As filed with the Securities and Exchange Commission on September29, 2023.

Registration No. 333-270486

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

__________________________________________

AMENDMENT NO. 5
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

__________________________________________

Origin Life Sciences, Inc.

(Exact name of registrant as specified in its charter)

__________________________________________

Delaware	3845	27-3705184
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification Number)

2 Research Way, Third Floor
Princeton, NJ 08540
(609) 250-6000(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

__________________________________________

Michael Preston
Chief Executive Officer
Origin Life Sciences, Inc.
2 Research Way, Third Floor
Princeton, NJ 08540
(609) 250-6000(Name, address, including zip code, and telephone number, including area code, of agent for service)

__________________________________________

With Copies To:

Leslie Marlow, Esq.
Hank Gracin, Esq.
Blank Rome LLP
1271 Avenue of the Americas
New York, New York 10020
Tel: (212) 885-5000 Spencer G. Feldman, Esq.
Olshan Frome Wolosky LLP
1325 Avenue of the Americas
15th Floor
New York, New York 10019
Tel: (212) 451-2300

__________________________________________

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 which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, 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.

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 jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS SUBJECT TO COMPLETION, DATED SEPTEMBER29, 2023

Origin Life Sciences, Inc.

3,000,000Shares

Common Stock

This is the initial public offering of our common stock. We are offering 3,000,000shares of our common stock, par value $0.01 per share, at the assumed public offering price of $5.00 per share.

No public market currently exists for our common stock. We have applied to list our common stock for trading on NYSE American LLC (“NYSE American”) under the symbol “OLSI.” This offering is contingent upon receiving approval of our listing from NYSE American.

We are an “emerging growth company” as defined under the federal securities laws and, as such, will be subject to reduced public company reporting requirements. See “Prospectus Summary — Implications of Being an Emerging Growth Company” for additional information.

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

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

	Per Share	Total
Public offering price	$	$
Underwriting discounts and commissions(1)	$	$
Proceeds, before expenses, to Origin Life Sciences, Inc.	$	$

____________

(1)We have agreed to pay the underwriters a cash fee equal to 7.0% of the aggregate gross proceeds from the sale of the common stock in this offering. Additionally, we have agreed to pay a non-accountable expense allowance and to reimburse the underwriters for certain expenses incurred by them in connection with this offering. See “Underwriting” beginning on page 142 of this prospectus for more information about the compensation payable to the underwriters, including warrants to purchase shares of our common stock.

We have granted the underwriters an option for a period of 45 days to purchase up to an additional 450,000shares of common stock. If the underwriters exercise the option in full, the total underwriting discounts and commissions payable by us will be $1,207,500, and the total proceeds to us, before expenses, will be $16,042,500.

Delivery of the shares is expected to be made on or about, 2023.

Sole Book-Running Manager

Boustead Securities, LLC

Prospectus dated, 2023

Prototype of the U.S. version of our therapy delivery platform that was used in our dose-ranging clinical trial and in our proof-of-concept studies. THIS DEVICE IS CURRENTLY UNDER DEVELOPMENT. THE PROTOTYPE DEPICTED ABOVE IS IN THE PROCESS OF BEING REENGINEERED AND, THEREFORE, IS NOT THE DEVICE WE INTEND TO USE IN OUR PIVOTAL CLINICAL TRIAL.

TABLE OF CONTENTS

	Page
PROSPECTUS SUMMARY	1
THE OFFERING	12
SUMMARY FINANCIAL DATA	15
RISK FACTORS	17
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS	57
MARKET, INDUSTRY AND OTHER DATA	58
USE OF PROCEEDS	59
DIVIDEND POLICY	61
CAPITALIZATION	62
DILUTION	65
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	69
BUSINESS	81
MANAGEMENT	108
EXECUTIVE COMPENSATION	114
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS	123
PRINCIPAL STOCKHOLDERS	126
DESCRIPTION OF SECURITIES	129
SHARES ELIGIBLE FOR FUTURE SALE	139
UNDERWRITING	142
LEGAL MATTERS	146
EXPERTS	146
WHERE YOU CAN FIND additional INFORMATION	146
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES	146
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 to you or to make any representations other than those contained in this prospectus, any amendment or supplement to this prospectus, or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We 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 shares offered hereby, and only under circumstances and in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front cover of this prospectus regardless of the time of delivery of this prospectus or of any sale of common stock. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus.

Neither we nor the underwriters have taken any action to permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States.

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, and observe any restrictions relating to, the offering of the common stock and the distribution of this prospectus outside the United States.

This prospectus contains trade names, trademarks and service marks of other companies that are the property of their respective owners. Solely for convenience, trademarks and tradenames referred to in this prospectus appear without the ® and TM 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 owners will not assert their rights, to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship by us of, these 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 in making your investment decision. Before deciding to invest in our common stock, you should read this entire prospectus carefully, including the sections of this prospectus entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus.

Unless the context otherwise requires, references in this prospectus to the “Company,” “Origin,” “we,” “us” and “our” refer to Origin Life Sciences, Inc.

Our Business

We are a clinical-stage biotechnology company that has been developing a proprietary patented high-energy plasma device that generates nitric oxide (“NO”) in the form of a plasma/NO stream and delivers it to targeted locations of the body. The stream can potentially be used for various therapeutic purposes, including as an anti-infective, anti-inflammatory and tissue-regenerative therapy for chronic wounds and skin and soft tissue infections (“SSTIs”). The U.S. Food and Drug Administration (the “FDA”) previously determined that our product will be a Class III medical device reviewed under a premarket approval (“PMA”) application with the FDA’s Center for Devices and Radiological Health (“CDRH”) consulting with the Center for Drug Evaluation and Research (“CDER”) as necessary. The cornerstone of the plasma/NO therapy is our patented delivery platform named “Ionojet” which allows us to turn atmospheric air into a plasma/NO stream that has been shown in investigations: (i) to be non-toxic, (ii) to generate NO activity up to 3 cm below the skin, and (iii) to stimulate sustained biological activity in tissue for up to an hour after delivery of the therapy. To date, our clinical activities have been focused on the clinical trials described below, including our dose-ranging feasibility clinical trial for the treatment of diabetic foot ulcers completed in 2018 using the plasma/NO stream generated from our Ionojet, and the preparation for our planned pivotal clinical trial, including finalization of the prototype of the Ionojet that we intend to use in our pivotal trial.

When used in this prospectus, the term “pivotal” trial is the clinical investigation intended to gather additional information about the safety and effectiveness of the Ionojet device that we believe will be the final clinical trial that will be required to support approval of a PMA for the device by the FDA for the treatment of diabetic foot ulcers. However, if the FDA should determine that such clinical trial (that we refer to as the pivotal trial) has not demonstrated reasonable assurance of the safety and effectiveness of the device, we may be required to conduct a further clinical trial to support approval of a PMA. Reference in this prospectus to the term “feasibility” trial refers to all clinical studies that precede the pivotal trial. Prior to commencing our pivotal trial in diabetic foot ulcers, we will need to submit, and receive approval of, a new Investigational Device Exemption (“IDE”) filing, permitting the use of the reengineered design of the Ionojet in a new clinical study. We anticipate that we will be able to submit the new IDE approximately six months after consummation of this offering and that it will take approximately three months after submission of the IDE to receive approval thereof from the FDA. After receiving approval of the new IDE, we expect that it will take approximately three months to commence the pivotal trial, which will require Institutional Review Board (“IRB”) approval of the study, identification and initiation of clinical trial sites and patient recruitment activities. We do not believe that the modifications to the device or the requirement to submit, and receive approval of, a new IDE has had, or will have, an effect on our expected timeline for commencement of the pivotal trial.

We plan to seek premarket approval of the Ionojet from the FDA as a Class III medical device, assuming we are able to complete our pivotal trial and the data are favorable. If we are unable to complete our pivotal trial or, upon completion of the trial, the outcomes of the trial design are not met, we may not be able to seek premarket approval of the Ionojet. We expect to submit our PMA application in the second quarter of 2024 and the FDA’s review of the PMA can range from 6 to 15 months depending on whether the FDA raises significant issues, including the need for additional trials, during its interactive review. There is no assurance that the FDA will approve a PMA in our anticipated timeline after completion of the planned pivotal trial, if at all. If we receive premarket approval from the FDA of our technology for the treatment of diabetic foot ulcers, our goal is to market our technology to hospitals, wound clinics and private podiatrist offices to treat diabetic foot ulcers and to generate revenue by charging for the device on a usage basis. We do not intend to generate revenue from the sale of the Ionojet device, of which we intend to retain ownership. In addition to wound healing, we believe that our technology has application in many additional indications including dermatology, infection control, podiatry, dentistry, pain and inflammation and cosmetics, as well as potentially in certain respiratory infections, both viral and bacterial, oral infections, dental indications, ophthalmic

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and facial applications and in topical indications, although to date the only pre-clinical and clinical studies we have conducted with our Ionojet device have been with regard to wound healing, and our pivotal clinical trial will focus solely on diabetic foot ulcers.

The plasma/NO stream generated by our device has the potential to promote healing in various ways as a result of the effect that NO has on immune system regulation, blood vessel regulation, tissue regeneration and defending against infection. In particular, NO represents a potential wound therapeutic agent due to its ability to regulate inflammation, increase blood flow, decrease blood pressure, eradicate bacterial infections, and promote the growth and activity of immune cells. Since the plasma/NO stream has been shown in investigations to generate NO activity up to 3 cm below the skin, we believe that the delivery of the NO via plasma energy allows the NO to pass through the skin and locally saturate the tissue and that this saturation enhances the NO pathways already present in the human body.

We believe that our therapy is novel in that it is intended to simultaneously both disinfect and promote the healing of infected wounds. We also are not aware of any currently approved technology to deliver site-specific and therapeutically relevant concentrations of NO to skin and soft tissue, as well as to joints and muscles, leading to significantly-increased levels of NO as much as three centimeters beneath the skin. We believe we are the furthest along in the clinical development of a therapy of this kind. We are continuing to explore and effect functional and aesthetic improvements to the device to meet the expectations of the U.S. market prior to commercial deployment and intend to use a portion of the proceeds of this offering to implement such improvements to our Ionojet technology and prepare for the submission of a new IDE for our pivotal trial in diabetic foot ulcers. However, the FDA may require additional trials, and there is no assurance that the FDA will approve a PMA in our anticipated timeline after completion of the planned pivotal trial, if at all.

We are a clinical-stage biotechnology company with a limited operating history. We also have a history of operating losses and expect to continue to incur substantial losses for the foreseeable future. Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. Our cash and the proceeds of this offering will only fund our operations for a limited time. The proceeds from this offering will be insufficient to allow us to fully fund completion of our pivotal clinical trial and the premarket approval process, which we estimate will cost $30million in total. In addition, the FDA may require additional trials which will require additional funding. We will need to raise additional capital to commence and complete the pivotal clinical trial.

The following is a summary of the medical fields within which we intend to explore the use of the therapy generated by the Ionojet device, or in certain fields, by adaptations to the reengineered Ionojet. It is anticipated that for all of the fields set forth below our reengineered Ionojet device will be used to generate a plasma/NO stream to be delivered topically to the patient, with the exception of the treatment of dental infections and upper respiratory infections, which will require adaptations to the reengineered Ionojet.

•Wounds — Our initial objective is to seek regulatory approvals for the use of our therapy to treat patients suffering from diabetic foot ulcers. At this time, we have completed the feasibility studies for the treatment of diabetic foot ulcers. An IRB approved observational study evaluating the promotion of wound-healing and control of infection in the treatment of various chronic wounds, including diabetic foot ulcers, was completed in 2013. We intend to evaluate the possible use of our therapy to treat other wounds including but not limited to acute wounds, venous leg ulcers, pressure ulcers, post-surgical wounds, thermal burns and radiation burns.

•Anti-infective— We believe that our therapy has the potential to be used as an anti-infective and we plan to investigate the treatment of various infected conditions including but not limited to onychomycosis (toenail fungus), surgical site infections and chronic infections. Infected pacemaker and defibrillator implant wounds and infected orthopaedic implant wounds were the subject of two IRB approved observational studies to examine the effect of plasma/NO in treating these infections.

•Dermal Therapeutics — We believe that our therapy has the potential to be used as a treatment for various dermatological conditions, including but not limited to chronic papulopustular and conglobate acne, cellulitis and plantar and viral warts. At this time, we have not completed any feasibility studies for such treatment, but we anticipate that we will be able to rely upon the safety and early feasibility studies that have been conducted to date using the Ionojet device, assuming that the Ionojet device is approved by the FDA for the treatment of diabetic foot ulcers.

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•Musculoskeletal — We intend to explore the treatment of various musculoskeletal conditions, including but not limited to rheumatoid arthritis, an autoimmune and inflammatory disease, osteo-arthritis, tendinitis, fasciitis and sports injuries. At this time, we have not completed any feasibility studies for such treatment, but we anticipate that we will be able to rely upon the safety and early feasibility studies that have been conducted to date using the Ionojet device, assuming that the Ionojet device is approved by the FDA for the treatment of diabetic foot ulcers.

•Cosmetic — We intend to explore the use of our therapy for various cosmetic applications, including but not limited to treatment of alopecia. At this time, we have not completed any feasibility studies for such treatment, but we anticipate that we will be able to rely upon the safety and early feasibility studies that have been conducted to date using the Ionojet device, assuming that the Ionojet device is approved by the FDA for the treatment of diabetic foot ulcers.

•Dental Infections — We intend to explore the use of our therapy, employing an adaptation of the reengineered Ionojet device, for various dental indications, including but not limited to periodontitis, gingivitis, implantitis and surgical extraction infections. At this time, we have not completed any feasibility studies for such treatment.

•Respiratory Tract Infections — We intend to explore the treatment of various viral and bacterial upper respiratory infections using an adaptation of the reengineered Ionojet device. At this time, we have not completed any feasibility studies for such treatment.

To market additional indications, we will need to obtain a new premarket authorization from the FDA specific to each indication. At this time, we are unable to determine the device class or regulatory pathway for each indication. The type of FDA authorization required for each indication — i.e., 510(k) clearance, de novo classification, a PMA, or a supplement to our original PMA — will depend on factors such as the risk classification of the new indication and the classification of previously authorized technologies. We anticipate that the pilot studies and studies for safety that we have conducted to date for the Ionojet device will be applicable to each of the indications in the chart above. Therefore, subject to the availability of additional financing, we intend to commence feasibility studies to evaluate the effectiveness of the plasma/NO stream for the treatment of each of these indications, assuming we receive FDA approval of our Ionojet device for the treatment of diabetic foot ulcers.

Planned Pivotal Clinical Trial

We have been working on preparations for our planned pivotal trial in diabetic foot ulcers, upon which FDA approval will primarily be based. While we believe this will be the final clinical trial that will be required to support approval of a PMA for the Ionojet device by the FDA for the treatment of diabetic foot ulcers, we may be required to conduct additional trials to support approval of a PMA if the FDA should determine that the results of our planned pivotal trial have not demonstrated reasonable assurance of the safety and effectiveness of the device. These preparations fall into three areas: (i) modifications to the Ionojet technology, (ii) medical, and (iii) administrative. The following is a summary:

(i)One of the purposes of a feasibility trial is to determine what modifications need to be made to a device prior to a pivotal trial, since the pivotal trial should be carried out with the form of the device that will be marketed post-approval. From clinician feedback and our own observations, we were able to identify several desirable changes that we believe will enhance commercial adoption, and we have been working on the reengineered design of our device in our own facility. We have made what we believe are significant improvements to our Ionojet technology, all of which we are seeking to protect with new U.S. and international patent filings. When these improvements have been completed, which is expected in early 2024, and subject to the availability of adequate funding and FDA approval of a new IDE for our pivotal trial in diabetic foot ulcers for the device with the modifications, we will look to commence the production of devices for our planned pivotal trial.

(ii)Medically, we have started work on the study design and protocol for our pivotal trial. There are several important decisions to be made about the design of the study, including the dose or doses to be studied. Subject to FDA approval of our protocol, we intend to employ an adaptive study design for the pivotal trial, under which our targeted delta, or superiority over standard of care (“SoC”) will not be finalized until we have seen the early results from the treatment arms.

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(iii)Administratively, we expect to begin identifying clinical sites and investigators for the pivotal trial and assembling the appropriate advisory and review panels in early 2023. The timing of the pivotal trial is dependent on the availability of adequate financing and regulatory approval to conduct the study.

Market Opportunity

Current Indications

Our initial objective is to seek regulatory approvals for our therapy to address the unmet needs of patients suffering from chronic wounds and SSTIs. As discussed, the observational, IRB approved study conducted by Dr. Treadwell in 2013 evaluated the promotion of wound-healing and control of infection in the treatment of various chronic wounds. Dr. Treadwell is a qualified wound surgeon who is expected to serve as our Chief Clinical Officer commencing at some time shortly prior to or upon the consummation of this offering. According to an article published by Fortune Business Insights entitled Chronic Wound Care Market Size, Share & COVID-19 Impact Analysis (March 2022), the chronic wound care market was estimated at $11.61 billion in 2021, of which an estimated $4.4 billion was attributable to North America. The global chronic wound care market is projected to grow from $12.36billion in 2022 to $19.52billion by 2029, exhibiting a compound annual growth rate (“CAGR”) of 6.7% during the forecast period. Diabetic foot ulcers comprise 43.1% of the global chronic wound care market, as reported by the same article.

In the United States, the treatment market size for SSTIs, also referred to as acute bacterial skin and skin structure infections (ABSSSI) by the FDA, was valued at $7.3 billion in 2018 and is projected to reach $14.9 billion by 2026, exhibiting a CAGR of 9.5%, as reported by Fortune Business Insights in an article entitled Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Treatment Market Size, Share and Industry Analysis (July 2019).

We initially plan to focus on the diabetic foot ulcer treatment market. According to a report published by GlobeNewswire on July 20, 2022, the global diabetic foot ulcer treatment market was valued at $8.6 billion in 2021 and is projected to reach $14.8 billion by 2030. The North American diabetic foot ulcer treatment market reached $3.8 billion in 2021, contributing to the highest market share that year. In due course we may also look to secure regulatory approval and market our therapy for chronic wounds outside the United States in partnership with local organizations. In the meantime, and in parallel with our pivotal trial on diabetic foot ulcers, we plan, subject to available capital resources, to broaden our approach into other therapeutic areas and, prior to that, to conduct confirmatory pre-clinical studies into blood-flow and infection-control.

The cost of the therapy to the patient is expected to be based upon the dose administered, as measured by frequency and duration of administration. Based upon the current costs associated with advanced wound therapy, we estimate that the reimbursed cost of the therapy administered using our Ionojet technology for diabetic foot ulcers will be approximately $10,000 per patient.

Our strategy is to undertake proof-of-concept work in other wound-healing indications as well as non-wound-healing areas. For the latter, we are looking at target indications in other treatment areas (known as verticals) such as dermatology, infection control, podiatry, dentistry, pain and inflammation and cosmetics, as we believe NO may have clinical relevance to all these verticals. By demonstrating our clinical relevance outside diabetic foot ulcers, we believe we can add greater shareholder value in a shorter timeframe. Selection of target indications will be made on the basis of such factors as market size, regulatory constraint, estimate of likely success and time to completion.

Initial proof-of-concept studies have been carried out under IRB approval in two important indications — infected pacemaker and defibrillator implant wounds (n=7) and infected orthopaedic implant wounds (n=8). Each study has been conducted by Dr. Treadwell as an observer initiated, open, non-controlled observational, IRB approved study to examine the effect of plasma/NO in treating patients with these conditions. Each study was the subject of a poster presented at conferences of the Symposium on Advanced Wound Care, one of the world’s leading wound care education organizations, in San Antonio, Texas in 2021, in Las Vegas, Nevada in 2022, and in National Harbor, Maryland in 2023. In the pacemaker and defibrillator study, seven patients were referred to Dr. Treadwell with infected pacemaker pockets. The therapy generated by the device was well-tolerated, and there were no adverse events reported during the study. All seven patients completed the protocol (clearance of the infection), with an average of ten weekly treatments, without removal of the implant.

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This trial remains open for additional qualified patients.

