As filed with the United States Securities and Exchange Commission on September 30, 2022

Registration No. 333-

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

______________

FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

______________

EPIEN MEDICAL, INC.

(Exact name of registrant as specified in its charter)

______________

Minnesota		3841		41-1710238
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification No.)

600 Highway 169 South, Suite 820
St. Louis Park,
MN 55426
(651) 653-3380

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

_______________________

Reginald Dupre
c/o EPIEN Medical, Inc.
600 Highway 169 South, Suite 820
St. Louis Park,
MN 55426
(651) 653-3380

(Name, address, including zip code, and telephone number, including area code, of agent for service)

_______________________

Copies of all communications, including communications sent to agent for service, should be sent to:

Richard I. Anslow, Esq.

Scott M. Miller, Esq.
Ellenoff Grossman & Schole LLP
1345 Avenue of the Americas, 11th Floor
New York, New York 10105
Telephone: (212) 370-1300
Fax: (212) 370-7889

Joseph M. Lucosky, Esq.
Lucosky Brookman LLP
101 Wood Avenue South, 5th Floor
Iselin, New Jersey 08830
Telephone: (732) 395-4400
Fax: (732) 395-4401

_______________________

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

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

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said section 8(a), may determine.

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EXPLANATORY NOTE

In connection with this offering, EPIEN Medical, Inc., a Minnesota corporation, the registrant whose name appears on the cover of this registration statement (“EPIEN MN”), intends to transfer its corporate domicile and become a Nevada corporation under the name EPIEN Medical, Inc. (“EPIEN NV”) pursuant to sections 302A.682 to 302A.692 of the Minnesota Business Corporation Act and Section 92A.270 of the Nevada Revised Statutes (the “Domicile Transfer”). As a result of the Domicile Transfer, every three shares of capital stock of EPIEN MN will be converted and exchanged into one share of capital stock of EPIEN NV on a three-for-one basis, and such shares shall carry the same terms in all material respects as the shares of EPIEN MN. The Domicile Transfer was approved on August 16, 2022 by shareholders of EPIEN MN holding a majority of the outstanding shares entitled to vote thereon.

The financial statements and summary historical financial data included in this registration statement are those of EPIEN MN and do not give effect to the Domicile Transfer. All disclosure herein related to our governance and corporate law give effect to the Domicile Transfer.

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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION, DATED SEPTEMBER 30, 2022

4,190,476 Units consisting of

4,190,476 Shares of Common Stock

and

4,190,476 Warrants to purchase 4,190,476 Shares of Common Stock

This is a firm commitment underwritten initial public offering by EPIEN Medical, Inc., a Minnesota corporation, which will be redomiciled in Nevada as a Nevada corporation prior to the offering of units (the “Units”), each of which consists of one share of the Company’s common stock, par value $0.0001 per share, and one warrant (a “Warrant” and collectively, the “Warrants”) exercisable to acquire one share of common stock. Prior to this offering there has been no public market for our common stock or Warrants comprising the Units. We anticipate that the initial public offering price of our Units will be between $4.25 and $6.25, and the number of Units offered hereby is based upon an assumed offering price of $5.25 per Unit, the midpoint of such estimated price range.

The Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The Warrants and common stock are immediately separable and will be issued separately in this offering. Each Warrant offered hereby is immediately exercisable on the date of issuance at an exercise price of $ per Warrant, which shall be equal to 100% of the public offering price per Unit (the “Initial Exercise Price”) and will expire five years from the date of issuance. The Company may, at its option, redeem the Warrants if shares of Common Stock trade at a price of at least 200% of the exercise price for 30 consecutive trading days. The Warrants will be exercisable, at the option of the holder, in whole or in part. Each Warrant entitles the holder thereof to purchase one share of common stock, and the Warrants are not exercisable for a fractional share. A holder of a Warrant may not exercise any portion of a Warrant to the extent that the holder, together with its affiliates and any other person or entity acting as a group, would own more than 4.99% of our outstanding shares of common stock after exercise, as such ownership percentage is determined in accordance with the terms of the Warrants, except that upon notice from the holder to us, the holder may waive such limitation up to a percentage, not in excess of 9.99%.

In the event of certain future dilutive issuances of securities by us that result in a reduction of the exercise price of the Warrants, in aggregate, to 50% of the Initial Exercise Price, then in connection with such reduction, each holder of Warrants that purchases at least Warrants in connection with this offering (a “Qualified Holder”), will receive two warrants (“Additional Warrants”) for each one Qualified Warrant (as defined below) held by such holder on the date of such reduction. The term “Qualified Warrants” means at least Warrants purchased in connection with the offering by any Warrant holder, including each beneficial holder of the Warrants, taken together with all affiliates of such Warrant holder and/or beneficial holder. The maximum number of Warrants subject to such adjustment by a given Qualified Holder will be limited to the number of Warrants purchased by such Qualified Holder in connection with this offering.

Additionally, on the date that is 90 calendar days immediately following the initial issuance date of the Warrants, the exercise price of the Warrants will be adjusted to be equal to the greater of (a) 50% of the Initial Exercise Price or (b) 100% of the lowest daily volume weighted average price per share of Common Stock occurring during the 90 calendar days following the issuance date of the Warrants (the “Reset Price”), provided that such value is less than the exercise price in effect on that date. The lowest Reset Price is $2.625 (which is 50% of Initial Exercise Price, based on an assumed public offering price of $5.25 per Unit, the midpoint of the price range of the Units).

To better understand the terms of the Warrants, you should carefully read the section “Description of our Securities — Warrants Offered in this Offering” in this prospectus.

Prior to this offering, there has been no public market for shares of our common stock, Warrants or the Additional Warrants. We have applied to have our shares of common stock and Warrants listed on the Nasdaq Capital Market (“Nasdaq”) under the symbols “EPMI” and “EPMIW,” respectively. No assurance can be given that our application will be approved. If our common stock and Warrants are not approved for listing on Nasdaq, we will not consummate this offering.

We are an “emerging growth company” as that term is defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and, as such, have elected to take advantage of certain reduced public company reporting requirements for this prospectus and future filings. See “Summary — Implications of Being an Emerging Growth Company.”

Investing in our common stock involves a high degree of risk. Please read “Risk Factors” beginning on page 17 of this prospectus.

	Per Unit	Total
Public offering price	$	$
Underwriting discounts and commissions(1)	$	$
Proceeds to us, before expenses	$	$

____________

(1) We have also agreed to reimburse the underwriters for certain of their expenses. See “Underwriting” beginning on page 132 of this prospectus for more information about these arrangements.

We have granted a 45-day option to the representative of the underwriters to purchase from us up to 628,571 additional shares of common stock and/or up to 628,571 additional Warrants to cover over-allotments, if any. The purchase price to be paid per additional share of common stock will be equal to the public offering price of one Unit less the underwriting discount, and the purchase price to be paid per over-allotment Warrant will be $0.01. If the underwriter exercises the option in full, the total underwriting discounts and commissions will be $1.9 million, and the proceeds to us, before expenses, will be $23.4 million.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

Delivery of the common stock is expected to be made on or about , 2022.

Sole Book Running Manager

EF HUTTON

division of Benchmark Investments, LLC

The date of this prospectus is , 2022

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TABLE OF CONTENTS

		Page
PROSPECTUS SUMMARY		1
THE OFFERING		9
SUMMARY FINANCIAL DATA		13
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY AND MARKET DATA		15
RISK FACTORS		17
USE OF PROCEEDS		53
DIVIDEND POLICY		55
CAPITALIZATION		56
DILUTION		58
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		61
BUSINESS		74
MANAGEMENT		101
EXECUTIVE AND DIRECTOR COMPENSATION		109
PRINCIPAL STOCKHOLDERS		120
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS		122
DESCRIPTION OF OUR SECURITIES		124
SHARES ELIGIBLE FOR FUTURE SALE		130
UNDERWRITING		132
LEGAL MATTERS		138
EXPERTS		138
WHERE YOU CAN FIND MORE INFORMATION		138
INDEX TO FINANCIAL STATEMENTS		F-1

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About this Prospectus

We have not, and the underwriters have not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the securities offered hereby, but only under the circumstances and in the jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date.

For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus or any applicable free writing prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus and any applicable free writing prospectus must inform themselves about, and observe any restrictions relating to, the offering of our securities and the distribution of this prospectus and any free writing prospectus outside the United States. See “Underwriting” for additional information on these restrictions.

Through and including , 2022 (25 days after the date of this prospectus), all dealers that buy, sell or trade our securities, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the obligation of dealers to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

Industry and Market Data

Unless otherwise indicated, information in this prospectus concerning economic conditions, our industry, our markets and our competitive position is based on a variety of sources, including information from third-party industry analysts and publications and our own estimates and research. Some of the industry and market data contained in this prospectus are based on third-party industry publications. This information involves a number of assumptions, estimates and limitations.

The industry publications, surveys and forecasts and other public information generally indicate or suggest that their information has been obtained from sources believed to be reliable. None of the third-party industry publications used in this prospectus were prepared on our behalf. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section called “Risk Factors” elsewhere in this prospectus. These and other factors could cause results to differ materially from those expressed in these publications.

Trademarks

This prospectus contains references to our registered trademarks and trade names, such as EPIEN®, HYBENX®, ERADX™, REVITY™, KONKURE™, DEBACTEROL® and ORALMEDIC™ (not registered in the U.S.). This prospectus also includes trademarks, trade names and service marks that are the property of other organizations and entities. Solely for convenience, trademarks and trade names referred to in this prospectus appear without the ® and ™ symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by any other companies.

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PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus and does not contain all of the information that you should consider before investing in our securities. This summary is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus. You should read this entire prospectus carefully, including the information set forth in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes thereto included elsewhere in this prospectus, before making an investment decision. Unless the context requires otherwise, references in this prospectus to “we,” “us,” “our,” “our Company,” “our business” or similar terminology refer to EPIEN Medical, Inc.

Overview

We are a specialty medical devices company that is developing products for treatment of oral inflammation and acute and chronic wounds based on our chemical formulations that act as aggressive desiccation and debriding agents. We refer to this proprietary process as Desiccation Shock Technology (“DST”). Eleven published clinical trials have shown that our products reduce and, very often, eliminate the need for antibiotics to treat topical infectious wounds, including oral infections and open infectious wounds. Standard treatments can take months and even years of daily antibiotic use to heal an open infectious wound. In 2021, our HYBENX and ERADX product lines received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”), as a medical device for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures, including scaling and root planing, to aid in the removal of contaminated debris from the sulcus. In 2013, the European Regulatory Agency cleared our HYBENX and ERADX product lines for the same uses. In 2022, we initiated a plan to obtain FDA 510(k) clearance for our REVITY product candidate for treatment of chronic wounds. However, in May, based on discussions with the FDA, we withdrew our 510(k) application for REVITY. Instead, we plan to initiate a “de novo” classification request with the FDA in the first quarter of 2023.

Our DST enables our easy-to-use, topically applied products to desiccate harmful bacteria in seconds. Under existing dental standard of care practices today, antibiotics are typically used to reduce harmful microorganisms. However, over the past fifteen years, serious medical concerns have been raised regarding antibiotic resistance and the overuse of antibiotics. HYBENX and ERADX assist in the removal of these harmful microorganisms and contaminated debris. More importantly, using HYBENX and ERADX avoids use of antibiotics, thereby avoiding the risk of resistance, as DST is a non-biologic formulation to which resistance could not develop.

Our REVITY acute and chronic wound care product candidate also uses our proprietary DST. In wounds, in addition to the wound itself, the colonizing of harmful bacteria causes inflammation, which further weakens the immune system’s ability to naturally fight infectious diseases. DST is a physical mechanism of action that uses a proprietary combination of sulfonated phenols to instantly extract water from all microorganisms. By using REVITY, a clinician can easily eliminate bacteria at a molecular level by debriding the tissue.

Our KONKURE product line also uses our proprietary DST in the oral veterinary market.

HYBENX, ERADX, REVITY and KONKURE are applied directly to the surface of a wound, using a syringe to deliver the product in liquid or gel form in the mouth or on the skin. Treatment times range from five to 60 seconds, depending on the severity of the infection. The products are then simply removed by rinsing with copious amounts of water.

With over ten million treatments of DEBACTEROL, ORALMEDIC and HYBENX sold in the U.S., Canada, Asia and the EU, there have only been approximately 130 instances of side effects reported to us by consumers who have purchased our DST-based products.

We have successfully completed approval processes with the European Regulatory Agency and the FDA over the past 15 years. Our HYBENX and ERADX dental products have been cleared as Medical Devices Class I in Europe and the United States for all indications where infectious conditions persist. Our ORALMEDIC product for oral ulcerations is cleared in 30 countries across Europe, Canada, and parts of Asia.

HYBENX and ERADX each received its latest clearance in September 2021 from the FDA for expansion of our oral products to treat periodontal disease in the U.S. market. This clearance complements the existing indications for use of HYBENX and ERADX to treat root canals by endodontic specialists.

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Our Products and Product Candidate

Our products and product candidate are designed to treat mouth ulcers, periodontic disease and chronic, non-healing wounds:

Current Products

• HYBENX: Our HYBENX product is a root canal cleanser used by oral endodontists to treat infected root canals. In addition to reducing any harmful bacteria, HYBENX also stops bleeding by sealing blood vessels and reduces pain by sealing nerve endings. By applying HYBENX, the dentist or endodontist can skip several steps that are in the standard operating procedure. HYBENX received European regulatory clearance in 2013 for use by dental professionals for treating bleeding and/or inflammatory mucosal tissue in relation to periodontal disease. In September 2021, the FDA provided commercial regulatory clearance for HYBENX for the same indications and we began sales of HYBENX in the U.S. in February 2022.

• ERADX: Our ERADX product, which is similar to HYBENX, is marketed for use in reducing bacteria during dental crown prep, cavity restorations and vital pulp exposures. Separate regulatory clearance for ERADX in the EU and with the FDA was not required due to its composition and mechanism of action being identical to HYBENX.

• KONKURE: Our KONKURE product has also been developed using our DST technology for veterinarians to use for animal oral care. KONKURE is a topical liquid or gel for veterinary use in the treatment of infected lesions of tissue in the mouth cavity of animals. The FDA does not require submission of a 510(k) or any pre-market approval for devices intended for animal use. However, our clinical studies have indicated that KONKURE has similar effects in animals as HYBENX and ERADX have in humans.

• DEBACTEROL: Our DEBACTEROL canker sore pain relief product is a liquid, topical debriding agent used for treating ulcerating oral mucosal lesions, commonly referred to as canker sores, aphthous ulcers, or oral ulcers, as well as minor oral abrasions. This product is only sold to U.S. dental professionals or by prescription. We plan to discontinue U.S. sales of DEBACTEROL when we achieve positive cash flow from our sales of HYBENX and ERADX.

• ORALMEDIC: Our ORALMEDIC product is commonly used to treat oral ulcers, also referred to as canker sores, aphthae, or aphthous ulcers. The product is intended to be used to relieve the local pain and discomfort caused by painful inflammation from erupted mucosal tissue. ORALMEDIC is presently sold outside the United States, where it is available as an over-the-counter consumer product in more than forty countries. We plan to license the rights to sell ORALMEDIC to a third-party licensee when we achieve positive cash flow from our sales of HYBENX and ERADX.

Product Candidate

• REVITY: REVITY, our product candidate, has also been developed using our DST technology to treat acute and chronic wound applications, including diabetic foot ulcers, pressure ulcers and vascular ulcers. We have initiated and plan to continue clinical trials during the remainder of 2022 for the purpose of obtaining FDA clearance for REVITY. We had initially applied for 510(k) clearance of REVITY by the FDA, but the FDA determined that REVITY was “not substantially equivalent” to a previously cleared device. We subsequently withdrew our 510(k) request and plan to submit, during the first quarter of 2023, a risk-based classification determination for our product in accordance with the “de novo” process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device. Our regulatory team is currently working on a “de novo” application for REVITY. Using the FDA’s “de novo” application process will allow us to establish a new “device type” along with classification, regulation, necessary controls and product code. We believe that obtaining a “de novo” classification for REVITY will be a benefit to our marketing and sale of REVITY.

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We hope to obtain FDA clearance for our REVITY product candidate and begin commercialization before the end of 2023, although no assurance can be given that we will be able to obtain such clearance by such date or at all. If we do not obtain clearance for REVITY under the “de novo” application process, we will likely initiate several new clinical studies and trials to provide additional evidence regarding the safety and effectiveness of REVITY before seeking approval from the FDA.

Our Industry and Market

Our products and product candidate are designed to address two different markets. Our HYBENX, ERADX, DEBACTEROL and ORALMEDIC products target oral care, including periodontics, general cleanings, peri-implantitis and endodontics. Our REVITY product candidate is intended for the treatment of acute and chronic, non-healing wounds, including diabetic foot ulcers, pressure ulcers and vascular ulcers. Since 2014, REVITY has been subject to off-label studies conducted by chronic wound specialists at CHRISTUS Health (TX, U.S.), Southwest Regional Wound Care Center (TX, U.S.), Vascular Surgery Associates (MN, U.S.), and Villa Berica (Italy), as well as two case studies that were covered in peer-reviewed wound journals. To date, more than 300 patients with diabetic foot ulcers and vascular ulcers have been successfully treated with REVITY. We believe that our product candidate, if it receives de novo clearance from the FDA, would be able to impact healthcare (hospital, clinic, and insurance payor) costs by reducing long-term hospital care and outpatient visits for acute and chronic wounds and eliminating the need for the use of drugs such as antibiotics, antiseptics, and opioids to treat them. Our belief is based, in part, on a peer reviewed paper published in the January 2020 Journal of Biological Regulators and Homeostatic Agents by Dr. Marcus Gitterle entitled “Treatment with novel HYBENX root canal cleanser suggests biofilms blocked healing of human wounds: case series.” The six-month evaluation period in the study provided data to support the hypotheses that pathogenic biofilm actively prevents the healing of chronic wounds, and that biofilm can be disrupted with a single treatment of HYBENX. Our belief is also supported, in part, by research studies performed by the University of Miami that validated these assumptions with respect to mechanical debridement, reduction of bacterial, fungal yeast infection, and reduction in the post inflammatory factors that maintain chronicity in wounds. Additionally, multiple studies in the oral and dental sciences over the past decade confirm the identical outcomes. However, we will not be able to fully assess such results, unless and until, we have received this clearance and REVITY has been used commercially for such purposes.

Oral Care

According to a 2012 report from the CDC, approximately 47% of adults (ages 30 and older) have some form of periodontal disease, which increases with age and occurs in approximately 70% of adults over the age of 65 years old. In a recent journal publication, Economic Burden of Periodontitis in the United States and Europe, it was estimated that the aggregate cost of periodontal disease in 2018 in the United States was approximately $3.49 billion. No cure for this periodontitis has been found to date, and based upon information available to us we believe that our products are the first products to reverse the damage caused by this disease. Countries that have poor hygiene practices have a more rampant problem with periodontal disease that generally continues unchecked. In its early stage, called gingivitis, the gums can become swollen, and typically some bleeding may persist. As the disease progresses to a more serious form, called periodontitis, the gum tissue begins to pull away from the tooth, allowing more bacteria to invade. At this stage, bone loss can be observed as tissue begins to pull away from the tooth surface. Without any cure or treatment, this disease usually progresses until dental implants are required, which is a very costly solution.

