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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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

2024/0245513 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.

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 and thus the patents licensed from the Henry Ford Health System are not material to the BioVentrix business.
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, patent prosecution costs and $16,250 annually. The license also requires
BioVentrix to pay 1% of net sales of the licensed product or licensed method, which is defined as products and methods covered by valid
claims of the licensed patents. BioVentrix is also required to pay due diligence and 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.

Representative
U.S. patents licensed by us from the Henry Ford Health System are:

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

9,375,313 Sept.
7, 2027 Intramyocardial
Patterning For Global Cardiac Resizing And Reshaping.

8,801,665 April
9, 2029 Apparatus
And Method For Controlled Depth Of Injection Into Myocardial Tissue

7,875,017 April
10, 2028 Cardiac
Repair, Resizing And Reshaping Using The Venous System Of The Heart

The patents licensed from the Henry
Ford Health System do not cover the Revivent System. The representative Henry Ford Health System patents listed above do not include lapsed patents or non-U.S. patents
licensed from the Henry Ford System.

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.