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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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.

Suppliers
are evaluated, qualified and approved as part of our supplier quality program, which includes verification and monitoring procedures
to ensure that our suppliers comply with FDA and ISO standards, as well as our own specifications and requirements. We inspect and verify
externally-sourced components under strict processes supported by internal policies and procedures. We maintain a rigorous change control
policy to assure that no product or process changes are implemented without prior review and approval. Our finished product candidates
are sterilized via gamma radiation by an approved supplier.

Regulatory
Pathway

Our
regulatory pathway for the Revivent System is strategically structured to facilitate clinical validation and eventual market approval,
following the FDA’s guidelines for Class III medical devices. The Revivent System, designed to treat ischemic heart failure through
minimally invasive ventricular remodeling, has been granted BDD status that underscores its potential to meet a critical unmet medical
need. This designation provides us with FDA priority review and enhanced guidance on regulatory submissions, with the goal of
expediting patient access to the device.

The
regulatory process for the Revivent System began with the completion of the ALIVE Trial, a PMA study that served as the basis for an
IDE. An IDE was granted by the FDA to initiate the pivotal RELIVE Trial, which is structured as the definitive study supporting PMA submission.
The RELIVE Trial, which began in 2025, evaluates the Revivent System’s safety and efficacy through a comprehensive
clinical protocol, including patient-specific endpoints such as left ventricular volume reduction, quality-of-life metrics, and device-related
adverse events. We anticipate completing the study and submitting the results to the FDA as part of its PMA application by 2028.

support regulatory compliance, we have conducted extensive preclinical studies, including biocompatibility testing, device fatigue assessments,
and animal model evaluations in alignment with FDA guidelines and ISO 13485 standards. These preclinical studies seek to validate
the durability and safety of the device’s External Anchor configuration (any such determinations would be made by the FDA),
designed to improve procedural outcomes and reduce adverse events compared to traditional cardiac surgery. We continue to engage with
the FDA through formal meetings and ongoing data submissions to streamline the regulatory process and align trial protocols with FDA
expectations.

addition to U.S. regulatory progress, we have initiated regulatory applications for the Revivent System in the European
Union, where it has achieved CE Mark approval for clinical use. This approval serves as a basis for the system’s potential expansion
to additional global markets and provides supportive evidence for its efficacy and safety in treating heart failure patients with severe
left ventricular scarring.

Through
its coordinated regulatory strategy, we aim to meet all FDA requirements for PMA submission while concurrently expanding its global market
presence. The Breakthrough Device Designation, combined with an IDE for the pivotal RELIVE Trial, along with
the already obtained CE Mark, positions us to bring the Revivent System to market as an innovative solution for ischemic heart failure,
with the potential to transform therapeutic standards in cardiac care.

and when the RELIVE trial is fully funded, we plan to use excess capital to fund Alginate’s clinical and regulatory development
through catheter development, a new or revised IDE submission, and a new trial. The earliest we expect to commence an Alginate trial
is 2028 and the earliest possible commercialization year for Alginate is estimated to be 2032.

Government
Regulation