Chronic Wounds

Chronic wounds include acute and chronic, non-healing wounds where harmful microorganisms reside and prevent open wounds from closing. Examples include diabetic foot ulcers, pressure ulcers and venous ulcers. In an article on Medmalfirm.com in December 2021, it was reported that across the United States there were estimated to be over 2.5 million people that develop a pressure ulcer each year. The vast majority of these injuries will develop in a healthcare setting. Pressure ulcers are painful, and increase the risk of complications including infection, sepsis, gangrene, or necessary amputation. Not only does a pressure ulcer increase the risk of health complications, but it is also a significant cause of death. Each year, around 60,000 patients die as a result of pressure ulcers. Additionally, Brown & Barron LLC, in a post on October 16, 2020, reported that out of the 3.42 million people in the United States suffering from diabetes, about 15% of these patients develop diabetic foot ulcers, which are open sores or wounds usually located in the sole of the foot, according to the American Podiatric Medical Association. Further,

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as reported in the September 2019 issue of American Family Physician, venous ulcers are the most common type of chronic lower extremity ulcers, affecting 1% to 3% of the U.S. population, representing between 330,000 and 990,000 venous ulcerations annually. In the aggregate, we believe that the chronic wound market consists of a broad population that is over 8 million patients annually in the U.S. who suffer from conditions such as venous leg ulcers, diabetic foot ulcers, pressure ulcers and complications of surgical site infections. Based on industry reports and our internal estimates, we believe that:

• Approximately $28 billion is spent annually treating chronic wounds;

• Chronic wounds’ total annual impact on the U.S. healthcare system is approximately $50 billion; and,

• By 2027, the total amount spent on wound care products in the U.S. will be approximately $5 billion.

Published studies in which REVITY was used off-label by wound clinicians to treat chronic wounds have indicated that our DST can successfully treat venous leg ulcers and diabetic foot ulcers. We intend to apply for FDA clearance, and we anticipate that if such clearance is received, we would begin commercializing REVITY for use in chronic wounds before the end of 2023, although no assurance can be given that we will be able to obtain such clearance by such date or at all.

Our Competitive Strengths

Based on the results from use of HYBEX in Canada, Asia and the EU, and more recently in the U.S., and the off-label studies mentioned above, with respect to REVITY, we believe that we have the ability to be a leader in the oral care and chronic wound markets and to present compelling value propositions for the following reasons:

• Broad Platform Technology. Our DST platform targets a range of applications covering significant markets, including oral health (including periodontal disease, gingivitis, peri-implantitis), and acute and chronic, non-healing wounds (diabetic ulcers, pressure ulcers and venous stasis ulcerations) in both humans and animals.

• Strong Intellectual Property Position. Through numerous patents and trade secrets, we hold intellectual property rights for treatment of any topical oral or wound infection based on our DST technology.

• Advantages over Standard of Care. Our DST platform can significantly reduce all microorganisms with one application. Other advantages include the stoppage of bleeding and reduction of pain. We also believe that HYBENX, ERADX and REVITY are alternatives to antibiotic treatment, which is the standard of care in the case of infection. Our belief is based, in part, on a peer reviewed paper published in the January 2020 Journal of Biological Regulators and Homeostatic Agents by Dr. Marcus Gitterle entitled “Treatment with novel HYBENX root canal cleanser suggests biofilms blocked healing of human wounds: case series.” The six-month evaluation period in the study provided data to support the hypotheses that pathogenic biofilm actively prevents the healing of chronic wounds, and that biofilm can be disrupted with a single treatment of HYBENX. Our belief is also supported, in part, by research studies performed by the University of Miami that validated these assumptions with respect to mechanical debridement, reduction of bacterial, fungal yeast infection, and reduction in the post inflammatory factors that maintain chronicity in wounds. We have multiple studies performed in the oral and dental sciences over the past decade that confirm the identical outcomes. In addition, certain antibiotics are too expensive for use by the public; side effects are common and sometimes cause serious complications; and bacteria can develop resistance to antibiotics over time. These concerns can be overcome with treatment using our DST-based products, which avoid antibiotic use.

• Distribution. Our ORALMEDIC mouth ulcer over-the-counter product is already sold in over thirty countries. We have initiated sales of HYBENX to dentists in Europe, since 2014, and product acceptance is growing. More recently in 2022, we have expanded the number of dental distributors in the United States who carry our HYBENX product from zero to eleven. For the past five years, our products have been used off-label by U.S. and Italian wound care specialists aimed at chronic, non-healing wounds, which we believe will support distribution if and when our REVITY product is cleared for distribution in the United States through our future distribution partners. We have strong relationships with distributors of dental supplies, who have distributed our legacy products.

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• Management. Our management has over 100 years of experience and includes clinical professionals who have had broad experience bringing medical products from the laboratory to market. For example, our VP of Regenerative Medicine has 20 years of chronic wound management experience at the Mayo Clinic in Rochester, MN, and our VP of Sales has 14 years of dental sales experience, including eleven years working with Patterson Dental, one of the largest dental distributors in the U.S. In addition, our VP of R&D has over 35 years of experience as a clinical pathologist and toxicologist at the University of Minnesota Medical Hospital and the U.S. Veteran’s Administration. We also recently hired a VP of Clinical Research who has 32 years of experience working on clinical trials with clinical research organizations.

Our Strategy

We intend to become a leading medical devices company focused on oral care and wound healing by developing, manufacturing, and commercializing novel products to address unmet needs in the fields of periodontal disease, acute, chronic and other hard-to-heal wounds, and dermatologic infections and inflamed skin problems. The key components of our growth strategy include:

• Build our commercial organization: We recently hired a VP of Sales with 14 years of dental sales management experience, including eleven years working with Patterson Dental (one of the largest dental distributors in the U.S.), and a VP of Regenerative Medicine with twenty-five years of experience with chronic wounds and twenty years at the Mayo Clinic. Both of these executives have significant experience in their fields to help effectively commercialize our HYBENX and ERADX products and REVITY product candidate. Their major objective will be to penetrate our dental and chronic wound markets by building their departments with staff who will ensure a smooth transition from development to commercialization.

• Penetrate the dental care market with HYBENX and ERADX: Following our receiving marketing clearance for HYBENX and ERADX from the FDA in September 2021, we intend to seek additional product clearances for worldwide commercialization of HYBENX and ERADX. In the United States market, we intend to focus on obtaining reimbursement for HYBENX and ERADX and educating the market regarding these products. We will seek to leverage our established long-term sales relationships with major distribution partners including Henry Schein, Inc., Patterson Dental, and Cardinal Health, Inc. to market our products.

• Obtain regulatory clearance for our product candidate: During 2021 and 2022, we initiated five pivotal studies at the University of Miami, Miller School of Dermatology. We intend to seek regulatory clearance for REVITY from the FDA and the European Union Medical Device Regulation (“EU MDR”), which is the latest European Union directive that governs how medical devices are produced and distributed in Europe, on the basis of those pivotal studies.

• Penetrate the wound care market: If REVITY is approved by the FDA, we intend to establish partnerships with major pharmaceutical companies in order to bring REVITY to market. We formed a Medical Advisory Board that will include key opinion leaders in the care of chronic wounds to educate healthcare providers regarding REVITY and its use cases.

• Develop additional product candidates and enter additional markets: We intend to expand the use of our DST to develop more product candidates. For example, we are seeking to develop product candidates aimed at treating topical infectious skin diseases, such as athlete’s foot, psoriasis, and possibly acne, as well as solid cancer tumors. We are also developing additional products aimed at the veterinary market. These potential new product candidates, if they obtain regulatory clearance, will allow us to enter new markets.

• Pursue business development opportunities. We will continue to explore additional business development opportunities to further drive growth. We will seek to engage in targeted business development activities, such as licensing, strategic partnerships, and acquisitions, which are synergistic with our business, to expand the market penetration of HYBENX, ERADX, REVITY and KONKURE, as well as our pipeline product candidates.

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Intellectual Property

Our intellectual property portfolio includes patents, trademarks, and key trade secrets.

Patents

Ten patents have been granted to date that cover our manufacturing process, our formulations, delivery methods and specific areas of use including dental, chronic wounds, and dermatology. We have several patents still pending. Some of our earlier patents, relating to our dental applications, will expire in 2024; however, in 2021, we obtained two new patents covering chronic wounds in Europe and the U.S. We believe that these new patents effectively extend the life span of our expiring dental patent claims, as periodontal disease is recognized in Europe and the U.S. as an infectious chronic wound. Other foreign patent applications have been filed or will be filed in various jurisdictions including Hong Kong, China, Canada, Japan and Mexico.

Summary of Risks Related to Our Business and Strategy

Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock. These risks are discussed more fully in “Risk Factors” beginning on page 17 of this prospectus. These risks include, but are not limited to, the following:

• If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

• We have incurred significant losses since our inception, expect to incur significant losses in the future and may never achieve or sustain profitability.

• We may be unsuccessful in obtaining regulatory approvals for use of the REVITY product candidate for the treatment of chronic wounds.

• We may be unsuccessful in commercializing our products due to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives.

• Our business and product candidates are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business.

• We face risks related to the Coronavirus pandemic (“COVID-19”) which could significantly disrupt our research and development, operations, sales, and financial results.

• We may not be able to expand our production capabilities or satisfy growing demand.

• We will need to increase the size of our organization, and we may experience difficulties in managing this growth.

• As a result of our current lack of financial liquidity, there exists substantial doubt regarding our ability to continue as a going concern.

• Additional delays to the completion of clinical studies may result from modifications being made to their respective protocols during those clinical trials, if such modifications are warranted and/or required by the occurrences in the given trial.

• There can be no assurance that the data generated from our clinical trials using modified protocols will be acceptable to the FDA or other regulatory authorities.

• We rely on third parties to manufacture the raw materials and products that we use in our products and our product candidate. Our business could be harmed if those third parties fail to provide us with sufficient quantities of these materials and products or fail to do so at acceptable quality levels or prices.

• Our collaborations with outside physicians and consultants may be subject to restriction and change.

• Our manufacturing resources are limited and if we are unable to produce an adequate supply of our products and product candidates for use in our current and planned clinical trials or for commercialization, our commercialization efforts may be delayed.

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• If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our products and product candidate and, as a result, there will be an adverse impact on our business until we are able to secure a new facility.

• We are subject to a number of other manufacturing risks, any of which could substantially increase our costs and limit supply of our products.

• We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected.

• Our long-term growth depends on our ability to develop and commercialize additional products.

• We must demonstrate to doctors, clinicians, and hospitals the merits of our products to facilitate adoption of our products.

• We have limited sales and marketing infrastructure and if we are unable to successfully secure sales and marketing partners or further develop a sales and marketing infrastructure, we may be unable to commercialize our products and product candidate, if approved, and may never generate sufficient revenue to achieve or sustain profitability.

Corporate Information

We were incorporated in the State of Minnesota, under the name Northern Research Laboratories, Inc. on January 6,1992. On March 22, 2005, our wholly-owned subsidiary, EPIEN Medical, Inc. was merged with and into us and in connection with the merger we changed our name to EPIEN Medical, Inc. Our principal executive offices are located at 600 Highway 169 South, Suite 820, St. Louis Park, Minnesota 55426.

In connection with this offering, EPIEN Medical, Inc., a Minnesota corporation, the registrant whose name appears on the cover of this registration statement (“EPIEN MN”), intends to transfer its corporate domicile and become a Nevada corporation under the same name (“EPIEN NV”) pursuant to sections 302A.682 to 302A.692 of the Minnesota Business Corporation Act and Section 92A.270 of the Nevada Revised Statutes (the “Domicile Transfer”). As a result of the Domicile Transfer, every three shares of capital stock of EPIEN MN will become one share of capital stock of EPIEN NV on a three-for-one basis, and such shares shall carry the same terms in all material respects as the shares of EPIEN MN. The Domicile Transfer was approved on August 16, 2022 by shareholders of EPIEN MN holding a majority of the outstanding shares entitled to vote thereon.

Our corporate website address is www.epien.com. The information contained on or accessible through our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.

Implications of Being an Emerging Growth Company

We qualify as an “emerging growth company,” as defined in the JOBS Act. For as long as we remain an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies. These provisions include, but are not limited to:

• being permitted to have only two years of audited financial statements and only two years of related selected financial data and management’s discussion and analysis of financial condition and results of operations disclosure;

• an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act;

• reduced disclosure about executive compensation arrangements in our periodic reports, registration statements, and proxy statements; and

• exemptions from the requirements to seek non-binding advisory votes on executive compensation or golden parachute arrangements.

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In addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are not choosing to “opt out” of this provision. We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of the completion of this offering, (ii) the last day of the first fiscal year in which our annual gross revenues exceed $1.07 billion, (iii) the date on which we have, during the immediately preceding three-year period, issued more than $1.0 billion in non-convertible debt securities and (iv) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeds $700 million as of the end of the second quarter of that fiscal year. We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our shareholders may be different than you might receive from other public reporting companies in which you hold equity interests.

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THE OFFERING

Units offered by us		4,190,476 Units, assuming a public offering price of $5.25 per Unit, the midpoint of the initial public offering price range reflected on the cover page of this prospectus. Each Unit will consist of one share of our common stock and one Warrant to acquire one share of common stock. The Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The shares of common stock and Warrants are immediately separable and will be issued separately in this offering.
Common stock outstanding before this offering(1)		10,136,322 Shares
Over-allotment option to purchase additional shares		We have granted to the underwriters an option exercisable for a period of 45 days from the date of this prospectus to purchase an aggregate of up to an additional 628,571 shares of common stock at the initial public offering price per share less the underwriting discounts and commissions and/or up to 628,571 additional Warrants to purchase up to 628,571 shares of common stock, in any combination thereof.
Common stock to be outstanding after this offering(1)		14,326,798 Shares
Representative Warrants		We have agreed to issue warrants to the representative or its designees to purchase up to a total of 209,524 shares of common stock (and up to 240,953 total shares of common stock assuming the Underwriters option is exercised in full), which is equal to 5% of the total number of shares of common stock included in the Units being sold in this offering (the “Representative Warrants”). The exercise price of the warrants is equal to 120% of the public offering price per Unit offered hereby. The Representative Warrants will be exercisable at any time and from time to time, in whole or in part, during the four and a half-year period commencing six months from the effective date of this offering. Please see “Underwriting — Representative Warrants” for a description of the Representative Warrants.
Use of proceeds		We currently intend to use the net proceeds from this offering, together with our existing cash, to fund our clinical trials, research and development activities, and the regulatory review process for our product candidate, as well as marketing and commercialization of our products and the remainder for working capital and other general corporate purposes. See “Use of Proceeds” on page 53.
Description of the Warrants		The exercise price of the Warrants is $ per share (100% of the initial public offering price per Unit) (the “Initial Exercise Price”). Each Warrant is exercisable for one share of common stock, subject to adjustment in the event of stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the common stock as described herein. Each Warrant will be exercisable immediately upon issuance and will expire five years after the initial issuance date. If shares of common stock trade at a price of at least 200% of the exercise price for 30 consecutive trading days, the Company may, at its option, redeem the Warrants. The terms of the Warrants will

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be governed by a Warrant Agent Agreement, dated as of the effective date of this offering, between us and VStock Transfer, LLC, as the warrant agent (the “Warrant Agent”). We have applied to list the Warrants on the Nasdaq Capital Market. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the Warrants.

Subject to certain exemptions set forth in the Warrant, for a period commencing on the date the Warrants are issued to the later of: (i) two years from the date of issuance of the Warrant, or (ii) on the date no Qualified Holders (as defined below) hold any Warrants, if we sell, enter into an agreement to sell, or grant any option to purchase, or sell, enter into an agreement to sell, or grant any right to reprice, or otherwise dispose of or issue (or announce any offer, sale, grant or any option to purchase or other disposition) any shares of common stock or a security convertible into shares of common stock, at an effective price per share less than the exercise price of the Warrant then in effect, (each a “Dilutive Issuance”), the exercise price of the Warrant shall be reduced to equal the effective price per share in such Dilutive Issuance; provided, however, that in no event shall the exercise price of the Warrant be reduced to an exercise price lower than 50% of the initial public offering price per Unit.

On the date that is 90 calendar days immediately following the initial issuance date of the Warrants, the exercise price of the Warrants will be reduced to the Reset Price, provided that such value is less than the exercise price in effect on that date. The Reset Price is equal to the greater of (a) 50% of the Initial Exercise Price or (b) 100% of the lowest daily volume weighted average price per share of our common stock occurring during the 90 calendar days following the issuance date of the Warrants. The lowest Reset Price is $2.625 per share of common stock, which is 50% of the initial public offering price, based on an assumed public offering price of $5.25 per Unit, the midpoint of the price range of the Units as set forth on the cover page of this prospectus.

To better understand the terms of the Warrants, you should carefully read the section titled “Description of our Securities — Warrants Offered in this Offering” elsewhere in this prospectus. You should also read the form of Warrant, which is filed as an exhibit to the registration statement that includes this prospectus.

Additional Warrants

In the event that the Reset Price is equal to 50% of the Initial Exercise Price, then each Qualified Holder will receive two Warrants (“Additional Warrants”) for each one Qualified Warrant held by such holder on the date that such Reset Price becomes effective. If there are no Additional Warrants issued as a result of the Reset Price, until the later of (a) two years after the date the Warrants are issued or (b) the date no Qualified Holders (as defined below) hold any Warrants, in the event of a reduction of the exercise price of the Warrants, in aggregate, to 50% of the Initial Exercise Price as a result of a Dilutive Issuance, each Qualified Holder will be issued two Additional Warrants for each one Qualified Warrant held by such holder on the date of such reduction. The maximum number of Warrants subject to such adjustment by a given Qualified Holder will be limited to the number of Warrants purchased by such Qualified Holder in connection with this offering. Additional Warrants shall only be issued to Qualified Holders if the Reset Price is equal to 50% of

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		the Initial Exercise Price or on the first Dilutive Issuance which causes the exercise price to be equal to 50% of the Initial Exercise Price, there being only one event requiring the issuance of the Additional Warrants. Additional Warrants shall be on substantially the same terms as the Warrants issued in connection with this offering; provided, however, that (i) the term of the Additional Warrants shall be five (5) years from the date they are issued, and (ii) such Additional Warrants and the shares of common stock underlying such Additional Warrants are being registered in the registration statement of which this prospectus forms a part, but will not be tradable warrants and not listed on any securities exchange or other nationally recognized trading system. The term “Qualified Holder” means each holder of Warrants that purchases at least Warrants in connection with this offering and the term “Qualified Warrants” means at least Warrants purchased in connection with the offering by any Warrant holder, including each beneficial holder of the Warrants, taken together with all affiliates of such Warrant holder and/or beneficial holder.
Risk Factors		See “Risk Factors” on page 17 for a discussion of certain factors to consider carefully before deciding to purchase any of our securities.
Proposed Nasdaq Capital Market symbols		We have applied to list our common stock and Warrants on the Nasdaq Capital Market under the ticker symbols “EPMI” and “EPMIW,” respectively. No assurance can be given that our application will be approved.
Lock Up		We have agreed with the underwriters not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any shares of our common stock or securities convertible into shares of our common stock for a period of six months following the date of this prospectus. See “Underwriting” section on page 132.

____________

(1) The number of shares of our common stock to be outstanding after this offering is based on 10,136,322 shares of common stock outstanding as of September 20, 2022 (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer, and excludes:

• 4,190,476 shares of common stock issuable upon the exercise of the Warrants issued in this offering at an exercise price of $ per share;

• up to shares of common stock which could be issuable upon the exercise of the Additional Warrants, to the extent issued, at the same exercise price per share as the Warrants;

• 1,061,896 shares of common stock issuable upon the conversion of $3,462,542 of principal and $1,008,540 of accrued interest on notes outstanding as of September 20, 2022, based on conversion prices equal to between 75% and 85% of the assumed public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus);

• 2,567,940 shares of common stock issuable upon the exercise of warrants as of September 20, 2022, with a weighted average exercise price of $1.59 per share (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer;

• 455,915 shares of common stock issuable upon the exercise of warrants as of September 20, 2022, with an exercise price of $4.73 per share (assuming an initial public offering price of $5.25 per Unit, the midpoint of the estimated price range set forth on the cover page of this prospectus);

• 3,022,191 shares of common stock issuable upon the exercise of outstanding stock options under our 1998 Option Plan, as of September 20, 2022, with a weighted average exercise price of $1.82 per share (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer;

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• 133,333 shares of common stock issuable upon the exercise of outstanding stock options granted outside of the 1998 Option Plan, as of September 20, 2022, with a weighted average exercise price of $6.00 per share (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer; and

• 520,759 shares of common stock that would be issuable upon the conversion of any deferred compensation owed to executive officers and former executive officers of the Company in the total amount of $2,733,987, assuming an initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus).

Unless otherwise indicated, all information contained in this prospectus assumes:

• no exercise by the underwriters of their over-allotment option to purchase up to an additional 628,571 shares of common stock and/or up to 628,571 additional Warrants to purchase up to 628,571 shares of common stock, in any combination thereof;

• no exercise of any of the Additional Warrants, as applicable;

• no exercise of the outstanding stock options described above;

• no exercise of the outstanding warrants described above;

• no conversion of the outstanding convertible notes described above;

• no conversion of the deferred compensation described above; and

• the Domicile Transfer, including, without limitation, the assumed conversion of shares of common stock of EPIEN MN to shares of common stock of EPIEN NV at a rate of one share of common stock of EPIEN NV for each three shares of EPIEN MN, and the filing of our Nevada Articles of Incorporation immediately prior to the closing of this offering.

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SUMMARY FINANCIAL DATA

The following tables set forth a summary of our historical financial data as of, and for the periods ended on, the dates indicated. The summary statement of operations data for the three and six months ended June 30, 2022 and 2021 and the summary balance sheet data as of June 30, 2022 are derived from our unaudited interim financial statements and related notes thereto that are included elsewhere in this prospectus. The unaudited interim financial statements have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of our unaudited interim financial statements. The summary statement of operations data for the years ended December 31, 2021 and 2020 and the summary balance sheet data as of December 31, 2021 and 2020 have been derived from our audited financial statements and related notes thereto included elsewhere in this prospectus.

The following summary financial information should be read in connection with, and is qualified by reference to, our financial statements and related notes thereto and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus. Our historical results are not necessarily indicative of results to be expected in any future period.

We adopted Accounting Standards Update 2016-02, Leases (“Topic 842”), effective January 1, 2022, using the optional transition method to the modified retrospective approach. As a result, our financial data as of and for the three and six months ended June 30, 2022 are presented on a different accounting basis from our financial data as of December 31, 2021 and for the three and six months ended June 30, 2021. For a description of Topic 842, refer to Note 14 to our unaudited interim financial statements included elsewhere in this prospectus.

Statement of Operations Data:

	For the six months ended						For the three months ended						For the year ended
	June 30, 2022			June 30, 2021			June 30, 2022			June 30, 2021			December 31, 2021			December 31, 2020
Statement of Operations Data:
Product sales	$	621,511		$	737,159		$	273,610		$	363,138		$	1,388,455		$	1,160,036
Cost of goods sold		159,176			192,732			66,291			92,317			341,400			333,444
Gross profit		462,335			544,427			207,319			270,821			1,047,055			826,592
Operating expenses:
General and administrative expenses		1,506,442			1,657,402			817,290			1,244,313			3,388,939			1,939,339
Selling expenses		45,303			36,269			33,631			11,988			80,645			62,202
Research and development		175,794			8,255			110,334			2,390			108,799			23,796
Total operating expenses		1,727,539			1,701,926			961,255			1,258,691			3,578,383			2,025,337
Loss from operations		(1,265,204	)		(1,157,499	)		(753,936	)		(987,870	)		(2,531,328	)		(1,198,745	)
Other income and expenses:
Interest expense		(689,690	)		(271,386	)		(368,494	)		(150,457	)		(732,477	)		(494,148	)
PPP loan forgiveness		130,203			129,400			130,203			129,400			129,400			—
Change in fair value of derivative liability		(56,918	)		—			(39,534	)		—			(15,838	)		—
Change in fair value of warrant liability		(73,779	)		—			(10,866	)		—			7,728			—
Total other expense		(690,184	)		(141,986	)		(288,691	)		(21,057	)		(611,187	)		(494,148	)
Net loss	$	(1,955,388	)	$	(1,299,485	)	$	(1,042,627	)	$	(1,008,927	)	$	(3,142,515	)	$	(1,692,893	)
Basic and diluted net loss per common share	$	(0.07	)	$	(0.05	)	$	(0.04	)	$	(0.04	)	$	(0.11	)	$	(0.06	)
Weighted-average common shares outstanding, basic and diluted		28,529,616			27,988,857			28,900,201			27,960,138			28,054,418			27,708,073

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Balance Sheet Data:

	As of June 30, 2022			As of December 31, 2021			As of December 31, 2020
Current assets	$	564,878		$	853,067		$	267,312
Total assets		1,380,707			1,054,249			415,664
Current liabilities		12,528,754			13,778,596			6,197,451
Total liabilities		15,704,951			15,879,926			13,322,742
Accumulated deficit		(58,586,787	)		(56,631,399	)		(52,161,166	)
Total shareholders’ deficit		(14,324,244	)		(14,825,677	)		(12,907,078	)

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
AND INDUSTRY AND MARKET DATA

Special Note Regarding Forward-Looking Statements

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” but are also contained elsewhere in this prospectus. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking statements include, but are not limited to, statements about:

• our ability to obtain FDA clearance to commercially sell our product candidate in a timely manner or at all;

• whether hospitals, physicians, dentists and patients in our target markets accept our proposed products and product candidate;

• the size of the markets for our products and product candidate;

• the expected growth of our business and our operations, and the capital resources needed to progress our business plan;

• failure to scale up the manufacturing process of our proposed products and product candidate in a timely manner, or at all;

• failure to manufacture our products and product candidate at a competitive price;

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

• reliance on third-party suppliers for certain components of our products and product candidate;

• reliance on third parties to commercialize and distribute our products and product candidate in the United States and internationally;

• changes in external competitive market factors;

• uncertainties in generating sustained revenue or achieving profitability;

• unanticipated working capital or other cash requirements;

• changes in FDA regulations, including testing procedures, of medical devices and related promotional and marketing activities;

• our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing;

• our ability to obtain and maintain intellectual property protection for our products and product candidate; and

• changes in our business strategy or an inability to execute our strategy due to unanticipated changes in the medical device industry.

You should read this prospectus, including the section titled “Risk Factors,” and the documents that we reference elsewhere in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual results may differ materially from

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what we expect as expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all.

These forward-looking statements represent our estimates and assumptions only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of our common stock. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this prospectus. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.

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RISK FACTORS

Investing in our securities involves a high degree of risk. You should carefully consider the following information about these risks, together with the other information appearing elsewhere in this prospectus, including our financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding to invest in our securities. The occurrence of any of the following risks could have a material adverse effect on our business, reputation, financial condition, results of operations and future growth prospects, as well as our ability to accomplish our strategic objectives. As a result, the trading price of our common stock could decline, and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and stock price.

Risks Related to Our Business and Strategy

If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

We have experienced negative operating cash flows since our inception and have funded our operations primarily from proceeds received from sales of our capital stock, the issuance of convertible notes, and the sale of our DEBACTEROL, ORALMEDIC and HYBENX products. We will seek to obtain additional funds in the future through equity or debt financings, or strategic alliances with third parties, either alone or in combination with equity financings. These financings could result in substantial dilution to the holders of our common stock or require contractual or other restrictions on our operations or on alternatives that may be available to us. If we raise additional funds by issuing debt securities, these debt securities could impose significant restrictions on our operations. Any such required financing may not be available in amounts or on terms acceptable to us, and the failure to procure such required financing could have a material adverse effect on our business, financial condition, and results of operations, or threaten our ability to continue as a going concern.

Our present and future capital requirements will be significant and will depend on many factors, including:

• the progress and results of our development efforts for our products and product candidate;

• the costs, timing and outcome of regulatory reviews of our products and product candidate;

• the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

• the effect of competing technological and market developments;

• market acceptance of our products;

• our rate of progress in establishing coverage and reimbursement arrangements with domestic and international commercial third-party payors and government payors;

• our ability to achieve revenue growth;

• the extent to which we acquire or license other products and technologies; and

• legal, accounting, insurance, and other professional and business-related costs.

We may not be able to acquire additional funds on acceptable terms, or at all. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets or delay, reduce the scope of, or eliminate some or all of our development programs.

If we do not have, or are not able to obtain, sufficient funds, we may be required to delay development or commercialization of our products or license to third parties the rights to commercialize our products or technologies that we would otherwise seek to commercialize ourselves. We also may have to reduce marketing or other resources devoted to our products or cease operations. Any of these factors could harm our operating results.

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We have incurred significant losses since our inception, expect to incur significant losses in the future and may never achieve or sustain profitability.

Although we have begun full-scale marketing and sales of our DEBACTEROL and HYBENX products in the United States and our ORALMEDIC product in other jurisdictions, such sales have been limited to date and we have not yet achieved profitability. We had net losses of $1,955,388 and $1,299,485 for the six-month periods ended June 30, 2022 and 2021, respectively, and $3,142,515 and $1,692,893 for our fiscal years ended December 31, 2021 and 2020, respectively. We anticipate that we will continue to incur losses at least until profits from sales of our products are adequate to fund operating expenses, which we anticipate will not be until our HYBENX and ERADX products are more widely accepted by dentists, which we believe will be sometime after the second quarter of 2023; provided, however, that there can be no assurance that dentists will widely accept our HYBENX and ERADX products by that date or ever. We may not be able to successfully achieve or sustain profitability. Successful transition to profitable operations is dependent upon achieving a level of revenues adequate to support our cost structure, including in new markets for which we are not presently approved.

We may be unsuccessful in obtaining regulatory approvals for use of the REVITY product candidate for the treatment of chronic wounds.

Although products based on our technology have been approved for use in the treatment of periodontal disease, they have not been approved for additional indications such as chronic wounds. We plan to expand these indications by conducting a series of chronic wound clinical trials in order to gain approval by the FDA for U.S. professional use, as well as approval in other jurisdictions. While certain clinical trials for such uses have been completed and published, additional trials are presently planned, and there can be no assurance that we will be successful in those clinical trials or ever receive approval by the FDA for such additional applications. Such a failure of approval would have a material negative effect on our future prospects.

We are subject to rigorous and extensive regulation by the FDA in the U.S. and by comparable agencies in other jurisdictions, including the European Medicines Agency (“EMA”) in the European Union (“EU”). While we have received FDA approval for some of our products, our product candidate REVITY has not received FDA approval. Our product candidate may not be marketed in the U.S. until it has been approved by the FDA and may not be marketed in other jurisdictions until it has received approval from the appropriate foreign regulatory agencies. Each product candidate requires significant research, development and preclinical testing and extensive clinical investigation before submission of any regulatory application for marketing approval.

Obtaining regulatory approval requires substantial time, effort and financial resources, and we may not be able to obtain approval of any of our product candidates on a timely basis, or at all. The number, size, design and focus of preclinical and clinical trials that will be required for approval by the FDA, the EMA, or any other foreign regulatory agency varies depending on the compound, the disease or condition that the products are designed to address, and the regulations applicable to any particular products. Preclinical and clinical data can be interpreted in different ways, which could delay, limit, or preclude regulatory approval. The FDA, the EMA and other foreign regulatory agencies can delay, limit, or deny approval of a product for many reasons, including, but not limited to:

• a product may not be shown to be safe or effective;

• the clinical and other benefits of a product may not outweigh its safety risks;

• clinical trial results may be negative or inconclusive, or adverse medical events may occur during a clinical trial;

• the results of clinical trials may not meet the level of statistical significance required by regulatory agencies for approval;

• regulatory agencies may interpret data from preclinical and clinical trials in different ways than we do;

• regulatory agencies may not approve the manufacturing process or determine that the manufacturing is not in accordance with current good manufacturing practices (“cGMPs”);

• a product may fail to comply with regulatory requirements;

• regulatory agencies might change their approval policies or adopt new regulations.

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If our product candidate is not approved at all or quickly enough to provide net revenues to defray our operating expenses, our business, financial condition, operating results and prospects could be harmed.

We may be unsuccessful in commercializing our products due to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives.

We expect that in the future, a significant source of payment for our products will be private insurance plans and managed care programs, government programs such as Medicare and Medicaid, worker’s compensation, and other third-party payors.

We cannot guarantee that we will receive favorable pricing and reimbursement terms and approvals. Additionally, we cannot predict the pricing and reimbursement of our products or product candidate in any other jurisdiction. The regulations that govern marketing approvals, pricing and reimbursement for new products vary widely from country to country.

As a result, we might obtain regulatory approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product and negatively impact the revenue we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in our products or product candidate, even after obtaining regulatory approval.

Additionally, we cannot be sure that reimbursement will be available for REVITY or any other product that we commercialize in the future and, if reimbursement is available, what the level of reimbursement will be. Reimbursement may affect the demand for, or the price of, any product for which we obtain marketing approval. Obtaining reimbursement for our products may be particularly difficult because of the higher prices often associated with products administered under the supervision of a physician. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize REVITY or any other product that we successfully develop. Eligibility for reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Payment rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services. Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in certain other countries, such as the United States. In the United States, third-party payors often rely upon other payors, such as a Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for our products and product candidate could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

The United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that may affect our ability to sell our products and product candidates profitably, if approved. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may adversely affect:

• the market acceptance or demand for our products and product candidates, if approved;

• the ability to set a price that we believe is fair for our products or any of our other candidates, if approved;

• our ability to generate revenues and achieve or maintain profitability;

• the level of taxes that we are required to pay; and

• the availability of capital.

Generally, private insurance companies do not cover or provide reimbursement for off-label use and may ultimately provide no coverage for our products or product candidates. Many private third-party payors use coverage decisions and payment amounts determined by the Center for Medicare and Medicaid Services (“CMS”), which

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administers the Medicare program, as guidelines in setting their coverage and reimbursement policies. We plan to start the process of obtaining reimbursement coverage from CMS and to have CMS issue a Healthcare Common Procedure Coding System Code for REVITY. These codes are used to identify medical products and supplies and to facilitate insurance claim submissions and processing for these items. However, while we believe that any ultimate positive reimbursement response by CMS will broaden coverage by private insurers, we cannot currently predict how long it would take for us to receive a coverage decision from CMS for any of our products nor can we predict other business elements that will be decided by CMS such as the reimbursement rate per unit or product labeling requirements. Even with a positive decision from CMS regarding a product of ours, future action by CMS or other government agencies may diminish possible payments to physicians, outpatient centers, and/or hospitals that purchase our products for use by their patients. Additionally, a decision by CMS to provide or not to provide reimbursement could influence other payors, including private insurers. If CMS declines to provide reimbursement of our products, or if its reimbursement rate is lower than that of other payors, our products may not be reimbursed at a cost-effective level or at all. Those private third-party payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for purchase of our products or their use in a hospital or other setting.

Third-party payors are developing increasingly sophisticated methods of controlling healthcare costs. These cost control methods include prospective payment systems, capitated rates, benefit redesigns and an exploration of other cost-effective methods of delivering healthcare. These cost control methods potentially limit the amount that healthcare providers may be willing to pay for our products, if they provide coverage at all. We may be unable to sell our products on a profitable basis if third-party payors deny coverage or provide insufficient levels of reimbursement.

We may not be able to expand our production capabilities or satisfy growing demand.

We will likely need to expand our manufacturing capabilities in order to increase our capacity to manufacture our products. We cannot guarantee that we will be able to obtain the requisite approvals, including meeting regulatory and quality requirements, or the necessary capital resources for such expansion, or if we do, that our facilities and equipment will satisfy additional growing demand. Conversely, there can be no assurance, even if we obtain additional capacity, that demand for our products will increase proportionately to the increased production capability. Furthermore, we cannot assure that this or similar projects will be implemented in a timely and cost-effective manner, and that our current production will not be adversely affected by the operational challenges of implementing the expansion project.

We face risks related to the Coronavirus pandemic (“COVID-19”) which could significantly disrupt our research and development, operations, sales, and financial results.

Our business could be further impacted by the effects of the COVID-19 outbreak. In addition to global macroeconomic effects, the COVID-19 outbreak and any other related adverse public health developments has caused disruption to our operations, fundraising and sales activities. Our third-party vendors, third-party distributors, and our customers have been and will be disrupted by worker absenteeism, quarantines and restrictions on employees’ ability to work, office and factory closures, disruptions to ports and other shipping infrastructure, border closures, or other travel or health-related restrictions. Depending on the magnitude of such effects on our activities or the operations of our third-party vendors and third-party distributors, the supply of our products will be delayed, which could adversely affect our business, operations, and customer relationships. In addition, COVID-19 or other disease outbreaks will in the short-run and may over the longer term adversely affect the economies and financial markets of many countries, resulting in an economic downturn that will affect demand for our products and services and impact our operating results. There can be no assurance that any decrease in sales resulting from COVID-19 will be offset by increased sales in subsequent periods. Although the magnitude of the impact of the COVID-19 outbreak on our business and operations remains uncertain, the continued spread of COVID-19 or the occurrence of other epidemics and the imposition of related public health measures and travel and business restrictions will adversely impact our business, financial condition, operating results, and cash flows. In addition, we have experienced and will experience disruptions to our business operations and our ability to obtain financing resulting from quarantines, self-isolations, or other movement and restrictions on the ability of our employees to perform their jobs that may impact our ability to develop and design our products and services in a timely manner or meet required milestones or customer commitments. These same factors may also adversely affect enrollment in our clinical trials and/or may cause unexpected delays in the conduct of clinical research activities.

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As a result of our current lack of financial liquidity, there exists substantial doubt regarding our ability to continue as a going concern.

As a result of our current lack of financial liquidity, the report of our independent registered accounting firm that accompanies our audited financial statements for the years ended December 31, 2021 and 2020, which are included as part of this prospectus, contains an emphasis of matter expressed by our independent registered public accounting firm regarding our ability to continue as a going concern, meaning that we may be unable to continue in operation for the foreseeable future or realize assets and discharge liabilities in the ordinary course of operations. Our lack of sufficient liquidity could make it more difficult for us to secure additional financing or enter into strategic relationships on terms acceptable to us, if at all, and may materially and adversely affect the terms of any financing that we may obtain and our public stock price generally.

