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

Chunk 26 of 83
Word Count: 1425
Character Count: 9297

Document Content:

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;

●	HIPAA,
as amended by the HITECH Act, and their respective implementing regulations, which governs the conduct of certain electronic healthcare
transactions and protects the security and privacy of protected health information. Failure to comply with the HIPAA privacy and
security standards can result in civil monetary penalties up to $50,000 per violation, not to exceed $1.5 million per calendar year
for non-compliance of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation
and/or imprisonment. State attorneys general can bring a civil action to enjoin a HIPAA violation or to obtain statutory damages
up to $25,000 per violation on behalf of residents of his or her state. HIPAA also imposes criminal penalties for fraud against any
healthcare benefit program and for obtaining money or property from a healthcare benefit program through false pretenses and provides
for broad prosecutorial subpoena authority and authorizes certain property forfeiture upon conviction of a federal healthcare offense.
Significantly, the HIPAA provisions apply not only to federal programs, but also to private health benefit programs. HIPAA also broadened
the authority of the U.S. Office of Inspector General of the U.S. Department of Health and Human Services to exclude participants
from federal healthcare programs;

●	the
federal physician sunshine requirements under the Patient Protection and Affordable Care Act, or PPACA, which requires certain manufacturers
of drugs, devices, biologics and medical supplies to report annually to the U.S. Department of Health and Human Services information
related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers and
teaching hospitals and ownership and investment interests held by physicians and their immediate family members. Manufacturers are
required to submit reports by the 90 th day of each calendar year. Failure to submit the required information may result
in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing
failures”) for all payments, transfers of value or ownership or investment interests not reported in an annual submission,
and may result in liability under other federal laws or regulations; 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 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 laws
that require device manufacturers to report information related to payments and other transfers of value to physicians and other
healthcare providers or marketing expenditures; and state 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. Any failure by us to ensure that our employees and agents comply with applicable state and foreign laws and regulations
could result in substantial penalties or restrictions on our ability to conduct business in those jurisdictions, and our results
of operations and financial condition could be materially and adversely affected.

The
risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the
regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Because of the breadth of these
laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of our
business activities, including our relationships with heart failure specialists, surgeons, and other healthcare providers,
some of whom recommend, purchase and/or prescribe our product candidates, and our distributors, could be subject to challenge under
one or more of such laws.