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

In November 2019, the Revivent
System received Breakthrough Device 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.” BDD 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, BDD 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.

Legislative
or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or
approvals for product candidates or to manufacture, market or distribute product candidates after clearance or approval is obtained.

From
time to time, legislation is drafted and introduced in the U.S. Congress that could significantly change the statutory provisions governing
the regulation of medical devices or the reimbursement thereof. In addition, the FDA regulations and guidance are often revised or reinterpreted
by the FDA in ways that may significantly affect our business and our product candidates. Any new statutes, regulations or revisions
or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future product candidates or
make it more difficult to manufacture, market or distribute our product candidates or future product candidates. We cannot determine
what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have
on our business in the future. Such changes could, among other things, require:

●	additional
testing prior to obtaining clearance or approval;

●	changes
to manufacturing methods;

●	recall,
replacement or discontinuance of our systems or future product candidates; or

●	additional
record keeping.

Any
of these changes could require substantial time and cost and could harm our business and our financial results.

The
highly publicized PIP scandal (use of non-medical grade silicone in breast implants) in 2010 led to publishing the first version of EU
Medical Device Regulation (MDR) by European Commission in 2012. After 347 amendments by European Parliament in 2014, followed by various
versions, the final version of the new EU Medical Device Regulation (MDR 2017/745) was published on May 5, 2017. Notified Bodies are
currently not accepting any new CE Mark applications under MDD (Medical Device Directives). All new medical devices, including ours,
must undergo assessment under MDR.

The
changes from EU Medical Device Directives (MDD) to Medical Device Regulation (MDR) are significant, with stricter clinical requirements
and post-market surveillance, shift from pre-approval to Life-cycle approach, centralized EUDAMED database for public transparency (e.g.
Periodic Safety Update Reports) and device registration, more device specific requirements (e.g. Common Specifications), legal liability
for defective devices, etc. The QMS audit under MDR will be much more rigorous, including audits and assessment of suppliers and device
testing.

Further,
under either the FDA’s Medical Device Reporting or MDR regulations, we are required to report to the FDA any incident in which
our product candidates may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the
malfunction were to recur, would likely cause or contribute to death or serious injury. Any adverse event involving our product candidates
could result in future voluntary corrective actions, such as product actions or customer notifications, or regulatory authority actions,
such as inspection, mandatory recall or other enforcement action. Repeated product malfunctions may result in a voluntary or involuntary
product recall, which could divert managerial and financial resources, impair our ability to manufacture our product candidates in a
cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.