SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-03-18
Accession Number: 0001493152-26-010642
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226010642/forms-1a.htm

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$1.645 billion for the combined acquisitions of JenaValve Technology and Endotronix, including approximately $1.2 billion upfront and up to $445 million in contingent milestone payments. Our Strategy Our strategy focuses on clinical validation, regulatory approval, and targeted commercialization of the Revivent System. We are advancing the pivotal RELIVE trial using only the external anchor approach and intend to seek PMA from the FDA by mid-2028. Assuming FDA approval, we expect to market the Revivent System to our RELIVE trial clinical sites and the top 30% (or approximately 336) cardiac surgery hospitals in the U.S., which provide over half of cardiac surgery procedures. We will also seek new procedure codes and reimbursement rates. also plan to expand our portfolio with Alginate, a hydrogel treatment for HFrEF patients without anterior scarring. We intend to access public capital markets as needed to support clinical, regulatory, and commercial expansion of Alginate. Our Competitive Strengths

●	Serving Large Unmet Medical Need : No alternative device
addresses severe anterior LV scarring post-STEMI. We believe this represents a $16 billion market available based on prevalence
and a $2 to 3 billion market based on incidence.

●	Providing Hospitals and Cardiothoracic Surgeons a High-Volume
and High-Value Procedure within Their Capabilities : Most cardiac surgery device innovation over the last two to three decades
supports catheter-based procedures performed by interventional cardiologists, not surgeries performed by cardiothoracic surgeons.
Hospitals typically seek to increase high-revenue elective surgeries, such as ours, and also seek to reduce bed utilization by deteriorating
heart failure patients, such as our eligible patients.

●	Utilizing Breakthrough Device Designation to Obtain Accelerated
FDA Review : We expect the RELIVE trial to demonstrate both adequate safety and efficacy, as determined by the FDA, and hope
to receive accelerated FDA review under Breakthrough Device Designation of its RELIVE trial safety and efficacy data. However,
the process of medical device development is inherently uncertain and there is no guarantee that this designation will accelerate
the timeline for approval or make it more likely that the Revivent System will be approved .

●	An Efficacious and Patent Protected Less Invasive Therapy :
We believe our Revivent System procedure offers a novel, less invasive procedure for left ventricular reconstruction in patients
with severe anterior wall scarring following myocardial infarction.

●	Prospect for Achieving the Same or Better Safety and Efficacy
Outcomes in Our RELIVE Trial that we Demonstrated with Statistical Significance in the ALIVE trial : We expect to achieve
the safety and efficacy endpoints based on the ALIVE Trial evidence and potentially achieve better results than the non-randomized
ALIVE Trial given that the treated and control patient populations in the RELIVE Trial should have equal health characteristics due
to randomization.

●	Access to a Large Market Driven by Potential Healthcare Savings
and Quality of Life Improvements : If the RELIVE trial indeed demonstrates a significant improvement in the hierarchical composite
endpoints which include death, heart failure hospitalization, quality of life, and functional measures and meets its safety endpoint
(as it did in the ALIVE trial), we expect the FDA to approve the Revivent System thus allowing us to provide a significant new treatment
for patients. However, the results of the ALIVE trial may not be replicated or ultimately accepted by the FDA as part of our PMA
submission.

●	Demonstrated Trial Progress : We are engaged with 16
sites needed for our RELIVE Trial of which eight sites have been activated. Activated sites include: Saint Luke’s
Hospital of Kansas City (part of Saint Luke's Health System), Oklahoma Heart Hospital (part of Ascension St. John Health System),
Penn State Health Milton S. Hershey Medical Center, Baptist Health South Florida, Banner University Medical Center Phoenix,
Duke University Hospital, University of Chicago Medical Center, and Tampa General Hospital.

●	Experienced Clinical Trial and Manufacturing Management across
Cardiovascular Devices and Specifically Running the Needed Trial : Our Chief Medical Officer and Co-CEO have played major
roles in running many cardiovascular trials. Complemented by a team of industry consultants, our leadership team brings deep medical
affairs, clinical trial management, regulatory, and manufacturing expertise and established relationships with leading clinical investigators
and trial sites.

●	Expanding Product Portfolio and Product Synergies : In
addition to the Revivent System, we hold ownership rights to Alginate, a therapeutic device designed to treat heart failure patients
without myocardial scarring. This device was CE-marked in Europe, had received an IDE in the U.S. (though the CE-mark has lapsed
and utilizing the IDE would require a meeting with the FDA regarding a proposed plan), and represents a significant opportunity for expanding our addressable market and
diversifying our product offerings.

●	Robust IP Portfolio : Multiple U.S. and international
patents, some of which extend through 2041.

Management

Our
management team is made up of experienced executives and medical professionals. In January 2024, we appointed David Richmond, our Chairman,
Co-Chief Executive Officer, and Chief Financial Officer. Mr. Richmond restored senior management running the clinical, manufacturing,
and regulatory functions, including Steven Chartier, our President and Co-Chief Executive Officer since January 2025 and Dr. Ori Ben-Yehuda,
who rejoined as Chief Medical Officer in January 2024. As of this filing our management team led the RELIVE Trial design, secured the
regulatory approvals necessary to start our trial, activated eight sites, maintained manufacturing and regulatory compliance,
secured German reimbursement, attracted clinical trial sites, recruited three board members, and recruited two national principal investigators.

Summary
of Risk Factors

Investing
in our common stock is speculative and involves a high degree of risk. These risks are discussed more fully in “Risk Factors”
and elsewhere in this prospectus. We urge you to read “Risk Factors” beginning on page 10 and this prospectus in full. Our
significant risks may be summarized as follows:

Risks
Related to Our Industry and Business

have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever generate revenue
or achieve profitability (of which no assurances can be given), we may not be able to sustain it.

will require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms
or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit,
reduce or eliminate our product development programs, commercialization efforts or other operations.

we are unable to establish an effective network for commercialization, including effective distribution channels and sales and marketing
functions, it may adversely affect our business, financial condition, results of operations, and prospects.

will initially depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on
a limited number of product candidates.

●	The
commercial success of our product candidates will depend upon attaining significant market acceptance of these product candidates
among physicians, healthcare payors and the medical community.

manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable
market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision
and may be smaller than we estimate.

●	Even
if we are able to launch our pipeline portfolio successfully, we may experience material delays in our commercialization program
relative to our current expectations.

hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for
procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they
will gain further acceptance.

●	Conducting
successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify
and recruit.

●	Clinical
trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to
develop new product candidates or seek new indications.

depend on a limited number of manufacturers and suppliers in connection with the manufacture of the Revivent System, which makes
us vulnerable to supply shortages and price fluctuations that could have a material adverse effect on our business, financial condition,
results of operations, and prospects.

●	The
report of our independent registered public accounting firm for the year ended December 31, 2025 includes a “going concern”
explanatory paragraph.

are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract
and retain personnel necessary for our success.

●	Product
liability claims could damage our reputation and adversely affect our financial results.

Risks
Related to Our Intellectual Property and Technology