Preferred Stock, Series E-2 Preferred Stock, and Series F Preferred Stock, pro rata based on the number of shares held by each such holder, treating for this purpose all such securities as if they had been converted to common stock pursuant to the terms of the Amended and Restated Certificate of Incorporation immediately prior to such liquidation, dissolution or winding up of the Corporation, or deemed liquidation event.

If upon the liquidation, dissolution, winding up of the Company, or deemed liquidation event, the assets of the Company legally available for distribution to the holders of the Preferred Stock are insufficient to permit the payment to such holders of the full liquidation preferences to which they are entitled, then the holders of the Company’s common stock will receive nothing in respect of their equity holdings in the Company.

A deemed liquidation event is defined as a merger or consolidation of the Company that results in a change of control, or the sale, lease, transfer, exclusive license, or other disposition of substantially all of the assets of the Company to another entity that is less than a wholly owned subsidiary, unless the holders of at least a majority of the outstanding shares of Preferred Stock, voting together as a single class and on an as converted to common stock basis, and the holders of at least a majority of the outstanding shares of Series F, voting exclusively and as a separate class, elect otherwise by written notice sent to the Company prior to the effective date of any such event.

Subsequent to March 31, 2026, immediately prior to the completion of the IPO, all the outstanding shares of Preferred Stock converted into an aggregate 18,831,868 shares of common stock and the related liquidation preferences terminated.

Conversion Rights

Each share of Preferred Stock is convertible at the option of the holder and at any time into common stock as determined by dividing the applicable original issue price by the applicable Conversion Price. Conversion Price is defined as initially the applicable original issue price for the applicable series of Preferred Stock, subject to certain adjustments in the event of any recapitalizations, stock splits and the like, and for certain subsequent dilutive issuances of common stock or deemed dilutive issuances of common stock, at a price per share less than the then applicable conversion prices of the Preferred Stock. Each share of each series of Preferred Stock converts into shares of common stock on a 1:3.483 basis.

Each share of the Preferred Stock shall automatically be converted into fully paid and nonassessable shares of common stock at the above then-effective respective conversion price upon, (1) the closing of a sale of shares of common stock to the public at a specified price (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to common stock) in a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $75,000,000 of gross proceeds to the Company, before deductions of underwriting discounts, commissions, and expenses, (2) the date and time, or the occurrence of an event, specified by vote or written consent of (x) the holders of at least a majority of the outstanding shares of Preferred Stock, voting together as a single class and on an as converted to common stock basis, and (y) the holders of at least a majority of the outstanding shares of Series F, voting exclusively and as a separate class, or (3) immediately prior to the closing of the IPO.

Subsequent to March 31, 2026, immediately prior to the completion of the IPO, all the outstanding shares of Preferred Stock converted into an aggregate 18,831,868 shares of common stock.

Voting Rights

Prior to the completion of the IPO, the holders of each share of Preferred Stock were entitled to one vote for each share of common stock into which such share could be converted on all matters presented to the shareholders for vote.

Redeemable Convertible Preferred Stock Warrants

As of March 31, 2026 and December 31, 2025, the Company had 908,000 warrants for Series B redeemable convertible preferred stock (“Series B Preferred Warrants”) outstanding. These warrants were issued during 2012 and 2013 in connection with the issuances of Series B redeemable convertible preferred stock. In addition, as of March 31, 2026 and December 31, 2025, the Company had 258,000 warrants for Series D redeemable convertible preferred stock (“Series D Preferred Warrants”) outstanding, respectively. These warrants were issued in connection with the promissory notes issued in 2017 which were exercised and converted to shares of Series D preferred stock in 2017.

Subsequent to March 31, 2026, in connection with the IPO, the Company received exercises of the warrants noted above for shares of redeemable convertible preferred stock. Any remaining warrants have expired. As such, subsequent to the completion of the IPO, there remains no outstanding redeemable convertible preferred stock warrants.

Note 10 – Common Stock

In March 2025, the Company’s Board of Directors amended and restated the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock to 86,600,000 shares at $0.01 per share. In May 2026, the Company’s Board of Directors amended the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock to 950,000,000 shares at $0.01 per share.

