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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compliance with FDA post-market requirements to be determined at time of approval. Proper agreed upon compliance and reporting is crucial for ongoing FDA oversight and enables proactive risk management for both us and the FDA. Additionally, we are subject to FDA requirements for field actions, including recalls or corrective actions. If we identify or are informed of any issues posing potential health risks, it must report these to the FDA and undertake corrective actions, which may include product recalls, notifications to healthcare providers, or technical adjustments to the device. The FDA retains authority to initiate or mandate additional post-market surveillance, such as long-term clinical studies or patient registries, to gather data on the device’s safety and effectiveness in larger, real-world populations. We proactively monitor all post-market data and incident reports, using this information to improve product performance and align with FDA post-market expectations. Foreign Regulatory Compliance and CE Mark Approval

addition to meeting U.S. regulatory standards, we have achieved CE Mark approval for the Revivent System in the European
Union, a significant milestone that enables commercialization across all EU member states. The CE Mark certifies that the Revivent System
meets stringent EU safety, performance, and quality standards under the EU Medical Device Directives. This approval is critical to our
global expansion strategy, allowing access to EU markets while serving as a recognized certification in additional international markets
that accept or require CE certification.

maintain the CE Mark, we must comply with EU-specific post-market requirements, including adverse event reporting and regular
assessments by notified bodies in the EU, which are authorized to review the device’s ongoing safety and performance. This includes
periodic audits and compliance with EU requirements on labeling, packaging, and clinical data reporting. CE Mark approval also facilitates
entry into other international markets that recognize EU regulatory standards, significantly expanding our potential market reach
for the Revivent System.

Federal,
State, and International Fraud, Abuse, and Privacy Regulations

operate within a complex regulatory landscape that includes federal and state laws designed to prevent healthcare fraud and abuse. In
the U.S., the federal Anti-Kickback Statute prohibits the exchange of any form of remuneration to induce the referral of business
reimbursable by government healthcare programs, while the False Claims Act restricts the submission of false claims for federal reimbursement.
Additionally, under the Physician Payment Sunshine Act, we must report payments and other transfers of value made to healthcare
providers. Compliance with these laws is critical, as violations can result in substantial civil and criminal penalties, exclusion from
federal healthcare programs, and significant reputational damage.

Data
privacy regulations also govern our handling of sensitive information. HIPAA in the U.S. mandates strict protocols for the collection, storage, and disclosure of patient health information.
In the European Union, we are subject to the General Data Protection Regulation (“GDPR”), which imposes stringent
rules on the use, transfer, and protection of personal data. Both HIPAA and GDPR carry significant penalties for non-compliance, and
we have implemented policies and safeguards to ensure adherence to these data protection laws. Compliance with international privacy
regulations is essential for protecting patient confidentiality, maintaining trust, and avoiding severe financial and operational penalties.

Employees

of December 31, 2024, we had two (2) full-time and two (2) subcontracted employees. None of our employees are represented by a collective
bargaining agreement, and we have never experienced any work stoppage. We believe we have good relations with our employees.

Properties
and Facilities

Our
corporate headquarters and sole manufacturing facility is located in Mansfield, Massachusetts. We occupy approximately 9,000 square feet
of leased space at this location pursuant to a lease agreement that expires in September 2028, with an option to renew for an additional
five years. This facility houses our manufacturing operations, quality control laboratory, research and development activities, limited
administrative functions, and serves as our corporate headquarters.

Our
Mansfield facility is designed and operated to comply with current cGMP as required by the FDA and the applicable requirements of the
European Union, including ISO 13485 certification. We manufacture product at this facility primarily to support our clinical studies,
commercial activities outside of the United States, and anticipated future commercial sales in the United States, subject to regulatory
approval.

While
this facility serves as our corporate headquarters, only one of our co-Chief Executive Officers is based at this location on a regular
basis. The majority of our other executive and administrative functions operate in a remote-first environment.

believe that our existing facility is adequate to meet our current needs for manufacturing, development, and limited corporate functions.
However, as we expand our operations and prepare for potential commercial-scale production, we may evaluate the need for additional manufacturing
capacity or expansion of our current facility. We believe that suitable additional or alternative space would be available in the Mansfield
area or other locations on commercially reasonable terms if required.

