SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.htm

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our management team led the RELIVE Trial design, secured the regulatory approvals necessary to start our trial, activated three sites, maintained manufacturing and regulatory compliance, secured German reimbursement, attracted clinical trial sites, recruited three board members, and recruited two national principal investigators during 2024 and 2025. 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.

●	Even
after receiving regulatory clearance or approval, our product candidates may be subject to product recalls, which could harm our
reputation and divert our managerial and financial resources.

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, 2024 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.

●	Litigation
and other legal proceedings may adversely affect our business.

●	Economic
conditions may adversely affect our business.

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
BTD 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

active trading market for our common stock currently exists, and an active trading market may not develop or be sustained following
this offering.

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

●	Certain
recent initial public offerings of companies with public floats comparable to our anticipated public float have experienced extreme
volatility that was seemingly unrelated to the underlying performance of the respective company. We may experience similar volatility,
which may make it difficult for prospective investors to assess the value of our common stock.

●	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”);

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

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

particular, in this prospectus, we have provided only two years of audited financial statements and have not included all of the executive
compensation-related information that would be required if we were not an emerging growth company. Accordingly, the information contained
herein may be different from the information you receive from other public companies in which you hold stock.