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

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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.

Numerous
federal and state laws and regulations, including HIPAA and the HITECH Act, govern the collection, dissemination, security,
use and confidentiality of health information that identifies specific patients. HIPAA and the HITECH Act require our surgeon and hospital
customers and potential customers to comply with certain standards for the use and disclosure of health information within their companies
and with third parties. The Privacy Standards and Security Standards under HIPAA establish a set of standards for the protection of individually
identifiable health information by health plans, health care clearinghouses and certain health care providers, referred to as Covered
Entities, and the business associates with whom Covered Entities enter into service relationships pursuant to which individually identifiable
health information may be exchanged. Notably, whereas HIPAA previously directly regulated only these Covered Entities, the HITECH Act
makes certain of HIPAA’s privacy and security standards also directly applicable to Covered Entities’ business associates.
As a result, both Covered Entities and business associates are subject to significant civil and criminal penalties for failure to comply
with Privacy Standards and Security Standards.

HIPAA
requires Covered Entities (like many of our customers and potential customers) and their business associates to develop and maintain
policies and procedures with respect to protected health information that is used or disclosed, including the adoption of administrative,
physical and technical safeguards to protect such information. The HITECH Act expands the notification requirement for breaches of patient-identifiable
health information, restricts certain disclosures and sales of patient-identifiable health information and provides for civil monetary
penalties for HIPAA violations. The HITECH Act also increased the civil and criminal penalties that may be imposed against Covered Entities
and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts
to enforce the federal HIPAA laws and seek attorney fees and costs associated with pursuing federal civil actions. Additionally, certain
states have adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. While we are
not directly subject to HIPAA as a Covered Entity or business associate, we may be required to comply with HIPAA requirements in connection
with the conduct of our clinical trials.

Any
new legislation or regulation in the area of privacy and security of personal information, including personal health information, could
also adversely affect our business operations. If we do not comply with existing or new applicable federal or state laws and regulations
related to patient health information, we could be subject to criminal or civil sanctions and any resulting liability could adversely
affect our financial condition.

addition, countries around the world have passed or are considering legislation that would impose data breach notification requirements
and/or require that companies adopt specific data security requirements. If we experience a data breach that triggers one or more of
these laws, we may be subject to breach notification obligations, civil liability and litigation, all of which could also generate negative
publicity and have a negative impact on our business.

are currently, and in the future may be, subject to various governmental regulations related to the manufacturing of product candidates
and their components, and we may incur significant expenses to comply with, experience delays in our product commercialization as a result
of and be subject to material sanctions if we or our contract manufacturers violate these regulations.