Note 11 – Share-Based Compensation

On December 15, 2022, the Board of Directors approved the Corporation’s 2022 Equity Incentive Plan (the “2022 Plan”) providing for the grants of non-qualified stock options, incentive stock options and other stock-based awards up to an aggregate of 7,575,181 shares of common stock, $0.01 par value per share. This consisted of the available reserve from the 2007 Equity Incentive Plan (the “2007 Plan”) plus all returned shares. The 2022 Plan serves as the successor to and continuation of the 2007 Plan, and all options that were granted under the 2007 Plan (unless forfeited, exercised or expired) remained outstanding as of December 31, 2022. Awards issued under the 2007 Plan remain subject to the terms of the 2007 Plan, and unissued authorized 2007 shares became available under the 2022 Plan. No issued 2007 Plan awards were converted. The 2007 Plan contained an antidilution provision. Following a 1,000-for-1 common stock split in June 2022, the number of option shares for prior periods was retrospectively adjusted to reflect the split. No other terms of these existing awards were changed except for the number of option shares and the exercise price

to reflect the stock split. Because the modification did not result in incremental fair value under ASC 718, no additional compensation expense was recognized in 2022.

Under the 2022 Plan, stock options generally vest and become exercisable in respect of 25% of the total number of Shares initially subject to the Options on the first anniversary of the Vesting Commencement Date, and in respect of 1/48th of the total number of Shares initially subject to the Option on each monthly anniversary of the Vesting Commencement Date thereafter, so that 100% of the Shares subject to the Option shall be vested on the fourth anniversary of the Vesting Commencement Date, in each case, subject to the Optionee remaining as a Service Provider (as defined in the Plan) through the applicable vesting date. Certain awards may vest immediately upon grant or may be subject to performance-based vesting conditions, as determined by the Board of Directors. During the year ended 2025, the Company granted two executive awards that include performance-based vesting conditions which are immaterial. The Board of Directors administers the 2022 Plan and determines the exercise prices of options based on the fair value of the Company’s common stock as determined by an independent valuation, in certain instances, options have been granted with an exercise price in excess of fair market value at the date of grant.

The fair market value of stock options was estimated using the Black-Scholes valuation model. Since the Company does not have sufficient trading history of its common stock, it estimates the expected volatility of its stock options at their grant date by taking the weighted average historical volatility of a group of comparable publicly traded companies over a period of time equal to the expected life of the options. The Company uses the simplified method to calculate the expected term and contractual terms. Under the simplified method, the expected life is equal to the average of the share-based award’s weighted average vesting period and its contractual term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. There were no expected dividends. The following assumptions were used in estimating the fair value of option grants issued:


	Three Months Ended
	March 31,
	2026	2025
Expected term (years)	6.0 - 6.1	3.3 - 6.1
Volatility	81.6% — 81.9%	51.5% — 52.9%
Risk-free interest rate	4.0% — 4.1%	4.0% — 4.2%
Dividend yield	—	—

Stock options - A summary of officer, employee, and non-employee options granted and outstanding, under the 2007 and 2022 Plans are presented below (in thousands, except for share and per share amounts):


	Options Outstanding
	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value
Outstanding as of December 31, 2025		4,046,266		$	3.51	7.90	$	1,611
Options Granted		524,180		$	7.91
Options Exercised		(119,226	)	$	3.01
Options Forfeited, Cancelled, or Expired		(68,341	)	$	3.62
Outstanding as of March 31, 2026		4,382,879		$	4.08	7.93	$	16,783
Vested and exercisable at March 31, 2026		1,915,208		$	3.38	6.46	$	8,683

The following table summarizes information about stock options outstanding as of March 31, 2026:


	Options Outstanding			Options Vested
		Weighted Average	Weighted Average
		Remaining	Remaining
	Number of	Weighted Average	Contractual Term	Number of	Weighted Average
Exercise Price	Shares	Exercise Price	(in years)	Shares	Exercise Price
$1.39	22,968	$1.39	3.61	22,968	$1.39
$1.45	2,871	$1.45	0.03	2,871	$1.45
$2.66	61,728	$2.66	4.44	61,728	$2.66
$2.79	84,409	$2.79	2.77	84,409	$2.79
$2.88	43,066	$2.88	5.10	43,066	$2.88
$3.24	264,009	$3.24	7.93	123,154	$3.24
$3.38	1,207,080	$3.38	6.78	1,094,091	$3.38
$3.41	36,891	$3.41	6.87	22,798	$3.41
$3.73	1,510,824	$3.73	8.46	426,872	$3.73
$3.94	525,228	$3.94	9.56	2,512	$3.94
$4.11	99,606	$4.11	3.99	30,739	$4.11
$7.91	524,199	$7.91	9.97	—	$7.91
$1.39 — $7.91	4,382,879	$4.08	7.93	1,915,208	$3.37

