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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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.

order to conduct a clinical investigation involving human subjects to demonstrate the safety and effectiveness of a medical device, a
company must first apply for and obtain FDA approval of an IDE application if the study involves a “significant risk” (as
defined by the FDA) to human health. Our product candidates are considered significant risk devices, requiring an IDE prior to
investigational use. With an IDE, which we received in November 2024 for the Revivent clinical trial, we can start the process
of obtaining Institutional Review Board (“IRB”) approvals at clinical sites before initiating studies at these sites. Despite
securing an IDE, we may encounter challenges in obtaining IRB approvals or conducting studies that fully comply with
the IDE and other regulations governing clinical investigations. Additionally, the data from any such trials may not support clearance
or approval of the investigational device. Failure to obtain necessary approvals or comply with regulatory requirements could have a
material adverse effect on our business, financial condition and results of operations. Furthermore, uncertainty remains as to whether
clinical trials will meet desired endpoints, produce meaningful or useful data, be free of unexpected adverse effects, or whether the
FDA will accept the validity of foreign clinical study data, if applicable. Such uncertainty could preclude or delay market clearance
or authorizations, resulting in significant financial costs and reduced revenue.

the case of the Revivent System, an IDE was initially approved in 2016 for the ALIVE study and a second IDE was approved in November
2024 for the RELIVE Study.

Our
product candidates may be subject to extensive governmental regulation in foreign jurisdictions, such as the European Economic Area (EEA),
and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.

the EEA, our product candidates will need to comply with the Essential Requirements set forth in Medical Device Directives (MDD) (Directive
93/42/EEC) and/or Medical Device Regulation (MDR). Compliance with these requirements is a prerequisite to be able to affix a CE mark
to a product, without which a product cannot be marketed or sold in the EEA. To demonstrate compliance with the Essential Requirements
and obtain the right to affix the CE mark to our product candidates, we must undergo a conformity assessment procedure, which varies
according to the type of medical device and its classification. The conformity assessment procedure requires the involvement of a Notified
Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments. The Notified
Body would audit and examine the Technical File and the quality system for the manufacture, design and final inspection of our product
candidates. The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure
and quality management system audit conducted in relation to the medical device and its manufacturer and their conformity with the Essential
Requirements. This Certificate entitles the manufacturer to affix the CE mark to its medical product candidates after having prepared
and signed a related EC Declaration of Conformity.

a general rule, demonstration of conformity of medical product candidates and their manufacturers with the Essential Requirements must
be based, among other things, on the evaluation of clinical data supporting the safety and performance of the product candidates during
normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal
conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against
the benefits of its intended performance, and that any claims made about the performance and safety of the device (e.g., product labeling
and instructions for use) are supported by suitable evidence. This assessment must be based on clinical data, which can be obtained from
(1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the
assessed device can be demonstrated or (3) both clinical studies and scientific literature. However, the pre-approval and post-market
clinical requirements are much more rigorous. The conduct of clinical studies in the EEA is governed by detailed regulatory obligations.
These may include the requirement of prior authorization by the competent authorities of the country in which the study takes place and
the requirement to obtain a positive opinion from a competent Ethics Committee. This process can be expensive and time-consuming.

The
FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable.