SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-12-12
Accession Number: 0001493152-25-027406
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225027406/filename1.htm

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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.

The
manufacturing processes, post-approval clinical data and promotional activities of any product candidate for which we obtain marketing
approval are subject to continual review and periodic inspections by the FDA and other regulatory bodies. Even if regulatory approval
of our product candidates is granted in the United States or elsewhere, the approval may be subject to limitations on the indicated uses
for which the product candidates may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor
the safety or effectiveness of the product. Later discovery of previously unknown and unanticipated problems with our product candidates,
including but not limited to unanticipated severity or frequency of adverse events, delays or problems with the manufacturer or manufacturing
processes, or failure to comply with regulatory requirements, may result in restrictions on such product candidates or manufacturing
processes, withdrawal of the product candidates from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals,
product seizures, injunctions or the imposition of civil or criminal penalties.

The
RELIVE Trial may not demonstrate sufficient efficacy to support regulatory approval.

Our
RELIVE pivotal trial is designed to evaluate the safety and efficacy of the Revivent System for patients with ischemic heart failure,
which would ultimately be determined by the FDA. While RELIVE incorporates what we believe to be appropriate refinements informed
by prior clinical experience (which did not achieve in full the desired results due to certain trial design issues described in the “Business—Overview”
section of this prospectus ), there is no assurance the current trial design and related protocols will produce favorable efficacy results,
including meeting its efficacy endpoints. If the RELIVE trial fails to meet its efficacy objectives or otherwise does not yield data
sufficient to support premarket approval by the FDA or other regulators, our ability to commercialize the Revivent System will be significantly
impaired, which would materially and adversely affect our business, financial condition, and prospects and could lead to the failure
of our company.

While
Breakthrough Therapy Designation allows for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee
product approval, faster approval, or commercial success.

November 2019, the Revivent System received Breakthrough Therapy Designation from the FDA for the “treatment of heart failure symptoms
in patients with left ventricular dilation due to a left ventricular aneurysm or scar.” BTD is intended to expedite the development
and regulatory review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating
conditions. The designation allows for increased interaction with FDA reviewers and prioritized review of submissions. However, BTD does
not guarantee product approval, faster approval, or commercial success. The Revivent System remains subject to extensive FDA regulatory
requirements, including but not limited to, PMA, manufacturing quality systems, labeling and post-market surveillance. Medical devices
may only be marketed for indications approved by the FDA, and we must comply with the FDA’s Quality System Regulation, which governs
manufacturing, testing, labeling, and documentation processes.

are required to report certain malfunctions, deaths and serious injuries associated with our product candidates once approved by regulatory
bodies, which can result in voluntary corrective actions or agency enforcement actions.

All
manufacturers marketing medical devices in the EEA are legally bound to report incidents involving devices they produce or sell to the
regulatory agency, or competent authority, in whose jurisdiction the incident occurred. Under the EU MDD, an incident is defined as any
malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the
instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons
or to a serious deterioration in their state of health. In addition, under the EU MDR, the manufacturers are obligated to publish Periodic
Safety Update Report (annually for high risk devices) which will be uploaded to European Database on Medical Devices (EUDAMED) and require
conformity assessment by Notified Bodies.

Malfunction
or misuse of our product candidates could result in future voluntary corrective actions, such as recalls, including corrections (e.g.,
customer notifications), or agency action, such as inspection or enforcement actions. If malfunctions or misuse do occur, we may be unable
to correct the malfunctions adequately or prevent further malfunctions or misuse, in which case we may need to cease manufacture and
distribution of the affected product candidates, initiate voluntary recalls, and redesign the product candidates or the instructions
for use for those product candidates. Regulatory authorities may also take actions against us, such as ordering recalls, imposing fines,
or seizing the affected product candidates. Any corrective action, whether voluntary or involuntary, will require the dedication of our
time and capital, may distract management from operating our business, and may harm our business, results of operations and financial
condition.