SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-05-15
Accession Number: 0001493152-26-023752
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226023752/forms-1a.htm

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product candidates relative to other treatment methods; ● the pricing and reimbursement of our product candidates relative to other treatment methods; and ● the marketing and distribution support for our product candidates. There is a risk that we may be unable to address any of these criteria or any additional criteria that might affect the market acceptance of our product candidates. If our product candidates achieve market acceptance, they may not maintain that market acceptance over time if competing product candidates or technologies are introduced that are received more favorably or are more cost-effective. Failure to achieve or maintain market acceptance would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition, results of operations and prospects. Our employees, independent contractors, consultants, commercial partners, distributors, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

operate in a highly regulated industry. We are exposed to the risk that our employees, independent contractors, consultants, commercial
partners, distributors, and vendors may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional,
reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the laws of the FDA and other similar
foreign regulatory bodies, including those laws requiring the reporting of true, complete and accurate information to such regulators;
(ii) manufacturing standards; (iii) healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws;
or (iv) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact, among other
things, 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 commissions, 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.

plan to adopt a code of business conduct and ethics in connection with the closing of this offering, but it may not always be possible
to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities
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. If any such actions are instituted against
us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant
fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement,
individual imprisonment, additional integrity reporting and oversight obligations, possible exclusion from participation in Medicare,
Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment
of operations, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not
we are successful in defending against any such actions or investigations, we could incur substantial costs, including legal fees, and
divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material
adverse effect on our business, financial condition, and results of operations.

may be unable to compete successfully with larger companies in our highly competitive industry.

The
medical device industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and
other market activities of industry participants. We compete or plan to compete with other providers of cardiovascular procedures. While
we believe that there are currently no direct substitutes to our product candidates available or in clinical development, a competitor
may develop a comparable product in the future. Many of these competitors are large, well-capitalized companies with significantly greater
market share and resources than we have. As a consequence, they are able to spend more on product development, marketing, sales and other
product initiatives than we can. We also compete with smaller medical device companies that have single product candidates or a limited
range of product candidates. Some of our competitors have:

●	significantly
greater name recognition;

●	broader
or deeper relations with healthcare professionals, customers and third-party payors;

●	more
established distribution networks;

●	additional
lines of product candidates and the ability to offer rebates or bundle product candidates to offer greater discounts or other incentives
to gain a competitive advantage;

●	greater
experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or
approval for product candidates; and

●	greater
financial and human resources for product development, sales and marketing and patent litigation.

believe that our intellectual property, technology and organization will be critical to our future success. Our competitive advantage
is driven by our ability to safely and effectively treat patients with left ventricle heart failure while improving outcomes and reducing
procedural costs. To sustain our success, we will need to:

●	develop
innovative, proprietary product candidates that can cost-effectively address significant clinical needs;

●	continue
to innovate and develop scientifically advanced technology;

●	obtain
and maintain regulatory clearances or approvals;

●	demonstrate
efficacy in our sponsored and third-party clinical trials and studies;

●	apply
our technology across product lines and markets;

●	attract
and retain skilled research and development and sales personnel; and

●	cost-effectively
manufacture and successfully market and sell product candidates.

addition, competitors with greater financial resources than ours could acquire other companies to gain enhanced name recognition and
market share, as well as new technologies or product candidates that could effectively compete with our existing product candidates,
which may cause our revenue to decline and would harm our business.

Our
competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, as well as in
acquiring technologies complementary to, or necessary for, our product candidates. Because of the complex and technical nature of our
product candidates and the dynamic market in which we compete, any failure to attract and retain a sufficient number of qualified employees
could materially harm our ability to develop and commercialize our product candidates, which would have a material adverse effect on
our business, financial condition and results of operations.

Technological
change may adversely affect sales of our product candidates and may cause our product candidates 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 product candidates. There can be no assurance that other companies
will not succeed in developing or marketing devices and product candidates that are more effective than the Revivent System or that would
render the Revivent System obsolete or noncompetitive. Additionally, new surgical procedures, medications and other therapies could be
developed that replace or reduce the importance of our product candidates. Our product candidates could be rendered obsolete because
of future innovations by our competitors or others in the treatment of cardiovascular diseases, which would have a material adverse effect
on our business, financial condition and results of operations. Accordingly, our success will depend in part on our ability to respond
quickly to medical and other changes through the development and introduction of new product candidates. Product development involves
a high degree of risk, and there can be no assurance that our new product development efforts will result in any commercially successful
product candidates.

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.

Growing
sales of our product depends on the availability of adequate coverage and reimbursement from third-party payors, including government
programs such as Medicare and Medicaid, private insurance plans, and managed care programs. Hospitals, clinicians, and other healthcare
providers that purchase or use medical devices generally rely on third-party payors to pay for all or part of the costs and fees associated
with the procedures performed with these devices.

Adequate
coverage and reimbursement for procedures performed with our product candidates is central to the acceptance of our current and future
product candidates. We may be unable to sell our product candidates on a profitable basis if third-party payors deny coverage, continue
to deny coverage or reduce their current levels of payment, or if our costs for the product increase faster than increases in reimbursement
levels.