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock for stock options that were in-the-money at period end. The aggregate intrinsic value of all options exercised for the three months ended March 31, 2026 and 2025 was $0.5 million and $34,000, respectively. The total fair value of options vested for the three months ended March 31, 2026 and 2025 was $0.5 million and $0.2 million, respectively. The options granted for the three months ended March 31, 2026 and 2025 had a weighted average grant date fair value of $5.71 per share and $1.95 per share, respectively. The options forfeited during the three months ended March 31, 2026 and 2025 had a weighted average grant date fair value of $1.95 per share and $1.74 per share, respectively. The total compensation cost related to non-vested stock options to be recognized in the future as of March 31, 2026, was $6.5 million over a weighted-average period of approximately 3.1 years.

A summary of share-based compensation expense by line items in the statements of operations is as follows (in thousands):


	Three Months Ended
	March 31,
	2026		2025
Research and development costs	$	68	$	—
Sales, general and administrative expenses		339		201
Total share based compensation expense	$	407	$	201

Note 12 – Net Loss Per Share

Net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per share is calculated similarly but includes potential dilution from the exercise of stock options and stock awards and conversion of redeemable convertible preferred stock, except when the effect would be anti-dilutive.

The following is a reconciliation of the numerators and denominators of the basic and diluted net loss per share computations for the periods presented (in thousands, except for share and per share amounts):


	Three Months Ended
	March 31,
	2026			2025
Net loss attributable to common stockholders	$	(17,740	)	$	(10,653	)

Share (denominator):
Weighted average number of common shares outstanding used in basic computation		918,935			821,160
Common shares issuable upon the exercise of stock options		—			—
Common shares issuable upon conversion of redeemable convertible preferred stock and warrants on redeemable convertible preferred stock		—			—
Weighted average number of common shares outstanding used in diluted computation		918,935			821,160

Net loss attributable to common stockholders, per common share
Basic	$	(19.30	)	$	(12.97	)
Diluted	$	(19.30	)	$	(12.97	)

The following table summarizes the as converted securities that were excluded from the diluted per share calculation because the effect of including these potential shares was anti-dilutive:


	Three Months Ended
	March 31,
	2026		2025
Series A redeemable convertible preferred stock		402,239		402,239
Series B redeemable convertible preferred stock		953,488		953,488
Series C redeemable convertible preferred stock		391,042		391,042
Series D redeemable convertible preferred stock		1,396,784		1,396,784
Series E redeemable convertible preferred stock		8,597,145		8,597,145
Series F redeemable convertible preferred stock		7,091,256		3,545,628
Warrants on redeemable convertible preferred stock		364,390		364,390
Convertible notes payable		3,333,324		—
Common shares issuable upon the exercise of stock options		4,382,879		3,196,660
Potentially dilutive securities		26,912,547		18,847,376

In connection with the IPO, on May 1, 2026, the Company effected a 1-for-3.483 reverse stock split. All share and per share amounts for all periods presented have been retroactively adjusted to reflect this reverse stock split.

Note 13 – Commitments and Contingencies

From time to time, the Company may become a party to claims, legal actions, and complaints arising in the ordinary course of business. Management is not aware of any such matters which would have a material effect on its financial positions, results of operations, or cash flows. The Company relies on third-party manufacturers for the production of its IPGs and stimulation leads. Certain of these arrangements include non-cancelable purchase commitments and binding forecast obligations. The Company issues purchase orders based on production requirements, which are generally non-cancelable once accepted by the supplier. As of March 31, 2026, the Company had outstanding non-cancelable purchase orders totaling approximately $11.6 million, which are expected to be fulfilled in the next twelve months. As of December 31, 2025, the Company had outstanding non-cancelable purchase orders totaling approximately $7.1 million, which are expected to be fulfilled during 2026.

During September 2024, the Company entered into an updated IPG supply agreement that expanded the scope of its supply arrangements with the third-party manufacturer. The agreement includes minimum annual purchase commitments over a five-year period commencing upon the first commercial shipment of product under the agreement. The first commercial shipment is currently expected to occur in 2028. The agreement also requires the Company to provide rolling twelve-month forecasts, portions of which

may become binding. As of March 31, 2026, no binding forecast commitments had been established under this agreement. The aggregate minimum purchase obligation over the five-year commitment period totals approximately $5.8 million.

