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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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.

the United States, our product candidates are regulated as medical devices. Before our medical device product candidates may be marketed
in the United States, we must submit, and the FDA must approve a PMA. For the PMA approval process, the FDA must determine that a proposed
device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical,
clinical trial, manufacturing and labeling data. In addition, modifications to product candidates that are approved through a PMA generally
require FDA approval. The time required to obtain approval, clearance or license by the FDA to market a new therapy is unpredictable
but typically takes years and depends upon many factors, including the substantial discretion of the FDA. This timeline may be further
extended as a result of the recent reduction in workforce that has taken place within the federal government, including at the FDA.

Our
product candidates could fail to receive regulatory approval, clearance or license for many reasons, including the following:

●	the
FDA may disagree with the design or implementation of our clinical trials or study endpoints;

may be unable to demonstrate to the satisfaction of the FDA that our product candidates are safe and effective for their proposed
indications or that our product candidates provide significant clinical benefits;

●	the
results of our clinical trials may not meet the level of statistical significance required by the FDA for approval, clearance or
license or may not support approval of a label that could command a price sufficient for us to be profitable;

●	the
FDA may disagree with our interpretation of data from preclinical studies or clinical trials;

●	the
opportunity for bias in the clinical trials as a result of the open-label design may not be adequately handled and may cause our
trial to fail;

●	our
product candidates may be subject to an FDA advisory committee review, which may be requested at the sole discretion of the FDA,
and which may result in unexpected delays or hurdles to approval;

●	the
FDA may determine that the manufacturing processes at our facilities or facilities of third-party manufacturers with which we contract
for clinical and commercial supplies are inadequate;

●	the
FDA may determine we cannot continue our clinical trials due to adverse patient reactions including patient deaths for reasons unrelated
to our product candidates; and

●	the
approval, clearance or license policies or regulations of the FDA may significantly change in a manner rendering our clinical data
insufficient for approval.

Even
if we were to obtain approval, clearance or license, the FDA may grant approval, clearance or license contingent on the performance of
costly post-marketing clinical trials or may approve our product candidates with a label that does not include the labeling claims necessary
or desirable for successful commercialization of our product candidates. Any of the above could materially harm our product candidates’
commercial prospects.

Even
if our product candidates are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we
experience unanticipated problems with our product candidates, our product candidates could be subject to restrictions or withdrawal
from the market.