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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development and commercialization activities with respect to licensed product candidates, and may need to satisfy specified milestone and royalty payment obligations. If we fail to comply with any obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole or in part, increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which case our ability to develop or commercialize product candidates covered by the license agreement will be impaired. addition, disputes may arise regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● our diligence obligations under the license agreement and what activities satisfy those obligations;

a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements,
we may be required to sublicense rights in that area to the third party, and that sublicense could harm our business; and

●	the
ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

Disputes
over intellectual property that we have licensed may prevent or impair our ability to maintain our current licensing arrangements on
acceptable terms, and we may be unable to successfully develop and commercialize our product candidates.

Obtaining
and maintaining our patent protection is a complex process that requires compliance with various procedures, documentation requirements,
fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated
for non-compliance with these requirements.

The
patent prosecution process is expensive, time-consuming and complex, and we may not be able to file, prosecute, maintain, enforce or
license all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail
to identify patentable aspects of our research and development output in time to obtain patent protection. Also, filing, prosecuting
and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. Consequently,
we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling
or importing product candidates made using our inventions in and into the United States or other jurisdictions.

There
can be no guarantee that any patents will issue from our pending patent applications or future patent applications that we file, if any,
and there can be no guarantee that any issued patents will adequately protect our intellectual property. We cannot be certain that we
were the first to make the inventions claimed in any of our patents or pending patent applications, or that we were the first to file
for patent protection for such inventions. Defects of form in the preparation or filing of our patents or patent applications may exist,
or may arise in the future, for example, with respect to proper priority claims, inventorship and the like. If there are material defects
in the form, preparation or prosecution of our patents or patent applications, such patents or applications may be invalid and unenforceable.
Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

The
legal standards relating to the validity, enforceability and scope of protection of patent and other intellectual property rights are
complex and often uncertain, and are subject to change that can affect the validity of patents issued under previous legal standards.
The U.S. Patent and Trademark Office, or USPTO, and various foreign governmental patent agencies further require compliance with a number
of procedural, documentary, fee payments (e.g., maintenance and annuity fee payments), and other provisions during the patent procurement
process as well as over the life span of an issued patent. Noncompliance can result in abandonment or lapse of a patent or patent application,
resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter
the market or compete more directly at an earlier time than would otherwise have been the case.

may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights
and we may be unable to protect our rights to, or use of, our technology.

Our
commercial success depends in part on our ability to operate without infringing the intellectual property and proprietary rights of third
parties. Our business, product candidates, and methods could infringe the patents or other intellectual property rights of third parties.
Our competitors may seek, or may already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use,
sell, offer to sell, and license our product candidates and technologies either in the United States or in international markets. It
may be difficult or impossible to identify, prior to receipt of notice from a third party, the patents, trade secrets, or other intellectual
property rights of a third party, either in the United States or in foreign jurisdictions, that relate to our business, product candidates,
and methods. We have not conducted an extensive search of patents issued or assigned to other parties, including our competitors, and
no assurance can be given that patents containing claims covering our product candidates, parts of our product candidates, technology
or methods do not exist, have not been filed or could not be filed or issued. In addition, because patent applications can take many
years to issue and because publication schedules for pending applications vary by jurisdiction, there may be applications now pending
of which we are unaware and which may result in issued patents which our current or future product candidates infringe. Also, because
the claims of published patent applications can change between publication and patent grant, there may be published patent applications
that may ultimately issue with claims that we infringe.

Our
industry is characterized by frequent and extensive litigation regarding patents and other intellectual property rights. Many companies
in our industry with substantially greater resources than us have employed intellectual property litigation as a way to gain a competitive
advantage. We may become involved in litigations, interference proceedings, derivation proceedings, inter partes review proceedings,
oppositions, reexaminations, protests or other potentially adverse intellectual property proceedings as a result of alleged infringement
by us of the rights of others, or as a result of priority of invention disputes or ownership disputes with third parties, either in the
United States or internationally. In those proceedings, Third parties may challenge the validity and enforceability of any of our issued
patents, and whether we own those patents. Even if we believe such claims are without merit, there is no assurance that a court would
find in our favor on questions of infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that
these third-party patents are valid, enforceable and infringed by our product candidates. In order to successfully challenge the validity
of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring
us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of
competent jurisdiction would invalidate the claims of any such U.S. patent. If we are found to infringe third-party patents, and we are
unsuccessful in demonstrating that such patents are invalid or unenforceable, such third parties may be able to block our ability to
commercialize the applicable product candidates or technology unless we obtain a license under the applicable patents, or until such
patents expire or are finally determined to be held invalid or unenforceable. Such a license may not be available on commercially reasonable
terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay significant license fees and/or
royalties, and the rights granted to us might be non-exclusive, which could result in our competitors gaining access to the same technology.
If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, we may be unable
to commercialize our product candidates, or such commercialization efforts may be significantly delayed, which could in turn significantly
harm our business.