SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.htm

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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.” The Revivent System The Revivent System is a less invasive surgical device designed to treat ischemic heart failure by excluding scarred anterior wall tissue in the left ventricle. The Revivent System uses titanium anchors connected by PEEK tethers to plicate or fold non-functional myocardium scarred tissue onto itself, reduce LV volume and restore cardiac function. The Revivent System can be implanted on a beating heart through a mini-thoracotomy in under 90 minutes, offering a less invasive alternative to heart transplants, ventricular assist devices, and other open-heart surgical approaches. CE Marked since 2016, the Revivent System is being evaluated in the U.S. through our pivotal RELIVE Trial. Our Industry and Market Opportunity

We are
targeting what we believe is a large, underserved global heart failure population with anterior wall scarring post-STEMI. We
estimate the total addressable market for the Revivent System, following approval by the FDA, at approximately $16
billion globally and $9.6 billion in the U.S., based on prevalence and expected reimbursement levels, similar to Barostim and Impella,
which are both FDA-approved HFrEF devices being used in the market. Barostim is an implantable device that provides
baroreceptor stimulation to reduce sympathetic activity in patients with HFrEF, and Impella is a percutaneous ventricular assist
device that provides temporary mechanical circulatory support. By contrast, the Revivent System is designed to achieve durable left
ventricular volume reduction through exclusion of scar tissue in patients with ischemic cardiomyopathy.

In the U.S., the Revivent
System has the potential to address 28,000 new cases annually and 192,000 existing monitored patients. Current treatments like ventricular
assist devices (known as VADs) and heart transplants are highly invasive, costly, and used in less than 3% of eligible patients,
creating an unmet need for other options such as the Revivent System. Innovative single commercial product medical
device companies have historically been acquired around approval or when revenue is meaningful and accelerating. We received
reimbursement authorization in Germany, in the ALIVE trial, and the RELIVE trial, however, we cannot guarantee that our product will
receive reimbursement in the United States assuming an FDA approval, nor what rate might be applied if reimbursement is granted.
See “Risk Factors – We 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.” and “Risk Factors – If 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.”

Additionally,
the cardiovascular medical treatment industry has experienced consolidation in recent years, which indicates that large medical
device companies are willing to pay for newly approved devices and treatments. For example cardiovascular medical device
transactions companies that have been acquired shortly following their FDA approval include Bolt (acquired by Boston Scientific),
V-Wave (acquired Johnson & Johnson), JenaValve (acquired by Edwards Lifesciences), Endotronix (acquired by Edwards
Lifesciences), Innovalve (acquired by Edwards Lifesciences), Laminar (acquired Johnson & Johnson), Farapulse (acquired by Boston
Scientific), Claret (acquired by Boston Scientific), Symetis (acquired by Boston Scientific), Valtech (acquired by Edwards
Lifesciences), and Twelve (acquired by Medtronic).

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.

●	Utilizing Breakthrough Therapy Designation to Obtain Accelerated
FDA Review : We expect the RELIVE trial to demonstrate both adequate safety and efficacy and hope to receive accelerated FDA
review under Breakthrough Therapy 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.

●	Demonstrated Trial Progress : We are engaged with half
of the potential sites needed for our RELIVE Trial and have activated three sites which are actively
screening subjects.

●	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., 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 three sites, maintained manufacturing and regulatory compliance,
secured German reimbursement, attracted clinical trial sites, recruited three board members, and recruited two national
principal investigators during 2024 and 2025.

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.