In order to continue as a going concern, we will need to, among other things, achieve positive cash flow from operations and, if necessary, seek additional capital resources to satisfy our cash needs. Our plans to achieve positive cash flow include engaging in offerings of equity and debt securities and negotiating up-front and milestone payments on our product candidates and royalties from sales of our products that secure regulatory approval and any milestone payments associated with such approved products. Our failure to obtain additional capital would have an adverse effect on our financial position, results of operations, cash flows, and business prospects, and ultimately on our ability to continue as a going concern.

We will need to increase the size of our organization, and we may experience difficulties in managing this growth.

As of September 20, 2022, we had 13 full-time employees. We will need to continue to expand our managerial, operational, finance and other resources to manage our operations, commercialize our products, continue our development activities, and fulfill public company financial reporting and other requirements. Our management and personnel, systems, and facilities currently in place may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:

• manage any of our future clinical trials effectively;

• identify, recruit, retain, incent and integrate additional employees;

• manage our internal development efforts effectively while carrying out our contractual obligations to third parties; and

• continue to improve our operational, financial and management controls, reporting systems and procedures.

Due to our limited financial resources and our limited experience in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our development and strategic objectives or disrupt our operations.

We may encounter substantial delays in any further clinical studies necessary to support any regulatory applications for additional commercial applications of our technology.

We cannot guarantee that any preclinical testing or clinical trials will be conducted as planned or completed on schedule, if at all. As a result, we may not achieve the expected clinical milestones necessary for qualification or approval by the FDA, or other regulators, for the use of REVITY for chronic wound treatment in the United States or other countries.

A failure in a clinical study or regulatory application can occur at any stage. Events that may prevent successful or timely commencement, enrollment, or completion of clinical development or a regulatory application include:

• delays in raising, or inability to raise, sufficient capital to fund the planned trials;

• delays in reaching a consensus with regulatory agencies on trial design;

• changes in trial design;

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• inability to identify, recruit and train suitable clinical investigators;

• inability to add new clinical trial sites;

• delays in reaching agreement on acceptable terms for the performance of the trials with prospective clinical research organizations and clinical trial sites;

• delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials;

• imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites;

• failure by any relevant party to adhere to clinical trial requirements;

• failure to perform in accordance with the FDA’s Good Clinical Practice (“GCP”) or applicable regulatory guidelines in other countries;

• delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;

• delays caused by clinical trial sites not completing a trial;

• failure to demonstrate adequate effectiveness;

• occurrence of serious adverse events in clinical trials that are associated with the product candidates that are viewed to outweigh their potential benefits;

• changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

• adverse events, safety issues, product recalls, manufacturing or supply chain interruptions, or poor clinical outcomes where our products are being used commercially; and

• disagreements with regulatory agencies in the interpretation of the data from our clinical trials.

Delays, including delays caused by the above factors, can be costly and could negatively affect our ability to complete clinical trials for our product candidate. If we are not able to successfully complete clinical trials or are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval for the use of REVITY for chronic wound treatment, which could have a material adverse effect on our business, financial condition, and results of operations.

Additional delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences in the given trial.

Each modification to the protocol during a clinical trial has to be submitted to the FDA. This could result in the delay or halt of a clinical trial while the modification is evaluated. In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data generated by the clinical trial are not poolable because the same protocol was not used throughout the trial. This might require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying approval of a product. Any such delay could have a material adverse effect on our business and results of operations.

There can be no assurance that the data generated from our clinical trials using modified protocols will be acceptable to the FDA or other regulatory authorities.

There can be no assurance that the data generated using modified protocols will be acceptable to the FDA or other regulatory authorities or that if future modifications during the trial are necessary, that any such modifications will be acceptable to the FDA or other regulatory authorities. If the FDA or other regulatory authorities believe that prior approval is required for a particular modification, they can delay or halt a clinical trial while they evaluate additional information regarding the change.

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Serious injury or death resulting from a failure of our product candidates during current or future clinical trials could also result in the FDA or other regulatory authority delaying our clinical trials or denying or delaying approval of a product.

Even though an adverse event may not be the result of the failure of our product candidate, the FDA or other regulatory authority could delay or halt a clinical trial for an indefinite period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.

Any delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from the FDA or other regulatory authorities, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval and commercialization of our products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

We rely on third parties to manufacture the raw materials and products that we use in our products and our product candidate. Our business could be harmed if those third parties fail to provide us with sufficient quantities of these materials and products or fail to do so at acceptable quality levels or prices.

We do not currently have the infrastructure or capability internally to manufacture the raw materials and other products that we use to manufacture our products and product candidate. There are a limited number of suppliers for these raw materials and products, and there may be a need to identify alternate suppliers to prevent a possible disruption to our sales and our clinical studies. These third parties may encounter problems during manufacturing for a variety of reasons, including unanticipated demand from larger customers, failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction, quality or yield problems and environmental factors. In certain cases, we rely on a sole provider, and there may be a need to identify additional providers in the future.

Our reliance on these third parties also subjects us to other risks that could harm our business, including:

• interruption of supply resulting from modifications to, or discontinuation of, a supplier’s operations;

• delays in product shipments resulting from defects, reliability issues or changes in raw materials from suppliers;

• price fluctuations due to a lack of long-term supply arrangements for key components with our suppliers;

• errors in manufacturing components, which could negatively impact the effectiveness or safety of our products or product candidates or cause delays in shipment of our products;

• discontinued production of raw materials, which could significantly delay our production and sales and impair operating profitability;

• inability to obtain adequate supplies in a timely manner or on commercially reasonable terms;

• difficulty locating and qualifying alternative suppliers, especially with respect to our sole-source supplies;

• delays due to evaluation and testing of raw materials from alternative suppliers and corresponding regulatory qualifications;

• the failure of our suppliers to comply with strictly enforced regulatory requirements, which could result in disruption of supply or increased expenses; and

• inability of suppliers to fulfill orders and meet requirements due to financial hardships.

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Our collaborations with outside physicians, scientists and consultants may be subject to restriction and change.

We work with physicians and scientists at academic and other institutions, and consultants who assist us in our research, development, and regulatory efforts, including the members of our medical advisory board. These consultants have provided, and we expect that they will continue to provide, valuable advice on our programs. These consultants are not our employees, may have other commitments that would limit their future availability to us and typically will not enter into non-compete agreements with us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. In addition, we will be unable to prevent them from establishing competing businesses or developing competing products. For example, if a key consultant acting as a principal investigator in any of our clinical trials identifies a potential product or compound that is more scientifically interesting to his or her professional interests, his or her availability to remain involved in our clinical trials could be restricted or eliminated.

We have entered into or intend to enter into non-competition agreements with certain of our employees. These agreements prohibit our employees, if they cease working for us, from competing directly with us or working for our competitors for a limited period. However, under current law, we may be unable to enforce these agreements against certain of our employees, and it may be difficult for us to restrict our competitors from gaining the expertise our former employees gained while working for us. If we cannot enforce our employees’ non-compete agreements, we may be unable to prevent our competitors from benefiting from the expertise of our former employees.

Our manufacturing resources are limited and if we are unable to produce an adequate supply of our products and product candidate for use in our current and planned clinical trials or for commercialization, our commercialization efforts may be delayed.

Our manufacturing resources for our products and product candidate are limited. We currently manufacture our products at our manufacturing facility in White Bear Lake, Minnesota. If our existing manufacturing facility experiences a disruption, we would have no other means of manufacturing our products and product candidate until we are able to restore the manufacturing capability at our current facility or develop alternative manufacturing facilities. Additionally, any damage to or destruction of our facilities or our equipment, prolonged power outage or contamination at our facilities would significantly impair our ability to produce our products and proposed product candidate and prepare our products product candidate for clinical trials.

Additionally, in order to produce our products in the quantities that will be required for increased commercialization, we will have to increase or “scale up” our production process over the current level of production. We may encounter difficulties in scaling up our production, including issues involving yields, controlling and anticipating costs, quality control and assurance, supply and shortages of qualified personnel. If our scaled-up production process is not efficient or results in a product that does not meet quality or other standards, we may be unable to meet market demand and our revenues, business and financial prospects would be adversely affected. Further, third parties with whom we may develop relationships may not have the ability to produce the quantities of the materials we may require for clinical trials or commercial sales or may be unable to do so at prices that allow us to price our products competitively.

If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our products and product candidate and, as a result, there will be an adverse impact on our business until we are able to secure a new facility.

Our facility and equipment would be costly to replace and could require substantial lead time to repair or replace. The facility may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, flooding, fire, vandalism, and power outages, which may render it difficult to operate our business for some period of time. While we have taken precautions to safeguard our facilities, any inability to operate our business during such periods could lead to the loss of customers or harm to our reputation. We also possess insurance for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all our potential losses, and this insurance may not continue to be available to us on acceptable terms, or at all.

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We are subject to a number of other manufacturing risks, any of which could substantially increase our costs and limit supply of our products.

The process of manufacturing our products is complex and subject to the risk of product loss due to equipment failure or improper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing processes or quality requirements for our products could result in reduced production yields, product defects and other supply disruptions.

Although we have not experienced any major equipment failures, or other similar manufacturing problems of such magnitude, any adverse developments affecting manufacturing operations for our products may result in shipment delays, inventory shortages, lot failures, withdrawals or recalls, or other interruptions in the supply of our products. We may also have to take inventory write-offs and incur other charges and expenses for our products that fail to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives.

We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected.

The dental care and chronic would care industries are intensely competitive and subject to rapid and significant technological change, as well as the introduction of new products or other market activities of industry participants. Our ability to compete successfully will depend on our ability to develop products that reach the market in a timely manner, are broadly adopted by customers and receive adequate reimbursement coverage from third-party payors.

We have numerous competitors, many of whom have substantially greater name recognition, commercial infrastructure and financial, technical and personnel resources than us. For example, OraPharma Inc., a subsidiary of Bausch Health Companies Inc., manufactures ARESTIN, which is used in dental clinics to help minimize bacterial growth. Additionally, among others, Dentsply Sirona Inc. manufactures the Cavitron ultrasonic scaling systems. In respect of REVITY, our competitors include 3M, which manufactures V.A.C. VERAFLO Therapy and Smith & Nephew, which manufactures ACTICOAT. Our competitors may develop and patent competing products or processes earlier than we can or obtain regulatory clearance or approvals for competing products more rapidly than we can, which could impair our ability to develop and commercialize similar products or processes. Additionally, our competitors may, in the future, develop technologies that render our products obsolete or uneconomical.

Many of our current and potential competitors are publicly traded, or are divisions of publicly traded, major wound treatment or technology companies that enjoy several competitive advantages. We face a challenge overcoming the long-standing preferences of some specialists for using existing standard of care. Specialists who have completed many successful procedures using the standard of care may be reluctant to try new products from a source with which they are less familiar. If these specialists do not try and subsequently adopt our products and services, we may be unable to generate sufficient revenue or growth. In addition, many of our competitors enjoy other advantages such as:

• greater financial resources for marketing and the ability to offer aggressive discounting;

• large and established sales, marketing and distribution networks with greater reach in both domestic and international markets;

• significantly greater brand recognition;

• established business and financial relationships with specialists, referring physicians, hospitals and medical schools;

• greater existing market share in our product market;

• greater resources devoted to research and development of competing products and greater capacity to allocate additional resources;

• greater experience in obtaining and maintaining regulatory clearances and approvals for new products and product enhancements;

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• products supported by long-term clinical data;

• more expansive patent portfolios and other intellectual property rights; and

• broader product portfolios, affording them greater ability to cross-sell their products or to incentivize hospitals or surgeons to use their products.

As a result of this increased competition, we believe there will be increased pricing pressure in the future. The entry of multiple new products and competitors may lead some of our competitors to employ pricing strategies that could adversely affect the pricing of our products and pricing in our markets generally. Additionally, because we expect that potential hospital and other healthcare provider customers will bill various third-party payors to cover all or a portion of the costs and fees associated with the procedures in which our products will be used, including the cost of the purchase of our products, changes in the amount such payors are willing to reimburse our customers for procedures using our products could create pricing pressure for us. If competitive forces drive down the prices we are able to charge for our products, our profit margins will shrink, which will adversely affect our ability to invest in and grow our business.

Our competitors may seek to obtain agreements, exclusive or otherwise, with the same partners or licensees that we intend to approach in order to develop and market our product candidates. In addition, our competitors may be able to meet these requirements and develop products that are comparable or superior to our products or that could render our technology or products obsolete or non-competitive.

Our long-term growth depends on our ability to develop and commercialize additional products.

The chronic wound care and dental industries, as well as other markets we may enter, are highly competitive and subject to rapid change and technological advancements. Therefore, it is important to our business that we continue to enhance our product offerings. Even if we are successful in developing additional products, the success of any new product offering or enhancements to existing products will depend on several factors, including our ability to:

• properly identify and anticipate physician and patient needs;

• develop and introduce new products or product enhancements in a timely manner;

• develop an effective and dedicated sales and marketing team;

• avoid infringing upon the intellectual property rights of third parties;

• demonstrate, if required, the safety and efficacy of new products with data from pre-clinical studies and clinical trials;

• obtain the necessary regulatory clearances or approvals for new enhancements;

• be fully FDA-compliant with marketing of new products;

• provide adequate training to potential users of our product candidates; and

• receive adequate coverage and reimbursement for procedures performed with our product candidates.

If we are unsuccessful in developing and commercializing additional products in other areas, our ability to increase our revenue may be impaired.

New technologies, techniques or products could emerge that might offer better combinations of price and performance than the products and services that we plan to offer. Existing markets for wound treatment products and devices are characterized by rapid technological change and innovation. It is critical to our success that we anticipate changes in technology and customer requirements and physician, hospital, and healthcare provider practices. It is also important that we successfully introduce new, enhanced, and competitive products to meet our prospective customers’ needs on a timely and cost-effective basis. At the same time, however, we must carefully manage our introduction of new products. If potential customers believe that such products will offer enhanced features or be sold for a more attractive price, they may delay purchases until such products are available. We may also continue to

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offer older, obsolete products as we transition to new products, and we may not have sufficient experience managing product transitions. If we do not successfully innovate and introduce new technology into our anticipated product lines or successfully manage the transitions of our technology to new product offerings, our revenue, results of operations and business could be adversely impacted.

Our competitors may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, industry standards, distribution reach or customer requirements. We anticipate that we will face strong competition in the future as current or future competitors develop new or improved products and as new companies enter the market with novel technologies.

We must demonstrate to doctors, dentists, hygienists, clinicians, and hospitals the merits of our products to facilitate adoption of our products.

Doctors, dentists, hygienists, clinicians, and hospitals continue to play a significant role in determining the products and devices used in treatment of chronic wounds and in assisting in obtaining approval by the relevant value analysis committee (“VAC”). Educating doctors and dentists on the benefits of our products will require a significant commitment by our marketing team and sales organization. Doctors, dentists, hygienists, clinicians, and hospitals may be slow to change their practices because of familiarity with existing devices and/or treatments, perceived risks arising from the use of new devices or treatments, lack of experience using new devices or treatments, lack of clinical data supporting the benefits of such devices or treatments, or the cost of new devices or treatments. There may never be widespread adoption of our products by doctors, dentists and hospitals. If we are unable to educate doctors, dentists, hygienists, clinicians, and hospitals about the advantages of our products incorporating our technology, as compared to treatments and devices which do not incorporate such technology, we may face challenges in obtaining approval, and we will not achieve significantly greater market acceptance of our products, gain momentum in our sales activities, significantly grow our market share or grow our revenue, and our business and financial condition will be adversely affected.

Our current and future international operations could subject us to regulatory and legal risks and certain operating risks, which could adversely impact our business, results of operations and financial condition.

The sale and shipment of our products across international borders and the purchase of components from international sources subject us to U.S. and foreign governmental trade, import and export, and customs regulations and laws. Compliance with these regulations and laws is costly and could expose us to penalties for non-compliance. We expect that our international activities will be dynamic over the foreseeable future as we continue to engage in, identify and pursue opportunities in international markets. Our international business operations are subject to a variety of risks, including:

• fluctuations in foreign currency exchange rates;

• difficulties in staffing and managing foreign and geographically dispersed operations;

• third-party reimbursement policies that may require some of the patients who undergo procedures using our products or who use our services to directly absorb costs or that may necessitate the reduction of the selling prices of our products;

• an inability, or reduced ability, to protect our intellectual property, including any effect of compulsory licensing imposed by government action;

• economic, political or social instability in certain countries and regions;

• the imposition of additional U.S. and foreign governmental controls or regulations;

• changes in duties and tariffs, license obligations and other non-tariff barriers to trade;

• the imposition of costly and lengthy new export licensing requirements;

• the imposition of restrictions on the activities of foreign agents, representatives and distributors;

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• the occurrence of an FDA inspection that results in adverse findings at our facilities, or the facilities of our vendors or suppliers, and any resulting import detention that prevents products made in such facilities from entering the United States;

• scrutiny of foreign tax authorities, which could result in significant fines, penalties and additional taxes being imposed on us;

• availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us;

• imposition of differing labor laws and standards;

• the ability of a foreign government to exclude us from, or limit our ability to compete in, the markets under its jurisdiction through collective tender processes or otherwise;

• longer payment cycles for products sold to customers outside the United States;

• difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; and

• the imposition of U.S. or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibit continued business with the sanctioned country, company, person or entity.

We expect that each additional international market we enter will pose particular regulatory and other hurdles to overcome, and future developments in these markets, including the uncertainty relating to governmental policies and regulations, could harm our business. If we expend significant time and resources on expansion plans that fail or are delayed, our reputation, business and financial condition may be harmed.

We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.

We expect to expand our business operations to meet anticipated growth in demand for our products. This future growth could strain our organizational, administrative and operational infrastructure, including manufacturing operations, quality control, technical support and customer service, salesforce management and general and financial administration. Our ability to effectively manage our growth properly will require us to continue to improve our operational, financial and management controls, as well as our reporting systems and procedures.

As our commercial operations and sales volume grow, we will need to continue to increase our workflow capacity for manufacturing, customer service, billing and general process improvements and expand our internal quality assurance program, among other things. We will also need to purchase additional equipment, some of which can take several months or more to procure, set up and validate, and increase our manufacturing, maintenance, software and computing capacity to meet increased demand. These increases in scale, expansion of personnel, purchase of equipment or process enhancements may not be successfully implemented.

We must also successfully increase production output to meet expected customer demand. In the future, we may experience difficulties with production yields, quality control, component supply and shortages of qualified personnel, among other problems. These problems could result in delays in product availability and increases in expenses. Any such delay or increased expense could adversely affect our ability to generate revenues.

We have limited sales and marketing infrastructure and if we are unable to successfully secure sales and marketing partners or further develop a sales and marketing infrastructure, we may be unable to commercialize our products and product candidate, if approved, and may never generate sufficient revenue to achieve or sustain profitability.