In the orthopaedic implant study, eight patients were seen by Dr. Treadwell because of infected implanted orthopaedic hardware. The therapy generated by the device was well-tolerated, and there were no adverse events reported during the study. All eight patients completed the protocol (clearance of the infection), with an average of 22 weekly treatments, without removal of the hardware. This trial remains open for additional qualified patients. Additional studies are planned in onychomycosis (toenail fungus), radiation burns and sickle cell ulcers subject to available funding.

Future Indications

In addition, we intend to conduct clinical trials and seek regulatory approval for the use of the plasma/NO therapy generated by our device in the treatment of the indications listed below, each of which would increase our market opportunity, and, collectively, would increase our market opportunity even more. Although we have not conducted clinical trials for any of the following indications, we anticipate that we will be able to rely upon the safety and early feasibility studies that have been conducted to date using the Ionojet device for our clinical studies in the following indications, assuming that the Ionojet device is approved by the FDA for the treatment of diabetic foot ulcers.

Onychomycosis is a fungal infection that occurs in the fingernails or toenails. According to Verified Market Research, the U.S. onychomycosis market size was valued $2.9 billion in 2021 and is projected to reach $5.5 billion by 2023, growing at a CAGR of 8.6% from 2022 to 2030.

Surgical Site Infection — The global surgical site infection control market was valued at $4.2 billion in 2021 and is expected to reach a value of $5.51 billion by 2027, exhibiting a CAGR of 4.63% from 2021 to 2027, as reported by Research and Markets. It is estimated that 35% of the market’s growth will originate from North America during the forecasted period.

Acne — The United States acne treatment market was valued at $4.27 billion in 2021 and is projected to grow to $6.12 billion by 2029, exhibiting a CAGR of 4.5%, according to Fortune Business Insights.

Rheumatoid arthritis is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation in the affected parts of the body. Joints in the hands, wrists and knees are commonly affected by rheumatoid arthritis. An article by Persistence Market Research reports that the global revenue from the rheumatoid arthritis treatment market is valued at $42.9 billion in 2022, with the global market expected to grow at a CAGR of 5.7% to reach a value of approximately $79.1 billion by the end of 2033. The United States market accounts for approximately 39.8% (or approximately $17 billion) of the global market.

Tendonitis — According to a report by Grandview Research, the global market size for tendonitis, a condition when a tendon is inflamed, was valued at $199.6 billion in 2021 and is projected to grow at a CAGR of 2.7% from 2022 to 2030. In 2021, North America dominated the global market, accounting for the largest share of 43.4% of the overall revenue, or approximately $86.6 billion.

Alopecia is a disease that develops when the body attacks its own hair follicles (where hair grows from), which can cause hair loss anywhere on the body, although it often causes hair loss on the scalp. The global alopecia market revenue was valued at $8.379 billion in 2021, with more than 36.4% being attributed to North America, according to a report by Acumen Research and Consulting. The global alopecia market is expected to grow at a CAGR of 8.2% from 2022 to 2030, achieving a market size of $16.76 billion by 2030.

Periodontal diseases are mainly the result of infections and inflammation of the gums and bone that surround and support the teeth. In its early stage, called gingivitis, the gums can become swollen and red, and they may bleed. In its more serious form, called periodontitis, the gums can pull away from the tooth, bone can be lost, and the teeth may loosen or even fall out. Transparency Market Research reported that the global periodontal treatment market size was valued at $7.6 billion in 2021 and North America held the major market share in 2021.

Respiratory tract infection — The United States respiratory tract infection therapeutic market size was estimated at $9 billion in 2022 and is expected to reach $9.9 billion in 2023, projecting a growth at a CAGR of 8.42% to reach $17 billion by 2030, according to an article by Report Linker. Estimated annual costs for viral upper respiratory infections in the United States, not related to influenza, exceeds $22 billion.

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Our Strategy

Our goal is to become the leading provider of topical NO treatments using our proprietary Ionojet device for various therapeutic purposes, including as an anti-infective, anti-inflammatory and tissue-regenerative therapy for chronic wounds and SSTIs.

Key elements of our strategy are as follows:

•Complete the final prototype of our Ionojet device.    Based upon clinician feedback and the results of our feasibility trial, we were able to identify several desirable changes that we believe will enhance commercial adoption of the Ionojet, and we have been working on the reengineered design of our device in our own facility. We have made what we believe are significant improvements to our Ionojet technology, all of which we are seeking to protect with new U.S. and international patent filings, and which will require FDA approval of an IDE to initiate our pivotal clinical trial.

•Pivotal trial.    Complete a pivotal clinical trial in diabetic foot ulcers and seek premarket approval of Ionojet from the FDA as a Class III medical device, utilizing a portion of the net proceeds of this offering and securing additional funding. The pivotal trial data, if favorable, will be the primary basis for FDA approval. Conversely, if the data are not favorable, then FDA approval is unlikely. However, the FDA may require additional trials, and there is no assurance that the FDA will approve a PMA in our anticipated timeline after completion of the planned pivotal trial, if at all.

•Create a commercial infrastructure for our product candidates.    If the Ionojet is approved as a Class III medical device, we intend to hire and train a focused and dedicated team to launch the marketing of our product to hospitals, wound clinics and private podiatrist offices for the treatment of diabetic foot ulcers. We also intend to use a trained and dedicated team, and/or to enter into marketing partnerships, to launch the marketing of our Ionojet technology for any additional indications that may receive regulatory approval and any of our future product candidates.

•Expand indications for use.    We believe that our technology has application in many indications in wound healing, as well as in dermatology, infection control, podiatry, dentistry, pain and inflammation and cosmetics. We believe that our technology could also have value in respiratory infections, both viral and bacterial, oral infections, dental indications, ophthalmic and facial applications and in topical indications where the modified stream allows greater comfort to the patient.

•Strategic Partnerships.    We are exploring the possibility of entering into strategic partnering arrangements to provide further financing for our pivotal clinical trial and for formal clinical studies into other pipeline indications, to supplement the proceeds of this offering.

Competition

While we believe that our proprietary patented high-energy plasma device that generates NO in the form of a plasma/NO stream is the first technology of its kind in the United States market, we believe other companies developing different forms of NO therapies to treat diabetic foot ulcers to be our closest competitors. One such competitor, SaNOtize Research and Development Corp., based in Vancouver, Canada, is recruiting patients for a Phase I/II efficacy study to evaluate its NO releasing footbath as a treatment for diabetic foot ulcer. Edixomed Ltd., a United Kingdom company, is developing a NO generating gel wound dressing to treat diabetic foot ulcers.

Recent Developments

First Private Placement

On June 20, 2022, we commenced a private placement (the “Private Placement”) of up to $5,000,000 of convertible promissory notes, pursuant to which we issued: (i) convertible promissory notes in the principal aggregate amount of $450,000 on June 30, 2022; (ii) convertible promissory notes in the principal aggregate amount of $60,000 on August 16, 2022; (iii) convertible promissory notes in the principal aggregate amount of $725,000 on September 23, 2022; (iv) convertible promissory notes in the principal aggregate amount of $315,000 on October 25, 2022; (v) convertible promissory notes in the principal aggregate amount of $288,000 on November30, 2022; and (vi) a convertible promissory note in the principal amount of $101,749.70 on December21, 2022 (collectively, the “Private Placement Notes”). The promissory note issued in December 2022 was

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pursuant to a Subscription Agreement that was executed on or before November30, 2022. In total, the aggregate principal amount of the Private Placement Notes issued in the Private Placement is $1,939,749.70, pursuant to which we received net proceeds of approximately $1,600,000. The Private Placement has terminated. The Private Placement Notes bear interest at 6% per annum and mature three years from the date of issuance. The principal amount due under the Private Placement Notes will be automatically converted into shares of our common stock upon the effectiveness of the registration statement of which this prospectus is a part, with all accrued interest under the Private Placement Notes waived upon conversion pursuant to the terms thereof. The Private Placement Notes are convertible into shares of common stock at a conversion price equal to the quotient obtained by dividing (i) the entire principal amount of the Private Placement Notes plus (if applicable) any accrued but unpaid interest under the Private Placement Notes by (ii) 50% of the initial offering price per share. The holders of the Private Placement Notes are prohibited from converting the Private Placement Notes if such conversion would result in a holder owning in excess of 4.99% of our outstanding common stock. The holders of the Private Placement Notes have agreed not to publicly sell or assign such common stock for a period of 180 days following completion of this offering.

Boustead Securities, LLC, the sole book-running manager of this offering, acted as the placement agent for the Private Placement and received a placement fee equal to 7.0% of the gross proceeds received by us from the sale of the Private Placement Notes, a non-accountable expense allowance equal to 1.0% of the gross proceeds received by us from the sale of the Private Placement Notes and five-year warrants to purchase shares of our common stock at an exercise price of $7.50 per share in an amount equal to 7.0% of the shares of common stock underlying the Private Placement Notes. See “Underwriting — Prior Relationship with Boustead Securities, LLC” for more information.

Second Private Placement

In May 2023, we commenced a private placement offering of up to 425,000shares of our common stock at a purchase price of $2.00 per share (the “Second Private Placement”). Between May30, 2023 and June30, 2023, eleven accredited investors, all of whom had a pre-existing relationship with us and/or Boustead Securities, LLC, purchased an aggregate of 424,800shares of common stock for gross proceeds to us of $849,600 (net proceeds of $781,632). On June30, 2023, we terminated the Second Private Placement with only 200shares remaining to be sold in the offering.

Boustead Securities, LLC, the sole book-running manager of this offering, acted as the placement agent for the Second Private Placement and received a placement fee equal to 7.0% of the gross proceeds received by us from the sale of the shares of common stock and a non-accountable expense allowance equal to 1.0% of the gross proceeds received by us. See “Underwriting — Prior Relationship with Boustead Securities, LLC” for more information.

Third Private Placement

In August 2023, we commenced a private placement offering of up to 2,000,000shares of our common stock at a purchase price of $2.50 per share (the “Third Private Placement”). As of the date of this filing, one accredited investor who had a pre-existing relationship with us, has purchased 20,000shares for gross proceeds of $50,000 (net proceeds of $46,000). The funds received in the Third Private Placement are being used for our short-term working capital needs pending the completion of this offering.

Boustead Securities, LLC, the sole book-running manager of this offering, is acting as the placement agent for the Third Private Placement and will receive a placement fee equal to 7.0% of the gross proceeds received by us from the sale of the shares of common stock and a non-accountable expense allowance equal to 1.0% of the gross proceeds received by us. See “Underwriting — Prior Relationship with Boustead Securities, LLC” for more information.

Amendments to Certificate of Incorporation

On March1, 2023, we filed a certificate of revival (the “Certificate of Revival”) to reinstate our amended and restated certificate of incorporation, as amended (the “Amended and Restated Certificate of Incorporation”), and to change the name of our corporation to Origin Life Sciences, Inc.

On March8, 2023, we filed a certificate of amendment (the “March Certificate of Amendment”) to our Amended and Restated Certificate of Incorporation for purposes of providing for the conversion of all outstanding shares of our special voting common stock (the terms of which are described under “Description of Securities — Summary of Charter and Bylaws In Effect Prior to Completion of this Offering — Common Stock and Special Voting Common Stock”) to common stock effective immediately upon filing thereof. Upon filing of the March Certificate of Amendment, all 8,936,000 outstanding shares of our special voting common stock were converted into 8,936,000shares of our common stock.

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On March8, 2023, we filed a certificate of elimination (the “Certificate of Elimination”) of our Series A 8% Convertible Preferred Stock (the “Series A Preferred Stock”), at which time the 30,000shares that had been designated as Series A Preferred Stock were returned to the status of authorized but unissued shares of our preferred stock.

On April28, 2023, we filed a certificate of amendment to our Amended and Restated Certificate of Incorporation for purposes of increasing the authorized shares of our common stock to two hundred million (200,000,000) and, immediately thereafter, we filed another certificate of amendment to our Amended and Restated Certificate of Incorporation for purposes of effecting a two hundred (200) for one (1) forward stock split of our outstanding shares of common stock such that, upon the filing thereof, each issued and outstanding share of our common stock was subdivided and reclassified into two hundred (200) validly issued, fully paid and non-assessable shares of our common stock.

Commercialization Agreement

On September15, 2023, we entered into a non-exclusive Commercialization Agreement (the “Commercialization Agreement”) with IIPRD, an Indian Partnership Firm that provides services related to the licensing of technologies. IIPRD is affiliated with Khurana & Khurana, a leading Indian firm of patent attorneys. The Commercialization Agreement may be terminated by either party upon seven days written notice to the other party. Pursuant to the Commercialization Agreement, IIPRD will assist Origin in identifying potential licensees or purchasers in India who may be interested in licensing or purchasing our Ionojet technology. If we enter into an agreement to license or sell our Ionojet technology with or to a person or entity in India who was introduced to us by IIPRD (an “IIPRD Prospect”) while the Commercialization Agreement remains in effect and for one year after termination thereof, we have agreed to pay IIPRD commissions ranging from 5% to 10% of the total gross consideration paid to us pursuant to any such licensing or purchase agreement. We have also agreed to pay IIPRD reduced commissions ranging from 2.5% to 5% if we enter into a license or purchase agreement with an IIPRD Prospect within 13 to 24months of termination of the Commercialization Agreement and commissions ranging from 1.25% to 2.5% if we enter into any such agreement with an IIPRD Prospect within 25 to 36months of termination of the Commercialization Agreement.

Financial Advisor Retention

The Life Sciences Division Ltd, a financial institution regulated by the Financial Conduct Authority in the United Kingdom, has been retained by us to provide advisory services. The Life Sciences Division Ltd, may be paid advisory fees in connection with this offering in the total amount of 5% of the gross proceeds received from investors in this offering referred by The Life Sciences Division Ltd. The Life Sciences Division Ltd is not a member of the Financial Industry Regulatory Authority. A portion of the advisory fees payable to The Life Sciences Division Ltd (2% of the gross proceeds received from investors in this offering referred by The Life Sciences Division Ltd) will be paid out of the underwriting commissions payable to the underwriters for this offering and 3% of the gross proceeds received from investors in this offering referred by The Life Sciences Division Ltd will be paid by us.

Summary of Risks Associated with Our Business

Our business is subject to numerous risks and uncertainties, including those highlighted in the section entitled “Risk Factors” immediately following this prospectus summary. These risks include, among others, the following:

Risks Related to Our Financial Position and Need for Capital

•We are a clinical-stage biotechnology company that has generated losses from operations;

•We are a clinical-stage company and to date we have not commercialized our medical technology;

•We have a history of operating losses;

•We have a relatively limited operating history and may not be able to execute on our business strategy;

•Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern;

•We believe that the proceeds of this offering, combined with our very limited funds currently on hand, will only be sufficient for us to operate for a relatively limited amount of time; and

•We expect to derive all our revenues from our principal technology.

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

•The regulatory approval process is expensive, time-consuming and uncertain;

•We may be unable to complete our clinical trials, and the data generated may not support FDA approval;

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•We may fail to obtain and maintain necessary marketing authorizations from regulatory authorities;

•New or reformed legislation and regulations may make it difficult to obtain marketing authorization;

•After approval of Ionojet, Ionojet will remain subject to ongoing regulatory obligations and review;

•The device used in our clinical trials is not the same device that we plan to use in our pivotal trial;

•Modifications to our products may require new marketing authorizations;

•Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations;

•Delays or failures in our clinical trials or investigations may prevent us from commercializing products;

•Our facilities are subject to regulation under the FDCA and FDA implementing regulations;

•We and our manufacturers are subject to extensive post-market regulation;

•Disruptions at the regulatory agencies could negatively impact our business;

•If we are found to have improperly promoted off-label uses, we may become subject to significant liability;

•Our business is subject to U.S. and foreign laws and regulations regarding privacy and data protection;

•If the third-parties or consultants do not successfully carry out their contractual duties, we may be unable to obtain regulatory approval for our product candidates;

•Data obtained from clinical trials are susceptible to varying interpretations or may be unfavorable;

•If the third-parties we rely upon fail to comply with stringent regulations, we may face delays;

•We may be required to redesign the device, and we may have insufficient resources to do so;

•Our Ionojet platform may contain undetected errors;

•We face intense competition, and we may not be able to compete in our industry;

•The continuing development of our products depends upon strong working relationships with physicians;

•It may be difficult for us to establish market acceptance of our therapy;

•If we fail to respond quickly to technological developments, our therapy may become uncompetitive;

•Developing medical technology entails significant technical, regulatory and business risks;

•Complaints or negative reviews about us or our technology could harm our reputation and brand;

•Healthcare regulatory reform may affect our ability to sell our products profitably;

•Product liability suits could be brought against us;

•Delays in the enrollment of patients in our clinical trials could increase costs and cause delays;

•If serious adverse effects are identified with respect to any of our product candidates or any of our approved products, we may need to modify or abandon our development of that product candidate;

•If we violate healthcare fraud and abuse laws we may be subject to penalties;

•Our ability to generate revenue will be diminished if we are unable to obtain adequate prices for the therapy; and

•The size and expected growth of our available market has not been established with precision.

Risks Related to Our Intellectual Property

•Our failure to maintain intellectual property would materially impact our business plan;

•Costly litigation may be necessary to protect our intellectual property rights;

•Involvement in opposition proceedings in foreign countries, may require spending of substantial sums and management resources; and

•Confidentiality agreements may not adequately prevent disclosure of trade secrets.

Risks Related to Our Industry

•We intend to utilize third-party providers which could delay or limit our ability to generate revenue;

•Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities;

•If we are unsuccessful in establishing a marketing team for Ionojet, our revenue and profits will be limited;

•We may rely on collaborations and license arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue;

•Our reliance on vendors in foreign countries, including China, subjects us to risks and uncertainties;

•International trade disputes could result in tariffs and other protectionist measures;

•The COVID-19 global health crisis may impact our planned operations, including our pivotal clinical trial;

•Our actual or perceived failure to comply with consumer protection laws could harm our business;

•Technological change may adversely affect commercialization of our products; and

•Consolidation in the medical device industry could have an adverse effect on our business.

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Risks Related to Ownership of Our Common Stock

•An active public trading market for our common stock may not develop or be sustained;

•We cannot be assured that we will be able to maintain our listing on NYSE;

•Our stock price may be extremely volatile;

•Stock prices in recent initial public offerings have been volatile;

•If analysts do not publish favorable reports about us, our stock price could decline;

•After this offering, our officers, directors, and principal stockholders will continue to exercise significant control over our Company;

•Future sales of common stock could depress the market price of our common stock;

•The offering price of the shares and the other terms of the initial public offering have been determined through negotiations between us and the underwriter;

•New investors will experience dilution;

•Our ability to use our net operating losses and carryforwards may be limited;

•Our second amended and restated charter documents, to be in effect prior to the effectiveness of this offering, will have anti-takeover provisions and provide for Delaware Chancery Court as the exclusive forum;

•Our management has broad discretion in the use of the net proceeds from this offering;

•Certain of our related parties will directly benefit from the proceeds of this offering;

•Claims for indemnification by our directors and officers may reduce our available funds;

•We do not intend to pay dividends in the foreseeable future;

•We will incur significant increased costs as a result of operating as a public company; and

•We are an emerging growth company and smaller reporting company and as such we have reduced disclosure requirements, which may make our common stock less attractive to investors.

General Risk Factors

•Our performance will depend on the continued engagement of key members of our management team;

•If we are not able to attract and retain highly-skilled personnel our business could be harmed;

•We may experience difficulties in managing the growth of our organization;

•If product liability lawsuits are brought against us, we may incur substantial liabilities;

•Our business and operations would suffer in the event of computer system failures;

•Any failure to maintain the information security could expose us to litigation or government action;

•Joint ventures or investments in other companies or technologies could harm our business; and

•Declining general economic or business conditions may have a negative impact on our business.

