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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“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.

our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us
now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion
from governmental health care programs and the curtailment or restructuring of our operations, any of which could adversely affect our
ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully
defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation
of our business.

Inadequate
funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent
new product candidates and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from
performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The
ability of the FDA to review and approve new product candidates can be affected by a variety of factors, including government budget
and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy
changes, including changes to the FDA’s priorities or processes. In addition, government funding of the SEC and other government
agencies on which our operations may rely, including those that fund research and development activities, is subject to the political
process, which is inherently fluid and unpredictable.

Disruptions
at the FDA and other agencies may also slow the time necessary for our product candidates or product candidates to be reviewed or approved
by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. federal
government has shut down several times and certain regulatory agencies, such as the FDA have had to furlough critical employees and stop
critical activities. If a prolonged government shutdown occurs, or if the FDA is otherwise hindered by inadequate funding, it could significantly
impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on
our business. Further, in our operations as a newly public company, future government shutdowns or similar funding issues could impact
our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Our
relationships with physician consultants, owners and investors could be subject to additional scrutiny from regulatory enforcement authorities
and could subject us to possible administrative, civil or criminal sanctions.

Federal
and state laws and regulations impose restrictions on our relationships with physicians who are consultants, owners and investors. We
may enter into consulting agreements, license agreements and other agreements with physicians in which we provide cash as compensation.
We have or may have other written and oral arrangements with physicians, including for research and development grants and for other
purposes.

could be adversely affected if regulatory agencies were to interpret our financial relationships with these physicians, who may be in
a position to influence the ordering of and use of our product candidates for which governmental reimbursement may be available, as being
in violation of applicable laws. If our relationships with physicians are found to be in violation of the laws and regulations that apply
to us, we may be required to restructure the arrangements and could be subject to administrative, civil and criminal penalties, including
exclusion from participation in government healthcare programs, imprisonment, and the curtailment or restructuring of our operations,
any of which could negatively impact our ability to operate our business and our results of operations.

Our
company and many of our collaborators and potential collaborators may be required to comply with the Federal Health Insurance Portability
and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act and implementing regulations affecting
the transmission, security and privacy of health information, and failure to comply could result in significant penalties and reputational
harm.