Legal
Proceedings

August 31, 2023, we received a complaint (the “Complaint”) by former stockholder Gary Moline (the “Plaintiff”)
that was filed in the Court of Chancery of the State of Delaware (the “Court”), in which the Plaintiff asserted various causes
of action, including breach of our charter, breach of fiduciary duties claims, and assertion of a class action designation plus attorney’s
fees, against BioVentrix, its officers and directors, and certain other parties in connection with a recapitalization of BioVentrix that
was consummated in February 2023. We believe that we have substantial defenses to these claims and intend to vigorously dispute these
allegations and defend against the assertions in the Complaint and filed a Motion to Dismiss the Complaint on October 5, 2023 and an
Opening Brief in support of our Motion to Dismiss on November 7, 2023. The Plaintiff responded to the Motion to Dismiss on December 15,
2023 in which the Plaintiff conceded that he no longer intends to pursue a breach of charter claim but otherwise opposed the remainder
of Defendants’ Motion to Dismiss. On January 5, 2024, the Defendants filed their Reply to Plaintiff’s Opposition to Defendants’
Motion to Dismiss. The Court dismissed Count I and Count III of the Plaintiff’s Complaint on May 1, 2024 and the Defendants filed
an Answer to Plaintiff’s Complaint with the Court on June 12, 2024. We are currently in the discovery process regarding this Complaint.

Changes
in and Disagreements with Accountants

None.

Corporate
Information and History

Our
predecessor, CHF Technologies, Inc. (“CHF”), was incorporated under the laws of the State of California on October 15, 2003. On June 8, 2012, we incorporated BioVentrix, Inc., under the laws of the State of Delaware, and subsequently
merged CHF Technologies, Inc. with and into BioVentrix, Inc. on June 18, 2012 with BioVentrix, Inc. being the surviving corporation in
the merger. Our principal executive office is located at 120 Forbes Blvd., Suite 125, Mansfield, MA 02048, and our telephone number is
(925) 290-1000. Our website is www.bioventrix.com. Information contained on, or available through, our website does not constitute
part of, and is not deemed incorporated by reference into, this prospectus, and investors should not consider any such information as
part of this prospectus.

December 23, 2021, we incorporated BVX Acquisition Inc, a wholly owned subsidiary of BioVentrix, Inc., under the laws of the State of
Delaware. On January 6, 2022, BVX Acquisition, Inc. was merged with and into MateraCor, Inc., a Delaware corporation (“MateraCor”),
through a reverse triangular merger, with MateraCor being the surviving corporation in the merger and in which the stockholders of MateraCor
received cash and shares of common stock of BioVentrix with the potential to receive additional shares of our common stock upon our achievement
of certain milestones.

BioVentrix
GmbH, our wholly-owned subsidiary, is a German limited liability company (Gesellschaft mit beschränkter Haftung) that was organized
under the laws of Germany in 2020 with a business address at Muehlenhof 7-9, 40721 Hilden, registered with the commercial register of
the local court (Amtsgericht) in Duesseldorf under HRB 90756.

Our lead device program,
the Revivent System, has a CE mark in Europe (where we have obtained approval but are currently not commercially operating in
order to preserve capital) and is in its pivotal trial in the United States.

We also have ownership rights
to Alginate, a hydrogel-based device treatment for HFrEF patients without anterior scarring. This device was CE-marked in Europe
and 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).

MANAGEMENT

Executive
Officers and Directors

The
following table sets forth information regarding our executive officers, directors and director nominees as of the date of this prospectus.

Name Age Position

David
Richmond 53 Chairman,
Co-Chief Executive Officer, and Chief Financial Officer

Steven
Chartier 57 President,
Co-Chief Executive Officer, and Director

Ori Ben-Yehuda 66 Chief
Medical Officer

Mark
Ravich 72 Independent
Director Nominee

Rishi Puri 48 Independent
Director Nominee

William Abraham 66 Independent
Director Nominee

Executive
Officers