Corporate History and Information

We were incorporated as a Delaware corporation on June 14, 2010 under the name Plasma Jet Technologies, Inc. and on September 18, 2014 we changed our name to Advanced Plasma Therapies, Inc. pursuant to an amended and restated certificate of incorporation. On October 8, 2015, we filed a certificate of amendment changing our name to Origin, Inc. On March1, 2023, we filed a Certificate of Revival to reinstate our Amended and Restated Certificate of Incorporation and to change the name of our corporation to Origin Life Sciences, Inc. References to Origin Life Sciences, Inc. also include references to our wholly owned subsidiaries: (i) Advanced Plasma Therapies, Inc., incorporated in Delaware; (ii) Origin Life Sciences Limited, incorporated in England and Wales; and (iii) Origin Agribusiness Limited, incorporated in England and Wales. On April28, 2023, we increased the authorized shares of our common stock to two hundred million (200,000,000) and, immediately thereafter, effected a two hundred (200) for one (1) forward stock split of our outstanding shares of common stock, pursuant to the filing of two certificates of amendment to our Amended and Restated Certificate of Incorporation.

Our principal executive offices are located at 2 Research Way, Third Floor, Princeton, NJ 08540, and our telephone number is 610-250-6000. Our website address is www.originww.com. The information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our common stock.

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Implications of Being an Emerging Growth Company and a Smaller Reporting Company

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). For as long as we remain an emerging growth company, we may take advantage of specified reduced reporting requirements and other burdens that are otherwise applicable generally to other public companies. These provisions include, but are not limited to:

•Reduced obligations with respect to financial data, including presenting only two years of audited financial statements and selected financial data, and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in our initial registration statement;

•an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended (“SOX”);

•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 stockholder approval of any golden parachute arrangements.

We may take advantage of some or all of these provisions until we are no longer an emerging growth company. 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 $1.235 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 date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission (the “SEC”). We may choose to take advantage of some but not all of these reduced burdens. For example, we have taken advantage of the reduced reporting requirements with respect to disclosure regarding our executive compensation arrangements, have presented only two years of audited financial statements and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus, and have taken advantage of the exemption from auditor attestation on the effectiveness of our internal control over financial reporting. To the extent that we take advantage of these reduced burdens, the information that we provide stockholders may be different than you might obtain from other public companies in which you hold equity interests.

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 have elected to use this extended transition period. As a result of this election, our timeline to comply with new or revised accounting standards will in many cases be delayed as compared to other public companies that are not eligible to take advantage of this election or have not made this election. Therefore, our financial statements may not be comparable to those of companies that comply with the public company effective dates for these accounting standards.

We are also a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, certain of the exemptions available to us as an “emerging growth company” may continue to be available to us as a “smaller reporting company,” including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation arrangements. We will continue to be a “smaller reporting company” until we have $250 million or more in public float (based on our common stock) measured as of the last business day of our most recently completed second fiscal quarter or, in the event we have no public float (based on our common stock) or a public float (based on our common stock) that is less than $700 million, annual revenues of $100 million or more during the most recently completed fiscal year.

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The offering

Share information presented below reflects a 200-for-1 forward stock split of our common stock, which was effected on April 28, 2023.

Common stock offered by us	3,000,000shares
Common stock outstanding immediately before this offering	40,052,800shares (as of September29, 2023)
Common stock to be outstanding immediately after this offering	43,982,980shares (or 44,432,980shares if the underwriters exercise their option to purchase additional shares in full).
Option to purchase additional shares	We have granted the underwriters an option for a period of 45 days from the date of this prospectus to purchase up to 450,000 additional shares of common stock from us.
Use of proceeds	We estimate that the net proceeds to us from this offering before making the payments set forth below will be approximately $12.6million, or approximately $14.9million if the underwriters exercise in full their option to purchase additional shares of common stock, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $5.00 per share.
	We intend to use a portion of the net proceeds from this offering as follows: (i) approximately $3,000,000 to fund our ongoing clinical program for Ionojet, of which approximately $2,200,000 will be used for completion of the reengineered design of the Ionojet technology and submission of a new IDE for our pivotal trial in diabetic foot ulcers; (ii) $1,749,452 for the redemption of all outstanding shares of the Series B Preferred Stock, including accumulated dividends calculated through September30, 2023, which amount may be increased by a premium payment up to an additional $1million pursuant to the terms of an agreement with the holder of the Series B Preferred Stock if the net proceeds of the initial public offering exceed $15million; (iii) $411,883 in full satisfaction of the amount owed under the LFEIF Note, including interest calculated through September30, 2023, the terms of which are described under “Description of Securities — Convertible Promissory Notes”; (iv) approximately $170,000 in repayment of loans which will be repaid to related parties; (v) approximately $974,000 in payment of deferred salaries in cash, calculated through September30, 2023, over the 18months subsequent to this offering, of which approximately $500,000 will be paid to related parties; (vi) approximately $300,000 in advisory fees to be paid in connection with this offering (see “Advisors”), which represents 3% of the gross proceeds expected to be raised by the Advisors; (vii) approximately $613,000 of prior periods’ accounts payable; and (viii) the balance for working capital, research and development and other general corporate purposes, which may include the acquisition or licensing of other products, businesses or technologies. See “Use of Proceeds” for additional information.

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Representative’s warrants	The registration statement of which this prospectus is a part also registers for sale warrants (the “Representative’s Warrants”) to purchase shares of our common stock that we will issue to Boustead Securities, LLC, as the representative of the underwriters (the “Representative”), as a portion of the underwriting compensation payable to the underwriters in connection with this offering. The Representative’s Warrants are exercisable commencing six months after the date of effectiveness of the registration statement of which this prospectus forms a part and will be exercisable for a period of five years from such effective date at an exercise price equal to 125% of the initial public offering price of the common stock. Please see “Underwriting — Representative’s Warrants” for a description of the Representative’s Warrants.
Risk factors	See “Risk Factors” beginning on page 17 and the other information included in this prospectus for a discussion of factors you should consider carefully before deciding to invest in our common stock.
Proposed NYSE American symbol	We have applied to list our common stock for trading on NYSE American under the symbol “OLSI.” This offering will not be consummated until we have received NYSE American’s approval of our application for the listing of our common stock. No assurance can be given that our application will be approved.

Unless otherwise stated in this prospectus, the number of shares of common stock to be outstanding after this offering, is based on 40,052,800shares of common stock outstanding as of September29, 2023, and includes:

•the conversion of the remaining outstanding Private Placement Notes, in the principal amount of $1,939,749.70, into an aggregate of 775,900shares of common stock at a conversion price of $2.50 per share, which is 50% of the assumed initial public offering price of $5.00 per share, upon the effectiveness of the registration statement of which this prospectus is a part;

•the sale of 3,000,000shares of common stock in this offering, assuming an initial public offering price of $5.00 per share of common stock;

•the issuance of 91,880shares of common stock in repayment of an aggregate of $459,400 of outstanding loans pursuant to agreements with the holders of such loans upon consummation of this offering; and

•the issuance of 62,400shares of common stock in consideration for $312,000 of outstanding accounts payable upon consummation of this offering;

and such number of shares to be outstanding after this offering excludes the following:

•4,500,400shares of common stock issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $2.83 per share;

•2,866,600shares of common stock issuable upon the exercise of outstanding warrants at a weighted-average exercise price of $2.62 per share;

•2,075,200shares of common stock reserved for future issuance under our 2014 Equity Incentive Plan (the “2014 Plan”), which shares will no longer be available for future issuance upon the effectiveness of the 2023 Stock Incentive Plan (the “2023 Plan”);

•5,000,000shares of common stock, which will be reserved for future issuance under the 2023 Plan upon the effectiveness thereof;

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•18,104shares of common stock issuable upon exercise of outstanding warrants issued to Boustead Securities, LLC, as placement agent for the Private Placement;

•180,000shares of common stock (or 207,000shares of common stock if the underwriters exercise their over-allotment option in full) issuable upon exercise of the Representative’s Warrants, which are expected to be issued to the Representative in connection with this offering;

•1,195,075shares of common stock issuable upon the exercise of warrants to be issued in exchange for deferred salaries and bonuses to officers and current and former employees in the aggregate amount of $5,975,357 upon consummation of this offering;

•225,664shares of common stock issuable upon the exercise of warrants to be issued in exchange for accrued consulting fees and commissions in the aggregate amount of $1,128,320 upon consummation of this offering;

•72,000shares of common stock issuable upon the exercise of warrants to be issued in exchange for $360,000 of deferred director fees upon consummation of this offering; and

•10,000shares of common stock issuable upon the exercise of a warrant to be issued in exchange for $50,000 of outstanding accounts payable upon consummation of this offering.

Unless otherwise indicated, all information in this prospectus assumes and reflects the following:

•The automatic conversion of the Private Placement Notes upon the effectiveness of the registration statement of which this prospectus is a part, in the amount of $1,939,749.70, into an aggregate of 775,900shares of our common stock, at a conversion price of $2.50 per share, which is 50% of the assumed initial public offering price of $5.00 per share;

•The redemption of 10,000shares of Series B 20% Preferred Stock (the “Series B Preferred Stock”) outstanding, at the price of $100 per share, plus accumulated dividends, pursuant to an agreement with the holder of the Series B Preferred Stock, which shall be paid out of the proceeds of this offering;

•The repayment of the LFEIF Note, which shall become due and payable thirty (30) days after the closing of this offering if not earlier converted at the direction of LFEIF;

•No exercise of the underwriters’ option to purchase up to an additional 450,000shares of common stock;

•No exercise of the Representative’s Warrants to be issued to the Representative upon completion of this offering;

•No exercise of any other outstanding warrants or stock options; and

•The filing and effectiveness of our second amended and restated certificate of incorporation and the effectiveness of our second amended and restated bylaws, which will occur prior to the effectiveness of this offering.

In addition, unless otherwise indicated, all share information reflects a 200-for-1 forward stock split of our common stock, which was effected on April28, 2023. The share and per share information in the financial statements and the related notes thereto included elsewhere in this prospectus have been adjusted to reflect the 200-for-1 forward stock split of our common stock.

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SUMMARY FINANCIAL DATA

The following table summarizes the relevant financial data for our business and should be read with our financial statements, which are included in this prospectus. We have derived the summary financial data for the years ended December 31, 2022 and 2021 from our audited consolidated financial statements and related notes and for the six months ended June30, 2023 and 2022 from our unaudited condensed consolidated interim financial statements, each included elsewhere in this prospectus. Our historical results are not necessarily indicative of results that may be expected in the future. You should read the following summary consolidated financial data together with our financial statements, and the related notes, included elsewhere in this prospectus and the information in the sections titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

	Year ended December 31,						Six Months Ended June 30,
	2022			2021			2023 (unaudited)			2022 (unaudited)
Operating Expenses
Salaries & benefits (including share-based compensation)	$	1,954,851		$	4,322,259		$	909,154		$	1,239,496
Consulting (including share-based compensation)	$	521,297		$	1,624,709		$	109,395		$	236,002
Other general and administrative	$	403,407		$	433,929		$	317,665		$	188,447
Research and development	$	52,139		$	9,848		$	10,689		$	666
Amortization	$	93,023		$	93,023		$	46,512		$	46,512
Total Operating Expenses	$	3,024,717		$	6,483,768		$	1,393,415		$	1,711,123
Forgiveness of paycheck protection program loan	$	183,737		$	201,250		$	—		$	183,737
Warrant Expense	$	(5,886,390	)	$	—		$	(26,788	)	$	(2,799,981	)
Interest Expense	$	(112,981	)	$	(50,123	)	$	(144,802	)	$	(25,000	)
Loss before Taxation	$	(8,840,351	)	$	(6,332,641	)	$	(1,565,005	)	$	(2,641,244	)
Provision for Taxation	$	—		$	—		$	—		$	—
Net loss	$	(8,840,351	)	$	(6,332,641	)	$	(1,565,005	)	$	(4,352,367	)
Net loss per common share – basic and diluted	$	(0.31	)	$	(0.23	)	$	(0.05	)	$	(0.15	)
Pro forma net loss per common share, basic and diluted (unaudited)	$	(0.25	)	$	(0.12	)	$	(0.03	)	$	(0.12	)

Balance Sheet Data:	June 30,2023			Pro Forma(1)			Pro Forma,As Adjusted(2)
Working capital	$	(9,982,973	)	$	(9,857,173	)	$	7,369,052
Total assets	$	2,155,592		$	2,201,592		$	11,440,257
Total liabilities	$	15,606,127		$	15,526,327		$	5,160,661
Stockholder’s (deficit)/equity	$	(14,450,535	)	$	(14,320,735	)	$	8,233,049

____________

(1)The pro forma balance sheet data in the table above gives effect to: (i) on August 18, 2023, the issuance of 20,000 shares of common stock to an investor in the Third Private Placement and the receipt of $46,000 in net cash proceeds; (ii) on September 7, 2023, the issuance of 11,400 shares of common stock to an investor whose funds were received in 2020 but who did not provide a subscription agreement until that date.

(2)The pro forma, as adjusted balance sheet data in the table above reflects the items described in footnote (1) above and gives effect to: (i) the sale and issuance by us of 3,000,000shares of our common stock in this offering, based upon the assumed initial public offering price of $5.00, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us; (ii) conversion of the Private Placement Notes upon the effectiveness of the registration statement of which this prospectus is a part into an aggregate of 775,900 shares of our common stock, at a conversion price of $2.50 per share, which is 50% of the assumed initial public offering price of $5.00 per share; (iii) the payment of $1,749,452 upon the redemption of 10,000 shares of Series B Preferred Stock currently outstanding, at the price of $100 per share, including accumulated dividends calculated through September 30, 2023, pursuant to an agreement with the holder of the Series B Preferred Stock; (iv) repayment of $411,883 in full satisfaction of the amount owed under the LFEIF Note, including interest calculated through September 30, 2023, which shall become due and payable thirty (30) days after the

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closing of this offering if not earlier converted at the direction of LFEIF; (v) the issuance of 91,880shares of common stock in repayment of an aggregate of $459,400 of outstanding loans pursuant to agreements with the holders of such loans upon consummation of this offering; (vi) a reduction of liability in the amount of $5,975,357 as a result of the issuance of warrants to purchase an aggregate of 1,195,075shares of common stock in exchange for deferred salaries and bonuses calculated through September 30, 2023 upon consummation of this offering; (vii) a reduction of liability in the amount of $1,128,320 as a result of the issuance of warrants to purchase an aggregate of 225,664 shares of common stock in consideration for accrued consulting fees and commissions upon consummation of this offering; (viii) the issuance of 62,400 shares of common stock in consideration for $312,000 of outstanding accounts payable upon consummation of this offering; (ix) a reduction of liability in the amount of $360,000 as a result of the issuance of warrants to purchase 72,000 shares of common stock in consideration for deferred director fees upon consummation of this offering; and (x) a reduction of liability in the amount of $50,000 as a result of the issuance of a warrant to purchase 10,000 shares of common stock in consideration of outstanding accounts payable upon consummation of this offering.

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Risk factors

Investing in our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, together with all the other information in this prospectus, including our financial statements and the related notes included elsewhere in this prospectus, before purchasing our common stock. If any of the following risks actually occurs, our business, operating results, financial condition, liquidity and prospects could be materially adversely affected. As a result, the trading price of our common stock could decline and you could lose part or all of your investment. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, operating results, financial condition, liquidity and prospects.

Risks Related to Our Financial Position and Need for Capital

We are a clinical-stage biotechnology company that has generated minimal revenue to date and has only generated losses from operations. We are therefore subject to the significant risks associated with such a company.

We are a clinical-stage biotechnology company that was formed in 2010 and have generated minimal revenue to date, and since inception we have only generated losses from operations. As of June 30, 2023 and December31, 2022, we had only approximately $432,000 and $606,000, respectively, in cash and cash equivalent resources (including restricted cash) and are thus presently only conducting relatively limited operations. We will therefore require the proceeds of this offering or other funding to move our business plan forward. We are a clinical-stage company with no meaningful history of operations, and our only assets consist of a small number of plasma/NO devices, our limited cash and cash equivalents, and our intellectual property related to our proposed therapy. We have to complete clinical trials and receive regulatory approval of our medical device and related therapies before commercial sales of our therapy can commence. The likelihood of success of our business plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with building and expanding similar businesses and the regulatory and competitive environment in which we operate. Medical technology development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.

Therefore, we are and expect for the foreseeable future to be, subject to all the significant risks and uncertainties inherent in a clinical-stage, pre-revenue medical technology business seeking regulatory approval for medical devices and related therapies. As a result, we still must establish many functions necessary to operate a business, including conducting necessary clinical trials, continuing product and technology development, implementing financial systems and controls and personnel recruitment. Even if we achieve regulatory approval for our therapy (of which no assurances can be given), we will need to establish commercial operations, which is also risky and uncertain.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the later stage of development, especially clinical biotechnical companies such as ours.

Potential investors should carefully consider the risks and uncertainties that our company will face. In particular, potential investors should consider that we cannot assure you that we will be able to:

•successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our therapy;

•secure acceptance of our therapy candidate in the medical community and with third-party payors and consumers;

•if approved for commercial sale, launch commercial sales of our product therapy, whether alone or in collaboration with others;

•successfully build an internal marketing team meeting our requirements for the launch of our therapy candidate;

•successfully manufacture our medical technology and establish commercial sales;

•secure market exclusivity and/or adequate intellectual property protection for our medical technology;

•attract and retain an experienced management, board and scientific advisory team;

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•successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound; and

•raise sufficient funds in the capital markets to effectuate our business plan.

If we cannot successfully execute any one of the foregoing, our business may not succeed and your investment will be adversely affected.

We are a clinical-stage company and to date we have not commercialized our medical technology.

We are a clinical-stage company and to date we have not commercialized our medical technology. Our success is dependent upon our ability to obtain regulatory approval for and commercialize our medical technology and related therapies. To date, we have not been granted regulatory approval for our medical technology. In order to obtain regulatory approval and successfully commercialize our medical technology, we will have to overcome risks frequently encountered in our industry and are still subject to many of the risks common to such enterprises, including our ability to implement our business plan, market acceptance of our proposed business and lead medical technology and therapies, under-capitalization, cash shortages, limitations with respect to personnel, financing and other resources, competition from better funded and experienced companies, and uncertainty of our ability to generate revenues. There is no assurance that our activities will be successful or will result in any revenues or profit, and the likelihood of our success must be considered in light of the stage of our development. In addition, no assurance can be given that we will be able to consummate our business strategy and plans, or that financial, technological, market, or other limitations may force us to modify, alter, significantly delay, or significantly impede the implementation of such plans. Investors should consider our prospects in light of the risk, expenses and difficulties we will encounter as a clinical-stage company. Our revenue and income potential is unproven and our business model is continually evolving. We are subject to the risks inherent to the operation of a development stage business enterprise and cannot assure you that we will be able to successfully address these risks.

We have a history of operating losses and expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if we do, be able to sustain profitability.

To date, we have only generated minimal revenue from operations and we expect to continue to incur significant operating losses in connection with the development our medical technology. We may continue to incur operating losses until such time, if ever, as we are able to achieve sufficient levels of revenue from operations. Our ability to achieve profitability will depend on regulatory approval of our medical technology and if approved, the market acceptance of our product offering and our capacity to develop, introduce and sell our product to our targeted markets. There can be no assurance that we will ever generate significant sales or achieve profitability. Accordingly, the extent of future losses and the time required to achieve profitability, if ever, cannot be predicted at this point.

Even if we succeed in developing and commercializing one or more medical technologies or therapies, we expect to incur substantial losses for the foreseeable future and may never become profitable. We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:

•continue to undertake the clinical trial for our medical technology and therapies;

•seek regulatory approvals for our medical technology and therapies;

•implement additional internal systems and infrastructure; and

•hire additional personnel.

We may not be able to generate revenue or achieve profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities and could prevent us from continuing as a going concern.

Even if we can secure such arrangements, we may continue to have obligations and expenses that exceed the revenue generated by these marketed products. In addition, we could incur significant development and other expenses if we were to make alterations to the manufacturing process for our medical technology, for preparation and submission of a supplemental information for such alterations, if required by the FDA, and in connection with the launch of our

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medical technology and therapies, if approved. Further, as we pursue FDA approval for our medical technology and therapies, we expect that our research and development expenses will continue to increase significantly as we advance our premarket approval process.

We have a relatively limited operating history and may not be able to execute on our business strategy.

We were originally incorporated in 2010 and began clinical trials of our therapy in 2016. Accordingly, we have a limited operating history, which makes an evaluation of our future prospects and execution ability difficult. Our revenue and income-producing potential is unproven, and our business model and strategy continue to evolve. Future revenues are contingent upon several factors, including, without limitation, our ability to develop and commercialize our Ionojet successfully, our ability to develop relationships with customers, as well as the clinical and market acceptance of our technology. We may need to make business decisions that could adversely affect our operating results, such as modifications to our pricing strategy, business structure or operations.

