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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generally first receive PMA from the FDA. This process can be expensive and lengthy, and can entail significant expenses, primarily related to clinical trials. It generally takes between one to three years to receive approval, or even longer, from the time the PMA application is submitted to the FDA. Regulatory clearances or approvals, either foreign or domestic, may not be granted on a timely basis, if at all. If we are unable to obtain regulatory approvals or clearances for use of our product candidates under development, or if the patient populations for which they are approved are not sufficiently broad, the commercial success of these product candidates could be limited. The FDA may also limit the claims that we can make about our product candidates. Any significant modifications to the design, materials, or intended use of those devices require FDA approval through PMA or humanitarian device extension (“HDE”) supplemental applications.

we do not receive FDA approval for one or more of our product candidates, we will be unable to market and sell those product candidates
in the U.S., which would have a material adverse effect on our operations and prospects.

also plan to market our product candidates in international markets, including the European Union.
Regulatory approval processes differ among those jurisdictions and approval in the U.S. or any other single jurisdiction does not guarantee
approval in any other jurisdiction. Obtaining foreign approvals could involve significant delays, difficulties and costs for us and could
require additional clinical trials.

Our
product candidates are subject to extensive regulatory requirements, including continuing regulatory review, which could affect the manufacturing
and marketing of our product candidates.

The
FDA and other regulatory agencies continue to review product candidates even after they have received initial approval. If and when the
FDA or another regulatory agency clears or approves our product candidates under development, the manufacture and marketing of these
product candidates will be subject to continuing regulation, post-approval clinical studies, including compliance with the FDA’s
adverse event reporting requirements, prohibitions on promoting a product for unapproved uses, and QSR requirements, which obligate manufacturers,
including third-party and contract manufacturers, to adhere to stringent design, testing, control, documentation and other quality assurance
procedures during the design and manufacture of a device.

Any
modification to an FDA approved device that could significantly affect its safety or effectiveness, or that would constitute a major
change in its intended use, requires a supplemental PMA, HDE or Emergency Use Authorization (“EUA”) approval. The FDA requires
each manufacturer to determine in the first instance whether a modification requires approval, but the FDA may review and potentially
disagree with any such decision. Modifications of this type are common with new product candidates. We anticipate that the first generation
of each of our product candidates will undergo a number of changes, refinements, enhancements and improvements over time. If the FDA
requires us to seek approval for modification of a previously approved product for which we have concluded that new clearances or approvals
are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval and we
may be subject to significant regulatory fines or penalties, which could have a material adverse effect on our financial results and
competitive position. We also cannot assure you that we will be successful in obtaining clearances or approvals for our modifications,
if required. We and our third-party suppliers of product components are also subject to inspection and market surveillance by the FDA
and other regulatory agencies for QSR and other requirements, the interpretation of which can change. Compliance with QSR and similar
legal requirements can be difficult and expensive. While we continue to monitor our quality management in order to improve our overall
level of compliance, our facilities are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit
compliance with the QSR and comparable foreign regulations. Enforcement actions resulting from failure to comply with government requirements
could result in fines, suspensions of approvals or clearances, recalls or seizure of product candidates, operating restrictions or shutdown,
and criminal prosecutions that could adversely affect the manufacture and marketing of our product candidates. The FDA or another regulatory
agency could withdraw a previously approved product from the market upon receipt of newly discovered information, including a failure
to comply with regulatory requirements, the occurrence of unanticipated safety problems of other defects in product candidates following
approval, or other reasons, which could adversely affect our operating results.

Consolidation
in the medical device industry could have an adverse effect on our revenue and results of operations.

Many
medical device companies are consolidating to create new companies with greater market power. As the medical device industry consolidates,
competition to provide goods and services to industry participants will become more intense. These industry participants may try to use
their market power to negotiate price concessions or reductions for our product candidates. If we reduce our prices because of consolidation
in the healthcare industry, our revenue would decrease, which could have a material adverse effect on our business, financial condition
and results of operations.

are subject to various U.S. and international bribery, anti-kickback, false claims, privacy, transparency, and similar laws, any breach
of which could cause a material, adverse effect on our business, financial condition, and profitability.

Our
relationships with physicians, hospitals, and other healthcare providers are subject to scrutiny under various U.S. and international
bribery, anti-kickback, false claims, privacy, transparency, and similar laws, often referred to collectively as “healthcare compliance
laws.” Healthcare compliance laws are broad, sometimes ambiguous, complex, and subject to change and changing interpretations.
Possible sanctions for violation of these healthcare compliance laws include fines, civil and criminal penalties, exclusion from government
healthcare programs, and despite our compliance efforts, we face the risk of an enforcement activity or a finding of a violation of these
laws. While our relationships with healthcare professionals and organizations are structured to comply with such laws, it is possible
that enforcement authorities may view our relationships as prohibited arrangements that must be restructured or for which we would be
subject to other significant civil or criminal penalties or debarment. In any event, any enforcement review of or action against us as
a result of such review, regardless of outcome, could be costly and time consuming. Additionally, we cannot predict the impact of any
changes in or interpretations of these laws, whether these changes will be retroactive or will have effect on a going-forward basis only.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing
and sale of our product candidates. The expense and potential unavailability of insurance coverage for liabilities resulting from our
product candidates could harm us and our ability to sell our product candidates.

face an inherent risk of product liability as a result of the marketing and sale of our product candidates. For example, we may be sued
if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during manufacturing, marketing
or sale. Any such product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of
dangers inherent in the product, negligence, strict liability or a breach of warranties. In addition, we may be subject to claims against
us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, we rely on physicians
in connection with the use of our product candidates on patients. If these physicians are not properly trained or are negligent, the
capabilities of our product candidates may be diminished, or the patient may suffer critical injury. We may also be subject to
claims that are caused by the activities of our suppliers, such as those who provide us with components and sub-assemblies.

we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit
or halt commercialization of our product candidates. Even successful defense would require significant financial and management resources.
Regardless of the merits or eventual outcome, liability claims may result in:

●	decreased
demand for our product candidates;

●	injury
to our reputation;

●	initiation
of investigations by regulators;

●	costs
to defend the related litigation;

diversion of management’s time and our resources;

●	substantial
monetary awards to trial participants or patients;

●	product
recalls, withdrawals or labeling, marketing or promotional restrictions;

●	loss
of revenue;

●	exhaustion
of any available insurance and our capital resources; and