Note 14 – Segment Information

The Company’s measure of segment profit or loss is net loss, which is used by the CODM to measure actual results versus expectations, set performance metrics, and during the Company’s budgeting and forecasting process to assess profitability and enable decision making. Significant segment expenses within net loss include cost of goods sold, research and development, and selling, general and administrative expenses. The only segment asset regularly reviewed by the CODM is cash and cash equivalents, which is reported on the balance sheets. No sales to an individual customer accounted for more than 10% of the Company’s total revenue for the three months ended March 31, 2026 and March 31, 2025, respectively.

The following table is representative of revenue and significant segment expense categories regularly provided to the CODM for purposes of managing the Company’s single operating and reportable segment. Segment revenue and net loss are consistent with the statements of operations (in thousands).


	Three Months Ended
	March 31,
	2026			2025
Revenue	$	12,074		$	5,661
Less:
Cost of goods sold		2,133			1,015
Research and development costs		1,692			1,354
Selling, general and administrative expenses (1)		25,186			13,596
Other segment items (2)		803			349
Net loss	$	(17,740	)	$	(10,653	)

(1)

Selling, general and administrative expenses include depreciation and amortization expense of $0.1 million and $31,000 for the three months ended March 31, 2026 and 2025, respectively.

(2)

Other segment items are comprised of change in fair value of convertible notes payable, interest expense, other income, net, and provision for income taxes, as shown on the statements of operations.

Note 15 – Subsequent Events

In April 2026, the Board of Directors approved the Company’s 2026 Incentive Award Plan (the “2026 Plan”) and 2026 Employee Stock Purchase Plan (the “2026 ESPP”). The stockholders of the Company approved the 2026 Plan and the 2026 ESPP in May 2026. Both plans became effective in connection with the IPO. The 2026 Plan provides for the grant of equity-based awards and authorizes an initial share reserve based on a percentage of the Company’s fully diluted capitalization at the pricing date, as well as annual increases in the number of shares available for issuance thereunder. The 2026 ESPP provides eligible employees with the opportunity to purchase shares of the Company’s common stock and includes an initial share reserve and annual increases based on a percentage of outstanding shares. No awards have been granted under the 2026 Plan or the 2026 ESPP as of March 31, 2026.

On May 11, 2026, the Company completed its IPO, in which it sold 10,000,000 shares of its common stock at a public offering price of $15.00 per share, for net proceeds of approximately $134.5 million, after deducting underwriters’ discounts and commissions and estimated offering costs paid by the Company. In addition, immediately prior to the completion of the IPO, all the outstanding shares of the Company’s redeemable convertible preferred stock were converted into an aggregate of 18,831,868 shares of common stock and the Company’s convertible promissory notes issued during the three months ended March 31, 2026 were converted into an aggregate of 3,333,324 shares of common stock.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our condensed unaudited interim financial statements (the condensed financial statements) and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2025, included in our prospectus dated May 7, 2026, filed with the U.S. Securities and Exchange Commission (SEC) pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Prospectus”) on May 8, 2026.

Overview

We are a commercial-stage medical device company redefining stroke recovery for survivors living with life-altering motor impairments. Our Vivistim Paired Vagus Nerve Stimulation (Paired VNS) System is the first and only clinically-validated, FDA-approved solution for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. Stroke is one of the leading causes of long-term disability in the United States. While advancements in acute stroke care over the past decade have significantly reduced mortality, innovation for chronic stroke recovery has lagged, resulting in a growing number of stroke survivors living with meaningful impairments. Our breakthrough Vivistim Paired VNS System (Vivistim System) addresses this unmet need. The Vivistim System includes an implanted pulse generator and lead that deliver stimulation to the vagus nerve when activated. During treatment (Vivistim Therapy), intentional bursts of stimulation are delivered during functional movement to increase neuroplasticity and durably restore motor function. Clinical data has demonstrated that Vivistim Therapy delivers meaningful improvements in upper limb function, which can help stroke survivors regain critical capabilities and independence and restore quality of life, regardless of the time elapsed since the patient’s stroke. We believe we are setting a new standard of care in chronic stroke recovery, facilitating a new treatment pathway for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. We have experienced rapid growth since our full commercial launch in 2023, and as of December 31, 2025, physicians have performed over 1,000 implants, including approximately 700 in 2025.