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

Our independent registered public accounting firm has issued a going concern opinion on our financial statements, expressing substantial doubt that we can continue as an ongoing business for the next twelve months after issuance of their report based on our current development plans and our operating requirements and us having suffered recurring losses from operations and having a net capital deficiency. As described in Note 1 of our accompanying audited financial statements for the year ended December31, 2022 as well as Note 1 of our accompanying unaudited financial statements for the quarter ended June 30, 2023, we anticipate that during 2023 we will not have sufficient capital and that our losses from operations and working capital deficiency raise substantial doubt about our ability as a going concern. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty. If we cannot raise the necessary capital to continue as a viable entity, we could experience a material adverse effect on our business and our stockholders may lose some or all of their investment in us.

Given our lack of current cash resources, revenue and cash flow, we will need to raise additional capital, which may be unavailable to us or, even if raised, may cause dilution or place significant restrictions on our ability to operate.

We believe that the proceeds of this offering, combined with our very limited funds currently on hand, will only be sufficient for us to operate for a relatively limited amount of time. Since we will be unable to generate sufficient, if any, revenue or cash flow to fund our operations for at least several years, we will need to seek additional equity or debt financing to provide the capital required to implement our business plan.

We believe that the proceeds of this offering, combined with our very limited funds currently on hand, will only be sufficient for us to operate for a relatively limited amount of time. Since we will be unable to generate sufficient, if any, revenue or cash flow to fund our operations for at least several years, we will need to seek additional equity or debt financing to provide the capital required to implement our business plan. We believe that the proceeds of this offering will only be sufficient for us to complete the reengineered design of the Ionojet and prepare the required new IDE submission for our pivotal trial in diabetic foot ulcers, but will not be sufficient to allow us to commence or complete the necessary pivotal trial which we estimate will cost approximately $15 million.

We do not currently have any arrangements or credit facilities in place as a source of funds, but we are exploring the possibility of entering into strategic partnering arrangements to provide further financing for our pivotal clinical trial, in addition to the proceeds of this offering. There can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all. If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be materially adversely affected.

If we raise additional capital by issuing equity securities, the percentage ownership of our existing stockholders will be reduced to the extent that they do not participate in such a raise or raises. Accordingly, these stockholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences and privileges senior to those of our common stock.

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Debt financing, if obtained, may involve agreements that include liens on our assets, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, could increase our expenses and require that our assets be provided as a security for such debt. Debt financing would also be required to be repaid regardless of our operating results.

If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our technologies or our proposed product, or to grant licenses on terms that are not favorable to us.

Funding from any source may be unavailable to us on acceptable terms, or at all. If we do not have sufficient capital to fund our operations and expenses, we may not be able to achieve our goals, which could lead to the failure of our business and the loss of your investment. We may also be required to liquidate or declare bankruptcy of our Company.

Any failure to raise capital in the future could have a negative impact on our financial condition and our ability to pursue our business strategies.

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

•the outcome, timing and cost of our current clinical trial to obtain regulatory approval for our medical technology and therapies in the United States;

•the degree and rate of market adoption of our medical technology and therapies, if approved;

•the emergence of new, competing technologies and therapies;

•the costs of R&D activities we undertake to develop new medical technologies and therapies for various indications;

•costs involved in preparing, filing, prosecuting, maintaining and enforcing patent, trademark and other intellectual property claims;

•the costs of commercialization activities, including sales, marketing and manufacturing;

•the costs of building an internal marketing team meeting our requirements for the launch of our medical technology and therapies, if approved;

•our ability to collaborate with third parties on the development and commercialization of our medical technology and therapies;

•the level of working capital required to support our growth; and

•our need for additional personnel, information technology or other operating infrastructure to support our growth and operations as a public company.

If we choose to pursue additional indications and/or geographies for any of our products or product candidates or otherwise expand more rapidly than we presently anticipate, we may also need to raise additional capital sooner than expected.

We expect to derive all our revenues from our principal technology, which leaves us subject to the risk of reliance on such technology, the clinical and consumer acceptance of which is unproven at this time.

We expect to derive all our revenues from the therapy delivered by our Ionojet technology. As such, any factor adversely affecting the use of our device, including the product release cycles, regulatory issues, market acceptance, product competition, claims that our technology infringes third party intellectual property rights, performance and reliability, reputation, price competition and economic and market conditions, would likely harm our operating results. We may be unable to develop other products utilizing our own or any alternative technology, which would likely lead to the failure of our business and the loss of your investment. It is not certain that our target customers will choose our technology for technical, cost, support or commercial reasons. If our target customers do not widely adopt and purchase our technology, our future growth will be limited. Further, our resources and investments may not be adequate to achieve the targeted level of sales set out in our business plan.

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Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

The regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our therapy.

The research, testing, manufacturing, labeling, approval, selling, marketing and distribution of medical devices are subject to extensive regulation by the FDA and non-U.S. regulatory authorities, which regulations differ from country to country.

We are not permitted to market our therapy in the United States until we receive premarket approval (“PMA”) from the FDA. We have not applied for, or received marketing approval of, our therapy for any indication. Obtaining PMA is a lengthy, expensive, and uncertain process. Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to permit a substantive review. If the FDA accepts the application for review, it has 180 days under the Federal Food, Drug, and Cosmetic Act(the “FDCA”) to complete its review of a PMA application, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. The upcoming pivotal clinical trial may not generate data that the FDA considers adequate to support approval. An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the FDA’s Quality System Regulation (the “QSR”). If the FDA fails to approve our therapy, we will be unable to market it for sale or lease.

Between 2013 and 2015, we engaged in extensive discussions with the FDA regarding how it plans to regulate our therapy, given that for U.S. regulatory purposes our therapy is part “drug” (i.e., the NO) and part “device” (the plasma/NO applicator). We believe we have come to agreement with the FDA that CDRH will take the lead in approving our device, consulting as needed with CDER. There is a risk that FDA could change its decision, which would likely cause delays or material changes to our clinical programs and would challenge our ability to obtain FDA approval of our therapy in a timely manner or at all.

In addition, failure to comply with FDA, non-U.S. regulatory authorities or other applicable U.S. and non-U.S. regulatory requirements may, either before or after product clearance or approval, if any, subject us to administrative or judicially imposed sanctions, including:

•restrictions on the products, manufacturers or manufacturing process;

•adverse inspectional observations (Form 483), warning letters or non-warning letters incorporating inspectional observations;

•civil and criminal penalties;

•injunctions;

•suspension or withdrawal of regulatory clearances or approvals;

•product seizures, detentions or import bans;

•voluntary or mandatory product recalls and publicity requirements;

•total or partial suspension of production;

•imposition of restrictions on operations, including costly new manufacturing requirements; and

•refusal to clear or approve pending applications or premarket notifications.

FDA and non-U.S. regulatory authorities can delay, limit or deny clearance or approval of a medical device, medicinal product or drug candidate for many reasons, including:

•the candidate may not be deemed safe or effective, in the case of a PMA application (such as will be required in the U.S. for our device);

•officials may not find the data from our clinical trials sufficient;

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•officials might not approve our third-party manufacturer’s processes or facilities; or

•FDA or other regulatory authorities may change their clearance or approval policies or adopt new regulations.

We may be unable to commence or complete our required clinical trials, or we may experience significant delays in completing such clinical trials, which could significantly delay our targeted approval and product launch timeframe and impair our viability and business plan.

In order to market our therapy, we will be required to complete additional clinical trials. The completion of our clinical trials could be delayed, suspended or terminated for several reasons, including but not limited to:

•our failure or inability to conduct the clinical trials in accordance with regulatory requirements;

•sites participating in the trials may drop out of the trial, which may require us to engage replacement sites which could result in delays;

•patients may not enroll in, remain in or complete, the clinical trials at the rates we expect (including, without limitation, as a result of the continuation of local, regional, national or international outbreaks of COVID-19 variants); and

•clinical investigators may not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol and good clinical practices.

If our clinical trials are delayed it will take us longer to ultimately achieve regulatory approval for and commercialize our therapy and generate revenues. Moreover, our development costs will increase if we have material delays in our clinical trials or if we need to perform more or larger clinical trials than planned.

If we fail to obtain and maintain necessary marketing authorizations from the FDA, other applicable foreign regulatory authorities, if marketing authorizations for future technology, technology modifications or enhancements, and indications are delayed or not issued, or if there are state, federal or international level regulatory changes, our commercial operations could be harmed.

Our Ionojet is subject to extensive regulation in the United States by the FDA and by corresponding state regulatory agencies and authorities. Likewise, our Ionojet will be subject to extensive medical device regulations and requirements in other countries. These regulations pertain to the design development, evaluation, manufacturing, testing, labeling, marketing sale, advertising, promotion, distribution, shipping and servicing of our products. These entities regulate and oversee record-keeping procedures, safety alerts, recalls, market withdrawals, removals and field corrective actions, post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to occur, could lead to death or serious injury, and product import and export.

The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. Further, the FDA, foreign regulatory agencies and U.S. state agencies have broad enforcement powers, and our failure to comply with state, federal and international regulations could lead to the issuance of warning letters or untitled letters, the imposition of injunctions, suspensions or loss of marketing authorizations, product recalls, safety alerts, termination of distribution, product seizures, consent decrees, civil penalties or import detention. In the most extreme cases, criminal sanctions or closure of our manufacturing facilities are possible.

The process of obtaining and maintaining marketing authorizations to market a medical device in the United States and other countries can be costly and time-consuming, and we may not be able to obtain or maintain these marketing authorizations on a timely basis, if at all. In addition, regulations regarding the development, manufacturing and sale of our products are subject to change. We cannot predict the impact, if any, that such changes might have on our business, financial condition and results of operations. Changes in existing laws or requirements or adoption of new laws or requirements could have a material adverse effect on our business, financial condition and results of operations. There can be no assurance that we will not incur significant costs to comply with applicable laws and requirements in the future or that applicable laws and requirements will not have a material adverse effect upon our business, financial condition and results of operations.

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New legislation and regulations and legislative and regulatory reforms may make it more difficult and costly for us to obtain marketing authorization of our new and modified products, to manufacture, market and distribute our products after marketing authorization is obtained and limit our ability to sell to our customers.

From time to time, legislation is drafted and introduced in the legislative bodies of the countries in which we may sell our therapies to revise the process for regulatory approval, clearance, authorization, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA 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. These modifications may have an effect on the way we conduct our business and these modifications may have an impact on the way we design and manufacture devices which could adversely affect our business, financial condition and results of operations.

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.

After approval of Ionojet, Ionojet will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional risk and expense.

Drug products and medical devices remain subject to the jurisdiction of the FDA and non-U.S. regulatory authorities after they have been approved. Even if we obtain regulatory approval of Ionojet and related therapies, the FDA and other regulatory authorities may impose significant restrictions on its indicated uses or marketing or the conditions of approval, or impose ongoing requirements for potentially costly and time-consuming post-approval trials, including additional clinical trials, and post-market surveillance to monitor safety and efficacy. Ionojet and related therapies, if approved, as well as our marketed products are subject to ongoing regulatory requirements governing the manufacturing, labeling, packaging, storage, distribution, safety surveillance, advertising, promotion, sampling, recordkeeping and reporting of adverse events and other post-market information. These requirements include registration with the FDA and continued compliance by our manufacturers with current Good Manufacturing Practice requirements (“cGMPs”) and current Good Clinical Practices requirements (“GCPs”) for any clinical trials that we conduct post-approval.

The device used in our clinical trials to date is not the same device that we plan to use in our pivotal trial or for commercialization.

Our pivotal trial should be carried out with the form of the device that will be marketed post-approval. From clinician feedback and our own observations, we were able to identify several desirable changes that we believe will enhance commercial adoption, and we have been working on the reengineered design of our device in our own facility. We have made what we believe are significant improvements to our Ionojet technology, however, there can be no assurance that the improvements will result in a device that is as effective as the Ionojet used in the prior clinical trials and that we will experience similar results with the new, improved Ionojet. There can be no assurance that the FDA will approve an IDE with the intended modifications.

Modifications to our products may require new marketing authorizations, and may require us to cease marketing or recall the modified products until marketing authorizations are obtained.

In the United States, any modification to an approved device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture, requires a new marketing authorization. The FDA regulations require every manufacturer to make this determination in the first instance, but the FDA may review such determinations and may not agree with our decisions regarding whether new marketing authorizations are necessary. If the FDA disagrees with our determination and requires us to submit new PMAs, for modifications to our previously cleared products for which we have concluded that new marketing authorizations are unnecessary, we may be required to cease marketing or to recall the modified products until we obtain marketing authorizations, and we may be subject to significant regulatory fines or penalties.

Environmental and health safety laws may result in liabilities, expenses and restrictions on our operations.

Federal, state, local and foreign laws regarding environmental protection, hazardous substances, climate change and human health and safety may adversely affect our business. Using hazardous substances in our operations, such as the use of NO, which can be rapidly oxidized in air at high concentrations to form nitrogen dioxide (NO2)

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(which at high concentrations can irritate airways in the human respiratory system), exposes us to the risk of accidental injury, contamination or other liability from the use, storage, importation, handling, or disposal of hazardous materials. If our or our contract manufacturers’ operations result in the contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and fines, and any liability could significantly exceed our insurance coverage and have a material adverse effect on our on our business, financial condition and results of operations.

Evolving climate change concerns or changes in regulations related to such concerns, including restrictions on the manufacture, supply, use and importation of NO, could subject us to additional costs, including the purchase of importation quotas and increased supply chain costs, and restrictions on the sales of our products. Furthermore, various jurisdictions and regulators may take different approaches to and impose differing or inconsistent requirements under environmental and climate change-related laws, which may make it more costly or difficult for us to sell our products (including by requiring that we monitor such developments, incur increased costs, increase time-to-market and develop additional country-specific variants for certain products) or prevent us from selling certain products in certain geographic markets. Future changes to environmental and health and safety laws, including the enactment of new laws, could cause us to incur additional expenses, redesign our products or restrict our operations, which could have a material adverse effect on our business, financial condition and results of operations, including:

•increasing our administrative and other costs;

•increasing or decreasing mandated services;

•causing us to abandon business opportunities we might have otherwise pursued; or

•requiring us to implement additional or different programs and systems.

The use of hazardous substances is regulated and monitored by various environmental regulatory authorities such as the Environmental Protection Agency (“EPA”). As such, we are subject to national, state and local laws, regulations and directives pertaining to hazardous substances, pollution and protection of the environment, health and safety, which govern, among other things, emissions to the air, discharges onto land or waters, the maintenance of safe conditions in the workplace, and the generation, handling, storage, transportation, treatment and disposal of waste materials. These laws include, without limitation, the Comprehensive Environmental Response, Compensation, and Liability Act, the Federal Facilities Compliance Act, the Hazardous Materials Transportation Act, and the Resource Conservation and Recovery Act.

Some of these laws, regulations and directives are subject to varying and conflicting interpretations. Many of these laws, regulations and directives provide for substantial fines and potential criminal sanctions for violations and require the installation of costly equipment to reduce the likelihood or impact of hazardous substance releases, whether permitted or not. Failure to comply with these laws and regulations could result in costs for corrective action, penalties or the imposition of other liabilities. We also are subject to laws and regulations that impose liability and clean-up responsibility for releases of hazardous substances into the environment. Under certain of these laws and regulations, a current or previous owner or operator of property may be liable for the costs of remediating the release or spill of hazardous substances on or from its property, without regard to whether the owner or operator knew of, or caused, the contamination, and such owner or operator may incur liability to third parties impacted by such contamination. Failure to comply with applicable environmental laws and regulations and the imposition of environmental liability could have a material adverse effect on our business, financial condition and results of operations.

Clinical trials or investigations will be necessary to support a marketing authorization. Such trials or investigations may require the enrollment of large numbers of patients and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials or investigations may prevent us from commercializing modified or new products and may adversely affect our business, financial condition and results of operations.

Initiating and completing the clinical trials or investigations necessary to support our current and future technologies will be time consuming and expensive and the outcome of any such clinical trials or investigations is uncertain. Moreover, the results of early clinical trials or investigations are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical trials or investigations. For example, the results from the interim analysis of our dose-ranging GENESIS trial may not be replicated in a larger, more rigorous pivotal trial with prespecified statistical comparison between groups. Regulatory authorities

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may disagree with our interpretation of data and results from our clinical trials or investigations, and data are often susceptible to various interpretations and analyses. Failure can occur at any stage of clinical testing. Our clinical studies or investigations may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and non-clinical testing in addition to those we have planned.

The initiation and completion of any clinical studies may be prevented, delayed, or halted for numerous reasons. We may experience delays in our ongoing clinical trials or investigations for a number of reasons, which could adversely affect the costs, timing or successful completion of our clinical trials or investigations, including related to the following:

•we may be required for future products to submit an IDE application to the FDA, which must become effective prior to commencing certain human clinical trials of medical devices, and the FDA may reject our IDE application and notify us that we may not begin clinical trials; similar requirements may apply in foreign countries;

•clinical trials or investigations may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or investigations or abandon product development programs;

•we might have to suspend or terminate clinical trials or investigations for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;

•we may have to amend clinical trial or investigation protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB or ethics committee and/or regulatory authorities for re-examination; and

•our current or future products may have undesirable side effects or other unexpected characteristics.

Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials or investigations may also ultimately lead to the denial of marketing authorization of our product candidates.

Our facilities are subject to regulation under the FDCA and FDA implementing regulations.

Our facilities and those of our contract manufacturers and suppliers are subject to regulation under the FDCA and FDA implementing regulations. The FDA may inspect our facilities periodically to determine if we are complying with provisions of the FDCA and FDA regulations. In addition, our facilities must comply with the FDA’s cGMP requirements. Our product suppliers are also required to meet certain standards applicable to their manufacturing processes. Our operations could be harmed if regulatory authorities make determinations that we, or our vendors, are not in compliance with these regulations. If the FDA finds a violation of cGMPs, it may enjoin our manufacturing operations, seize product, restrict importation of goods, and impose administrative, civil or criminal penalties or take other enforcement actions, such as requesting or requiring recalls. If we or our contract manufacturers or suppliers fail to comply with applicable regulatory requirements, we or they could be required to take costly corrective actions, including suspending manufacturing operations, changing product designs, suspending sales, or initiating product recalls or market withdrawals. In addition, compliance with these regulations has increased and may further increase the cost of manufacturing certain of our products to ensure and maintain compliance. Any of these outcomes could have a material adverse effect on our business, financial condition and results of operations.

Even after marketing authorizations for our products are obtained, we and our contract manufacturers are subject to extensive post-market regulation by the FDA and foreign regulatory authorities. Our failure to meet strict regulatory requirements could result in our being required to stop sales of our products, conduct voluntary or mandatory product recalls, pay fines, incur other costs or even close our facilities.

Even after devices receive marketing authorizations, there are significant post-market regulations with which we must comply. For example, we are required to comply with the FDA’s QSR which covers the methods used in, and the facilities and controls used for, the design, manufacture, quality assurance, labeling, packaging, sterilization, storage, shipping, installation, distribution and servicing of our marketed products. The FDA enforces the QSR through periodic announced and unannounced inspections of manufacturing facilities. Any failure by us or our contract manufacturers to take satisfactory corrective action in response to an adverse QSR inspection could result in enforcement actions against us or our contract manufacturers.

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Later discovery of previously unknown problems with our products, including unanticipated adverse events, adverse events of unanticipated severity or frequency, or manufacturing problems, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, a requirement to repair, replace or refund the cost of any medical device that we manufacture or distribute, fines, import refusals, product seizures, injunctions, the suspension, variation or withdrawal of marketing authorizations or the imposition of civil, administrative or criminal penalties or other enforcement or regulatory actions, each of which could adversely affect our business, financial condition and results of operations.

The FDA and similar foreign governmental authorities also have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture or in the event that a product poses an unacceptable risk to health. Manufacturers may, on their own initiative, recall a product if any material deficiency in a device is found or conduct a correction or removal of a device to reduce a risk to health posed by the device, to remedy a violation of law or even if no violation of law has occurred. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, manufacturing errors, other problems with design or labeling, packaging defects or other deficiencies or failures to comply with applicable regulations.

Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA, other applicable foreign regulatory authorities may require, or we may decide, that we will need to obtain marketing authorizations for the product before we may market or distribute the corrected product. Seeking such marketing authorizations may delay our ability to replace the recalled or withdrawn products in a timely manner. Moreover, if we do not adequately address problems associated with our products, we may face additional regulatory enforcement action, including warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines. Companies often are required to maintain certain records of recalls and withdrawals, even if they are not reportable to the applicable regulatory authority. We may initiate voluntary withdrawals for our products in the future that we determine do not require notification of the FDA, other applicable foreign regulatory authorities. If such regulatory authority disagrees with our determinations, it could require us to report those actions as recalls and we may be subject to enforcement action.

Any future recalls or market withdrawals of any of our products would divert managerial and financial resources and have an adverse effect on our reputation, business, financial condition and results of operations, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits. A future recall announcement or corrective action, whether voluntary or involuntary, could also potentially lead to product liability claims against us.

The FDA’s medical device reporting regulations and similar foreign regulations require us to report to the FDA and other foreign governmental authorities when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have experienced a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting obligations or any other regulatory requirements, the FDA and other foreign governmental authorities could take action, including issuances of warning letters or untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our marketing authorizations or failure to grant new marketing authorizations, seizure of our products or delay in marketing authorizations of future products, recalls, requirements for customer notifications or repairs, operating restrictions or partial suspension or total shutdown of production. Any of these enforcement actions or sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and results of operations.

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Disruptions at the FDA or foreign regulatory agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.

The ability of the FDA and foreign regulatory agencies to review and clear, approve or certify new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees and statutory, regulatory and policy changes. Average review times at these organizations have fluctuated in recent years as a result. In addition, government funding of other government agencies that oversee marketing authorizations and that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at these agencies may slow the time necessary for new devices to be reviewed and/or cleared, approved or certified, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. Separately, in response to the global COVID-19 pandemic, in March 2020, the FDA temporarily postponed all domestic and foreign routine surveillance facility inspections. Subsequently, in July 2020, the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system and in May 2021, the FDA issued a new report outlining the agency’s plan to move toward a more consistent state of inspectional capacity and priorities for domestic and foreign inspections that were not performed during the pandemic. The FDA’s report continues to prioritize mission-critical inspections and higher priority inspections that are not considered mission-critical, such as for-cause inspections, as well as high-risk assignments based on FDA’s risk-based work plan, over lower priority inspections such as routine surveillance. Regulatory authorities outside the United States may adopt similar restrictions, inspection priorities or other policy measures in response to the COVID-19 pandemic or rely on remote interactive evaluations, record requests or information from trusted regulatory partners if on-site inspections are not feasible. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA, other foreign regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA and other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

The FDA and other regulatory enforcement agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.

The FDA and other regulatory enforcement agencies strictly regulate the promotional claims that may be made about medical devices. For example, devices authorized for marketing clearance cannot be marketed for any intended use beyond the cleared indications. The FDA does not restrict or regulate a physician’s use of a medical product within the practice of medicine, and we cannot prevent a physician from using our products for an off-label use. The use of our products for indications other than those for which our products have been cleared by the FDA or approved or authorized by foreign regulatory enforcement authorities may not effectively treat the conditions not referenced in product indications, which could harm our reputation in the marketplace among practitioners and patients. If we are found to have promoted such “off-label” uses, we may become subject to significant government fines and other related liability. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority 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, and the curtailment of our operations. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The government has also required companies to enter into consent decrees or imposed permanent injunctions under which specified promotional conduct is changed or curtailed.

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Our business is subject to complex and evolving U.S. and foreign laws and regulations regarding privacy and data protection. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, monetary penalties, increased costs of operations or otherwise harm our business, financial condition and results of operations.

We are subject to a variety of laws and regulations in the United States and abroad regarding privacy and data protection, some of which can be enforced by private parties or government entities and some of which provide for significant penalties for non-compliance. There are numerous laws in the countries in which we operate regarding privacy and the storage, sharing, use, processing, disclosure and protection of this kind of information, the scope of which are constantly changing, and in some cases, inconsistent and conflicting and subject to differing interpretations, as new laws of this nature are proposed and adopted and we currently, and from time to time, may not be in technical compliance with all such laws.

As our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the U.S., the Health Insurance Portability and Accountability Act (“HIPAA”) imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable health information. Certain states have also adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. In addition, the California Consumer Privacy Act of 2018 (the “CCPA”), went into effect on January 1, 2020. The CCPA creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability, and many similar laws have been proposed at the federal level and in other states. Further, the California Privacy Rights Act (the “CPRA”), recently passed in California, which expands upon CCPA and will impose further obligations on covered businesses when it becomes effective on January 1, 2023. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.

In response to these laws, we have reviewed and amended our information practices involving applicable customers, patients and employees, as well as our use of service providers or interactions with other parties to whom we disclose personal information. We cannot yet predict the full impact of these laws and their respective implementing regulations on our business or operations, but these laws may require us to further modify our information practices and policies, and to incur substantial costs and expenses in an effort to comply. We make public statements about our use and disclosure of personal information through our privacy policy, information provided on our website and press statements. We may at times fail to comply with our public statements or be alleged to have failed to do so. We may be subject to potential government or legal action if such policies or statements are found to be deceptive, unfair or misrepresentative of our actual practices. In addition, from time to time, concerns may be expressed about whether our products and services compromise the privacy of our users and others. Any concerns about our data privacy and security practices (even if unfounded), or any failure, real or perceived, by us to comply with our posted privacy policies or with any legal or regulatory requirements, standards, certifications or orders or other privacy or consumer protection-related laws and regulations applicable to us, could cause our users to reduce their use of our products and services.

There is no assurance that we will not be subject to claims that we have violated applicable laws or codes of conduct, that we will be able to successfully defend against such claims or that we will not be subject to significant fines and penalties in the event of non-compliance. In addition, to the extent multiple state-level laws are introduced with inconsistent or conflicting standards and there is no federal law to preempt such laws, compliance with such laws could be difficult to achieve and we could be subject to fines and penalties in the event of non-compliance. Any failure or perceived failure by us or our employees, representatives, contractors, consultants, collaborators, or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could result in additional cost and liability to us, damage our reputation, and adversely affect our business and results of operations.

U.S. and foreign laws and regulations regarding privacy and data security may also affect our products as well as the design, clearance and approval of future products. Compliance with existing, not yet effective, and proposed privacy and data protection laws and regulations can be costly and can delay or impede our ability to market and sell our products, impede our ability to conduct business through websites we and our partners may operate, change and limit

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the way we use patient information in operating our business, cause us to have difficulty maintaining a single operating model, result in negative publicity, increase our operating costs, require significant management time and attention, or subject us to inquiries or investigations, claims or other remedies, including significant fines and penalties or demands that we modify or cease existing business practices. In addition, if our privacy or data security measures fail to comply with applicable current or future laws and regulations, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data or our marketing practices, fines or other liabilities, as well as negative publicity and a potential loss of business.

We will rely on third-parties and consultants to conduct all of our clinical trials. If these third-parties or consultants do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, we may be unable to obtain regulatory approval for our Ionojet device or our future product candidates.

We will rely on medical institutions, clinical investigators, contract laboratories, collaborative partners and other third-parties, such as CROs, to conduct clinical trials on our Ionojet device or our future product candidates. The third-parties with whom we may contract for execution of any of our future clinical trials may play a significant role in the conduct of these trials and the subsequent collection and analysis of data. These third-parties would not be our employees, and except for contractual duties and obligations, we would have limited ability to control the amount or timing of resources that they devote to any of our future programs. Although we may rely on these third-parties to conduct our clinical trials, we would remain responsible for ensuring that each of our preclinical trials and clinical trials is conducted in accordance with applicable legal requirements, the investigational plan and the protocol. Moreover, whether we conduct trials ourselves or hire third parties to do so, the FDA and other similar regulatory authorities require us to comply with GCPs when we conduct, monitor, record and report the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that the trial subjects are adequately informed of the potential risks of participating in clinical trials.

In addition, the execution of clinical trials, and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover, these third parties may also have relationships with other commercial entities, some of which may compete with us. If the third parties or consultants conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical trial protocols or GCPs, or for any other reason, we may need to conduct additional clinical trials or enter into new arrangements with alternative third parties, which could be difficult, costly or impossible, and our clinical trials may be extended, delayed or terminated or may need to be repeated. If any of the foregoing were to occur, we may not be able to obtain, or may be delayed in obtaining, regulatory approval for and will not be able to, or may be delayed in our efforts to, successfully commercialize our Ionojet device or any future product candidates being tested in such trials.

Data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approvals.

Data already obtained, or data we may obtain in the future, from studies and clinical trials do not necessarily predict the results that will be obtained from later non-clinical studies and clinical trials. Moreover, non-clinical and clinical data are susceptible to multiple and varying interpretations or may simply be viewed by FDA as inadequate to support the proposed indications for use, which could delay, limit or prevent regulatory approval. Several companies in the biotechnology and pharmaceutical industries, including those involved in medical devices, have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. The failure to demonstrate adequately the safety and effectiveness of a product under development could delay or prevent regulatory clearance of the product, resulting in delays to commercialization, and could materially harm our business. In addition, our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our therapy, and thus our proposed therapy may not be approved for marketing.

We will rely on third-parties to manufacture and supply the device component of our therapy.

We do not own or operate manufacturing facilities for the production of our Ionojet platform. We lack the resources and the capability to manufacture our device either for clinical trials or on a commercial scale. If our manufacturing partners are unable to produce the device components of our therapy in the numbers that we require, we may not be

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able to establish a contract with and obtain a sufficient alternative supply from another supplier on a timely basis and in the numbers we require. We expect to depend on third-party contract manufacturers for the foreseeable future. While our service providers have generally met our expectations in the past, their ability and willingness to continue to do so going forward, and the ability and willingness of any new service provider to meet our expectations in the future, may be limited for several reasons, including our relative importance as a customer or disruptions caused by the COVID-19 pandemic.

Any of our contract manufacturers will be subject to ongoing periodic unannounced inspection by FDA and other non-U.S. regulatory authorities to ensure strict compliance with quality system regulations, including current good manufacturing practices and other applicable government regulations and corresponding standards. If our contract manufacturers fail to achieve and maintain high manufacturing standards in compliance with quality system regulations, we may experience manufacturing errors resulting in patient injury or death, product recalls or withdrawals, delays or interruptions of production or failures in product testing or delivery, delay or prevention of filing or approval of marketing applications for our therapy, cost overruns or other problems that could seriously harm our business.

Any performance failure on the part of our contract manufacturers could delay clinical development or regulatory clearance or approval of our therapy or commercialization of our therapy, depriving us of potential product revenue and resulting in additional losses. In addition, our dependence on a third-party for manufacturing may adversely affect our future profit margins. Our ability to replace an existing manufacturer may be difficult because the number of potential manufacturers is limited, and FDA and other relevant regulators must approve any replacement manufacturer before it can begin manufacturing the device component of our therapy. Such approval would require additional testing and compliance inspections. It may be difficult or impossible for us to identify and engage a replacement manufacturer on acceptable terms in a timely manner, or at all.

If the manufacturers upon whom we rely fail to comply with stringent regulations, we may face delays in the development and commercialization of, or be unable to meet demand for, our medical technology and may lose potential revenues.

Any problems or delays our contract manufacturers experience in preparing for commercial-scale manufacturing of a medical technology, including our Ionojet device, or a component thereof, may result in a delay in product development timelines and the FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and may materially harm our business, financial condition, results of operations, stock price and prospects.

In addition, manufacturers of medical devices and drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents. Although we do not have day-to-day control over our contract manufacturers’ compliance with these requirements, we are responsible for ensuring compliance with such requirements. Our failure, or the failure of our contract manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, revocation of licenses, seizures or recalls of medical technology, operating restrictions and criminal prosecutions, any of which would significantly and adversely affect supplies of our medical technology and our business. If a contract manufacturer’s facilities do not pass a pre-approval inspection or do not have a cGMP compliance status acceptable to the FDA or a comparable foreign regulatory authority, our medical technology or therapies will not be approved.

Any deviations from regulatory requirements may also require remedial measures that may be costly and/or time-consuming for us or a third-party to implement and that may include the temporary or permanent suspension of a clinical trial or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business. Any delays in obtaining products or product candidates that comply with the applicable regulatory requirements may result in delays to product approvals, and commercialization. It may also require that we conduct additional trials.

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If our therapy fails to satisfy current or future regulatory or customer requirements, we may be required to make significant expenditures to redesign the device, and we may have insufficient resources to do so.

Our therapy is being designed to address an evolving marketplace and must comply with current and evolving customer requirements in order to gain market acceptance. There is a risk that our therapy will not meet anticipated customer requirements or desires. If we are required to redesign our therapy to address regulatory or customer demands or otherwise modify our business model, we may incur significant unanticipated expenses and losses, and we may be left with insufficient resources to engage in such activities. If we are unable to redesign our therapy, develop new products or modify our business model to meet regulatory or customer demands or requirements that may emerge, our business might fail.

Our Ionojet platform may contain undetected errors, which could limit our ability to provide our services and diminish the attractiveness of our product and service offerings.

Our Ionojet platform may contain undetected errors, defects or bugs. As a result, our customers or end users may discover errors or defects in our devices, software or the systems we design, or the products or systems incorporating our designs and intellectual property may not operate as expected. We may discover significant errors or defects in the future that we may not be able to fix. Our inability to fix any of those errors could limit our ability to provide our therapy, impair the reputation of our brand and diminish the attractiveness of our offerings to our customers.

In addition, we may utilize third-party technology or components in our device and we may rely on those third-parties to provide support services to us. Failure of those third-parties to provide necessary support services could materially adversely impact our business.

We face intense competition, and we may not be able to compete in our industry.

We are a “start-up” company with minimal history of revenue generating operations. We face intense competition in the wound care market, and most of our competitors have long histories and strong reputations within the industry. In the treatment of wounds we face competition from standard of care products currently being used to treat wounds as well as companies using NO to treat indications. In fact, there are currently five clinical trials listed on clinicaltrials.gov that are using or have used NO, or stimulated the production of NO, in their trials to help treat diabetic foot ulcers, two of which are currently recruiting patients. Our competitors have significantly greater financial and human resources than we do. Our competitors also have more experience and capabilities in researching and developing testing products, obtaining regulatory approvals and intellectual property protection for those products, and manufacturing and marketing those products than we do. There is a significant risk that we may be unable to overcome the advantages held by our competition, and our inability to do so could lead to the failure of our business and the loss of your investment in our Company.

The continuing development of our products depends upon our maintaining strong working relationships with physicians.

The research, development and marketing of our current product and potential new and improved products or future product indications for which we receive regulatory clearance or approval depend upon our maintaining working relationships with physicians. We rely on these professionals to provide us with considerable knowledge and experience regarding the development and marketing of our products. Physicians assist us in clinical trials and in marketing, and as researchers, product consultants and public speakers. If we cannot maintain our strong working relationships with these professionals and continue to receive their advice and input, the development and marketing of our products could suffer, which could have a material adverse effect on our business, financial condition and results of operations. At the same time, the medical device industry’s relationship with physicians is under increasing scrutiny by the U.S. Department of Health and Human Services Office of Inspector General (the “OIG”), the U.S. Department of Justice (the “DOJ”), the state attorney generals and other foreign and domestic government agencies. Our failure to comply with requirements governing the industry’s relationships with physicians or an investigation into our compliance by the OIG, the DOJ, state attorney generals and other government agencies, could have a material adverse effect on our business, financial condition and results of operations.

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It may be difficult for us to establish market acceptance of our therapy, which would significantly impair our viability.

We are faced with the risk that the marketplace will not be receptive to our therapy in preference to competing therapies and that we will be unable to compete effectively. Failure of our therapy to achieve market acceptance could have a material adverse effect on our business, financial condition and results of operations. Factors that could affect our ability to establish our therapy include the development of products or platforms that could result in a shift of customer preferences away from our therapy and significantly decrease revenue. If we are unable to establish market acceptance of our therapy, our business would likely fail and you would lose your investment in our Company.

The degree of market acceptance of any medical technology and therapies depends on a number of factors, such as:

•effectively competing with other therapies;

•the prevalence and severity of any side effects;

•success of patients in well-controlled clinical trials compared to real-world success of patients post FDA approval;

•our ability to educate and increase physician awareness of the benefits of our products relative to competing medical technology and therapies;

•the willingness of physicians and healthcare organizations to change their current treatment practices;

•the willingness of hospitals and hospital systems to include our therapies as treatment options;

•efficacy and potential advantages compared to alternative treatments;

•the price we charge for our therapies;

•interpretations of the results of our clinical trials;

•the status of our therapies on the formularies of third-party payers;

•convenience and ease of administration compared to alternative treatments;

•the willingness of the target patient population to try new therapies and of physicians to implement these therapies;

•the willingness of the target patient population to pay for our products, including co-pays under their health coverage plans;

•the strength of marketing and distribution support; and

•the availability of third-party coverage and adequate reimbursement.

The failure to attain market acceptance among the medical community, patients and third-party payors may have an adverse impact on our operations and profitability.

If we fail to respond quickly to technological developments, our therapy may become uncompetitive and obsolete.

The markets in which we plan to compete experience rapid technology developments, changes in industry standards, changes in customer requirements, and frequent new product introductions and improvements. If we are unable to respond quickly to these developments, we may lose competitive position, and our therapy or technologies may become uncompetitive or obsolete, causing revenues and operating results to suffer.

Developing medical technology entails significant technical, regulatory and business risks.

We may fail to adapt our technology to user requirements or emerging treatment standards. Plasma-NO is not currently considered standard of care for wounds such as foot ulcers and may not ever be considered standard of care. Treatment standards may not evolve to incorporate our product. New industry standards for the development, manufacture and

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marketing of medical devices may evolve and we may not be able to conform to the changes, meet new standards in a timely fashion or maintain a competitive position in the market. If we face material delays in introducing our products and new technology, we may fail to attract new customers.

Customer or third-party complaints or negative reviews or publicity about us or our technology could harm our reputation and brand.

We will be heavily dependent on customers who use our technology to provide good reviews and word-of-mouth recommendations to contribute to our growth. Customers who are dissatisfied with their experiences with our technology and resulting therapy may post negative reviews. We may also be the subject of blog, forum or other media postings that include inaccurate statements and/or create negative publicity. In addition, any negative news regarding NO may adversely impact our business. Any negative reviews or publicity, whether real or perceived, disseminated by word-of-mouth, by the general media, by electronic or social networking means or by other methods, could harm our reputation and brand and could severely diminish consumer confidence in our products.

Healthcare regulatory reform may affect our ability to sell our products profitably and could adversely affect our business, results of operations and financial condition.

In the United States and in certain foreign jurisdictions, there has been a number of legislative and regulatory proposals to change the regulatory and healthcare systems in ways that could prevent or delay marketing approval or certification of our products in development, restrict or regulate post- approval or certification activities of our products and impact our ability to sell our products profitably. In the United States in recent years, new legislation has been proposed and adopted at the federal and state level that is effecting major changes in the healthcare system. In addition, new regulations and interpretations of existing healthcare statutes and regulations are frequently adopted. By way of example, the Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the (“ACA”) substantially changed the way healthcare is financed by both governmental and private insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industry. Among other things, the ACA:

•increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

•created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

•extended manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid-managed care organizations;

•expanded eligibility criteria for Medicaid programs;

•established a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical effectiveness research in an effort to coordinate and develop such research; and

•implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Prior to the Supreme Court’s decision, President Biden issued an executive order to initiate a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, from February 15, 2021 through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

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We cannot predict with certainty what impact any U.S. federal and state health reforms will have on us, but such changes could impose new and/or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. The Budget Control Act of 2011, among other things, reduced Medicare payments to providers by 2% per fiscal year, effective on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of the temporary suspension from May 1, 2020, through March 31, 2022, unless additional Congressional action is taken. Additionally, the American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Third-party payers also regularly update payments to physicians and hospitals where our products are used. By way of example, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), enacted on April 16, 2015, repealed the formula by which Medicare made annual payment adjustments to physicians and replaced the former formula with fixed annual updates and a new system of incentive payments that are based on various performance measures and physicians’ participation in alternative payment models such as accountable care organizations. It is unclear what effect new quality and payment programs, such as MACRA, may have on our business, financial condition, results of operations or cash flows. These and other payment updates could directly impact the demand for our products or any products we may develop in the future, if cleared or approved.

