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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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 activated three sites which are actively screening subjects.

●	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.

●	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 designs are protected through a series of U.S. and international patents and pending
applications owned by BioVentrix. These patents cover surgical deployment techniques and anchors for systems developed by
BioVentrix, including the Revivent System. Representative U.S. patents owned by BioVentrix and the other jurisdictions in which
related patents have issued are:

Utility Patent Other
Jurisdictions Expiration
Date (if maintenance fees are paid) Title

10,575,953 Europe and Israel June 9, 2037 Heart anchor positioning devices, methods, and systems for treatment
of congestive heart failure and other conditions

11,559,212 Israel May 20, 2034 Cardiac tissue penetrating devices, methods, and systems for treatment
of congestive heart failure and other conditions

11,331,190 Europe Aug. 21, 2026 Steerable lesion excluding heart implants for congestive heart failure

11,903,834 Europe and Israel Aug. 29, 2034 Heart anchor positioning devices, methods, and systems for treatment
of congestive heart failure and other conditions

11,540,822 Europe and Israel Aug. 28, 2034 Cardiac tissue anchoring devices, methods, and systems for treatment
of congestive heart failure and other conditions

11,744,615 None yet. Oct. 21, 2041 Pericardial inflation catheter and systems and methods employing
same

the above listed patents, 11,540,822 includes claims directed to the Revivent System.

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 our 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. We have also worked with third-party manufacturing to develop proprietary
equipment to ensure accurate and consistent deployment of the Revivent anchors with every implantation.

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 a patent license from the Henry Ford Health System 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 license includes licenses to patents held by the Henry Ford Health System related to techniques and
instruments to deliver hydrogels to walls in a heart. Under the license, BioVentrix is obligated to pay license maintenance fees of $35,000
after execution of the agreement, $36,000 within 300 days of the effective date of the agreement, and $25,000 annually. The license also
requires BioVentrix to pay 1% of net sales of the licensed product or licensed method. BioVentrix is also required to pay milestone payments
that include $200,000 upon approval of the first IND or IDE from the U.S. FDA; $500,000 upon U.S. regulatory market approval; $125,000
upon a second IND or IDE, and $250,000 upon second U.S. regulatory market approval. The term of the license is until the expiration or
abandonment of the last of the licensed patents.

hold a license from CLPH, LLC for instruments for implanting heart anchors. The license includes licenses for U.S. Patents 7,842,015
and U.S. patent applications 15/284,466 (now U.S. patents 10,500,332; 11,517,662 and 12,303,662) and 15/729,661 (now U.S. patent 11,266,810
and pending application 17/688,523). The license from CLPH requires BioVentrix to pay on certain milestone events (including without
limitation $40,000 upon each of securing funding of $2 million, submission of device master file, initiation of clinical study, securing
function of $10 million, receiving regulatory clearance from U.S. or E.U; and recording first commercial sale), a $250,000 annual maintenance
fee and an earned royalty of $100 per unit of licensed products sold by BioVentrix. CLPH may terminate the agreement if BioVentrix is
delinquent on reports or payments, does not diligently develop and commercialize the licensed products, misses milestone payment(s),
breaches the agreement or provides a false report to CLPH, or becomes insolvent. BioVentrix’s obligation to pay royalties survives
termination of the agreement.