In order to commercialize products that are approved by regulatory agencies, we must either collaborate with third parties that have such commercial infrastructure, engage third-party distributors, or further develop our own sales and marketing infrastructure. We have a limited sales and marketing team, and we may not be able to enter into collaborations on acceptable terms or at all, which would leave us unable to progress our business plan. We will face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for collaboration will depend upon, among other things, our assessment of the collaborator’s resources and expertise,

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the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to maintain or reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of our product candidates, reduce or delay development programs, delay potential commercialization of our product candidates or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

Moreover, even if we are able to maintain and/or enter into such collaborations, such collaborations may pose a number of risks, including the following:

• collaborators may not perform their obligations as expected;

• disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of our product candidates, might lead to additional responsibilities for us with respect to such devices, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

• collaborators could independently develop or be associated with products that compete directly or indirectly with our products;

• collaborators could have significant discretion in determining the efforts and resources that they will apply to our arrangements with them, and thus we may have limited or no control over the sales, marketing and distribution activities;

• a collaborator with marketing and distribution rights to our products may not commit sufficient resources to the marketing and distribution of such products;

• collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

• collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and

• collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to either find alternative collaborators (which we may be unable to do) or raise additional capital to pursue further development or commercialization of our products on our own.

Our business would be materially or perhaps significantly harmed if any of the foregoing or similar risks comes to pass with respect to our key collaborations.

If we elect to further develop or expand our sales and marketing infrastructure, we may not realize a positive return on this investment. We will have to compete with established and well-funded companies to recruit, hire, train and retain sales and marketing personnel. Once hired, the training process is lengthy because it requires significant education of new sales representatives to achieve the level of clinical competency with our products expected by specialists. Upon completion of the training, our sales representatives typically require lead time in the field to grow their network of accounts and achieve the productivity levels we expect them to reach in any individual territory. If we are unable to attract, motivate, develop and retain a sufficient number of qualified sales personnel, or if our sales representatives do not achieve the productivity levels in the time period we expect, our revenue will not grow at the rate we expect and our business, results of operations and financial condition will suffer. Additionally, to the extent we hire sales personnel from our competitors, we may be required to wait until applicable non-competition provisions have expired before deploying such personnel in restricted territories or incur costs to relocate personnel outside of such territories. In addition, we may, in the future, be subject to allegations that these new hires have been improperly solicited, or that they have divulged to us proprietary or other confidential information of their former employers. Any of these risks may adversely affect our ability to increase sales of our products. If we are unable to expand our sales and marketing capabilities, we may not be able to effectively commercialize our products, which would adversely affect our business, results of operations and financial condition.

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Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products and limit commercialization of any products that we may develop.

Our business exposes us to the risk of product liability claims that are inherent in the manufacturing, distribution, and sale of medical treatment methods. This risk exists even if a device is cleared or approved for commercial sale by the FDA and manufactured in facilities licensed and regulated by the FDA or an applicable foreign regulatory authority. Manufacturing and marketing of our products and clinical testing of our product candidates under development may expose us to product liability and other tort claims. Furthermore, physicians or dentists may misuse our products or use improper techniques if they are not adequately trained, potentially leading to injury and an increased risk of product liability. If our products are misused or used with improper technique, we may become subject to costly litigation by our customers or their patients. Regardless of the merit or eventual outcome, product liability claims may result in:

• significant litigation costs;

• distraction of management’s attention from our primary business operations;

• decreased demand for our products and any products that we may develop;

• damage to our reputation;

• withdrawal of clinical trial participants;

• substantial monetary awards to trial participants, patients or other claimants;

• loss of revenue; and

• the inability to commercialize any products that we may develop.

Although we intend to maintain liability insurance, the coverage limits of our insurance policies may not be adequate, and one or more successful claims brought against us may have a material adverse effect on our business and results of operations. If we are unable to obtain insurance in the future at an acceptable cost or on acceptable terms with adequate coverage, we will be exposed to significant liabilities.

We bear the risk of warranty claims on our products.

We provide limited product warranties against manufacturing defects of our products. Thus far, we have not accrued a significant liability contingency for potential warranty claims, due to the fact that we have had nominal warranty claims to date.

If we experience warranty claims in excess of our expectations, or if our replacement costs associated with warranty claims increase significantly, we will incur liabilities for potential warranty claims that may be greater than we expect. An increase in the frequency of warranty claims or amount of warranty costs may harm our reputation and could have a material adverse effect on our business, results of operations and financial condition.

The loss of our executive officers or our inability to attract and retain qualified personnel may adversely affect our business, financial conditions and results of operations.

Our business and operations depend to a significant degree on the skills, efforts and continued services of our executive officers who have critical industry experience and relationships. Although we have entered into employment agreements with our executive officers, they may terminate their employment with us at any time. Accordingly, these executive officers may not remain associated with us. The efforts of these persons will be critical to us as we continue to develop our products and business. We do not carry key person life insurance on any of our management, which would leave our company uncompensated for the loss of any of our executive officers.

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Our employees, consultants, independent sales agencies, distributors and other commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk that our employees, consultants, collaborators, distributors and other commercial partners may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless, or negligent conduct or other unauthorized activities that violate the regulations of the FDA and non-U.S. regulators, including those laws requiring the reporting of true, complete, and accurate information to such regulators, manufacturing standards, healthcare fraud and abuse laws and regulations in the United States and abroad or laws that require the true, complete, and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. It is not always possible to identify and deter misconduct by our employees, sales agencies, distributors and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations.

We may not be able to successfully complete any future acquisitions and any acquisitions, joint ventures or other investments may result in dilution of our shareholders’ ownership, increase our debt, or cause us to incur significant expense.

We may seek to grow our business through the acquisition of additional products, technologies, services or businesses that we believe have significant commercial potential. Growth through acquisitions will depend upon the continued availability of suitable acquisition candidates at favorable prices and on commercially acceptable terms and conditions. Even if these opportunities are present, we may be unable to successfully identify suitable acquisition candidates. In addition, we may not be able to successfully integrate any acquired companies or achieve the commercial potential or synergies projected for any acquisition. Future acquisitions may also divert management’s attention from other business activities. Further, any such acquisitions may result in the incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill, any of which could have a negative impact on our cash flows, financial condition, and results of operations.

Additionally, we may pursue strategic alliances and joint ventures that leverage our technology and industry experience. We may be unable to find suitable partners or, in the event we identify such a partner, we may be unable to realize the anticipated benefits of any such alliance or joint venture. To finance any such acquisitions, alliances, or joint ventures, we may choose to issue shares of capital stock as consideration, which could dilute the ownership of our shareholders. If the market price of our common stock is low or volatile, however, we may not be able to acquire other companies or fund a joint venture project using our stock as consideration.

If we experience significant disruptions in our information technology systems, our business may be adversely affected.

We depend on our information technology systems for the efficient functioning of our business, including accounting, data storage, compliance, purchasing and inventory management. We do not have redundant systems at this time. While we will attempt to mitigate interruptions, we may experience difficulties in implementing some upgrades, which would impact our business operations, or experience difficulties in operating our business during the upgrade, either of which could disrupt our operations, including our ability to timely ship and track product orders, project inventory requirements, manage our supply chain and otherwise adequately service our customers. In the event we experience significant disruptions as a result of the current implementation of our information

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technology systems, we may not be able to repair our systems in an efficient and timely manner. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse effect on our results of operations and cash flows.

We are increasingly dependent on sophisticated information technology for our infrastructure. Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance existing systems. Failure to maintain or protect our information systems and data integrity effectively could have a material adverse effect on our business. For example, third parties may attempt to hack into systems and may obtain our proprietary information.

The increasing use of social media platforms presents new risks and challenges.

Social media is increasingly being used to communicate about clinical development programs and we intend to utilize appropriate social media in connection with our commercialization efforts following approval of our product candidate, if any. Social media practices in the biomedical industry continue to evolve, and regulations and regulatory guidance relating to such use are evolving and not always clear. This evolution creates uncertainty and risk of non-compliance with regulations applicable to our business, resulting in potential regulatory actions against us, along with the potential for litigation related to off-label marketing or other prohibited activities and heightened scrutiny by the FDA, the SEC and other regulators. For example, patients may use social media channels to comment on their experience in an ongoing clinical trial or to report an alleged adverse event. If such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we may fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our product candidates. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us or the products we are marketing or developing on any social networking website. In addition, we may encounter attacks on social media regarding our company, management, product candidates or products. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions, or incur other harm to our business.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

As of December 31, 2021, we had available federal and state net operating loss carryforwards (“NOLs”) of approximately $6.8 million and $0.3 million, respectively, which begin to expire in the year ending December 31, 2028. In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” (generally defined as a cumulative change in equity ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period) may be subject to limitations on its ability to utilize its NOLs and certain credit carryforwards to offset future taxable income and taxes. Under legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act (the “TCJA”) as modified in 2020 by the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), unused U.S. federal NOLs generated in tax years beginning after December 31, 2017, will not expire and may be carried forward indefinitely, but the deductibility of such federal NOLs in taxable years beginning after December 31, 2020, is limited to 80% of taxable income. It is uncertain if and to what extent various states will conform to the TCJA or the CARES Act. Future changes in our stock ownership, including this or future offerings, as well as other changes that may be outside of our control, could result in ownership changes. Our NOLs may also be limited under similar provisions of state law. We have recorded a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future tax benefits of such assets.

Risks Related to Regulatory Approval and Other Governmental Regulations

Our business, products and product candidates are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business.

Our products and operations are subject to extensive regulation in the United States by the FDA and by regulatory agencies in other countries where we anticipate conducting business activities. The FDA regulates the development, testing, manufacturing, labeling, storage, record-keeping, promotion, marketing, sales, distribution and post-market support and reporting of medical devices in the United States. The regulations to which we are subject are complex and may become more stringent over time. Regulatory changes could result in restrictions on our ability to carry out or expand our operations, higher than anticipated costs or lower than anticipated sales.

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In order to conduct a clinical investigation involving human subjects for the purpose of demonstrating the safety and effectiveness of a medical device, a company must, among other things, apply for and obtain Institutional Review Board (“IRB”) approval of the proposed investigation. In addition, if the clinical study involves a “significant risk” (as defined by the FDA) to human health, the sponsor of the investigation must also submit and obtain FDA approval of an Investigational Device Exemption (“IDE”) application. Our REVITY product is a device requiring IDE approval prior to investigational use. We may not be able to obtain FDA or IRB approval to undertake clinical trials in the U.S. for any new products we intend to market in the United States in the future. If we obtain such approvals, we may not be able to conduct studies which comply with the IDE and other regulations governing clinical investigations, or the data from any such trials may not support clearance or approval of the investigational device. Failure to obtain such approvals or to comply with such regulations could have a material adverse effect on our business, financial condition, and results of operations. It is uncertain whether clinical trials will meet desired endpoints, produce meaningful or useful data and be free of unexpected adverse effects, or that the FDA will accept the validity of foreign clinical study data, and such uncertainty could preclude or delay market clearance or authorizations resulting in significant financial costs and reduced revenue.

Our products may also be subject to extensive governmental regulation in foreign jurisdictions, such as Europe and Asia, and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.

In the European Union, we are required to comply with applicable medical device directives, including the Medical Devices Directive, and obtain a CE mark in order to market medical device products. The CE mark is applied following approval from an independent notified body or declaration of conformity. As is the case in the United States, the process of obtaining marketing approval or clearance from comparable agencies in foreign countries for new products, or with respect to enhancements or modifications to existing products, could:

• take a significant period of time;

• require the expenditure of substantial resources;

• involve rigorous pre-clinical and clinical testing;

• require extensive post-marketing surveillance;

• require changes to products; and

• result in limitations on the indicated uses of products.

In addition, exported products are subject to the regulatory requirements of each country to which the product is exported. Most foreign countries possess medical devices regulations and require that they be applied to medical products and devices before they can be commercialized. There can be no assurance that we will receive the required approvals for our products on a timely basis or that any approval will not be subsequently withdrawn or conditioned upon extensive post-market study requirements.

Our global regulatory environment is becoming increasingly stringent and unpredictable, which could increase the time, cost and complexity of obtaining marketing authorization for our products, as well as the clinical and regulatory costs of supporting those approvals. Several countries that did not previously have regulatory requirements for medical devices have established such requirements in recent years and other countries have expanded existing regulations. Certain regulators are exhibiting less flexibility by requiring, for example, the collection of local pre-clinical and/or clinical data prior to approval. While harmonization of global regulations has been pursued, requirements continue to differ significantly among countries. We expect the global regulatory environment to continue to evolve, which could impact our ability to obtain future approvals for our products and increase the cost and time to obtain such approvals. By way of example, the European Union regulatory bodies recently finalized a new Medical Device Regulation (“MDR”). The MDR changes several aspects of the existing regulatory framework, such as clinical data requirements, and introduces new ones, such as Unique Device Identification.

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If we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products or product candidates, our products or product candidates could be subject to restrictions or withdrawal from the market.

The manufacturing processes, post-approval clinical data and promotional activities of any product for which we obtain or have obtained marketing approval will be subject to continual review and periodic inspections by the FDA and other regulatory bodies. Even if regulatory approval of our product candidates is granted in the United States, the approval may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor the safety or effectiveness of the product. Later discovery of previously unknown and unanticipated problems with our products, including but not limited to unanticipated severity or frequency of adverse events, delays or problems with the manufacturer or manufacturing processes, or failure to comply with regulatory requirements, may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties.

Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products or to produce, market, or distribute our products after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in the legislative bodies of the countries in which we sell our products to revise the process for regulatory approval, clearance, authorization, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA, European Economic Area (“EEA”) and other applicable foreign regulations and guidance are often revised or reinterpreted by the applicable competent authority in ways that may significantly affect our business and our products. For example, the MDR may impose increased compliance obligations for us to access EEA member State markets. These modifications may have an effect on the way we conduct our business in the EEA member States and these modifications may have an impact on the way we design and manufacture products and the way we conduct our business in the EEA member States, which could adversely affect our business, financial condition and results of operations.

As another example, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more difficult to obtain clearance for, manufacture, market, or distribute our products. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require additional testing prior to obtaining clearance; changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional recordkeeping.

In addition, regulatory authorities’ policies may change, and additional laws or regulations may be enacted or promulgated that could prevent, limit or delay marketing authorizations for our products. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing authorizations that we may have obtained and we may not achieve or sustain profitability.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products or limit our ability to sell to our customers. It is impossible to predict whether legislative changes will be enacted or if regulations, guidance or interpretations will change and what the impact of such changes, if any, may be. Such changes could require, among other things:

• additional testing prior to obtaining clearance or approval;

• changes to manufacturing methods;

• recall, replacement or discontinuance of our systems or current or future products; or

• additional record-keeping.

Any of these changes could require substantial time and cost and could harm our business and our financial results.

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Our products may in the future be subject to recalls or market withdrawals that could harm our business, financial condition, and results of operations.

Manufacturers may, on their own initiative, initiate actions, including a non-reportable market withdrawal or a reportable product recall, for the purpose of correcting a material deficiency, improving device performance or other reasons. Additionally, the FDA and similar foreign governmental authorities have the authority to require the recall of commercialized devices in the event of material deficiencies or defects in the design, manufacture or labeling, in the event that a product poses an unacceptable risk to health. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious adverse health consequences or death. Manufacturers may, under their own initiative, conduct a device notification to inform surgeons of changes to instructions for use or of a deficiency, or of a suspected deficiency, found in a device. A government-mandated recall or voluntary recall by us or one of our distributors could occur as a result of manufacturing errors, design or labeling defects or other issues. Recalls, which include certain notifications and corrections as well as removals, of any of our products, could divert managerial and financial resources and could have an adverse effect on our financial condition, harm our reputation with customers and reduce our ability to achieve expected revenues.

Further, under the MDR regulations, we are required to report to the FDA any incident in which our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Any adverse event involving our products could result in future voluntary corrective actions, such as product actions or customer notifications, or regulatory authority actions, such as inspection, mandatory recall, or other enforcement action. Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition, and operating results.

Moreover, depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new approvals or clearances for the device before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace products in a timely manner. Moreover, if we do not adequately address problems associated with our product candidates, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties, withdrawals or clearances or approvals or civil or criminal fines. We may also be required to bear other costs or take other actions that may have a negative impact on our sales as well as face significant adverse publicity or regulatory consequences, which could harm our business, including our ability to market our products in the future.

We are required to report certain malfunctions, deaths and serious injuries associated with our products and product candidates, which can result in voluntary corrective actions or agency enforcement actions.

Under MDR regulations, medical device manufacturers are required to submit information to the FDA when they become aware of information that reasonably suggests a device may have caused or contributed to a death or serious injury or has malfunctioned, and, upon recurrence, the malfunction would likely cause or contribute to death or serious injury. If we determine that an MDR report is not required to be submitted for an event, and the FDA disagrees with that determination, it could take enforcement action against us for failing to report the event. All manufacturers marketing medical devices in the EEA are legally bound to report incidents involving devices they produce or sell to the regulatory agency, or competent authority, in whose jurisdiction the incident occurred. Under the EU Medical Devices Directive (Directive 93/42/EEC), an incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.

Malfunction or misuse of our products could result in future voluntary corrective actions, such as recalls, including corrections (e.g., customer notifications), or agency action, such as inspection or enforcement actions. If malfunctions or misuse do occur, we may be unable to correct the malfunctions adequately or prevent further malfunctions or misuse, in which case we may need to cease manufacture and distribution of the affected products, initiate voluntary recalls, and redesign the products or the instructions for use for those products. Regulatory authorities may also take actions against us, such as ordering recalls, imposing fines, or seizing the affected products. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, may distract management from operating our business, and may harm our business, financial condition, and results of operations.

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The potential misuse or off-label promotion of our products may harm our reputation in the marketplace, result in injuries that lead to product liability litigation or result in costly investigations and sanctions by regulatory bodies.

If our products are cleared by the FDA and CE Marked in the EEA for specific indications, we may only promote or market our products for their specifically cleared or approved indications. We will train our marketing and salesforce against promoting our future products for uses outside of the cleared or approved indications for use, known as “off-label uses.”

If the FDA determines that our promotional materials or training constitute promotion of unsupported claims or an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations. Any of these events could significantly harm our business, financial condition, and results of operations.

Further, the contemplated advertising and promotion of our products will be subject to EEA Member States laws implementing Directive 93/42/EEC concerning Medical Devices, or the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State legislation governing the advertising and promotion of medical devices. EEA Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. In addition, voluntary EU and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals harming our business, results of operations and financial condition.

We are subject to federal, state, and foreign healthcare laws and regulations, and a finding of failure to comply with such laws and regulations could have a material adverse effect on our business.