We expect that other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and in additional downward pressure on the price that we receive for any cleared or approved products. Furthermore, we believe that many individuals who have obtained insurance coverage through the health insurance exchanges which arose as a result of the ACA have done so with policies that have significantly higher deductibles than policies they may have obtained prior to its enactment. Because the out-of-pocket costs of undergoing certain procedures for patients who have not met their deductible for a given year would be significantly higher than they historically would have been, these patients may be discouraged from undergoing certain procedures due to the cost. Any reluctance on the part of patients to undergo procedures utilizing our products due to cost could impact our ability to expand sales of our products and could adversely impact our business, results of operations and financial condition.

Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of our therapy. These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance rates.

If our Ionojet device is defectively designed or manufactured, contains defective components or is misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation. Misusing our therapy or failing to adhere to the operating guidelines could cause significant harm to patients, including death. In addition, if our operating guidelines are found to be inadequate, we may be subject to liability. Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us. Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, could harm our reputation in the industry and could reduce revenue. Product liability claims in excess of our insurance coverage would be paid out of cash reserves, thus harming our financial condition and adversely affecting our results of operations.

Delays in the enrollment of patients in any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory submissions.

We may not be able to initiate or continue clinical trials for our Ionojet device or any future product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities. COVID-19 outbreaks may make this even more challenging. Even if we are able to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidates may increase, and the completion of our trials may be delayed or our trials could become too expensive to complete.

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If serious adverse effects are identified with respect to our Ionojet device and related therapy, or any of our future product candidates, or any of our approved products, we may need to modify or abandon our development of that product candidate, discontinue sale of an approved product, or change our labeling to reflect new safety risks.

It is impossible to guarantee when, or if, any of our product candidates, including the Ionojet device, will prove safe enough to receive regulatory approval. It is impossible to guarantee that safety issues that may arise during development will not significantly decrease the commercial potential of our product candidates. In addition, there can be no assurance that our clinical trials will identify all relevant safety issues. Known or previously unidentified adverse effects can adversely affect regulatory approvals or marketing of approved products. In such an event, we might need to abandon marketing efforts or development of that product or product candidate or enter into a partnership to continue development. While there have been no device-related or therapy-related adverse events reported in any of our clinical trials of our Ionojet device to date, there is no guarantee that there will not be adverse events reported in our pivotal clinical trial.

If a regulatory agency discovers adverse events of unanticipated severity or frequency it may impose restrictions on that product or us, including requiring withdrawal of the product from the market. Among other legal and administrative actions, a regulatory agency may:

•mandate modifications to product labelling or promotional materials or require us to provide corrective information to healthcare practitioners;

•withdraw any regulatory approvals;

•place any ongoing clinical trials on clinical hold;

•refuse to approve pending applications or supplements to approved applications filed by us, our partners or our potential future partners;

•impose restrictions on operations, including costly new manufacturing, licensing or packaging requirements; or

•seize or detain products or require a product recall.

In addition, the occurrence of any of the foregoing, even if promptly remedied, could (1) negatively impact the perception of us or the relevant product among the medical community, patients or third-party payors and (2) result in product liability litigation that could result in the company paying substantial amounts of money in settlements or verdicts.

If we fail to comply with U.S. federal and state fraud and abuse and other healthcare laws and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business operations and financial condition could be adversely affected.

Healthcare providers and third-party payors play a primary role in the distribution, recommendation, and use of any medical device for which we have or obtain marketing clearance or approval. Any future arrangements that we have with principal investigators, healthcare professionals, and third-party payors, will expose us to broadly applicable anti-fraud and abuse, anti-kickback, false claims and other healthcare laws and regulations that may constrain our business, our arrangements and relationships with customers, and how we market and distribute our marketed medical devices. It will not always be possible to identify and deter misconduct by our employees and other third-parties, and the precautions we intend to take to detect and prevent noncompliance may not be effective in protecting us from governmental investigations for failure to comply with applicable fraud and abuse or other healthcare laws and regulations.

In the United States, we are subject to various state and federal anti-fraud and abuse laws, including, without limitation, the federal healthcare Anti-Kickback Statute (“Anti-Kickback Statute”) and federal civil False Claims Act. There are similar laws in other countries. Our relationships and our distributors’ relationships with physicians, other health care professionals and hospitals will be subject to scrutiny under these laws.

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Healthcare fraud and abuse laws and related regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include:

•the Anti-Kickback Statute, which prohibits, among other things, knowingly and willingly soliciting, offering, receiving or paying remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual, or the purchase, order or recommendation of, items or services for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value, and the government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate. In addition, the government may assert that a claim, including items or services resulting from a violation of the Anti-Kickback Statute, constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. The Anti-Kickback Statute is subject to evolving interpretations and has been applied by government enforcement officials to a number of common business arrangements in the medical device industry. There are a number of statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution under the Anti-Kickback Statute; however, those exceptions and safe harbors are drawn narrowly, and there is no exception or safe harbor for many common business activities, such as reimbursement support programs, educational and research grants or charitable donations. Practices that involve remuneration to those who prescribe, purchase or recommend medical devices, including discounts, providing items or services for free or engaging such individuals as consultants, advisors or speakers, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor and would be subject to a facts and circumstances analysis to determine compliance with the Anti-Kickback Statute;

•federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibits, among other things, persons or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds and knowingly making, using or causing to be made or used, a false record or statement to get a false claim paid or to avoid, decrease or conceal an obligation to pay money to the federal government. A claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Actions under the federal civil False Claims Act may be brought by the government or as a qui tam action by a private individual in the name of the government. These individuals, sometimes known as “relators” or, more commonly, as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial financial settlements with the federal government under the federal civil False Claims Act for a variety of alleged improper activities, including causing false claims to be submitted as a result of the marketing of their products for unapproved and thus non-reimbursable uses and interactions with prescribers and other customers, including those that may have affected their billing or coding practices and submission of claims to the federal government. Federal civil False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory monetary penalties for each false or fraudulent claim or statement. Because of the potential for large monetary exposure, healthcare and medical device companies often resolve allegations without admissions of liability for significant and material amounts to avoid the uncertainty of treble damages and per claim penalties that may be awarded in litigation proceedings;

•HIPAA, which imposes criminal and civil liability for, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or knowingly and willfully falsifying, concealing or covering up a material fact or making a materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.

•HIPAA, as amended by HITECH Act, and their implementing regulations, also impose obligations, including mandatory contractual terms, on covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers, as well as their business associates that perform certain services for them or on their behalf involving the use or disclosure of individually identifiable

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health information with respect to safeguarding the privacy, security and transmission of individually identifiable health information. We believe we are not a covered entity for purposes of HIPAA, and we believe that we generally do not conduct our business in a manner that would cause us to be a business associate under HIPAA;

•the federal Physician Payment Sunshine Act, also known as Open Payments, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually, with certain exceptions to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments or other “transfers of value” made to physicians and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members. Applicable manufacturers are also required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives; 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 medical 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 beneficiary inducement laws, which are state laws that require medical device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign 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.

State and federal regulatory and enforcement agencies continue to actively investigate violations of healthcare laws and regulations, and the U.S. Congress continues to strengthen the arsenal of enforcement tools. The Bipartisan Budget Act of 2018 (“BBA”) increased the criminal and civil penalties that can be imposed for violating certain federal health care laws, including the Anti-Kickback Statute. Enforcement agencies also continue to pursue novel theories of liability under these laws. In particular, government agencies recently have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and patient support programs, including bringing criminal charges or civil enforcement actions under the Anti-Kickback Statute, federal civil False Claims Act and HIPAA’s healthcare fraud and privacy provisions.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that our intended marketing of our Ionojet device, if approved, and financial arrangements with physicians, other healthcare providers, and other customers, could be subject to challenge under one or more such laws. The Anti-Kickback Statute includes, among others, space and equipment rental safe harbors. These safe harbors require, among other things, that the aggregate payment between the parties is set in advance and consistent with fair market value. If our Ionojet device, or any components thereof, are provided for free, and no payment is made for storage thereof at customers’ facilities, these arrangements will likely not satisfy these or other safe harbors or statutory exceptions. Therefore, if our intended arrangements were to be investigated in the future, they would be subject to a facts and circumstances analysis to determine whether they include prohibited remuneration under the Anti-Kickback Statute. If an arrangement were deemed to violate the Anti-Kickback Statute, it may also subject us to violations under other fraud and abuse laws such as the federal civil False Claims Act and civil monetary penalties laws. Moreover, such arrangements could be found to violate comparable state fraud and abuse laws.

Achieving and sustaining compliance with applicable federal and state anti-fraud and abuse laws may prove costly. If we or our employees are found to have violated any of the above laws we may be subjected to substantial criminal, civil and administrative penalties, including imprisonment, exclusion from participation in federal healthcare programs, such as Medicare and Medicaid, and significant fines, monetary penalties, forfeiture, disgorgement and damages, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any action or investigation against us for the violation of these healthcare fraud and abuse laws, even if successfully defended, could result in significant legal expenses and could divert our management’s attention from the operation of our business. Companies settling federal civil False Claims Act, Anti-Kickback Statute

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or civil monetary penalties law cases also may be required to enter into a Corporate Integrity Agreement with the OIG in order to avoid exclusion from participation (i.e., loss of coverage for their products) in federal healthcare programs such as Medicare and Medicaid. Corporate Integrity Agreements typically impose substantial costs on companies to ensure compliance. Defending against any such actions can be costly, time-consuming and may require significant personnel resources, and may have a material adverse effect on our business, financial condition and results of operations.

Our ability to generate revenue will be diminished if we are unable to obtain adequate prices for the therapy using our Ionojet device or patients are unable to obtain adequate levels of reimbursement for the therapy.

Our ability to commercialize our Ionojet device, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

•government and health administration authorities;

•private health maintenance organizations and health insurers; and

•other healthcare payers.

Patients generally expect that medical therapies they receive, such as the therapy using our Ionojet technology if it is approved by the FDA, are covered and reimbursed by third-party payors for all or part of the costs and fees associated with the therapy. If such therapies are not covered and reimbursed then patients may be responsible for the entire cost of the therapy, which can be substantial. Therefore, health care providers generally do not prescribe therapies or products that are not covered and reimbursed by third-party payors in order to avoid subjecting their patients to such financial liability. The existence of adequate coverage and reimbursement for the therapies or products by government and private insurance plans is central to the acceptance of our Ionojet device and any future products we may commercialize in the future.

During the past several years, third-party payors have undertaken cost-containment initiatives including different payment methods, monitoring health care expenditures, and anti-fraud initiatives. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state Medicaid programs may not pay an adequate amount for the therapy from our Ionojet device, if approved by the FDA, or any of our other future products or therapies, or may make no payment at all. Furthermore, the health care industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control health care costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore, we cannot be certain that the therapy from our Ionojet device, or any of our future products or therapies, will be reimbursed at a level that is sufficient to meet our costs.

Obtaining coverage and reimbursement approval of a therapy or product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given therapy or product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Patients are unlikely to use our products or any future product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of the therapy or any future product candidates.

We intend to seek approval to market Ionojet, as well as future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for our products or any future product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the European Union, the pricing of medicinal products and drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for product candidates and may be affected by existing and future health care reform measures.

Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to earn profits on the therapy from our Ionojet device, if approved, or any future product candidates. In particular,

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in the ACA, among other things, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs, including product candidates, under the Medicaid Drug Rebate Program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, particularly in light of the new presidential administration in the United States, and any proposed changes to healthcare laws that could potentially affect our clinical development or regulatory strategy. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

•the demand for our products or future product candidates, if we obtain regulatory approval;

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

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

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

•the availability of capital.

Any reduction in reimbursement from Medicare, Medicaid or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

The size and expected growth of our available market has not been established with precision and may be smaller than we estimate.

Our data on the available market for our current products and future products is based on a number of internal and third-party research reports, estimates and assumptions. While we believe that such research, our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct. In addition, the statements in this prospectus relating to, among other things, the expected growth in the market for our therapy are based on a number of internal and third-party data, estimates and assumptions, and may prove to be inaccurate. If the actual number of consumers who would benefit from our products, the price at which we can sell our therapy or the available market for our products is smaller than we estimate, it could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Intellectual Property

Our failure to maintain patents, licensing agreements and other intellectual property would materially impact our ability to effectuate our business plan.

In order for our business to be viable and to compete effectively, we need to develop and/or maintain, and we will heavily rely on, a strong position with respect to our product candidate and intellectual property. Our ability to own, license, enforce and maintain patents, maintain trade secret protection and operate without infringing the proprietary rights of others is important to our commercializing our therapy. Without ownership of or an appropriate license to use any intellectual property rights comprised in our technologies, our ability to exploit those technologies could be prevented or restricted and the sales of our therapy within the United States or elsewhere could be prohibited. Therefore, any disruption in access to our technologies could substantially delay the development and sale of our therapy.

The patent positions of biotechnology and medical device companies are frequently uncertain and involve complex legal and factual questions, and we may not be able to adequately expand our patent and intellectual property protections. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued. Consequently, our patents, patent applications and other intellectual property rights may not provide protection

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against competitive technologies or may be held invalid if challenged or could be circumvented. Our competitors may also independently develop technologies or products similar to ours or design around or otherwise circumvent patents owned, issued to, or licensed by, us. In addition, the laws of some foreign countries may not protect our proprietary rights to the same extent as U.S. law.

Furthermore, our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer, or otherwise gain access to our proprietary technology. We may be unable to meaningfully protect our rights in trade secrets, technical know-how and other non- patented technology, which could seriously impair our business.

Costly litigation may be necessary to protect our intellectual property rights and we may be subject to claims alleging the violation of the intellectual property rights of others.

We may face significant expense and liability as a result of litigation or other proceedings relating to patents and intellectual property rights of others. For example, in the event that another party has also filed a U.S. patent application or been issued a U.S. patent relating to an invention or technology claimed by us in pending applications, we may be required to participate in an interference or derivation proceeding declared by the United States Patent and Trademark Office to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us. We, or our licensors, also could be required to participate in interference proceedings involving issued patents and pending applications of another entity. An adverse outcome in an interference or derivation proceeding could require us to cease using the technology, substantially modify it or to license rights from prevailing third parties.

The cost to us of any patent litigation or other proceeding relating to our licensed patents or patent applications, even if resolved in our favor, could be substantial, especially given our early stage of development. Our ability to enforce our patent protection could be limited by our financial resources and may be subject to lengthy delays. A third party may claim that we are using inventions claimed by their patents and may go to court to stop us from engaging in our normal operations and activities, such as research, development and the sale of any future products. Such lawsuits are expensive and would consume significant time and other resources. There is a risk that a court will decide that we are infringing the third party’s patents and will order us to stop the activities claimed by such patents. In addition, there is a risk that a court will order us to pay the other party damages for having infringed their patents.

Moreover, there is no guarantee that any prevailing patent owner would offer us a license so that we could continue to engage in activities claimed by the patent, or that such a license, if made available to us, could be acquired on commercially acceptable terms. In addition, third parties may, in the future, assert other intellectual property infringement claims against us with respect to our services, technologies or other matters.

International patent protection is particularly uncertain, and if we are involved in opposition proceedings in foreign countries, we may have to expend substantial sums and management resources.

Patent and other intellectual property law outside the United States can be even more uncertain than in the United States and is continually undergoing review and revisions in many countries. Further, the laws of some foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States. For example, certain countries do not grant patent claims that are directed to business methods and processes. In addition, we may have to participate in opposition proceedings to determine the validity of our foreign patents or our competitors’ foreign patents, which could result in substantial costs and diversion of our efforts.

Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.

We rely substantially upon proprietary materials, information, trade secrets and know-how to conduct our research and development activities. We take steps to protect our proprietary rights and information, including the use of confidentiality and other agreements with our employees and consultants and with academic and commercial relationships. However, these steps may be inadequate, agreements may be violated, or there may be no adequate remedy available for a violation of an agreement. We cannot assure you that our proprietary information will not be disclosed or that we can meaningfully protect our trade secrets. Our competitors may independently develop substantially equivalent proprietary information or may otherwise gain access to our trade secrets, which could adversely affect our ability to compete in the market.

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Risks Related to Our Industry

We intend to utilize third-party service provides for the distribution, marketing, and support capabilities related to our technology, although we do not currently have any such agreements in place, which could delay or limit our ability to generate revenue.

We plan to utilize third-party service providers for the distribution and marketing and support of Ionojet, if approved. Upon approval, we intend to collaborate with third parties in addition to building our own commercial infrastructure. Reliance on third-party service providers may prevent our direct control of key aspects of those critical functions including regulatory compliance, import and export operations, supply chain security, warehousing and inventory management, distribution, contract administration, invoicing, sales deductions administration, accounts receivable management and call center management. Any future distribution partners may hold significant control over important aspects of the commercialization of our products, including market identification, regulatory compliance, marketing methods, pricing, composition of marketing team and promotional activities.

We may not be able to control the amount and timing of resources that any future third-party distribution partners may devote to our products or prevent any third-party from pursuing the development of alternative technologies or products that compete with our products, except to the extent our contractual arrangements protect us against such activities. Also, we may not be able to prevent any other third-party from withdrawing its support of our products.

If third-party service providers fail to comply with applicable laws and regulations, fail to meet expected deadlines, encounter natural or other disasters at their facilities or otherwise fail to perform their services to us in a satisfactory or predicted manner, or at all, our ability to deliver product to meet commercial demand could be significantly impaired. In addition, we may use third parties to perform various other services for us relating to sample accountability and regulatory monitoring, including adverse event reporting, safety database management and other product maintenance services. If the quality or accuracy of the data maintained by these service providers is insufficient, our ability to continue to market our products could be jeopardized or we could be subject to regulatory sanctions, and any indemnity we may receive from such third-party service providers could be limited by such provider’s ability to pay and otherwise might not be sufficient to cover all losses we may experience.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to: (i) comply with the requirements of the FDA and other similar foreign regulatory bodies; (ii) provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; (iii) comply with manufacturing standards we have established; (iv) comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (v) report financial information or data accurately or to disclose unauthorized activities to us. Any such misconduct or noncompliance could negatively affect the FDA’s review of our regulatory submission, including delaying approval or disallowance of certain information to support the submission, and/or delay a federal or state healthcare programs or a commercial insurer’s determination regarding the availability of future reimbursement for product candidates. If we obtain FDA approval of any product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct 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 be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare

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laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, 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 our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of any product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

We intend to establish a team to launch the Ionojet, if approved, and to launch or market any of our future product candidates. If we are not successful in doing so, our ability to generate revenue and profits will be limited.

Although certain of our employees have commercialization experience, as a company we do not have an internal marketing team and we currently have only limited commercial capabilities. We intend to establish an internal specialty marketing team for the promotion of the use of Ionojet, if approved, and to launch or market any future product candidates. Establishing a marketing team is a difficult undertaking. Experienced and competent representatives and managers must be recruited, hired, trained, assigned appropriate territories, managed and compensated in such a way that they can achieve success in marketing products to a sophisticated audience of healthcare professionals who frequently have little or no time to spend with sales personnel. In addition, our prospective marketing team will compete against the marketing teams of other biotechnology companies, who will be promoting competing products. If we fail to hire and field a high-quality marketing team, we may be unable to generate expected revenues and profits.

In addition, there are significant expenses and risks involved with establishing our own sales and marketing capabilities, including our ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact the commercialization of our product candidates. For example, if we recruit any sales representatives or establish marketing capabilities prior to commercial launch and the commercial launch is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

In addition to our own internal marketing team, we may choose to collaborate with third parties that have direct marketing teams and established distribution systems, either to augment our own marketing team and distribution systems or in lieu of our own marketing team and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates. To the extent we commercialize our product candidates by entering into agreements with third-party collaborators, we may have limited or no control over the marketing and distribution activities of these third parties, in which case our future revenues would depend heavily on the success of the efforts of these third parties. If we are not successful in commercializing Ionojet or any future product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we could incur significant additional losses.

