SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm

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measures and meets its safety endpoint (as it did in the ALIVE trial), we expect the FDA to approve the Revivent System thus allowing us to provide a significant new treatment for patients. However, the results of the ALIVE trial may not be replicated or ultimately accepted by the FDA as part of our PMA submission. ● Demonstrated Trial Progress : We are engaged with more than half of the potential sites needed for our RELIVE Trial and have activated six sites which are actively screening subjects. ● Experienced Clinical Trial and Manufacturing Management across Cardiovascular Devices and Specifically Running the Needed Trial : Our Chief Medical Officer and Co-CEO have played major roles in running many cardiovascular trials. Complemented by a team of industry consultants, our leadership team brings deep medical affairs, clinical trial management, regulatory, and manufacturing expertise and established relationships with leading clinical investigators and trial sites.

●	Expanding Product Portfolio and Product Synergies : In
addition to the Revivent System, we hold ownership rights to Alginate, a therapeutic device designed to treat heart failure patients
without myocardial scarring. This device was CE-marked in Europe, had received an IDE in the U.S. (though the CE-mark has lapsed
and utilizing the IDE would require a meeting with the FDA regarding a proposed plan), and represents a significant opportunity for expanding our addressable market and
diversifying our product offerings.

●	Robust IP Portfolio : Multiple U.S. and international
patents, some of which extend through 2041.

Management

Our
management team is made up of experienced executives and medical professionals. In January 2024, we appointed David Richmond, our Chairman,
Co-Chief Executive Officer, and Chief Financial Officer. Mr. Richmond restored senior management running the clinical, manufacturing,
and regulatory functions, including Steven Chartier, our President and Co-Chief Executive Officer since January 2025 and Dr. Ori Ben-Yehuda,
who rejoined as Chief Medical Officer in January 2024. As of this filing our management team led the RELIVE Trial design, secured the
regulatory approvals necessary to start our trial, activated six sites, maintained manufacturing and regulatory compliance,
secured German reimbursement, attracted clinical trial sites, recruited three board members, and recruited two national principal investigators.

Summary
of Risk Factors

Investing
in our common stock is speculative and involves a high degree of risk. These risks are discussed more fully in “Risk Factors”
and elsewhere in this prospectus. We urge you to read “Risk Factors” beginning on page 10 and this prospectus in full. Our
significant risks may be summarized as follows:

Risks
Related to Our Industry and Business

have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever generate revenue
or achieve profitability (of which no assurances can be given), we may not be able to sustain it.

will require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms
or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit,
reduce or eliminate our product development programs, commercialization efforts or other operations.

we are unable to establish an effective network for commercialization, including effective distribution channels and sales and marketing
functions, it may adversely affect our business, financial condition, results of operations, and prospects.

will initially depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on
a limited number of product candidates.

●	The
commercial success of our product candidates will depend upon attaining significant market acceptance of these product candidates
among physicians, healthcare payors and the medical community.

manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable
market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision
and may be smaller than we estimate.

●	Even
if we are able to launch our pipeline portfolio successfully, we may experience material delays in our commercialization program
relative to our current expectations.

hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for
procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they
will gain further acceptance.

●	Conducting
successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify
and recruit.

●	Clinical
trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to
develop new product candidates or seek new indications.

depend on a limited number of manufacturers and suppliers in connection with the manufacture of the Revivent System, which makes
us vulnerable to supply shortages and price fluctuations that could have a material adverse effect on our business, financial condition,
results of operations, and prospects.

●	The
report of our independent registered public accounting firm for the year ended December 31, 2025 includes a “going concern”
explanatory paragraph.

are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract
and retain personnel necessary for our success.

●	Product
liability claims could damage our reputation and adversely affect our financial results.

Risks
Related to Our Intellectual Property and Technology

we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary
or confidential data, employee data or personal data, or if customers, patients and other partners are reluctant to use our devices
because of concerns about the privacy or security of their data, we may face additional costs, loss of revenue, significant liabilities,
harm to our brand, decreased use of our platform and business disruption.

will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties.

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

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

●	Intellectual
property rights do not necessarily address all potential threats.

Risks
Related to Regulatory Approval and Other Governmental Regulations

intend to expand sales of any approved product candidates internationally in the future, but we may experience difficulties in obtaining
regulatory clearance or approval in the United States or in successfully marketing our product candidates internationally even if
approved. A variety of risks associated with marketing our product candidates internationally could materially adversely affect our
business.

we fail to obtain and maintain necessary governmental approvals for our product candidates and indications, we may be unable to market
and sell our product candidates in certain jurisdictions.

●	Our
product candidates are subject to extensive regulatory requirements, including continuing regulatory review, which could affect the
manufacturing and marketing of our product candidates.

●	Our
product candidates may be subject to extensive governmental regulation in foreign jurisdictions, such as the European Economic Area
(EEA), and our failure to comply with applicable requirements could cause our business, results of operations and financial condition
to suffer.

●	The
FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable.

●	While
BDD allows for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval,
faster approval, or commercial success.

Risks
Related to Our Securities and this Offering

●	The
trading price of our common stock may be volatile, and you could lose all or part of your investment.

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

●	Our
management will have broad discretion in how we use the net proceeds from this offering and might not use them effectively.

●	You
will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future.

Implications
of Being an Emerging Growth Company

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 certain exemptions from various reporting requirements
that are applicable to other public companies. These provisions include, but are not limited to:

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

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