Our operations are, and will continue to be, directly and indirectly affected by various federal, state, or foreign healthcare laws, including, but not limited to, those described below. These laws include:

• the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Violations of the federal Anti-kickback Statute may result in substantial civil or criminal penalties, including criminal fines of up to $25,000, imprisonment of up to five years, civil penalties under the Civil Monetary Penalties Law of up to $50,000 for each violation, plus three times the remuneration involved, civil penalties under the federal False Claims Act of up to $11,000 for each claim submitted, plus three times the amounts paid for such claims and exclusion from participation in the Medicare and Medicaid programs;

• the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the False Claims Act, the government may impose penalties of not less than $5,500 and not more than $11,000, plus three times the amount of the damages that the government sustains due to the submission of a false claim and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

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• the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

• The Health Insurance Portability and Accountability Act of 1966 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”) and their respective implementing regulations, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information. Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $50,000 per violation, not to exceed $1.5 million per calendar year for non-compliance of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment. State attorneys general can bring a civil action to enjoin a HIPAA violation or to obtain statutory damages up to $25,000 per violation on behalf of residents of his or her state. HIPAA also imposes criminal penalties for fraud against any healthcare benefit program and for obtaining money or property from a healthcare benefit program through false pretenses and provides for broad prosecutorial subpoena authority and authorizes certain property forfeiture upon conviction of a federal healthcare offense. Significantly, the HIPAA provisions apply not only to federal programs, but also to private health benefit programs. HIPAA also broadened the authority of the U.S. Office of Inspector General of the U.S. Department of Health and Human Services to exclude participants from federal healthcare programs;

• the federal physician Sunshine Act requirements under the Patient Protection and Affordable Care Act, which require certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers and teaching hospitals and ownership and investment interests held by physicians and their immediate family members. Manufacturers are required to submit reports to CMS by the 90th day of each calendar year. Failure to submit the required information may result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing failures”) for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations; and

• analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Any failure by us to ensure that our employees and agents comply with applicable state and foreign laws and regulations could result in substantial penalties or restrictions on our ability to conduct business in those jurisdictions, and our results of operations and financial condition could be materially and adversely affected.

The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of our business activities, including our relationships with surgeons and other healthcare providers, some of whom recommend, purchase and/or prescribe our products, and our distributors, could be subject to challenge under one or more of such laws.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and

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our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

Many of our customers and potential customers are required to comply with the federal HIPAA, the HITECH Act and implementing regulation affecting the transmission, security and privacy of health information, and failure to comply could result in significant penalties.

Numerous federal and state laws and regulations, including HIPAA and HITECH Act, govern the collection, dissemination, security, use and confidentiality of health information that identifies specific patients. HIPAA and the HITECH Act require our physician and hospital customers and potential customers to comply with certain standards for the use and disclosure of health information within their companies and with third parties. The Privacy Standards and Security Standards under HIPAA establish a set of standards for the protection of individually identifiable health information by health plans, health care clearinghouses and certain health care providers, referred to as Covered Entities, and the business associates with whom Covered Entities enter into service relationships pursuant to which individually identifiable health information may be exchanged. Notably, whereas HIPAA previously directly regulated only these Covered Entities, the HITECH Act makes certain of HIPAA’s privacy and security standards also directly applicable to Covered Entities’ business associates. As a result, both Covered Entities and business associates are now subject to significant civil and criminal penalties for failure to comply with Privacy Standards and Security Standards.

HIPAA requires Covered Entities (like many of our customers and potential customers) and business associates to develop and maintain policies and procedures with respect to protected health information that is used or disclosed, including the adoption of administrative, physical and technical safeguards to protect such information. The HITECH Act expands the notification requirement for breaches of patient-identifiable health information, restricts certain disclosures and sales of patient-identifiable health information and provides for civil monetary penalties for HIPAA violations. The HITECH Act also increased the civil and criminal penalties that may be imposed against Covered Entities and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek recovery of attorney fees and costs associated with pursuing federal civil actions. Additionally, certain states have adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA.

Any new legislation or regulation in the area of privacy and security of personal information, including personal health information, could also adversely affect our business operations. If we do not comply with existing or new applicable federal or state laws and regulations related to patient health information, we could be subject to criminal or civil sanctions and any resulting liability could adversely affect our financial condition.

In addition, countries around the world have passed, or are considering legislation that would impose, data breach notification requirements and/or require that companies adopt specific data security requirements. If we experience a data breach that triggers one or more of these laws, we may be subject to breach notification obligations, civil liability, and litigation, all of which could also generate negative publicity and have a negative impact on our business.

We could be negatively impacted by violations of global anti-bribery laws, including the U.S. Foreign Corrupt Practices Act.

Certain anti-bribery laws, including the U.S. Foreign Corrupt Practices Act (“FCPA”) or the UK Bribery Act of 2010, prohibit covered entities from offering, promising, authorizing or giving anything of value, directly or indirectly, to foreign officials or other commercial parties with the intent to influence the recipient’s act or decision, to induce action or inaction in violation of lawful duty, or for the purpose of improperly obtaining or retaining business or other advantages. In addition, the FCPA imposes record-keeping and internal controls requirements on publicly traded corporations and their foreign affiliates. As we expect to generate substantial revenue from countries outside the United States, we are subject to the risk that we, our employees, or any third parties such as sales agents and distributors acting on our behalf in foreign countries may take action determined to be in violation of applicable anti-corruption laws, including the FCPA. Any violations of these laws, or even allegations of such violations, can lead to an investigation, which could disrupt our operations, involve significant management distraction, lead to significant costs and expenses, including legal fees, and could result in a material adverse effect on our business,

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prospects, financial condition, or results of operations. We could also suffer severe penalties, including criminal and civil penalties, disgorgement, and other costly remedial measures. Likewise, any investigation of any potential violations of these laws by respective government bodies could also have an adverse impact on our reputation, our business, financial condition, and results of operations.

Although we intend to implement a program designed to ensure our employees and distributors comply with the FCPA and other anti-bribery laws, this program may not prevent all potential violations of the FCPA and other anti-corruption laws. Similarly, our books and records and internal control policies and procedures do not guarantee that we will, in all instances, comply with the accounting provisions of the FCPA.

Our relationships with physician consultants, owners and investors could be subject to additional scrutiny from regulatory enforcement authorities and could subject us to possible administrative, civil, or criminal sanctions.

Federal and state laws and regulations impose restrictions on our relationships with physicians who are consultants, owners, or investors. We have entered into, and intend to enter into, consulting agreements, license agreements and other agreements with physicians in which we provide cash as compensation. We have other written and oral arrangements with physicians, including for research and development grants and for other purposes as well.

We could be adversely affected if regulatory agencies were to interpret our financial relationships with these physicians, who may be in a position to influence the ordering of and use of our products for which governmental reimbursement may be available, as being in violation of applicable laws. If our relationships with physicians are found to be in violation of the laws and regulations that apply to us, we may be required to restructure the arrangements and could be subject to administrative, civil, and criminal penalties, including exclusion from participation in government healthcare programs, imprisonment, and the curtailment or restructuring of our operations, any of which could negatively impact our ability to operate our business and our results of operations.

Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets.

There have been and continue to be proposals by the federal government, state governments, regulators, and third-party payors to control or manage the increased costs of healthcare and, more generally, to reform the U.S. healthcare system. Certain of these proposals could limit the prices we are able to charge for our products or the coverage and reimbursement available for our products and could limit the acceptance and availability of our products. The adoption of proposals to control costs could have a material adverse effect on our business, financial condition, and results of operations.

There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future or their full impact. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may harm:

• our ability to set a price that we believe is fair for our products;

• our ability to generate revenue and achieve or maintain profitability; and

• the availability of capital.

Further, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal legislation designed to bring transparency to product pricing and reduce the cost of products and services under government healthcare programs. While some of these measures may require additional authorization to become effective, Congress has indicated that it will continue to seek new legislative and/or administrative measures to control product costs. Additionally, individual states in the United States have also increasingly passed legislation and implemented regulations designed to control product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. Moreover, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what products to purchase and which suppliers will be included in their healthcare programs. Adoption of price controls and other cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures may prevent or limit our ability to generate revenue and attain profitability.

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Various new healthcare reform proposals are emerging at the federal and state level. It is also possible that additional governmental action is taken to address the COVID-19 pandemic. Any new federal and state healthcare initiatives that may be adopted could limit the amounts that federal and state governments will pay for healthcare products and services and could have a material adverse effect on our business, financial condition and results of operations.

Our business involves the use of hazardous materials and we and our current or future third-party manufacturers must comply with environmental laws and regulations, which may be expensive and restrict how we do business.

Our activities involve the controlled storage, use and disposal of hazardous materials. We and our manufacturers are subject to federal, state, local and foreign laws and regulations governing the use, generation, manufacture, storage, handling, and disposal of these hazardous materials. We currently carry no insurance specifically covering environmental claims relating to the use of hazardous materials. Although we believe that our safety procedures for handling and disposing of these materials and waste products comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental injury or contamination from the use, storage, handling, or disposal of hazardous materials. In the event of an accident, state or federal or other applicable authorities may curtail our use of these materials and interrupt our business operations. In addition, if an accident or environmental discharge occurs, or if we discover contamination caused by prior operations, including by prior owners and operators of properties we acquire, we could be liable for clean-up obligations, damages, and fines. If such unexpected costs are substantial, this could significantly harm our financial condition and results of operations.

Regulations related to “conflict minerals” may force us to incur additional expenses, may make our supply chain more complex and may result in damage to our reputation with customers.

The Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) required the SEC to establish new disclosure and reporting requirements for those companies that use certain minerals and metals mined in the Democratic Republic of Congo and adjoining countries, known as conflict minerals, in their products, whether or not these products or the components containing such conflict minerals are manufactured by third parties. Currently, none of our products or product candidates contain any such conflict minerals and, although it is unlikely that any of our future products will contain any such conflict minerals, it is possible that in the future we may be required to include and make use of conflict minerals in connection one or more of our products. This rule may affect sourcing at competitive prices and availability in sufficient quantities of certain minerals used in the manufacture of our products. The number of suppliers who provide conflict-free minerals may be limited. In addition, there may be material costs associated with complying with the disclosure requirements, such as costs related to determining the source of certain minerals used in our products, as well as costs of possible changes to products, processes, or sources of supply as a consequence of such verification activities. Since our supply chain is complex, we may not be able to verify the origins for these minerals used in our products sufficiently through the due diligence procedures that we implement, which may prevent us from certifying our products as conflict-free, harming our reputation. In addition, we may encounter challenges to satisfy those customers who require that all of the components of our products be certified as conflict-free, which could place us at a competitive disadvantage if we are unable to do so.

Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers such as us from certain markets, which could have an adverse effect on our business, results of operations or financial condition.

Because healthcare costs have risen significantly, numerous initiatives and reforms initiated by legislators, regulators, and third-party payors to curb these costs have resulted in a consolidation trend in the healthcare industry to aggregate purchasing power. As the healthcare industry consolidates, competition to provide products and services to industry participants has become and will continue to become more intense. This in turn has resulted and will likely continue to result in greater pricing pressures and the exclusion of certain suppliers, including us, from important market segments as group purchasing organizations (GPOs), independent delivery networks and large single accounts continue to use their market power to consolidate purchasing decisions for hospitals. We expect that market demand, government regulation, third-party coverage and reimbursement policies and societal pressures

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will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers, which may reduce competition, exert further downward pressure on the prices of our products and may adversely impact our business, financial condition, or results of operations.

If coverage and reimbursement from third-party payors for procedures using our products significantly decline, physicians, hospitals and other healthcare providers may be reluctant to use our product candidates and our sales may decline.

In the United States, healthcare providers who may purchase our products or product candidates, if approved, will generally rely on third-party payors, principally Medicare, Medicaid and private health insurance plans, to pay for all or a portion of the cost of our products and product candidates in the procedures in which they are employed. Further, any decline in the amount payors are willing to reimburse our customers for the procedures using our products and product candidates may make it difficult for existing customers to continue using, or adopt, our products and could create additional pricing pressure for us. We may be unable to sell our product candidates, if approved, on a profitable basis if third-party payors deny coverage or reduce their current levels of reimbursement.

To contain costs of new technologies, governmental healthcare programs and third-party payors are increasingly scrutinizing new and even existing treatments by requiring extensive evidence of favorable clinical outcomes. Physicians, hospitals, and other healthcare providers may not purchase our product candidates if they do not receive satisfactory reimbursement from these third-party payors for the cost of the procedures using our product candidates.

Moreover, some healthcare providers in the United States have adopted or are considering a managed care system in which the providers contract to provide comprehensive healthcare for a fixed cost per person. Healthcare providers may attempt to control costs by authorizing fewer surgical procedures or by requiring the use of the least expensive devices available. Additionally, as a result of reform of the U.S. healthcare system, changes in reimbursement policies or healthcare cost containment initiatives may limit or restrict coverage and reimbursement for our product candidates and cause our revenue to decline.

We are currently, and in the future our contract manufacturers may be, subject to various governmental regulations related to the manufacturing of our products and product candidates, and we may incur significant expenses to comply with, experience delays in our product commercialization as a result of, and be subject to material sanctions if we or our contract manufacturers violate these regulations.

Our manufacturing processes and facility are required to comply with the FDA’s Quality System Regulation (“QSR”), which covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of our product candidates. Although we believe we are compliant with the QSR, the FDA enforces the QSR through periodic announced or unannounced inspections of manufacturing facilities. We have been, and anticipate in the future being, subject to such inspections, as well as to inspections by other federal and state regulatory agencies. We are required to register our manufacturing facility with the FDA and list all devices that are manufactured. We also operate an International Organization for Standards (“ISO”) 13485 certified facility, and annual audits are required to maintain that certification. The suppliers of our components are also required to comply with the QSR and are subject to inspections. We have limited ability to ensure that any such third-party manufacturers will take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of our products. Failure to comply with applicable FDA requirements, or later discovery of previously unknown problems with our products or manufacturing processes, including our failure or the failure of one of our third-party manufacturers to take satisfactory corrective action in response to an adverse QSR inspection, can result in, among other things:

• administrative or judicially imposed sanctions;

• injunctions or the imposition of civil penalties;

• recall or seizure of our products;

• total or partial suspension of production or distribution;

• the FDA’s refusal to grant future clearance or pre-market approval for our products;

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• withdrawal or suspension of marketing clearances or approvals;

• clinical holds;

• warning letters;

• refusal to permit the import or export of our products; and

• criminal prosecution of us or our employees.

Any of these actions, in combination or alone, could prevent us from marketing, distributing, or selling our products and would likely harm our business. In addition, a product defect or regulatory violation could lead to a government-mandated or voluntary recall by us. Regulatory agencies in other countries have similar authority to recall devices because of material deficiencies or defects in design or manufacture that could endanger health. Any recall would divert management attention and financial resources, could expose us to product liability or other claims, including contractual claims from parties to whom we sold products, and harm our reputation with customers. A recall involving any of our products would be particularly harmful to our business and financial results and, even if we remedied a particular problem, may have a lasting negative effect on our reputation and demand for our products.

Risks Related to Our Intellectual Property

If we are unable to adequately protect our proprietary technology or maintain issued patents that are sufficient to protect our products and product candidates, others could compete against us more directly, which could harm our business, financial condition, and results of operations.

Our success will be heavily dependent on our ability to obtain and maintain meaningful patent protection for our technologies and products throughout the world. Patent law relating to the scope of claims in the technology fields in which we will operate is still evolving. The amount of ongoing protection for our proprietary rights therefore is uncertain. We will rely on patents to protect a significant part of our intellectual property and to enhance our competitive position. However, our presently pending or future patent applications may be denied, and any patent previously issued to us may be challenged, invalidated, held unenforceable, or circumvented. Furthermore, the patent protections we have been granted may not be broad enough to prevent competitors from producing products similar to ours. In addition, the laws of various foreign countries in which we may compete, such as China, may not protect our intellectual property to the same extent as do the laws of the United States. If we fail to obtain adequate patent protection for our proprietary technology, our ability to be commercially competitive will be materially impaired.

In the ordinary course of business and as appropriate, we intend to apply for additional patents covering both our technologies and products, as we deem appropriate. Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from developing competing products and technologies. In addition, because patent law is evolving in the medical device industry, the patent positions of companies like ours are uncertain. As a result, the validity and enforceability of our patents cannot be predicted with certainty.

Our patents may not have, or our pending patent applications that mature into issued patents may not include, claims with a scope sufficient to protect our products, any additional features we develop for our current products, or any new products. Other parties may have developed technologies that may be related or competitive to our products, may have filed or may file patent applications and may have received or may receive patents that overlap or conflict with our patent applications, either by claiming the same methods or devices or by claiming subject matter that could dominate our patent position. The patent positions of companies like ours, including our patent position, may involve complex legal and factual questions, and, therefore, the scope, validity and enforceability of any patent claims that we may obtain cannot be predicted with certainty. Patents, if issued, may be challenged, deemed unenforceable, invalidated or circumvented. Proceedings challenging our patents could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application. In addition, such proceedings may be costly. Thus, any patents that we may own may not provide any protection against competitors. Furthermore, an adverse decision in an interference proceeding can result in a third party receiving the patent right sought by us, which in turn could affect our ability to commercialize our products.

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Furthermore, though an issued patent is presumed valid and enforceable, its issuance is not conclusive as to its validity or its enforceability and it may not provide us with adequate proprietary protection or competitive advantages against competitors with similar products. Competitors may also be able to design around our patents. Other parties may develop and obtain patent protection for more effective technologies, designs, or methods. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, suppliers, vendors, former employees, and current employees. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the United States, and we may encounter significant problems in protecting our proprietary rights in these countries. If any of these developments were to occur, they each could have a negative impact on our business and competitive position.

Our ability to enforce our patent rights depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the components that are used in their products. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded if we were to prevail may not be commercially meaningful.

In addition, proceedings to enforce or defend our patents could put our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Such proceedings could also provoke third parties to assert claims against us, including that some or all of the claims in one or more of our patents are invalid or otherwise unenforceable. If any of our patents covering our products are invalidated or found unenforceable, our financial position and results of operations could be negatively impacted. In addition, if a court found that valid, enforceable patents held by third parties covered one or more of our products, our financial position and results of operations could be harmed.

We rely upon unpatented trade secrets, unpatented know-how and continuing technological innovation to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our employees and our collaborators and consultants. We also have agreements with our employees and selected consultants that obligate them to assign their inventions to us and have non-compete agreements with some, but not all, of our consultants. It is possible that technology relevant to our business will be independently developed by a person that is not a party to such an agreement. Furthermore, if the employees and consultants who are parties to these agreements breach or violate the terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets through such breaches or violations. Further, our trade secrets could otherwise become known or be independently discovered by our competitors.

Obtaining and maintaining our patent protection depends on compliance with various procedures, document submission requirements, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The U.S. Patent and Trademark Office (“USPTO”), and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payments such as maintenance and annuity fee payments and other provisions during the patent procurement process as well as over the life span of an issued patent. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.

The lives of our patents may not be sufficient to effectively protect our products and business.

Patents have a limited life span. In the United States and most foreign jurisdictions, the natural expiration of a patent is generally 20 years after its first effective filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from other dental and wound care product manufacturers. Our issued patents will expire on dates ranging from 2024 to 2035, subject to any patent extensions that may be available for such patents. In addition, although upon issuance in the United States a patent’s life can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected.

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Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

We employ individuals who previously worked with other companies, including potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third party. Litigation may be necessary to defend against these claims. If we fail in defending any such claims or settling those claims, in addition to paying monetary damages or a settlement payment, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and/or be a distraction to management and other employees.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.

Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. Our business, products and methods could infringe the patents or other intellectual property rights of third parties.