We may rely on collaborations and license arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue and adversely affect our profitability.

We may rely on collaboration and other agreements with third-parties with respect to our product candidates and future marketed products. Any future collaborations or license arrangements may not be successful. We may license our products, in which case we would depend upon collaborations with third-parties to develop these product candidates in the licensed territories and we would depend substantially upon third-parties to commercialize these product candidates. If we are unable to maintain current collaborations or enter into additional collaborations with established biotechnology or biotechnology service companies to provide the services we need, we may not be able to successfully commercialize our products.

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Our reliance on vendors in foreign countries, including China, subjects us to risks and uncertainties relating to foreign laws and regulations and changes in relations between the United States and such foreign countries.

Certain electronic micro-components for our Ionojet devices are sourced from China and Taiwan, and we may in the future source components from vendors located in other foreign countries. Under its current leadership, the government of China has been pursuing economic reform policies, including by encouraging foreign trade and investment. However, there is no assurance that the Chinese government will continue to pursue such policies, that such policies will be successfully implemented, that such policies will not be significantly altered, or that such policies will be beneficial to our partnerships in China. China’s system of laws, as well as the laws of other foreign countries where we may source components, can be unpredictable, especially with respect to foreign investment and foreign trade. The United States government has called for substantial changes to foreign trade policy with China and has raised tariffs on several Chinese goods. China has retaliated with increased tariffs on United States goods. Any further changes in United States trade policy could trigger retaliatory actions by affected countries, including China, resulting in trade wars. Changes to Chinese regulations affecting the manufacture of electronic components may also be unpredictable. Changes to regulations in any other country where we may source components in the future may also be unpredictable and could affect the manufacture of electronic components in such countries and our ability to purchase components on a cost-effective basis. Any regulatory changes and changes in United States and China relations, or changes in relations with the United States any other country where we may source components in the future, may have a material adverse effect on our vendors in China and other such countries which could materially harm our business and financial condition.

International trade disputes could result in tariffs and other protectionist measures that could have a material adverse effect on our business, financial condition and results of operations.

Tariffs could increase the cost of our products and raw materials that go into making them. These increased costs could adversely impact the gross margin that we earn on our products. Tariffs could also make our products more expensive for customers, which could make our products less competitive and reduce customer demand. Countries may also adopt other protectionist measures that could limit our ability to offer our products. Political uncertainty surrounding international trade disputes and protectionist measures could also have a negative effect on consumer confidence and spending, which could have a material adverse effect on our business, financial condition and results of operations.

The ongoing COVID-19 global health crisis or any other health crisis may impact our planned operations, including our pivotal clinical trial.

In January 2020, the World Health Organization declared a global pandemic for the novel strain of coronavirus, COVID-19. Since then, the COVID-19 coronavirus has spread to multiple countries, including throughout the United States. We may experience disruptions as a result of the pandemic if the pandemic continues or increases in severity or any other pandemic, including:

•unwillingness of potential study participants to enroll in our pivotal clinical trial and/or visit healthcare facilities;

•postponement of enrollment in our pivotal clinical trial;

•postponement of the initiation of our pivotal clinical trial;

•diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our pivotal clinical trial sites and hospital staff supporting the conduct of our pivotal clinical trial;

•interruption of key clinical trial activities, such as clinical site visits by study participants and clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;

•limitations in employee resources that would otherwise be focused on the conduct of our pivotal clinical trial, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

•delays in receiving approval from local regulatory authorities to initiate our pivotal clinical trial;

•delays in clinical sites receiving the supplies and materials needed to conduct our pivotal clinical trial;

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•interruption in global shipping that may affect the manufacture and transport of clinical trial materials necessary for our pivotal clinical trial;

•changes in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which our pivotal clinical trial is conducted, which may result in unexpected costs, or to discontinue the pivotal clinical trial altogether;

•delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; and

•delay in the timing of interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention to approval of other therapeutics or other activities related to COVID-19.

Our business and the business of the suppliers of our clinical product candidate is expected to continue to be materially and adversely affected by the pandemic. While we are currently not experiencing material delays, such events could result in the delay or complete or partial closure of clinical trial sites or one or more manufacturing facilities which could impact our supply of our clinical product candidate. In addition, it could impact economies and financial markets, resulting in an economic downturn that could impact our ability to raise capital or slow down potential partnering relationships.

The effects of the governmental orders may negatively impact productivity, disrupt our business and delay our clinical trial program and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

In addition, the COVID-19 outbreak could disrupt our operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by members of management and other employees who elect not to come to work due to the illness affecting others in our office, or due to quarantines. The COVID-19 illness could also impact members of our Board of Directors resulting in absenteeism from meetings of the directors or committees of directors, making it more difficult to convene the quorums of the full Board of Directors or its committees needed to conduct meetings for the management of our affairs.

The global outbreak of the virus continues to rapidly evolve. The extent to which the virus may continue to impact our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. We do not yet know the full extent of potential delays or impacts on our business, operations, or the global economy as a whole. While the spread of COVID-19 may eventually be contained or mitigated, there is no guarantee that a future outbreak of this or any other widespread epidemics will not occur, or that the global economy will recover, either of which could seriously harm our business.

While we are currently not experiencing any delays, we may in the future experience delays. These delays may result in the need for trials to be redesigned and may impact whether they will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including the COVID-19 pandemic, delays in obtaining regulatory approval to commence a clinical trial, in securing clinical trial agreements with prospective sites with acceptable terms, in obtaining institutional review board approval to conduct a clinical trial at a prospective site, in recruiting patients to participate in a clinical trial or in obtaining sufficient supplies of clinical trial materials. Manufacturing considerations for clinical development candidates may include an expected several month lead time following a decision to commence any clinical trial(s) and capacity considerations of our third-party contract manufacturers to provide clinical supply of our product candidates could cause delays in clinical trials. Furthermore, due to the COVID-19 pandemic, many manufacturers have been prioritizing the manufacture of COVD-19 related products, increasing the manufacturing lead times for non-COVID-19 related products. Many factors affect patient enrollment, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, competing clinical trials and new drugs approved for the conditions we are investigating. Clinical investigators will need to decide whether to offer their patients enrollment in clinical trials of our product candidates versus treating these patients with commercially available drugs that have established safety and efficacy profiles. Any delays in completing our clinical trials will increase our costs, slow down our product development and timeliness and approval process and delay our ability to generate revenue.

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We will be subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business, and changes in such regulations or laws could require us to modify our products or marketing or advertising efforts.

In connection with the marketing or advertisement of our therapy, we could be the target of claims relating to false, misleading, deceptive or otherwise noncompliant advertising or marketing practices, including under the auspices of the FTC and state consumer protection statutes. If we rely on third parties to provide any marketing and advertising of our products, we could be liable for, or face reputational harm as a result of, their marketing practices if, for example, they fail to comply with applicable statutory and regulatory requirements.

If we are found to have breached any consumer protection, advertising, unfair competition or other laws or regulations, we may be subject to enforcement actions that require us to change our marketing and business practices in a manner that may negatively impact us. This could also result in litigation, fines, penalties and adverse publicity that could cause reputational harm and loss of customer trust, which could have a material adverse effect on our business, financial condition and results of operations.

Technological change may adversely affect commercialization of our products and may cause our products to become obsolete.

The medical device market is characterized by extensive research and development and rapid technological change. Technological progress or new developments in our industry could adversely affect sales of our products. Our products could be rendered obsolete because of future innovations by our competitors or others in the treatment of vascular diseases, which would have a material adverse effect on our business, financial condition and results of operations.

Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.

Many medical device companies are consolidating to create new companies with greater market power. As the medical device industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions for our products. If we reduce our prices because of consolidation in the healthcare industry, our revenue would decrease, which could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Ownership of Our Common Stock

An active public trading market for our common stock may not develop or be sustained.

Prior to this offering, there has been no public market or active private market for trading shares of our common stock. We will list our common stock on NYSE American, in connection with this offering; however, an active trading market may not develop following the completion of this offering or, if developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active market may also reduce the price of shares of common stock. An inactive market may impair our ability to raise capital by selling shares and our ability to use our capital stock to acquire other companies or technologies. We cannot predict the prices at which our common stock will trade. The initial public offering price of our common stock may not bear any relationship to the market price at which our common stock will trade after this offering.

We cannot be assured that we will be able to maintain our listing on NYSE American.

We anticipate that our securities will be listed on NYSE American, a national securities exchange, upon consummation of this offering. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our common stock on NYSE American or that our securities will continue to be listed on NYSE American in the future. If NYSE American should determine after initial listing that we fail to meet NYSE American requirements, we may be subject to a delisting action by NYSE American. Nonetheless, this offering is contingent upon our obtaining NYSE American listing and, in the event such listing is not approved, this offering will be terminated.

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Even if we complete this offering, if NYSE American delists our securities from trading on its exchange at some future date, we could face significant material adverse consequences, including:

•a limited availability of market quotations for our securities;

•reduced liquidity with respect to our securities;

•a determination that our common stock is a “penny stock” which will require brokers trading in our ordinary shares to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our ordinary shares;

•a limited amount of news and analyst coverage for our company; and

•a decreased ability to issue additional securities or obtain additional financing in the future.

Our stock price may be extremely volatile, and your investment in our common stock could suffer a decline in value.

You should consider an investment in our common stock risky and invest only if you can withstand a significant loss and wide fluctuations in the market value of your investment. Investors who purchase our common stock may not be able to sell their shares at or above the purchase price. Security market prices for securities of biotechnology companies have been highly volatile. In addition, the volatility of biotechnology company stocks often does not correlate to the operating performance of the companies represented by such stocks. Some of the factors that may cause the market price of our common stock to fluctuate include:

•adverse results or delays in our clinical trials;

•the timing or delay of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the receipt of regulatory approval or the establishment or termination of a commercial partnership for one or more of our product candidates;

•announcement of FDA approval or non-approval of our product candidates or delays in the FDA review process;

•actions taken by regulatory agencies with respect to our product candidates, our clinical trials or our sales and marketing activities;

•the commercial success of any product approved by the FDA or its foreign counterparts;

•regulatory developments in the United States and foreign countries;

•changes in the structure of healthcare payment systems;

•any intellectual property infringement lawsuit involving us;

•announcements of technological innovations or new products by us or our competitors;

•market conditions for the biotechnology or pharmaceutical industries in general;

•changes in financial estimates or recommendations by securities analysts;

•sales of large blocks of our common stock;

•sales of our common stock by our executive officers, directors and significant stockholders;

•direct sales of our common stock through financing arrangements;

•restatements of our financial results and/or material weaknesses in our internal controls;

•the loss of any of our key scientific or management personnel; and

•announcements regarding the ongoing exploration of the strategic options available to us.

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Stock markets in general, and the markets for biotechnology stocks in particular, have experienced extreme volatility and price and volume fluctuations that have often been unrelated or disproportionate to the operating performance or prospects of particular companies. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. In the past, class action litigation has often been instituted against companies whose securities have experienced periods of volatility in market price. Any such litigation brought against us could result in substantial costs, which would hurt our financial condition and results of operations, divert management’s attention and resources, and possibly delay our clinical trials or commercialization efforts.

Stock prices in recent initial public offerings have been volatile.

Certain recent initial public offerings of companies with public floats comparable to our anticipated public float have experienced instances of extreme price run-ups followed by rapid price declines and stock volatility seemingly unrelated to the underlying performance of the respective company. Our common stock may experience similar rapid and substantial price volatility following our initial public offering, and any such volatility, including any stock-run up, may be unrelated to our actual or expected operating performance and financial condition or prospects, which could make it difficult for prospective investors to assess the rapidly changing value of our stock. Although the specific cause of such volatility is unclear, our anticipated public float may amplify the impact the actions taken by a few stockholders have on the price of our shares, which may cause our share price to deviate, potentially significantly, from a price that better reflects the underlying performance of our business. Should our securities experience run-ups and declines that are seemingly unrelated to our actual or expected operating performance and financial condition or prospects, prospective investors may have difficulty assessing the rapidly changing value of our securities. In addition, investors of our securities may experience losses, which may be material, if the price of our common stock declines after this offering or if such investors purchase shares of our common stock prior to any price decline.

If financial or industry analysts do not publish research or reports about our business or if they issue inaccurate or unfavorable commentary or downgrade our common stock, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that industry or financial analysts publish about us or our business. We do not control these analysts or the content and opinions included in their reports. As a new public company, we may be slow to attract research coverage, and the analysts who publish information about our common stock will have had relatively little experience with our company, which could affect their ability to accurately forecast our results and make it more likely that we fail to meet their estimates. In the event we obtain industry or financial analyst coverage, if any of the analysts who cover us issue an inaccurate or unfavorable opinion regarding our stock price, our stock price would likely decline. In addition, the stock prices of many companies in the biotechnology industry have declined significantly after those companies have failed to meet, or often times failed to exceed, the financial guidance publicly announced by the companies or the expectations of analysts. If our financial results fail to meet, or significantly exceed, our announced guidance or the expectations of analysts or public investors, analysts could downgrade our common stock or publish unfavorable research about us. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

After this offering, our officers, directors and principal stockholders will continue to exercise significant control over our company, and may be able to control our management and operations, acting in their best interests and not necessarily those of other stockholders.

When this offering is completed, our executive officers, directors and principal stockholders who beneficially own more than 5% or more of our outstanding common stock before this offering will in the aggregate, beneficially own shares representing approximately 49.8% of our outstanding capital stock. When this offering is completed, Michael Preston, our Chairman and Chief Executive Officer, will beneficially own 31.16% of our outstanding capital stock. As a result, Mr.Preston together with these other stockholders, acting together, may be able to significantly influence any matters requiring approval by our stockholders, including the election of directors, the approval of mergers or other business combination transactions. The interests of this group of stockholders may not always coincide with our interests or the interests of other stockholders. The significant concentration of stock ownership may adversely affect the trading price of our common stock due to the perception that conflicts of interest may exist or arise. Therefore, you should not invest in reliance on your ability to have any control over our company.

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Future sales of common stock by our officers and directors and principal stockholders or others of our common stock, or the perception that such sales may occur, could depress the market price of our common stock.

Sales of a substantial number of shares of our common stock after this offering, particularly sales by our directors, executive officers and principal stockholders could adversely affect the market price of our common stock and may make it more difficult to sell common stock at a time and price that you deem appropriate. Based on the total number of outstanding shares of our common stock as of September 29, 2023, upon completion of this offering, the issuance of 154,280shares of common stock upon the conversion of outstanding loans and accounts payable and the issuance of 775,900shares (the “Note Shares”) of common stock upon conversion of our outstanding Private Placement Notes (as described under “Description of Securities”), we will have an aggregate of 43,982,980shares of common stock outstanding, assuming no exercise of our outstanding warrants or stock options, and assuming the underwriters do not exercise their option to purchase additional shares.

All of the shares of common stock sold in this offering will be freely tradable without restrictions or further registration under the Securities Act of 1933, as amended (the “Securities Act”), except for any shares held by our affiliates as defined in Rule 144 under the Securities Act.

A substantial amount of our outstanding shares of common stock is currently restricted from resale as a result of market standoff and “lock-up” agreements, as more fully described in “Shares Eligible for Future Sale.” These shares will become available to be sold 181 days after the date of this prospectus, in the case of non-affiliate shareholders holding between 1% and 4.99% of our common stock, and 366 days after the date of this prospectus, in the case of our executive officers, directors, and shareholders holding 5% or more of our common stock. Shares held by directors, executive officers and other affiliates will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements. In addition, the underwriters may, in their sole discretion, release all or some portion of the shares subject to market standoff or lock-up agreements prior to the expiration of the lock-up period. See the section entitled “Shares Eligible for Future Sale” for more information. Sales of a substantial number of such shares upon expiration of the market standoff and lock-up agreements, or the perception that such sales may occur, or early release of these agreements, could cause our market price to fall or make it more difficult for you to sell your common stock at a time and price that you deem appropriate.

We intend to file a registration statement on Form S-8 under the Securities Act covering approximately 4,585,200shares of common stock issued or issuable upon the exercise of stock options, or subject to outstanding options under our 2014 Plan and 5,000,000shares of common stock, which will be reserved for issuance under the 2023 Plan upon the effectiveness thereof. Once we register the offer and sale of these shares, they can be freely sold in the public market upon issuance, subject to the market standoff or lock-up agreements or unless they are held by “affiliates,” as that term is defined in Rule 144 of the Securities Act. If the holders of these shares choose to sell a large number of shares, they could adversely affect the market price for our common stock.

We may also issue shares of our common stock or securities convertible into shares of our common stock from time to time in connection with a financing, acquisition, investment or otherwise. Any such issuance could result in substantial dilution to our existing stockholders and cause the trading price of our common stock to decline.

The offering price of the shares and the other terms of the initial public offering have been determined through negotiations between us and the underwriter.

The initial public offering price of our common stock and other terms of the initial public offering have been determined through negotiations between the Company and the underwriter. This determined price may not reflect the price at which investors in the market will be willing to buy and sell our shares following this offering. You may be unable to sell your shares of common stock at or above the initial offering price. The market price of shares of our common stock following this offering could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control.

Our initial public offering price is substantially higher than the pro forma, as adjusted net tangible book value per share of our outstanding common stock, and new investors will experience immediate and substantial dilution.

Our initial public offering price is substantially higher than the pro forma, as adjusted net tangible book value per share of our common stock based on the expected total value of our total assets, less our goodwill and other intangible assets, less our total liabilities immediately following this offering. If you purchase shares of our common stock in

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this offering, you will experience immediate and substantial dilution of $4.86 per share in the price you pay for our common stock as compared to the pro forma, as adjusted net tangible book value as of December31, 2022, after giving effect to the issuance of shares of our common stock in this offering at the assumed initial public offering price of $5.00 per share. Furthermore, if the underwriters exercise their option to purchase additional shares, if outstanding options are exercised, if we issue awards to our employees under our equity incentive plans, or if we otherwise issue additional shares of our common stock, you could experience further dilution. For a further description of the dilution that you will experience immediately after this offering, see the section entitled “Dilution.”

Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to certain limitations.

In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change net operating losses (“NOLs”), and its research and development credit carryforwards to offset future taxable income. Our existing NOLs and research and development credit carryforwards may be subject to limitations arising from previous ownership changes, and if we undergo an ownership change, our ability to utilize NOLs and research and development credit carryforwards could be further limited by Sections 382 and 383 of the Code. In addition, our ability to deduct net interest expense may be limited if we have insufficient taxable income for the year during which the interest is incurred, and any carryovers of such disallowed interest would be subject to the limitation rules similar to those applicable to NOLs and other attributes. Future changes in our stock ownership, some of which might be beyond our control, could result in an ownership change under Section 382 of the Code. For these reasons, in the event we experience a change of control, we may not be able to utilize a material portion of the NOLs, research and development credit carryforwards or disallowed interest expense carryovers, even if we attain profitability.

Anti-takeover provisions in our charter documents, which will be effective prior to the effectiveness of this offering, and under Delaware law, could make an acquisition of our company more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.

Provisions in our second amended and restated certificate of incorporation and second amended and restated bylaws, as they will be in effect prior to the effectiveness of this offering, may have the effect of delaying or preventing a change of control or changes in our management. Our second amended and restated certificate of incorporation and second amended and restated bylaws will include provisions that:

•authorize our board of directors to issue, without further action by the stockholders, shares of undesignated preferred stock with terms, rights, and preferences determined by our board of directors that may be senior to our common stock;

•require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent;

•specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, our Chief Executive Officer or our President (in the absence of a Chief Executive Officer);

•establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for election to our board of directors;

•prohibit cumulative voting in the election of directors;

•establish that our board of directors will be divided into three classes — Class I, Class II, and Class III — with each class serving staggered three-year terms;

•provide that, so long as our board of directors is classified, directors may only be removed for cause;

•provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; and

•require the approval of our board of directors or the holders of two-thirds of our outstanding shares of voting stock to amend our bylaws and certain provisions of our certificate of incorporation.

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These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management. In addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally, subject to certain exceptions, prohibits a Delaware corporation from engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three years following the date on which the stockholder became an “interested” stockholder. Any of the foregoing provisions could limit the price that investors might be willing to pay in the future for shares of our common stock, and they could deter potential acquirers of our company, thereby reducing the likelihood that you would receive a premium for your shares of our common stock in an acquisition.

