SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-05-15
Accession Number: 0001493152-26-023752
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226023752/forms-1a.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. However, the results of the ALIVE trial
may not be replicated or ultimately accepted by the FDA as part of our PMA submission. 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, it is reasonable to expect that CMS
will assign appropriate MS_DRG groups to the Revivent procedure. Based on similar reimbursement to TAVR and TEER 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 16 potential sites needed for our RELIVE Trial of which eight are activated and 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. (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.

●	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 (TAVR-UNLOAD), Cardiovalve (TARGET), Medinol (Bionics, BLADE-PCI), Heartflow (PRECISE), and Microport
(Target IV-NA). Our Co-CEO has played a significant role in running many clinical trials, including BioVentrix
(ALIVE, RELIVE), PROSPECT 2, PROSPECT Absorb, Sirtex (DOORwaY90),
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.

The
following table lists U.S. patents and patent applications are owned by BioVentrix and material to the Revivent System used in the RELIVE
clinical trial. The table identifies other jurisdictions in which related patent applications were filed:

Utility Patents and Applications Other
Jurisdictions Expiration
Date (if maintenance fees are paid) Title

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

12,582,524 Europe
and Israel Aug.
29, 2034 Heart
anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions

2025/0005759 Europe Oct.
14, 2042 Device
and methods for monitoring heart function for treatment of congestive heart failure and other conditions

We believe that all other patents
owned by us are not material to the Revivent System or have lapsed. In our view, we hold no patent licenses that are material to the
Revivent System. The following table lists some of the other U.S. patents owned by us that are directed to a hybrid procedure or other
technologies that may or may not be used by the Revivent System:

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

Pat.
12,533,235 Europe,
Australia, and Israel. Jul.
25, 2035 Heart
anchor positioning systems for treatment of congestive heart

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

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

11,185,414 Europe
and Israel Jan.
31, 2037 Systems
and methods for deploying a cardiac anchor

11,051,942 Europe,
Israel, and Australia Dec.
12, 2032 Trans-catheter
ventricular reconstruction structures, methods, and systems for treatment of congestive heart failure and other conditions

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.

were previously party to a license agreement with CLPH, LLC relating to catheter development for our Alginate product, which we terminated
in October 2025. As of December 31, 2025, milestone payments in an aggregate amount of approximately $196,500 remain outstanding under
this agreement.