The medical device industry is characterized by frequent and extensive litigation regarding patents and other intellectual property rights. Many medical device companies with substantially greater resources than us have employed intellectual property litigation as a way to gain a competitive advantage. We may become involved in litigation, interference proceedings, oppositions, reexamination, protest, or other potentially adverse intellectual property proceedings as a result of alleged infringement by us of the rights of others or as a result of priority of invention disputes with third parties, either in the U.S. or abroad. We may also become a party to patent infringement claims and litigation or interference proceedings declared by the USPTO to determine the priority of inventions. Third parties may also challenge the validity of any of our issued patents, and we may initiate proceedings to enforce our patent rights and prevent others from infringing on our intellectual property rights. Any claims relating to the infringement of third-party proprietary rights or proprietary determinations, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, diversion of our management’s attention and resources, or entrance into royalty or license agreements that are not advantageous to us. In any of these circumstances, we may need to spend significant amounts of money, time and effort defending our position. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the intellectual property rights of others, we may be required to seek a license, defend an infringement action, challenge the validity of intellectual property in court, or redesign our products.

We may not be able to adequately protect our intellectual property rights throughout the world.

The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. This could make it difficult for us to stop infringement of our foreign patents, if obtained, or the misappropriation of our other intellectual property rights. For example, some foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition, some countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business. Accordingly, our efforts to protect our intellectual property

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rights in such countries may be inadequate. In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our technology and the enforcement of our intellectual property.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks or names. We may not be able to protect our rights in these trademarks and trade names, which we need in order to build name recognition with potential customers in our markets of interest. In addition, third parties may register trademarks similar and identical to our trademarks in foreign jurisdictions and may in the future file for registration of such trademarks. If they succeed in registering or developing common law rights in such trademarks, and if we were not successful in challenging such third-party rights, we may not be able to use these trademarks to market our products in those countries. In any case, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business, results of operations and financial condition may be adversely affected.

Risks Related to this Offering and Ownership of Our Securities

The market price of our securities may be highly volatile, and you could lose all or part of your investment.

Prior to this offering, there was no public market for shares of our common stock or the Warrants. The offering price for the securities sold in this offering will be determined by negotiation between the underwriters and us. This price may not reflect the market price of our common stock or the Warrants following this offering. As a result, the trading prices of our common stock and Warrants are likely to be volatile, which may prevent you from being able to sell your shares of common stock or Warrants at or above the public offering price. Our securities could be subject to wide fluctuations in response to a variety of factors, which include:

• whether we achieve our anticipated corporate objectives;

• actual or anticipated fluctuations in our financial condition and operating results;

• changes in financial or operational estimates or projections;

• the development status of our product candidates and when our products receive regulatory approval;

• our execution of our sales and marketing, manufacturing, and other aspects of our business plan;

• performance of third parties on whom we rely to manufacture our products, product components and product candidates, including their ability to comply with regulatory requirements;

• the results of our clinical studies and clinical trials;

• results of operations that vary from those of our competitors and the expectations of securities analysts and investors;

• changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;

• our announcement of significant contracts, acquisitions or capital commitments;

• announcements by our competitors of competing products or other initiatives;

• announcements by third parties of significant claims or proceedings against us;

• regulatory and reimbursement developments in the United States and abroad;

• future sales of our common stock;

• product liability claims;

• healthcare reform measures in the United States;

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• additions or departures of key personnel; and

• general economic or political conditions in the United States or elsewhere.

In addition, the stock market in general, and the stock of medical technology companies like ours, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the issuer. Such broad market and industry factors may negatively affect the market price of our common stock and Warrants, regardless of our actual operating performance.

We may be subject to securities litigation, which is expensive and could divert our management’s attention.

The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.

We have broad discretion in the use of the net proceeds from this offering and may invest or spend the proceeds in ways with which you disagree or that may not yield a return.

While we set forth our anticipated use for the net proceeds from this offering in the section titled “Use of Proceeds,” our management will have broad discretion on how to use and spend any proceeds that we receive from this offering and may use the proceeds in ways that differ from the anticipated uses set forth in this prospectus. Investors in this offering will need to rely upon the judgment of our management with respect to the use of proceeds, with only limited information concerning management’s specific intentions. It is possible that we may decide in the future not to use the proceeds of this offering in the manner described in this offering. Our management may spend a portion or all of the net proceeds from this offering in ways that holders of our common stock may not desire or that may not yield a significant return or any return at all. Investors will receive no notice or vote regarding any such change and may not agree with our decision on how to use such proceeds. If we fail to utilize the proceeds we receive from this offering effectively, our business and financial condition could be harmed, and we may need to seek additional financing sooner than expected. Pending their use, we may also invest the net proceeds from this offering in a manner that does not produce income or that loses value.

There is no existing market for our securities, and we do not know if one will develop to provide you with adequate liquidity.

Prior to this offering, there has not been a public market for our securities. Although we have applied to have our common stock and the Warrants listed on Nasdaq, an active trading market for our common stock or Warrants may never develop or be sustained following this offering. You may not be able to sell your shares of common stock or Warrants quickly or at the market price if trading in our common stock or Warrants is not active. The initial public offering price for the Units will be determined by negotiations between us and the underwriters and may not be indicative of prices that will prevail for our shares of common stock and the Warrants in the trading market. You may not be able to sell your shares of our common stock or Warrants at or above the price you paid in the offering. As a result, you could lose all or part of your investment. Further, an inactive market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using our shares of common stock as consideration.

Our principal shareholders and management own a significant percentage of our capital stock and will be able to exert a controlling influence over our business affairs and matters submitted to shareholders for approval.

After this offering, and assuming a public offering price of $5.25 per Unit, which is the midpoint of the range set forth on the cover page of this prospectus, and also assuming the it is anticipated that our officers and directors, together with holders of 5% or more of our outstanding common stock before this offering and their respective affiliates, will beneficially own or control 6,232,136 shares of our common stock, which in the aggregate will represent approximately 37.07% of the outstanding shares of our common stock, or approximately 35.70% if the underwriters’ over-allotment option to purchase additional shares is exercised in full. As a result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted to our shareholders for approval, including the election and removal of directors, amendments to our certificate of incorporation and bylaws, the approval of any business combination and any other significant corporate transaction.

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These actions may be taken even if they are opposed by other shareholders. This concentration of ownership may also have the effect of delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could prevent our shareholders from receiving a premium for their shares. Some of these persons or entities who make up our principal shareholders may have interests different from yours.

Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock.

If, after listing, we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to de-list our common stock. Such a de-listing would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. If we do not obtain or retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore shareholders may have difficulty selling their shares.

Future sales of our common stock may adversely affect the market price of our securities and our ability to raise funds in new offerings.

Sales of our common stock in the public market following this offering or at the conclusion of any required lock-up periods could lower the market price of our common stock. Sales may also make it more difficult for us to sell equity securities or equity-related securities in the future at a time and price that our management deems acceptable or at all. Of the 10,136,322 shares of common stock outstanding as of September 20, 2022, after giving effect to the assumed conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN, in connection with the Domicile Transfer, ________ shares are, or will be, freely tradable without restriction immediately after the consummation of this offering, and approximately ________ of these shares, representing shares not held by our “affiliates,” generally may be resold under SEC Rule 144 beginning 90 days from the effectiveness of the registration statement of which this prospectus forms a part, subject to any lock-up agreements entered into between such stockholder and EF Hutton.

Additionally, we intend to register shares of common stock that are reserved for issuance under the 1998 Option Plan. For more information, see the section entitled “Shares Eligible for Future Sale — Registration Statements on Form S-8.”

Sales of substantial amounts of our common stock in the public market after this offering, or the perception that such sales will occur, could adversely affect the market price of our common stock and make it difficult for us to raise funds through securities offerings in the future. Of the shares to be outstanding after this offering, the shares offered by this prospectus will be eligible for immediate sale in the public market without restriction by persons other than our affiliates.

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The Warrants offered by this prospectus may not have any value.

The Warrants offered by this prospectus will be exercisable for five years from the date of initial issuance at an initial exercise price of $ per share (which shall be equal to 100% of the public offering price per Unit). There can be no assurance that the market for shares of our common stock will ever equal or exceed the price of the Warrants. In the event that the price per share of our common stock does not exceed the exercise price of the Warrants during the period when the Warrants are exercisable, the Warrants may not have any value.

A Warrant does not entitle the holder to any rights as a holder of our shares of common stock until the holder exercises the Warrant for a share of common stock.

Until you acquire shares of common stock upon exercise of your Warrants, your Warrants will not provide you any rights as a holder of common stock. Upon exercise of your Warrants, you will be entitled to exercise the rights of a holder of common stock only as to matters for which the record date occurs after the exercise date.

Since the Warrants are executory contracts, they may have no value in a bankruptcy or reorganization proceeding.

In the event a bankruptcy or reorganization proceeding is commenced by or against us, a bankruptcy court may hold that any unexercised Warrants are executory contracts that are subject to rejection by us with the approval of the bankruptcy court. As a result, holders of the Warrants may, even if we have sufficient funds, not be entitled to receive any consideration for their Warrants or may receive an amount less than they would be entitled to if they had exercised their Warrants prior to the commencement of any such bankruptcy or reorganization proceeding.

We may amend the terms of the Warrants in a way that may be adverse to holders with the approval by the holders of a majority of the then outstanding Warrants.

Our Warrants will be issued in book entry form under a warrant agreement. The warrant agreement provides that the terms of the Warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision. All other modifications or amendments, including any amendment to increase the exercise price of the Warrants or shorten the exercise period of the Warrants, shall require the written consent of the registered holders of a majority of the then outstanding Warrants.

The Additional Warrants will not be listed on any securities exchange or other nationally recognized trading system.

We have not applied and we do not intend to apply to have the Additional Warrants issuable to Qualified Holders upon the occurrence of certain dilutive events listed on any securities exchange or other nationally recognized trading system. Therefore, there can be no assurance that there will be any active trading market for the Additional Warrants.

Our outstanding Warrants may have an adverse effect on the market price of our common stock and make it more difficult to effect a business combination.

We will be issuing Warrants to purchase shares of common stock as part of this offering. To the extent we issue shares of common stock to effect a future business combination, the potential for the issuance of a substantial number of additional shares upon exercise of these Warrants could make us a less attractive acquisition vehicle in the eyes of a target business. Such securities, when exercised, will increase the number of issued and outstanding shares of common stock and reduce the value of the shares issued to complete the business combination. Accordingly, our Warrants may make it more difficult to effectuate a business combination or increase the cost of acquiring a target business. Additionally, the sale, or even the possibility of sale, of the shares of common stock underlying the Warrants could have an adverse effect on the market price for our securities or on our ability to obtain future financing. If and to the extent these warrants are exercised, you may experience dilution to your holdings.

If you purchase our securities in this offering, you will suffer immediate dilution of your investment.

The public offering price of the common stock issued in this offering will be substantially higher than the net tangible book value per share of our common stock. Therefore, if you purchase our securities in this offering, you will pay a price per share that substantially exceeds our net tangible book value per share after this offering. To the

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extent shares subsequently are issued under outstanding stock options, you will incur further dilution. Based on an assumed initial public offering price of $5.25 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $4.81 per share, representing the difference between our pro forma net tangible book value per share, after giving effect to this offering, and the assumed initial public offering price. In addition, purchasers of securities in this offering will have contributed approximately 32.5% of the aggregate price paid by all purchasers of our common stock but will own only approximately 29.7% of our common stock outstanding after this offering.

We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act. We may remain an “emerging growth company” until as late as December 31, 2027 (the fiscal year-end following the fifth anniversary of the completion of our initial public offering), though we may cease to be an “emerging growth company” earlier under certain circumstances, including (1) if the market value of our common stock that is held by nonaffiliates exceeds $700 million as of any June 30, in which case we would cease to be an “emerging growth company” as of the following December 31, or (2) if our gross revenue exceeds $1.07 billion in any fiscal year. “Emerging growth companies” may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. Investors could find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

In addition, Section 102 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. An “emerging growth company” can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We have identified a material weakness in our internal control over financial reporting. If we experience material weaknesses in the future or otherwise fail to implement and maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us, and as a result, the value of our common stock may decline.

As a privately-held company, we were not required to evaluate our internal control over financial reporting in a manner that meets the standards of publicly traded companies required by Section 404(a) of the Sarbanes-Oxley Act (“Section 404”). As a public company, we will be subject to significant requirements for enhanced financial reporting and internal controls. The process of designing and implementing effective internal controls is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain a system of internal controls that is adequate to satisfy our reporting obligations as a public company. In addition, we will be required, pursuant to Section 404, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting in the second annual report following the completion of this offering. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual and interim financial statements will not be detected or prevented on a timely basis.

The rules governing the standards that must be met for our management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation. Testing and maintaining internal controls may divert management’s attention from other matters that are important to our business. Once we are no longer an “emerging growth company,” or a “smaller reporting company”, our auditors will be required to issue an attestation report on the effectiveness of our internal controls on an annual basis.

In the course of preparing the financial statements that are included in this prospectus, management has determined that a material weakness exists within the internal controls over financial reporting. The material weakness identified relates to the preparation and review of debt and equity valuations. We concluded that the

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material weakness in our internal control over financial reporting occurred because, prior to this offering, we were a private company and did not have the necessary business processes, systems, personnel, and related internal controls necessary to satisfy the accounting and financial reporting requirements of a public company.

Further, additional weaknesses in our disclosure controls and internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective controls or any difficulties encountered in their implementation or improvement could harm our business or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods. Any failure to implement and maintain effective internal control over financial reporting also could adversely affect the results of periodic management evaluations and annual independent registered public accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting that we will eventually be required to include in our periodic reports that will be filed with the SEC. Ineffective disclosure controls and procedures and internal control over financial reporting could also cause investors to lose confidence in our reported financial and other information, which would likely have a negative effect on the trading price of our common stock. In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on the Nasdaq Capital Market. We are not currently required to comply with the SEC rules that implement Section 404 of the Sarbanes-Oxley Act and are therefore not required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose. As a public company, we will be required to provide an annual management report on the effectiveness of our internal control over financial reporting commencing with our second Annual Report on Form 10-K.

Our independent registered public accounting firm is not required to formally attest to the effectiveness of our internal control over financial reporting until our first annual report filed with the SEC where we are an accelerated filer or a large accelerated filer. At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed or operating. Any failure to maintain effective disclosure controls and internal control over financial reporting could harm our business and could cause a decline in the trading price of our common stock.

We will incur significant costs as a result of operating as a public company and our management expects to devote substantial time to public company compliance programs.

As a public company, we will incur significant legal, accounting, and other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley Act, as well as rules implemented by the SEC and Nasdaq. Shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business. Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly.

To comply with the requirements of being a public company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting or internal audit staff in order to address weaknesses in our internal control over financial reporting, as described above, which will also add to the costs of operating as a public company.

Our management team has limited experience managing a public company.

Most members of our management team have limited experience managing a publicly traded company, interacting with public company investors and complying with the increasingly complex laws pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of securities analysts and investors. These new obligations and constituents will require significant attention from our senior management and could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial condition, and results of operations.

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If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.

The trading market for our common stock and Warrants will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on us. If no securities or industry analysts commence coverage of us, the price for our common stock and Warrants could be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our common stock or Warrants or publish inaccurate or unfavorable research about our business, the price of our common stock and Warrants could decline. In addition, if our operating results fail to meet the forecast of analysts, the price of our common stock and Warrants could decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our common stock and Warrants could decrease, which might cause the price of our common stock and Warrants, as well as trading volume to decline.

Once the Domicile Transfer is completed, our Nevada Articles of Incorporation and our Amended and Restated Bylaws to be adopted in connection with this offering and Nevada law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Our Nevada Articles of Incorporation and our Amended and Restated Bylaws and Nevada law, which will be applicable to us following this offering, could make it more difficult for a third party to acquire us, even if closing such a transaction would be beneficial to our stockholders. Our Nevada Articles of Incorporation will authorize us to issue up to 10,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve control by the present management.

Provisions of our Nevada Articles of Incorporation, our Amended and Restated Bylaws and Nevada law also could have the effect of discouraging potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our Nevada Articles of Incorporation, our Amended and Restated Bylaws and Nevada law, as applicable, among other things:

• provide the board of directors with the ability to alter the bylaws without stockholder approval;

• place limitations on the removal of directors;

• establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and

• provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.

Any provision of our Nevada Articles of Incorporation, Amended and Restated Bylaws or Nevada law that has the effect of delaying, preventing, or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the price that some investors are willing to pay for our common stock.

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Our Amended and Restated Bylaws, which will be applicable to us following this offering, designate the Second Judicial District Court of Washoe County of the State of Nevada as the sole and exclusive forum for certain actions, which could limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company and its directors, officers, or other employees and may discourage lawsuits with respect to such claims.

Unless we consent in writing to the selection of an alternative forum, the Second Judicial District Court of Washoe County of the State of Nevada (the “Court”) shall be the sole and exclusive forum for any stockholder (including a beneficial owner) to bring (i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (iii) any action asserting a claim against us, any director or our officers or employees arising pursuant to any provision of the Nevada Revised Statutes (“NRS”), Chapters 78 or 92A of the NRS or our Nevada Articles of Incorporation or our Nevada Bylaws, or (iv) any action asserting a claim against us, any director or our officers or employees governed by the internal affairs doctrine. However, each of these clauses (i) through (iv) will not apply to any claim (x) as to which the Court determines that there is an indispensable party not subject to the jurisdiction of the Court (and the indispensable party does not consent to the personal jurisdiction of the Court within ten (10) days following such determination), (y) for which the Court does not have subject matter jurisdiction, or (z) which is vested in the exclusive jurisdiction of a court or forum other than the Court, including pursuant to Section 27 of the Exchange Act, which provides for exclusive federal jurisdiction over suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. Furthermore, Section 22 of the Securities Act provides for concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder, and as such the exclusive jurisdiction clauses set forth above would not apply to such suits.

We do not anticipate paying any cash dividends on our common stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

We have never declared or paid cash dividends on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. In addition, any future loan arrangements we enter into may contain terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

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USE OF PROCEEDS

We estimate that the net proceeds to us from our issuance and sale of the securities in this offering will be approximately $19.3 million (or $22.4 million if the underwriters exercise their over-allotment option to purchase additional shares of common stock and/or Warrants in full), based upon an assumed initial public offering price of $5.25 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $3.9 million, assuming that the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of Units we are offering. An increase (decrease) of 1,000,000 in the number of Units we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $4.9 million, assuming the initial public offering price stays the same.

An increase of 1,000,000 in the number of Units we are offering, together with a $1.00 increase in the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus), would increase the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $9.7 million. A decrease of 1,000,000 in the number of Units we are offering, together with a $1.00 decrease in the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus), would decrease the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $7.8 million. We do not expect that a change in the offering price or the number of Units by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital.

The principal purposes of this offering are to increase our financial flexibility, create a public market for our common stock and to facilitate our access to the public equity markets. We intend to use the net proceeds of this offering primarily for (i) clinical trials, (ii) research and development activities, (iii) regulatory review process for our product candidates, (iv) marketing and commercialization of our products, and (v) working capital and general purposes.