Chronic stroke recovery presents a significant market opportunity. According to the American Heart Association (AHA), approximately 87% of the strokes in the United States are ischemic. This equates to approximately 9 million ischemic stroke survivors in the United States, of which we estimate that more than 4 million are chronic ischemic stroke survivors living with moderate to severe upper extremity impairment. This population falls within the current on-label indication for the Vivistim System. We believe that an initial market opportunity comprises approximately 1 million of those survivors that demonstrate the requisite overall health, cognition and motivation to participate in therapy and have received some amount of post-stroke therapy, which we estimate represents an initial market opportunity of over $30 billion based on the average selling price of the Vivistim System. Vivistim Therapy is effective for recent stroke survivors as well as patients who initiate treatment many years post-stroke. Based on a report published by the AHA in 2025, we estimate that each year approximately 200,000 new stroke survivors in the United States meet our indication for use, with 50,000 of these survivors representative of our initial market opportunity.

Our commercial strategy is designed to encourage Vivistim Therapy adoption at stroke centers and therapy sites through a coordinated, evidence-based approach. We sell the Vivistim System to customers, primarily stroke hospitals, in the United States, and our commercial organization is responsible for driving adoption of the Vivistim System through customer outreach, education, and relationship management activities. Our team includes Territory Managers (TMs), who support initial customer onboarding efforts at stroke centers and maintain commercial relationships with physicians and administrators, and Therapy Development Specialists (TDSs), who focus on outreach to therapy sites and provide general educational information regarding the clinical use of the Vivistim System. These activities are intended to facilitate customer adoption and utilization of the Vivistim System. Our commercial efforts are currently focused on primary and comprehensive stroke centers, which are hospitals that have cross-functional teams with the capabilities to treat acute stroke at the highest level of care and in compliance with AHA guidelines. These centers see significant volumes of acute stroke patients and are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure necessary for efficient implementation of Vivistim Therapy. We work with these stroke centers to establish Vivistim Therapy as a treatment option for stroke survivors. Over time, we believe these centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use Vivistim Therapy. According to data from the stroke center accreditation organizations, there were approximately 1,500 primary and

comprehensive stroke centers in the United States as of December 2025. In addition, according to stroke claims data, approximately 70% of acute strokes in the United States are seen at 900 hospitals.

We rely on third-party contract manufacturers to manufacture the Vivistim System and accessories. We believe this strategy provides the expertise and capacity required to effectively and efficiently scale production based on demand, and helps to reduce our need for capital investment and reduce operational expenses.

To date, our primary sources of capital have been private placements of preferred stock, debt financing arrangements, revenue from sales of our Vivistim System and, subsequent to March 31, 2026, net proceeds from our initial public offering in May 2026 (the “IPO”). For the three months ended March 31, 2026, we generated revenue of $12.1 million, with a gross margin of 82.3%, and had a net loss of $17.7 million, compared to revenue of $5.7 million, with a gross margin of 82.1%, and a net loss of $10.7 million for the three months ended March 31, 2025. As of March 31, 2026, we had cash and cash equivalents of $55.7 million and an accumulated deficit of approximately $175.5 million. In May 2026, we completed our IPO and received net proceeds of approximately $134.5 million.

Key Factors and Trends Affecting our Business

We believe that our performance, results of operations and future success depend on several factors, including:

