SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-12-12
Accession Number: 0001493152-25-027406
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225027406/filename1.htm

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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 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 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 BioVentrix 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 claims of 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.

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.

addition, we have historically maintained collaborative relationships with leading academic institutions, cardiac specialists,
and contract research organizations to enhance our research and development capabilities. These relationships have facilitated
access to specialized expertise and clinical insights, supporting the development of new procedural techniques and therapeutic approaches.
BioVentrix regularly conducts educational webinars, hands-on training sessions, and physician workshops to gather insights that drive
targeted improvements in product design and support broader adoption of the Revivent System. There were no collaborative agreements
in place during the periods presented in this prospectus that we consider to be material to our business.

Production/Manufacturing

currently utilize a combination of in-house manufacturing and outsource manufacturing to assemble our Revivent System. In-house
manufacturing occurs at a 1,200 square foot ISO 13485 certified facility in Mansfield, Massachusetts within our 9,000 square
foot lease. We have the ability to inspect, assemble, test, package, store and ship finished product candidates from this facility.
The components are assembled and pouch sealed in a certified Class 8 controlled environment located at the BioVentrix Mansfield facility.
We outsource production of the Force Gauge component of the finished system. We receive the Force Gauges, inspect the lot and then ships
the units to the approved sterilization supplier. our have intentionally pursued primarily a vertically integrated manufacturing strategy,
as it believes this offers important advantages, including rapid product iteration and control over product quality. We believe that
its current manufacturing capacity is sufficient to meet its current expected demand for at least the next 12 months.

are required to manufacture its product candidates
in compliance with the FDA’s QSR. We moved to our current Mansfield, Massachusetts facility in January 2023, and
manufacturing and distribution from that facility is being undertaken under the IDE which was received by FDE in September
2024 relating to the RELIVE Trial.

have received International Organization for Standardization,
or ISO, 13485:2016 certification for our quality management system. ISO certification generally includes recertification audits
every third year, scheduled annual surveillance audits and periodic unannounced audits. We recently received our recertification audit
in October 2024. The most recent surveillance audit was conducted on the new Mansfield facility in August 2024 and no major non-conformities
were identified. To date, our surveillance and unannounced audits have not identified any major non-conformities. The BioVentrix notified
body, BSI, is a well-established notified body, also extended the CE certificate during the most recent audit and stated the BioVentrix
QMS is compliant to the European Union (“EU”) under the current Medical Device Directive.

use a combination of internally manufactured and
externally-sourced components to produce the Revivent System. Externally-sourced components include off-the-shelf materials, sub-assemblies
and custom parts that are provided by approved suppliers. Almost all of these components are provided by single-source suppliers. While
there are other suppliers that could make or provide any one of our externally-sourced components, we seek to manage single-source supplier
risk by regularly assessing the quality and capacity of its suppliers, implementing supply and quality agreements where appropriate and
actively managing lead times and inventory levels of sourced components. We generally seek to maintain sufficient supply levels to help
mitigate any supply interruptions and enable it to find and qualify another source of supply. For certain components, we estimate that
it would take up to six months to find and qualify a second source. Order quantities and lead times for externally sourced components
are based on our forecasts, which are derived from historical demand and anticipated future demand. Lead times for components may vary
depending on the size of the order, time required to fabricate and test the components, specific supplier requirements and current market
demand for the materials, sub-assemblies and parts.