We anticipate an approximate allocation of the use of net proceeds as follows:

Net Proceeds after underwriters’ discount and offering expenses		19,300,000

Letter of credit reduction		1,500,000
Repayment of outstanding indebtedness (due by December 31, 2022)(1)		948,658
Research and development		500,000
FDA and MDR clearance of REVITY		500,000
Clinical trials and studies:

Dental — HYBENX and ERADX		500,000
Wound — REVITY		2,000,000
Veterinary — KONKURE		250,000
Working Capital		13,101,342

____________

(1) A portion of the net proceeds will be used to discharge $948,658 of related party notes payable with interest rates ranging from 6% to 10% due on December 31, 2022. In addition, to the extent certain outstanding convertible notes are not converted into shares of our common stock prior to December 31, 2022, we will be required to utilize a portion of the net proceeds totaling $2,007,216 (as of September 20, 2022) to repay the principal and accrued interest on such notes with interest rates ranging from 6% to 12%.

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We currently believe the net proceeds from this offering will be sufficient to complete two on-going post-marketing studies related to our HYBENX and ERADX products, a clinical trial for our REVITY product candidate, and several case studies related to our KONKURE product. In the event that the net proceeds from this offering are not sufficient to fund our research and development programs, management retains broad discretion over allocation of the net proceeds from this offering and may reallocate funding as it deems necessary. Additionally, we would, in all likelihood, be required to raise additional financing after this offering in order to fund our operations and to develop any additional product candidates. The issuance of additional shares of common stock could have a dilutive effect on investors in this offering and there can be no assurance that we will be able to raise additional funds on terms acceptable to us.

This expected use of net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from clinical trials, our sales, marketing and manufacturing efforts, any collaborations that we may enter into with third parties for our products and any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering.

We believe opportunities may exist from time to time to expand our current business through the acquisition or in-license of complementary products and product candidates. While we have no current agreements or commitments for any specific acquisitions or in-licenses at this time, we may use a portion of the net proceeds for these purposes.

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and U.S. government securities.

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DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock. We do not anticipate paying cash dividends on our common stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. Any future determination related to our dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects, the requirements of current or then-existing debt instruments and other factors our board of directors may deem relevant.

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CAPITALIZATION

The following table sets forth our cash and capitalization as of June 30, 2022:

• on an actual basis;

• on a pro forma basis to reflect (a) the Domicile Transfer and the filing of our Nevada Articles of Incorporation immediately prior to the closing of this offering, including the assumed conversion and exchange of three (3) shares of capital stock of EPIEN MN for each one (1) share of capital stock of EPIEN NV, and (b) the reclassification of the warrant liability from a long-term liability to stockholders’ deficit due to the establishment of a fixed exercise price at the time of this offering; and

• on a pro forma as adjusted basis to give further effect to our sale of 4,190,476 Units in this offering at an assumed initial public offering price of $5.25 per Unit, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma and pro forma as adjusted information below is illustrative only and our capitalization following the completion of this offering is subject to adjustment based on the initial public offering price of the Units and other terms of this offering determined at pricing. You should read the following table in conjunction with “Use of Proceeds,” “Selected Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Description of our Securities” and other financial information contained in this prospectus, including the financial statements and related notes appearing elsewhere in this prospectus.

	As of June 30, 2022
	Actual			Pro Forma			Pro Forma As Adjusted(1)
				(unaudited)
Cash	$	141,579		$	141,579		$	19,441,579
Total debt	$	12,293,819		$	12,293,819		$	12,293,819
Warrant liability		1,440,124			—			—

Shareholders’ (deficit) equity:
Common stock, par value $0.01 per share; 60,000,000 shares authorized, 29,785,880 shares issued and outstanding, actual; 300,000,000 shares authorized (par value $0.0001 per share), 9,928,626 shares issued and outstanding, pro forma; 300,000,000 shares authorized (par value $0.0001 per share), 13,928,626 shares issued and outstanding, pro forma as adjusted		297,860			993			1,412
Preferred stock, 10,000,000 shares authorized (par value $0.0001 per share), no shares issued or outstanding, actual, pro forma or pro forma as adjusted		—			—			—
Additional paid-in capital		44,014,183			45,751,174			65,050,755
Subscriptions receivable		(49,500	)		(49,500	)		(49,500	)
Accumulated deficit		(58,586,787	)		(58,586,787	)		(58,586,787	)
Total shareholders’ (deficit) equity		(14,324,244	)		(12,884,120	)		6,415,880
Total capitalization	$	(590,301	)	$	(590,301	)	$	18,709,699

Each $1.00 increase (decrease) in the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the amount of cash, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $3.9 million, assuming the number of Units, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of one million Units offered by us would increase (decrease) cash, total stockholders’ equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $4.9 million, assuming the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated

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price range set forth on the cover page of this prospectus) remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Each one million Unit increase in the number of Units offered by us together with a concomitant $1.00 increase in the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase each of cash and total stockholders’ (deficit) equity by approximately $9.7 million after deducting underwriting discounts and commissions and any estimated offering expenses payable by us. Conversely, each one million Unit decrease in the number of Units offered by us together with a concomitant $1.00 decrease in the assumed initial public offering price of $5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus) would decrease each of cash and total stockholders’ (deficit) equity by approximately $7.8 million after deducting underwriting discounts and commissions and any estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

The number of shares of our common stock to be outstanding after this offering is based on 29,785,880 shares of common stock outstanding as of June 30, 2022 (9,928,626 shares assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer, and excludes:

• 4,190,476 shares of common stock issuable upon the exercise of the Warrants issued in this offering at an exercise price of $ per share;

• up to shares of common stock which could be issuable upon the exercise of the Additional Warrants, to the extent issued, at the same exercise price per share as the Warrants;

• 1,125,767 shares of common stock issuable upon the conversion of $3,613,086 of principal and $1,103,628 of accrued interest on notes outstanding as of June 30, 2022, based on conversions prices equal to between 75% and 85% of the assumed public offering price per 5.25 per Unit (the midpoint of the estimated price range set forth on the cover page of this prospectus);

• 2,590,163 shares of common stock issuable upon the exercise of warrants as of June 30, 2022, with a weighted average exercise price of $1.59 per share (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer;

• 455,915 shares of common stock issuable upon the exercise of warrants as of June 30, 2022, with an exercise price of $4.73 per share (assuming an initial public offering price of $5.25 per Unit, the midpoint of the estimated price range set forth on the cover page of this prospectus);

• 3,095,658 shares of common stock issuable upon the exercise of outstanding stock options under our 1998 Option Plan, as of June 30, 2022, with a weighted average exercise price of $1.80 per share (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer;

• 133,333 shares of common stock issuable upon the exercise of outstanding stock options granted outside of the 1998 Option Plan, with a weighted average exercise price of $6.00 per share (assuming the conversion and exchange of one share of common stock of EPIEN NV for each three shares of EPIEN MN), in connection with the Domicile Transfer; and

• 520,759 shares of common stock that would be issuable upon the conversion of any deferred compensation owed to executive officers and former executive officers of the Company in the total amount of $2,733,987 (assuming an initial public offering price of $5.25 per Unit, the midpoint of the estimated price range set forth on the cover page of this prospectus).

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering. Net tangible book value per share of common stock is determined by dividing our total tangible assets less total liabilities by the number of outstanding shares of our common stock.

Our historical net tangible book value (deficit) as of June 30, 2022 was ($14,477,690), or ($0.49) per share of common stock. Our pro forma net tangible book value (deficit) as of June 30, 2022 was ($13,037,566) or ($1.31) per share of common stock.

Pro forma as adjusted net tangible book value is our pro forma net tangible book value (deficit), after giving further effect to (i) the sale of 4,190,476 shares of our common stock in this offering at an assumed initial public offering price of $5.25 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, and (ii) the application of the net proceeds from this offering as described in the section of this prospectus entitled “Use of Proceeds.” This amount represents an immediate increase in pro forma net tangible book value (deficit) of $1.75 per share to our existing shareholders, and an immediate dilution of $4.81 per share to new investors participating in this offering.

The following table illustrates this dilution on a per share basis to new investors:

Assumed initial public offering price per share				$	5.25
Historical net tangible book value (deficit) per share as of June 30, 2022	$	(0.49	)
Pro forma net tangible book value (deficit) per share as of June 30, 2022, before giving effect to this offering		(1.31	)
Increase in pro forma net tangible book value per share attributable to new investors participating in this offering		1.75
Pro forma as adjusted net tangible book value per share after this offering					0.44
Dilution in pro forma net tangible book value per share to new investors participating in this offering				$	4.81

The pro forma information discussed above is illustrative only and will change based on the actual initial public offering price, number of shares and other terms of this offering determined at pricing.

A $1.00 decrease in the assumed initial public offering price of $5.25 per Unit (the midpoint of the price range set forth on the cover page of this prospectus) would decrease our pro forma as adjusted net tangible book value as of June 30, 2022 after this offering by approximately $3.9 million, or approximately $0.27 per share, and would decrease dilution to investors in this offering to approximately $0.73 per share, assuming that the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us. A $1.00 increase in the assumed initial public offering price of $5.25 per Unit (the midpoint of the price range set forth on the cover page of this prospectus) would increase our pro forma as adjusted net tangible book value as of June 30, 2022 after this offering by approximately $3.9 million, or approximately $0.28 per share, and would increase dilution to investors in this offering to approximately $0.72 per share, assuming that the number of Units offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us. We may also increase or decrease the number of Units we are offering. An increase of 1,000,000 in the number of Units we are offering would increase our pro forma as adjusted net tangible book value as of June 30, 2022 after this offering by approximately $4.9 million, or approximately $0.30 per share, and would decrease dilution to investors in this offering to approximately $0.30 per share, assuming the assumed initial public offering price per Unit remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us. A decrease of 1,000,000 in the number of Units we are offering would decrease our pro forma as adjusted net tangible book value as of June 30, 2022 after this offering by approximately $4.9 million, or approximately $0.33 per share, and would increase dilution to investors in this offering to approximately $0.33 per share, assuming the assumed initial public offering price per Unit remains the same, after deducting the estimated underwriting discount and estimated offering expenses payable by us.

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If the underwriters exercise their option in full to purchase 628,571 additional shares of common stock and/or Warrants in this offering at the assumed initial offering price of $5.25 per Unit, the pro forma net tangible book value per share after this offering would be $0.63 per share of common stock, the increase in the pro forma as adjusted net tangible book value per share to existing stockholders would be $1.55 per share of common stock and the dilution to new investors purchasing securities in this offering would be $4.62 per share of common stock.

The following table sets forth, as of June 30, 2022, on the pro forma as adjusted basis described above, the differences between our existing shareholders and the purchasers of shares of common stock in this offering with respect to the number of shares of common stock purchased from us, the total consideration paid to us and the weighted average price paid per share paid to us, based on an assumed initial public offering price of $5.25 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting underwriting discounts and commissions and estimated offering expenses payable by us.

The following table illustrates our pro forma proportionate ownership, upon completion of this offering by present stockholders and investors in this offering, compared to the relative amounts paid by each. The charts reflect payment by present stockholders as of the date the consideration was received and by investors in this offering at the public offering price. The table further assumes no changes in net tangible book value other than those resulting from the offering.

	Shares Purchased			Total Consideration				Weighted Average Price per Share
	Number	Percent		Amount		Percent		Weighted Average Price per Share
Existing shareholders	9,928,626	70.3	%	$	45,702,667	67.5	%	$	4.60
New investors	4,190,476	29.7			22,000,000	32.5			5.25
Total	14,119,102	100.0	%	$	67,702,667	100.0	%		4.80

We may choose to raise additional capital through the sale of equity or equity-linked securities due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that any options are issued under our equity incentive plan or we issue additional shares of common stock or equity-linked securities in the future, there will be further dilution to investors purchasing in this offering.

• 4,190,476 shares of common stock issuable upon the exercise of the Warrants issued in this offering at an exercise price of $ per share;

• up to shares of common stock which could be issuable upon the exercise of the Additional Warrants, to the extent issued, at the same exercise price per share as the Warrants;

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• 520,759 shares of common stock that would be issuable upon the conversion of any deferred compensation owed to executive officers and former executive officers of the Company in the total amount of $2,733,987 (assuming an initial public offering price of $5.25 per Unit, the midpoint of the estimated price range set forth on the cover page of this prospectus).

Unless otherwise indicated, all information contained in this prospectus assumes:

• no exercise of any of the Additional Warrants, as applicable;

• no exercise of the outstanding stock options described above;

• no exercise of the outstanding warrants described above;

• no conversion of the outstanding convertible notes described above;

• no conversion of the deferred compensation described above; and

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion of our financial condition and results of operations in conjunction with “Selected Financial Data” and our audited financial statements and unaudited interim financial statements and related notes, each included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties, and assumptions. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk Factors” section of this prospectus to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section entitled “Cautionary Note Regarding Forward-Looking Statements and Industry and Market Data” in this prospectus.

Overview

We are a specialty medical devices company that is developing products for treatment of oral inflammation and chronic wounds based on our class of chemical formulations that act as aggressive desiccation and debriding agents. Eleven published clinical trials have shown that our products reduce and, very often, eliminate the need for antibiotics to treat topical infectious wounds, including oral infections and open infectious wounds. Standard treatments can take months and even years of daily antibiotic use to heal an open infectious wound. In 2013, the European Regulatory Agency cleared our HYBENX and ERADX product lines for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures, including scaling and root planing, to aid in the removal of contaminated debris from the sulcus. In 2021, our HYBENX and ERADX product lines received 510(k) clearance from the FDA as a medical device for the same use. We plan to initiate several limited clinical trials to support an FDA de novo clearance for our REVITY product line for treatment of chronic wounds in 2023.

Our products and product candidate are designed to address two different markets. Our DEBACTEROL, ORALMEDIC, HYBENX and ERADX products target oral care, including periodontics, general cleanings, peri-implantitis and endodontics. Our REVITY product candidate is intended for the treatment of chronic, non-healing wounds, including diabetic foot ulcers, pressure ulcers and vascular ulcers. Since 2014, REVITY has been subject to off-label studies conducted by chronic wound specialists at CHRISTUS Health (TX, U.S.), Southwest Regional Wound Care Center (TX, U.S.), Vascular Surgery Associates (MN, U.S.), and Villa Berica (Italy), as well as two case studies that were covered in peer-reviewed wound journals. To date, more than 300 patients with diabetic foot ulcers and vascular ulcers have been successfully treated with REVITY. Based on this, we believe that, if it receives de novo clearance from the FDA, our product candidate will have a dramatic impact on healthcare (hospital, clinic, and insurance payor) costs by reducing long-term hospital care and visits and eliminating the need for the use of drugs such as antibiotics, antiseptics and opioids. Our belief is based, in part, on a peer reviewed paper published in the January 2020 Journal of Biological Regulators and Homeostatic Agents by Dr. Marcus Gitterle entitled “Treatment with novel HYBENX root canal cleanser suggests biofilms blocked healing of human wounds: case series.” The six-month evaluation period in the study provided data to support the hypotheses that pathogenic biofilm actively prevents the healing of chronic wounds, and that biofilm can be disrupted with a single treatment of HYBENX. Our belief is also supported, in part, by research studies performed by the University of Miami that validated these assumptions with respect to mechanical debridement, reduction of bacterial, fungal yeast infection, and reduction in the post inflammatory factors that maintain chronicity in wounds. Additionally, we have multiple studies performed in the oral and dental sciences over the past decade that confirm the identical outcomes.

In the future, our product candidates may require us to successfully complete significant clinical trials to demonstrate the safety and efficacy of each product candidate before it will be able to be approved by the FDA. The completion of these clinical trials will require a significant amount of capital and the hiring of additional personnel.

Recent Financings

In August 2021, we agreed to issue to accredited investors, convertible notes in the aggregate principal amount of $1,775,000 (the “Bridge Notes”) and warrants (the “Bridge Warrants”, and together with the Bridge Notes, the “Bridge Securities”), to purchase shares of our common stock, subject to adjustments, in exchange for an aggregate

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purchase price of $1,775,000, payable in two tranches. The Bridge Securities were issued in reliance upon the exemption from registration under Section 4(a)(2) of the Securities Act. This transaction (the “Bridge Financing”) was conducted as a bridge financing to provide us with sufficient capital prior to this offering. On August 13, 2021, 12 accredited investors funded the first tranche of this investment, in a total amount equal to $900,000 of the purchase price in cash, and on September 17, 2021, 12 investors funded the second tranche, consisting of the remaining $875,000 of the aggregate purchase price. A total of 13 accredited investors funded the Bridge Financing.

The Bridge Notes are senior secured obligations and are secured by all of our personal properties and assets, wherever located, whether tangible or intangible, and whether owned upon the date of the Bridge Notes or thereafter acquired or arising. Additionally, the Bridge Notes carry interest at the rate of 10% per annum (with a minimum of one year of interest to be paid to the investors) and mature on August 13, 2023 and September 17, 2023, respectively, each being 24 months after issuance of the applicable Bridge Notes, subject to acceleration. The Bridge Notes are convertible at the option of the holder following the completion of this offering at a discount of 85% of the public offering price of our common stock in this offering.

The Bridge Warrants are exercisable at a price equal to 90% of the public offering price in our initial public offering and are exercisable for a period of five years after the completion of this offering. The number of shares issuable upon exercise of the Bridge Warrants is based on a formula which requires the outstanding principal amount of the Bridge Notes in connection with which the Bridge Warrants were issued, and the public offering price of our common stock in this offering. For more information on the Bridge Warrants see “Description of our Securities — Warrants” on page 124.

In connection with the Bridge Financing, the investors and Poppleton Partners LLC, are entitled to preemptive rights (except in connection with an initial public offering) for 20% of any equity securities that we propose to issue as well as “demand” and “piggyback” registration rights. In connection with the Bridge Financing, we also agreed to certain covenants, including, among others, affirmative covenants relating to reporting to the investors as well as negative covenants providing limitations on incurring liens, incurring senior indebtedness, and limitations on certain dispositions.

After the Bridge Financing and since September 2021, we have raised additional convertible debt financing from five accredited investors in an aggregate principal amount of $474,000 to provide us with additional financing prior to this offering. The terms of these investments were similar to the Bridge Financing, except that the convertible notes are unsecured, there are no preemptive rights and only two of the five investors were provided with registration rights, which are the same as the registration rights provided to the holders of the Bridge Securities.

Factors and Trends Affecting Our Business and Results of Operations

The following trends and uncertainties either affected our financial performance historically or are likely to impact our results of operations in the future:

• FDA clearance of our HYBENX product in September 2021 and the ongoing efforts to receive de novo clearance for our REVITY product from the FDA and the European Regulatory Agency;

• The increased level of acceptance of our HYBENX and ERADX products by dentists and hygienists;

• Our overall level of indebtedness, the interest rates charged by our lenders and our ability to refinance such debt or find other sources of debt or equity financing;

• The progress and results of future clinical trials involving our products and product candidate;

• We anticipate that our general and administrative expenses will increase in the future as a result of increased costs associated with being a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, attorneys, and accountants, and personnel-related stock-based compensation costs, among other expenses, and, in the case of public company-related expenses, services associated with strengthening our internal control over financial reporting, maintaining compliance with Nasdaq listing and SEC reporting requirements, director and officer liability insurance costs, and investor and public relations costs, among other expenses.

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Results of Operations

EPIEN MEDICAL, INC. S-1