•

Market development and awareness of Vivistim Therapy. Our mission is to redefine stroke recovery for survivors living with life-altering functional impairments by establishing Vivistim Therapy as the standard of care for chronic stroke recovery. As there are currently very limited options to support chronic stroke recovery, we are focused on developing this new market and driving awareness of Vivistim Therapy as a potential treatment option for stroke survivors. To accomplish this, we intend to continue to educate healthcare providers on the capabilities and benefits of Vivistim Therapy, work closely with hospitals to incorporate Vivistim Therapy as a treatment option, and activate care programs that use Vivistim Therapy at stroke centers and therapy sites. In addition, we intend to continue to expand our clinical evidence to support a robust cadence of publications regarding the benefits of Vivistim Therapy. We believe these efforts will support the growth of our business by generating broader awareness, which can support adoption and increase utilization of Vivistim Therapy. Candidates for Vivistim Therapy generally result from three primary sources: physician referrals, therapist referrals, and direct patient engagement. A diverse network of care providers, including stroke interventionalists, neurosurgeons, neurologists, physical medicine and rehabilitation physicians, occupational and physical therapists, stroke coordinators and nurses, support and interact with stroke survivors. We directly engage with each of these stakeholders through our field-based commercial team and specialized events, summits, and conferences. In addition, we engage in direct patient education activities, such as webinars, outreach through support groups, digital advertising and other targeted activities. We believe that establishing strong referral patterns between providers and engaging directly with stroke survivors and their caregivers will help to further market development, awareness and utilization. For example, we believe that as awareness and utilization increase, stroke centers will naturally integrate Vivistim Therapy into standard care pathways for stroke survivors upon discharge and establish self-sustaining care programs that use Vivistim Therapy over time. Our financial performance will be significantly impacted by the extent to which we can increase awareness and utilization, as well as the timing and rate of adoption of our products by healthcare providers.

•

Growing our commercial organization. To promote awareness and utilization, we expect to continue to efficiently invest in and grow our commercial organization. For example, our selling, general and administrative expenses were $25.2 million for the three months ended March 31, 2026 compared to $13.6 million for the three months ended March 31, 2025. We intend to continue to make significant investments in our commercial organization by scaling our team, which we believe will broaden our geographic reach, drive penetration, and increase access to our products. We seek to scale deliberately and efficiently using our scalable commercial model, which initially targets a highly concentrated group of high-volume primary and comprehensive stroke centers. These stroke centers are typically surrounded by a network of therapy sites with neurorehabilitation capabilities, providing the infrastructure for efficient implementation of Vivistim Therapy. Historically, substantially all Vivistim System implants have been performed at primary and comprehensive stroke centers. While we aim

to expand strategically and efficiently, the rate at which we grow our commercial organization and the speed at which newly hired personnel become effective will impact our revenue growth and our costs incurred in anticipation of such growth.

•

Reimbursement and expanding payor coverage. Healthcare providers generally rely on third-party payors, including Medicare, Medicaid, Medicare Advantage and commercial insurance plans, to cover and reimburse all or part of the cost of the Vivistim System. As a result, demand for our Vivistim System depends in part on the availability of reimbursement from such payors and the rates that such payors reimburse for implantation procedures with the Vivistim System. The Vivistim System implantation procedure falls under a long-established Category 1 CPT code. Effective January 1, 2026, this code was assigned to a New Technology Ambulatory Payment Classification (APC) by CMS, which established an elevated payment level. Future changes in payment levels could have a significant impact on patient access to the Vivistim System, and thus on our revenue, either positively or negatively. Medicare fee-for-service patients can typically access Vivistim Therapy when medically necessary, without prior authorization. Commercial insurance plans, Medicaid and Medicare Advantage generally require prior authorization. Our in-house market access team works to provide support in navigating the prior authorization process and facilitating positive coverage decisions by third-party payors, including by utilizing our robust clinical evidence, demonstrating economic value, and leveraging endorsements from key opinion leaders. Our recent growth was, and our future success will be, driven in part by our ability to facilitate streamlined prior authorization processes and increase coverage by third-party payors, and improve market access.

•

Expanding our clinical evidence. We have built, and remain committed to expanding, a robust body of clinical evidence demonstrating the safety, efficacy and durability of Vivistim Therapy. We believe the extent of our clinical evidence is important for increasing awareness and adoption of, and driving broader coverage decisions for the Vivistim System. We are actively enrolling patients in our GRASP registry and plan to publish 12-, 24-, and 36-month outcomes. We anticipate that our real-world evidence will also support a robust cadence of publications in the future that will further validate our clinical trials and the direct experiences of patients and healthcare providers. We plan to build our base of clinical evidence by supporting new clinical studies.

•

Continued investment in research and development. We focus on innovation to develop new products and product enhancements, including to improve clinical outcomes, optimize patient experience, enhance physician usability, increase utilization, and increase patient engagement. We expect to continue to invest in supporting these initiatives. Our near-term research and development activities are primarily directed toward continued technological advancement of the Vivistim System, and development of a next-generation Vivistim System with enhanced features. We also expect to invest in exploring expansions into other functional impairments (e.g., lower limb) or stroke etiologies (e.g., intracerebral hemorrhage).

