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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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.

Claims
against us relating to the infringement of third-party proprietary rights or proprietary determinations, even if not meritorious, could
result in costly litigation, lengthy governmental proceedings, diversion of our management’s attention and resources, or entrance
into royalty or license agreements that are not advantageous to us. In any of these circumstances, we may need to spend significant amounts
of money, time and effort defending our position. Some of our competitors may be able to sustain the costs of complex patent litigation
more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation
and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these
proceedings, which could have a material and adverse effect on us. If we are unable to avoid infringing the intellectual property rights
of others, we may be required to seek a license, defend an infringement action, challenge the validity of intellectual property in court,
redesign our product candidates, product candidates, or methods, or cease production of our product candidates altogether.

Competitors
may also infringe our patents. If we file an infringement proceeding to enforce one or more of our patents, a court may decide that patents
owned by us are invalid or unenforceable, or may refuse to enjoin the other party from using the technology at issue on the grounds that
our patents do not cover such technology. An adverse result in any litigation proceeding could put one or more of our patents at risk
of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during
litigation. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us
to incur significant expenses and could distract our management and other personnel from their normal responsibilities. In addition,
there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities
analysts or investors perceive these results to be negative, it could have a substantial adverse effect on our common stock price. Such
litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities
or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation
or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively
than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties
resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our
ability to compete in the marketplace. Any of the foregoing could have a material adverse effect on our business, financial condition
or results of operations.

our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest
and our business may be adversely affected.

Our
trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be violating or infringing other
marks. We may not be able to protect our rights to these trademarks and trade names to build name recognition among potential partners
and customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to
ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential
trade name or trademark infringement or dilution claims brought by owners of other trademarks. Over the long term, if we are unable to
establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may
be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names or
other intellectual property may be ineffective, could result in substantial costs and diversion of resources and could adversely affect
our business, financial condition and results of operations.

Intellectual
property rights do not necessarily address all potential threats.

The
degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations
and may not adequately protect our business or permit us to maintain our competitive advantage. For example, in addition to the factors
discussed above:

●	others
may be able to make product candidates that are similar to our product candidates or utilize similar technology but that are not
covered by the claims of our patents or that incorporate certain technology in our product candidates that is in the public domain;

or our future licensors or collaborators, might not have been the first to make the inventions covered by the applicable issued patent
or pending patent application that we own now or may own or license in the future;

or our future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their
inventions;

●	others
may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual
property rights;

●	our
competitors or other third parties might conduct research and development activities in countries where we do not have patent rights
and then use the information learned from such activities to develop competitive product candidates for sale in our major commercial
markets;

may not develop additional proprietary technologies that are patentable; and

may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a
patent covering such intellectual property.

Any
of the foregoing could have a material adverse effect on our business, financial condition and results of operations.

Risks
Related to Regulatory Approval and Other Governmental Regulations

Our
business and product candidates are subject to extensive governmental regulation and oversight, and our failure to comply with applicable
regulatory requirements could harm our business.

Our
product candidates and operations are subject to extensive regulation in the United States by the FDA and by regulatory agencies in other
countries where we anticipate conducting business activities. The FDA in the U.S., and regulatory agencies in other jurisdictions
regulate the development, testing, manufacturing, labeling, storage, record-keeping, promotion, marketing, sales, distribution and post-market
support and reporting of medical devices. The regulations to which we are subject are complex and may become more stringent over time.
Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or
lower than anticipated sales.