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

Legislative
or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or
approvals for product candidates or to manufacture, market or distribute product candidates after clearance or approval is obtained.

From
time to time, legislation is drafted and introduced in the U.S. Congress that could significantly change the statutory provisions governing
the regulation of medical devices or the reimbursement thereof. In addition, the FDA regulations and guidance are often revised or reinterpreted
by the FDA in ways that may significantly affect our business and our product candidates. Any new statutes, regulations or revisions
or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future product candidates or
make it more difficult to manufacture, market or distribute our product candidates or future product candidates. We cannot determine
what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have
on our business in the future. Such changes could, among other things, require:

●	additional
testing prior to obtaining clearance or approval;

●	changes
to manufacturing methods;

●	recall,
replacement or discontinuance of our systems or future product candidates; or

●	additional
record keeping.

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

The
highly publicized PIP scandal (use of non-medical grade silicone in breast implants) in 2010 led to publishing the first version of EU
Medical Device Regulation (MDR) by European Commission in 2012. After 347 amendments by European Parliament in 2014, followed by various
versions, the final version of the new EU Medical Device Regulation (MDR 2017/745) was published on May 5, 2017. Notified Bodies are
currently not accepting any new CE Mark applications under MDD (Medical Device Directives). All new medical devices, including ours,
must undergo assessment under MDR.

The
changes from EU Medical Device Directives (MDD) to Medical Device Regulation (MDR) are significant, with stricter clinical requirements
and post-market surveillance, shift from pre-approval to Life-cycle approach, centralized EUDAMED database for public transparency (e.g.
Periodic Safety Update Reports) and device registration, more device specific requirements (e.g. Common Specifications), legal liability
for defective devices, etc. The QMS audit under MDR will be much more rigorous, including audits and assessment of suppliers and device
testing.

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

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

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

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

●	the
federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering
or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase,
order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare
and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific
intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services
resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False
Claims Act. Violations of the federal Anti-kickback Statute may result in substantial civil or criminal penalties, including criminal
fines of up to $100,000, imprisonment of up to ten years, civil penalties under the Civil Monetary Penalties Law of up to $50,000
for each violation, plus three times the remuneration involved, civil penalties under the federal False Claims Act of up to $11,000
for each claim submitted, plus three times the amounts paid for such claims and exclusion from participation in the Medicare and
Medicaid programs;

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

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