Components of Results of Operations

Revenue

We currently generate all of our revenue from the sale of our Vivistim System to customers, mainly primary and comprehensive stroke centers, in the United States. Our customers typically purchase an initial stocking order and then reorder replenishment product as procedures are performed. No single customer accounted for 10% or more of our revenue during the three months ended March 31, 2026 or 2025. We expect revenue to increase as we expand our commercial organization and sales territories, add customers and expand patient and customer awareness. We have expanded our commercial organization to help us drive and support revenue growth and intend to continue this expansion. We also expect that demand, and thus revenue growth, will be positively impacted by, and to the extent that, we obtain additional positive coverage policies with payors. While we have experienced strong revenue growth, our revenue may fluctuate from quarter to quarter due to a variety of factors.

Cost of goods sold and gross margin

Cost of goods sold primarily consists of acquisition costs of finished goods and components, depreciation, warranty costs to replace aged, damaged or unusable items, product replacement costs, shipping costs, packaging costs, and allocated costs including facilities and information technology. We expect cost of goods sold to increase in absolute terms as our revenue grows.

We calculate gross margin as gross profit divided by revenue. Our gross profit has been and will continue to be affected by a variety of factors, including sales volumes, purchase volumes of inventory, cost of goods sold, tariffs, inflation, and product yields. Our gross margin will likely fluctuate from quarter to quarter.

Research and development costs

Research and development costs primarily consist of expenses related to product development, engineering, clinical studies related to new clinical indications, regulatory expenses, testing, consulting services and other costs associated with product improvements and next generation versions of our products. Other research and development expenses include salaries, employee benefits, stock-based compensation and other headcount-related costs, depreciation expense and allocated costs related to facilities and information technology. We expect our research and development costs to increase in absolute dollars in the future as we pursue product development initiatives, including product improvements and next-generation versions of our products, and continue to expand our clinical data. We expect research and development costs as a percentage of revenue to vary over time depending on the level and timing of initiating product development efforts and clinical development activities.

Selling, general and administrative expenses

Selling, general and administrative expenses primarily consist of compensation for personnel, including salaries, employee benefits, stock-based compensation, commissions associated with our commercial organization, spending related to sales and marketing, finance, information technology and human resource functions, expenses related to clinical studies and our registry for our current clinical indication, legal expenses related to regulatory matters, and training. Other expenses include travel expenses, advertising, conferences, trade shows, consulting and professional services fees, insurance costs, and general corporate expenses, including facilities-related expenses. The activities of our TMs and TDSs to facilitate customer adoption and utilization of the Vivistim System, and of our in-house market access team in facilitating the administrative prior authorization process, are included in selling, general and administrative expenses and do not represent contractual obligations or services provided to customers after product delivery. We expect selling, general and administrative expenses to continue to increase in absolute dollars as we expand our commercial organization, including with respect to TMs and TDSs, to both drive and support our planned growth in revenue, fund clinical studies and our registry for our current clinical indication, and incur additional expenses associated with operating as a public company, including costs related to legal, accounting, insurance, compliance with exchange listing and Securities and Exchange Commission requirements, and investor relations. We also expect an increase in our stock-based compensation expense with the establishment of the new equity plan in connection with our IPO and related grants thereunder. However, we expect selling, general and administrative expenses to decrease as a percentage of revenue primarily as, and to the extent, our revenue grows.

Other income (expense), net

Other income (expense), net consists primarily of interest expense on our debt obligations, including our Loan and Security Agreement, as well as amortization of debt issuance costs, interest income on our cash and cash equivalents and fair value adjustments related to our redeemable convertible preferred stock warrants and redeemable convertible preferred stock tranche liability. We expect our other income (expense), net to vary in future periods depending on the extent of our debt obligations.

Provision for Income Taxes

Provision for income taxes consists of income taxes in the United States and includes deferred taxes on temporary differences for tax and financial statement purposes.

Results of Operations

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025.


	Three Months Ended March 31,				Change
	2026		2025		$		%
(in thousands, except percentage)
Revenue	$	12,074	$	5,661	$	6,413		113.3	%
Cost of revenue		2,133		1,015		1,118		110.1	%
Gross profit		9,941		4,646		5,295		114.0	%
Operating expenses:
Research and development costs		1,692		1,354		338		25.0	%
Selling, general and administrative expenses		25,186		13,596

Mobia Medical, Inc. 10-Q