SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS
Document Type: DRS
Date Filed: 2025-08-05
Accession Number: 0001641172-25-022123
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000164117225022123/filename1.htm

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lack of randomization and a healthier control group at baseline), as well as the exclusive use of external anchors in the upcoming RELIVE trial (the external only approach has shown better safety compared with the hybrid approach, as measured by number of SAEs), we expect the RELIVE trial to demonstrate both adequate safety and efficacy and hopes to receive accelerated FDA review under BTD of its RELIVE trial safety and efficacy data. 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. If the RELIVE Trial meets its endpoints, it will demonstrate that the Revivent System procedure is safer, easier to perform, faster to recover from, and more beneficial to patient quality-of-life than current advanced therapy alternatives, such as heart transplant and left ventricular assist devices.

●	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 : The
ALIVE Trial demonstrated statistically significant safety and efficacy outcomes with 23 External Anchor patients and provided valuable
data to inform the pivotal RELIVE Trial. While the FDA requires an additional trial with at least 84 treated patients and 42 control
patients, 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. In the ALIVE Trial the control patients were demonstrably healthier than the treated
patients.

●	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. We believe, based on our completed and current studies,
that we will have sufficient evidence to show significant savings for payors, largely driven by reduced hospitalizations, and improved
quality adjusted life years. Given recent experience with heart failure devices, such as Impella (Abiomed/J&J) and Barostim
(CVRx), it is reasonable to expect that an appropriate (or new) DRG code will be assigned to the Revivent procedure which we estimate
would increase the reimbursement rate, consistent with the Impella and Barostim devices. Based on similar
reimbursement to the Impella and Barostim devices and an estimated $2-3 billion global total addressable market, we believe that
the Revivent System offers attractive revenue potential.

●	Demonstrated Trial Progress: We
are engaged with half the sites needed, have received approved from two sites which are already screening subjects, and anticipate
our first human subject in August 2025

●	Expanding
Product Portfolio and Product Synergies : In addition to the Revivent System, we hold ownership of Alginate, a therapeutic
device designed to treat heart failure patients without myocardial scarring. This device is CE-marked in Europe, has IDE approval
in the U.S., and represents a significant opportunity for expanding our addressable market and diversifying our product offerings.

●	Experienced Clinical Trial and Manufacturing Management across Cardiovascular Devices and Specifically Running the Needed Trial :
Our Chief Medical Officer has played a major role in running many cardiovascular trials, including Gilead Sciences (TERISA, RIVER-PCI),
Abbott (COAPT), Edwards (PARTNER 3, TAVR-UNLOAD), Cardiovalve (TARGET), Medinol (Bionics, BLADE-PCI), Heartflow (PRECISE), Microport
(Target IV-NA), and BuMA (PIONEER III). Our Co-CEO has played a significant role in running many clinical trials, including BioVentrix
(ALIVE, RELIVE), PROSPECT 2, PROSPECT Absorb, ORACLE - NIRS Registry, PREVENT), Sirtex (DOORwaY90, MIDwaY90, LAVA), CCSF (ATHEM-HFrEF),
Anika Therapeutics (Cingal 16-02, Cingal 17-02). 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. 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.

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

Intellectual
Property

maintain a robust intellectual property portfolio that protects its proprietary technology underlying the Revivent System, a minimally
invasive device for ventricular remodeling in patients with ischemic heart failure. Our intellectual property strategy is designed
to secure its competitive advantage within the cardiac therapeutic market by safeguarding its innovative approach to ventricular remodeling.

The
Revivent System’s proprietary design is protected through a series of U.S. and international patents and pending applications,
covering surgical deployment techniques and anchors for the Revivent System, such as disclosed in U.S. Patents 8,492,455; 10,575,953;
11,559,212; 11,331,190; 11,903,834; 11,540,822; 11,903,834; and 11,744,615, which have expiration dates from 2031 to 2041. We have
filed patents in key markets, including the United States, the European Union, Hong Kong and Israel, to protect essential features of
the Revivent System. This includes its novel anchoring mechanism, which allows for precise exclusion of non-functional myocardial tissue
without the need for open-heart surgery and indicators of tension on the tether when seating an anchor against a heart wall. This novel
approach to scar tissue targeting is central to enhancing procedural efficiency and improving patient outcomes.

The
inventors named on the BioVentrix patents and applications include founder Lon S. Annest and BioVentrix former biomedical engineers Ernest
Heflin, Kevin Van Bladel, Gilbert Mata, Jr., William Butler and Michael Dana. The inventors assigned their patent rights to BioVentrix.

addition, we have developed specialized manufacturing processes for the Revivent System to ensure consistent quality and regulatory
compliance. These proprietary processes encompass the use of advanced materials, precise fabrication techniques, and stringent sterilization
protocols, all of which align with FDA and ISO standards. We employ rigorous quality control and assurance programs within its production
strategy to maintain the high standards required for life-sustaining medical devices. The specialized manufacturing processes are protected
as trade secrets through applicable confidentiality provisions.

also remain committed to continuous innovation within
its intellectual property framework, seeking to further enhance the Revivent System’s capabilities and expand its potential applications.
This includes refining procedural techniques and exploring new features to identify suitable patients for ventricular remodeling. As
we advance these innovations, it actively pursues intellectual property protection to expand and reinforce its existing portfolio.

hold licenses from the Henry Ford Health System
and CLPH, LLC for techniques and instruments to deliver hydrogels to walls in a heart. The delivery of hydrogel is a therapeutic technique
for ventricular remodeling in patients with ischemic heart failure. We are not currently developing this technique.

The
term of individual patents depends upon the legal term for patents in the countries in which they are granted. In most countries, including
the United States, the patent term is 20 years from the earliest claimed filing date of a non-provisional patent application in the applicable
country. In the United States, a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates
a patentee for administrative delays by the United States Patent and Trademark Office in examining and granting a patent, or may be shortened
if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration
date. We cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued patents,
and we can give no assurance that any patents that have issued or might issue in the future will protect our current or future product
candidates, will provide us with any competitive advantage, and will not be challenged, invalidated, or circumvented. Maintenance or
annuity fees must be paid to government patent offices to keep a patent enforceable for its entire term.

Research
and Development

are dedicated to advancing minimally invasive
cardiac therapies through rigorous research and development efforts focused on innovation, clinical efficacy, and continuous improvement
of its proprietary Revivent System. Our research and development strategy centers on refining our core technology to optimize
patient outcomes, expand therapeutic applications, and enhance the overall usability and procedural efficiency of its device for healthcare
providers.

Over
the past four years, we have accelerated our research initiatives to support the ALIVE and RELIVE Trials, gathering additional
data to strengthen the clinical foundation for PMA. These efforts include extensive device testing, protocol development, and patient
selection criteria, all tailored to meet regulatory standards and improve clinical results. To advance the Revivent System’s therapeutic
capabilities, our research team has conducted iterative design enhancements and prototyping to address both clinician feedback
and patient-specific needs. Each iteration of the device undergoes comprehensive bench testing, mechanical evaluations, and clinical
simulations to validate functionality, durability, and ease of use.