Our second amended and restated certificate of incorporation and second amended and restated bylaws, to be in effect prior to the effectiveness of this offering, will provide that the Court of Chancery of the State of Delaware or the federal district court for the District of Delaware will be the exclusive forum for certain disputes between us and our stockholders, which could result in increased costs for our stockholders to bring a claim and could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our second amended and restated certificate of incorporation and second amended and restated bylaws, both of which will be in effect prior to the effectiveness of this offering, will provide that, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by, or other wrongdoing by, any director, officer, employee or agent of the Company to the Company or our stockholders, creditors or other constituents; (iii) any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our second amended and restated certificate of incorporation or our second amended and restated bylaws; (iv) any action to interpret, apply, enforce or determine the validity of our second amended and restated certificate of incorporation or our second amended and restated bylaws; or (v) or any action asserting a claim against us that is governed by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Securities Act, Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, or the Company consents in writing to the selection of an alternative forum, such action may be brought in another state or federal court sitting in the State of Delaware. Our second amended and restated certificate of incorporation and second amended and restated bylaws will also provide that the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action against us or any of our directors, officers, employees or agents and arising under the Securities Act or Exchange Act. Nothing in our second amended and restated certificate of incorporation or second amended and restated bylaws will preclude stockholders that assert claims under the Exchange Act from bringing such claims in state or federal court, subject to applicable law.

We believe these provisions may benefit us by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. However, this choice of forum provision could result in increased costs for our stockholders to bring a claim and could may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice of forum provision that will be contained in our second amended and restated certificate of incorporation and second amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

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Our management has broad discretion in the use of the net proceeds from this offering, and our use of the net proceeds may not enhance our operating results or the price of our common stock.

We intend to use the net proceeds we receive from this offering to fund our ongoing clinical program for Ionojet, primarily for the completion of the reengineered design of the Ionojet technology and submission of a new IDE for our pivotal trial in diabetic foot ulcers, the redemption of all outstanding shares of Series B Preferred Stock, including the premium payments related thereto, the full satisfaction of the amount owed under the LFEIF Note, including interest, the repayment of loans (including related party loans), payment of deferred salaries, advisory fees, and for general corporate purposes, including working capital, sales and marketing activities, research and development activities, general and administrative matters and capital expenditures (see “Use of Proceeds” for additional information). We may use a portion of the net proceeds to acquire complementary businesses or products. While we do not have agreements or commitments for any specific acquisitions at this time, we continually evaluate potential acquisition candidates to enhance our product offerings. Accordingly, our management will have considerable discretion over the specific use of the net proceeds that we receive in this offering and might not be able to obtain a significant return, if any, on investment of these net proceeds. You will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Investors in this offering will need to rely upon the judgment of our management with respect to the use of proceeds. Until the net proceeds are used, they may be placed in investments that do not produce significant income, may be held in demand deposit accounts, or in investments intended to be highly liquid that may nevertheless lose value. If we do not use the net proceeds that we receive in this offering effectively, our business and prospects could be harmed, and the market price of our common stock could decline.

Certain of our related parties will directly benefit from the proceeds of this offering.

Prior to this offering, certain of our officers, directors and greater than 5% shareholders made loans to our company, some of which will be repaid out of the proceeds of this offering. Specifically, Michael Preston, our Chairman and Chief Executive Officer, will be repaid $50,000, David Dantzker, our Deputy Chairman and Chief Medical Officer, will be repaid $30,000, John Fernandes, our Chief Financial Officer, will be repaid approximately $42,000, Alexander Dolgopolsky, a holder of more than 5% of our outstanding capital stock and our Chief Scientist, will be repaid $13,000 and Square Table LLC, a limited liability company of which Michael Preston is the sole manager, will be repaid $35,000. In total, related parties will receive approximately $170,000 in repayment of loans out of the proceeds of this offering. Additionally, approximately $500,000 in payment of deferred salaries in cash, calculated through September30, 2023, will be paid to related parties out of the proceeds of this offering, which payments will be paid over the 18months subsequent to this offering (approximately $100,000 to Mr.Preston, approximately $250,000 to Mr.Fernandes, approximately $100,000 to Dr. Dantzker, and approximately $50,000 to Dr. Dolgopolsky. Accordingly, the aforementioned related parties will directly benefit from the proceeds of this offering. See “Use of Proceeds” and “Certain Relationships and Related Party Transactions.”

Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Our second amended and restated certificate of incorporation and second amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law.

In addition, as permitted by Section 145 of the DGCL, our second amended and restated bylaws and the indemnification agreements that we intend to enter into with our directors and officers, among other things provide that:

•We will indemnify our directors and officers for serving us in those capacities, or for serving as a director, officer, employee or agent of other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that we may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interest and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.

•We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.

•We will be required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.

•The rights conferred in our bylaws will not be exclusive. We may not retroactively amend our bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.

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As a result, claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.

We have never declared or paid any cash dividends on our common stock. We currently intend to retain all available funds and any future earnings for use in the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Any determination to pay dividends in the future will be at the discretion of our board of directors. Consequently, your only opportunity to achieve a return on your investment in our company will be if the market price of our common stock appreciates and you sell your shares at a profit. There is no guarantee that the price of our common stock that will prevail in the market after this offering will ever exceed the price that you pay. For additional information about our dividend policy, see the section entitled “Dividend policy” elsewhere in this prospectus.

We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, we will incur legal, accounting and other expenses that we did not incur as a private company. We will be subject to the reporting requirements of the Exchange Act, and will be required to comply with the applicable requirements of SOX, and the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”). The listing requirements of the NYSE American, and the rules of the SEC, require that we satisfy certain corporate governance requirements. Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all these requirements. Moreover, the reporting requirements, rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. Any changes we make to comply with these obligations may not be sufficient to allow us to satisfy our obligations as a public company on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors or board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

After this offering, we will be subject to Section 404 of SOX (“Section 404”), and the related rules of the SEC, which generally require our management and independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting. In order to maintain effective internal controls, we will need additional financial personnel, systems and resources. Beginning with the second annual report on Form 10-K that we will be required to file with the SEC, Section 404 requires an annual management assessment of the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, we will need to upgrade our systems including information technology; implement additional financial and management controls, reporting systems, and procedures; and hire additional accounting and finance staff.

To date, we have never conducted a review of our internal controls for the purpose of providing the reports required by these rules. During the course of our review and testing, we may identify additional deficiencies and be unable to remediate them before we must provide the required reports. Furthermore, if we have a material weakness in our internal control over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated. We or our independent registered public accounting firm may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of our stock to fall. In addition, as a public company we will be required to file accurate and timely quarterly and annual reports with the SEC under the Exchange Act. Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from NYSE American or other adverse consequences that would materially harm our business and reputation.

For so long as we remain an emerging growth company as defined in the JOBS Act, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements

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of Section 404. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (i) following the fifth anniversary of the completion of this offering, (ii) in which we have total annual gross revenue of at least $1.235 billion, or (iii) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

We are an emerging growth company and we cannot be certain if (i) the reduced disclosure requirements or (ii) extended transition periods for complying with new or revised accounting standards applicable to emerging growth companies will make our common stock less attractive to investors. In addition, as a smaller reporting company we will also have reduced disclosure requirements.

We qualify as an emerging growth company. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company, or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

In addition, for as long as we continue to be an emerging growth company, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies including, but not limited to, 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 stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we will 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.

We are also a “smaller reporting company” as defined in the Exchange Act, and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualify as a “smaller reporting company” as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, certain of the exemptions available to us as an “emerging growth company” may continue to be available to us as a “smaller reporting company,” including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation arrangements. We will continue to be a “smaller reporting company” until we have $250 million or more in public float (based on our common stock) measured as of the last business day of our most recently completed second fiscal quarter or, in the event we have no public float (based on our common stock) or a public float (based on our common stock) that is less than $700 million, annual revenues of $100 million or more during the most recently completed fiscal year.

General Risk Factors

Our future performance will depend on the continued engagement of key members of our management team.

Our future performance depends to a large extent on the continued services of members of our current management and other key personnel. Our management team is very seasoned and retaining key management is a key element of our success. In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse effect on our business, operations and prospects. We presently do not maintain “key person” life insurance on our executives, which leaves us exposed to the loss of the services of our executives.

If we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully.

We believe that our management team must be able to act decisively to apply and adapt our business model in the rapidly changing markets in which we will compete. In addition, we will rely upon technical and scientific employees or third-party contractors to effectively establish, manage and grow our business. Consequently, we believe that our

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future viability will depend largely on our ability to attract and retain highly-skilled managerial, scientific and technical personnel. In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently expect and such higher compensation payments would have a negative effect on our operating results.

Competition for experienced, high-quality personnel is intense and we cannot assure that we will be able to recruit and retain such personnel. We may not be able to hire or retain the necessary personnel to implement our business strategy. Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively.

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

As of September 29, 2023, we had seven employees who work full-time and one employee who works part-time. We will need to expand our managerial, operational, finance and other resources to manage our operations, commercialize Ionojet and related therapies or any other product candidates, if approved, and continue our development activities. 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, incentivize 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.

Because of our limited financial resources and the limited experience of certain members of our management team 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.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our Ionojet device or any future products we develop.

We face an inherent risk of product liability as a result of the clinical testing of Ionojet and related therapies and any of our future product candidates. We will face further risk if we commercialize Ionojet, our related therapies or any of our product candidates. For example, we may be sued if any product we sell or any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial losses or be required to limit commercialization of our products. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

•decreased demand for our products;

•termination of clinical trial sites or entire trial programs;

•injury to our reputation and significant negative media attention;

•withdrawal of clinical trial participants or cancellation of clinical trials;

•significant costs to defend the related litigation;

•a diversion of management’s time and our resources;

•substantial monetary awards to trial participants or patients;

•regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;

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•loss of revenue;

•the inability to commercialize any products we develop; and

•a decline in our share price.

Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent or inhibit the commercialization of Ionojet or any of our therapies or any future products that we develop. We intend to carry product liability insurance covering our clinical trials and, if approved, our marketed products. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If and when we obtain approval for marketing our products, we intend to expand our insurance coverage to include the sale of NO and the lease of the Ionojet, however, we may be unable to obtain this liability insurance on commercially reasonable terms.

Our business and operations would suffer in the event of computer system failures.

Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusions, including by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our current or future product development programs. For example, the loss of clinical trial data from completed or any future ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation, and the further development of our product candidates could be delayed.

Any failure to maintain the security of information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise, could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm our reputation.

In connection with the pre-clinical and clinical development, sales and marketing of our products and services, we may from time to time transmit confidential information. We also have access to, collect or maintain private or confidential information regarding our clinical trials and the patients enrolled therein, employees, and suppliers, as well as our business. Cyberattacks are rapidly evolving and becoming increasingly sophisticated. It is possible that computer hackers and others might compromise our security measures, or security measures of those parties that we do business with now or in the future and obtain the personal information of patients in our clinical trials, vendors, employees and suppliers or our business information. A security breach of any kind, including physical or electronic break-ins, computer viruses and attacks by hackers, employees or others, could expose us to risks of data loss, litigation, government enforcement actions, regulatory penalties and costly response measures, and could seriously disrupt our operations. Any resulting negative publicity could significantly harm our reputation, which could cause us to lose market share and have an adverse effect on our results of operations.

We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

As part of our business strategy, we may pursue acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that leverage our technology and industry experience to expand our offerings or other capabilities.

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Though certain company personnel have business development and corporate transaction experience, including with licensing, mergers and acquisitions, and strategic partnering, as a company we have no experience with acquiring other companies and limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing business. We may experience losses related to investments in other companies, which could have a material negative effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.

To finance any acquisitions or joint ventures, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.

Declining general economic or business conditions may have a negative impact on our business.

Continuing concerns over U.S. health care reform legislation and energy costs, geopolitical issues, the availability and cost of credit and government stimulus programs in the United States and other countries have contributed to increased volatility and diminished expectations for the global economy. These factors, combined with low business and consumer confidence, could precipitate an economic slowdown and recession. Additionally, political changes in the U.S. and elsewhere in the world have created a level of uncertainty in the markets. If the economic climate does not improve or deteriorates, our business, as well as the financial condition of our suppliers and our third-party payors, could be adversely affected, resulting in a negative impact on our business, financial condition and results of operations.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains “forward-looking statements.” We use words such as “could,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project,” and other similar expressions to identify some forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in this prospectus.

The forward-looking statements contained in this prospectus are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments, and other factors we believe are appropriate under the circumstances. As you read and consider this prospectus, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control), and assumptions. Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance anticipated in the forward-looking statements. We believe these factors include, but are not limited to, those described under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements.

Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this prospectus to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

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MARKET, INDUSTRY AND OTHER DATA

This prospectus includes market and industry data and forecasts that we have derived from independent consultant reports, publicly available information, various industry publications, and our internal data and estimates.

Our internal data and estimates are based upon information obtained from trade and business organizations and other contacts in the markets in which we operate and our management’s understanding of industry conditions. Although we believe that such information is reliable, we have not had this information verified by any independent sources.

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USE OF PROCEEDS

We estimate that the net proceeds from the sale of shares of our common stock in this offering will be approximately $12.6million before making the payments set forth below, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $5.00 per share. If the underwriters exercise in full their option to purchase additional shares of common stock, we estimate that the net proceeds to us from this offering will be approximately $14.9million before making the payments set forth below, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $5.00 per share.

Each $1.00 increase (decrease) in the assumed initial public offering price of $5.00 per share of common stock would increase (decrease) the net proceeds to us from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $2.8million, assuming that the number of shares we are offering, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares of common stock we are offering. Each increase (decrease) of 1,000,000 in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $4.6million, assuming the assumed initial public offering price per share, as set forth on the cover page of this prospectus, remains the same.

We expect to use the net proceeds from this offering as follows:

•$3,000,000 to fund our ongoing clinical program for Ionojet, of which $2,200,000 will specifically be used for completion of the reengineered design of the Ionojet technology and the submission of a new IDE for our pivotal trial in diabetic foot ulcers;

•$1,749,452 for the redemption of all outstanding shares of the Series B Preferred Stock, including accumulated dividends at the simple annual rate of 20% per annum, based upon the stated value of $100 per share, calculated through September30, 2023, which amount may be increased by a premium payment up to an additional $1million pursuant to the terms of an agreement with the holder of the Series B Preferred Stock if the net proceeds of the initial public offering exceed $15million;

•$411,883 in full satisfaction of the amount owed under the LFEIF Note, including interest at the fixed simple rate of 20% per annum calculated through September30, 2023, which note matures thirty (30) days after the closing of this offering;

•approximately $170,000 in repayment of loans which will be repaid to related parties ($50,000 to Michael Preston, our Chairman and Chief Executive Officer; $30,000 to David Dantzker, our Deputy Chairman and Chief Medical Officer; approximately $42,000 to John Fernandes, our Chief Financial Officer; $13,000 to Alexander Dolgopolsky, a holder of more than 5% of our outstanding capital stock and our Chief Scientist and $35,000 to Square Table LLC a limited liability company of which Michael Preston is the sole manager with sole voting and disposition power over such shares);

•approximately $974,000 in payment of deferred salaries in cash, calculated through September30, 2023, over the 18months subsequent to this offering, of which approximately $500,000 will be paid to related parties (approximately $100,000 to Michael Preston, our Chairman and Chief Executive Officer; approximately $250,000 to John Fernandes, our Chief Financial Officer, approximately $100,000 to David Dantzker, our Deputy Chairman and Chief Medical Officer; and approximately $50,000 to Alexander Dolgopolsky, a holder of more than 5% of our outstanding capital stock and our Chief Scientist);

•approximately $613,000 in payment of prior periods’ accounts payable;

•approximately $300,000 in advisory fees to be paid in connection with this offering (see “Advisors”), which represents 3% of the gross proceeds expected to be raised by the Advisors; and

•the remainder for working capital, research and development, general and administrative matters and general corporate purposes.

We will require a total of approximately $15 million to complete the reengineered design of the Ionojet technology and the submission of a new IDE for our pivotal trial in diabetic foot ulcers and an additional $15 million to complete the pivotal clinical trial and the premarket application submission process, assuming the completion of such pivotal

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trial and that the primary and/or secondary outcomes of the trial design are met. Therefore, we will require additional funding of approximately $20 to $25million, which, although there can be no assurance, we intend to raise in subsequent offerings, both public and private, or by commercial arrangements.

The expected use of the net proceeds from this offering and our existing cash represent our intentions based upon our current plans and business conditions. The amounts and timing of our actual expenditures may vary significantly depending on a number of factors, including the progress of our development and commercialization efforts, the status of and results from our clinical trials, and any collaborations that we may enter into with third parties for our products or product candidates, as well as any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering. We have no current understandings, agreements or commitments for any material acquisitions or licenses of any products or product candidates, businesses or technologies.

Pending our application of the net proceeds from this offering, we plan to invest the net proceeds in a variety of capital preservation investments, including short and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

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DIVIDEND POLICY

We have never declared or paid, and we do not anticipate declaring or paying in the foreseeable future, any cash dividends on our common stock. Each holder of the Series B Preferred Stock is entitled to receive dividends at the simple annual rate of twenty percent (20%) of the stated value of $100 per share per annum, payable in cash upon the redemption of such shares. We intend to reinvest any earnings in developing and expanding our business. Any future determination relating to the declaration and payment of dividends will be at the discretion of our board of directors and will depend on then-existing conditions, including our operating results, financial conditions, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant.

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of June 30, 2023:

•on an actual basis;

•on a pro forma basis to give effect to: (i) on August18, 2023, the issuance of 20,000shares of common stock to an investor in the Third Private Placement and the receipt of $46,000 in net cash proceeds; (ii) on September7, 2023; (ii) the issuance of 11,400shares of common stock to an investor whose funds were received in 2020 but who did not provide a subscription agreement until that date; and (iii) the filing and effectiveness of our second amended and restated certificate of incorporation prior to the effectiveness of this offering; and

•on a pro forma, as adjusted basis to additionally give effect to: (i) the pro forma adjustments set forth above; (ii) the conversion of the Private Placement Notes upon the effectiveness of the registration statement of which this prospectus is a part, into an aggregate of 775,900shares of common stock at an conversion price of $2.50 per share, which is 50% of the assumed initial public offering price of $5.00 per share, (iii) the sale of 3,000,000shares of common stock in this offering, assuming an initial public offering price of $5.00 per share of common stock, after deducting underwriting discounts and commissions and estimated offering expenses payable by us; (iv) the payment of $1,749,452 upon the redemption of 10,000shares of Series B Preferred Stock outstanding, at the price of $100 per share, including accumulated dividends calculated through September30, 2023, pursuant to an agreement with the holder of the Series B Preferred Stock; (v) the repayment of $411,883 in full satisfaction of the LFEIF Note, including interest calculated through September30, 2023, which shall become due and payable thirty (30) days after the closing of this offering if not earlier converted at the direction of LFEIF; (vi) the issuance of 91,880shares of common stock in repayment of an aggregate of $459,400 of outstanding loans pursuant to agreements with the holders of such loans upon consummation of this offering; (vii) a reduction of liability in the amount of $5,975,357 as a result of the issuance of warrants to purchase an aggregate of 1,195,075shares of common stock in exchange for deferred salaries and bonuses calculated through September30, 2023 upon consummation of this offering; (viii) a reduction in liability in the amount of $1,128,320 as a result of the issuance of warrants to purchase an aggregate of 225,664shares of common stock in consideration for accrued consulting fees and commissions upon consummation of this offering; (ix) the issuance of 62,400shares of common stock in consideration for $312,000 of outstanding accounts payable upon consummation of this offering; (x) a reduction of liability in the amount of $360,000 as a result of the issuance of warrants to purchase an aggregate of 72,000shares of common stock in consideration for deferred director fees upon consummation of this offering; and (xi) a reduction of liability in the amount of $50,000 as a result of the issuance of a warrant to purchase 10,000shares of common stock in consideration for outstanding accounts payable upon consummation of this offering.

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The information set forth in the table below is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering as determined at pricing. You should read the information in this table together with our audited financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this prospectus.