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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limited total addressable market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision, and may be smaller than we estimate.” and “Risk Factors – If hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they will gain further acceptance.” The cardiovascular medical device industry has experienced consolidation in recent years as large medical technology companies have expanded their product portfolios through acquisitions of companies developing innovative structural-heart and heart-failure therapies. These acquisitions, which we believe can be part of the life cycle for cardiovascular device companies, have occurred across a range of development stages, including prior to FDA approval, following the obtaining of a CE Mark in Europe, and after early commercialization.

Many
of the companies acquired were developing novel or first-in-class device platforms addressing significant cardiovascular disease markets,
which we intend for our Revivent System. We believe these acquisitions illustrate value creation and resulting strategic activity in
the structural-heart and adjacent cardiovascular device sectors as large medical technology companies seek to expand their therapeutic
offerings. As we continue to develop our products and strategy, our management considers these representative transactions to be useful
examples of companies who are developing novel therapeutic devices in the cardiovascular space, similar to us.

Selected
examples of publicly reported acquisitions in the structural-heart and adjacent cardiovascular device sectors are summarized below. Readers
are cautioned that the transactions cited illustrate industry activity and are not intended to be strictly indicative of the current
or potential value of our company or our technology. Moreover, we are not presently in discussions for the sale of our company or all
or any portion of our assets. Further, no assurances can be given that we will sell our company or assets, nor do we commit to enter
into any such discussions, following this offering on terms similar to those set forth below, or at all.

Selected
Illustrative Structural-Heart and Cardiovascular Device Industry Transactions

Announcement Date Acquirer Target FDA Development Stage at Acquisition Product / Technology Capital
Raised Prior to Acquisition ($MM) 2 Upfront
Consideration ($MM) 1 Potential
Milestone Consideration ($MM) 1 Total
Potential Consideration ($MM) 1

Feb 2026 3 Medtronic CathWorks Early Commercial FFRangio / angiography-based FF Not
disclosed 585 — 585

Mar 2025 Boston Scientific SoniVie Pre-Approval Intravascular Ultrasound System 63 400 200 600

Feb 2025 Stryker Inari Mature venous thromboembolism (VTE) clot removal 371 4,900 — 4,900

Aug 2024 Johnson & Johnson V-Wave Pre-Approval Interatrial Shunt Device 132 600 1,100 1,700

Jul 2024 5 Edwards Lifesciences JenaValve 4 Pre-Approval Transcatheter Aortic Valve System 364 1,200 445 1,645

Endotronix Post-Approval (June 2024); Pre- Revenue Cordella Pulmonary Artery Pressure Monitoring System 155

Apr 2024 Johnson & Johnson Shockwave Medical Commercial Intravascular lithotripsy — 13,100 — 13,100

Apr 2023 Abbott Cardiovascular Systems Mature Atherectomy System 277 890 — 890

Nov 2022 Johnson & Johnson Abiomed Commercial Impella heart pump platform — 16,600 3,500 20,100

Sources: Company
press releases, SEC filings, and publicly available transaction announcements

Notes:

(1)	Consideration
values reflect publicly reported upfront and potential milestone consideration where disclosed.

(2)	Capital
raised reflects approximate venture funding prior to acquisition announcement based on publicly
accessible PitchBook information and company disclosures.

(3)	Medtronic
announced an intent to acquire CathWorks on February 3, 2026; the transaction was still pending
regulatory clearance and expected to close by the end of Medtronic’s fiscal 2026

(4)	Edwards
announced on January 9, 2026 that it would not acquire JenaValve after a court blocked the
transaction.

(5)	Edwards
Lifesciences disclosed total potential consideration of approximately $1.645 billion for
the combined acquisitions of JenaValve Technology and Endotronix, including approximately
$1.2 billion upfront and up to $445 million in contingent milestone payments.

Our
Strategy

Our
strategy focuses on clinical validation, regulatory approval, and targeted commercialization of the Revivent System. We are advancing
the pivotal RELIVE trial using only the external anchor approach and intend to seek PMA from the FDA by mid-2028.
Assuming FDA approval, we expect to market the Revivent System to our RELIVE trial clinical sites and the
top 30% (or approximately 336) cardiac surgery hospitals in the U.S., which provide over half of cardiac surgery
procedures. We will also seek new procedure codes and reimbursement rates.

also plan to expand our portfolio with Alginate, a hydrogel treatment for HFrEF patients without anterior scarring. We
intend to access public capital markets as needed to support clinical, regulatory, and commercial expansion of Alginate.

Our
Competitive Strengths

●	Serving Large Unmet Medical Need : To our knowledge,
no alternative device addresses severe anterior LV scarring post-STEMI. We believe this represents an $18 billion market
available based on prevalence and a $1.9 billion market based on incidence.

●	Providing Hospitals and Cardiothoracic Surgeons a High-Volume
and High-Value Procedure within Their Capabilities : Most cardiac surgery device innovation over the last two to three decades
supports catheter-based procedures performed by interventional cardiologists, not surgeries performed by cardiothoracic surgeons.
Hospitals typically seek to increase high-revenue elective surgeries, such as ours, and also seek to reduce bed utilization by deteriorating
heart failure patients, such as our eligible patients.

●	Utilizing Breakthrough Device Designation to Obtain Accelerated
FDA Review : We expect the RELIVE trial to demonstrate both adequate safety and efficacy, as determined by the FDA, and hope
to receive accelerated FDA review under Breakthrough Device Designation of its RELIVE trial safety and efficacy data. However,
the process of medical device development is inherently uncertain and there is no guarantee that this designation will accelerate
the timeline for approval or make it more likely that the Revivent System will be approved .

●	An Efficacious and Patent Protected Less Invasive Therapy :
We believe our Revivent System procedure offers a novel, less invasive procedure for left ventricular reconstruction in patients
with severe anterior wall scarring following myocardial infarction.

●	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 : 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.

●	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.

●	Demonstrated Trial Progress : We are engaged with 18
sites needed for our RELIVE Trial of which eight sites have been activated. Activated sites include: Saint Luke’s Hospital
of Kansas City (part of Saint Luke’s Health System), Oklahoma Heart Hospital (part of Ascension St. John Health System), Penn
State Health Milton S. Hershey Medical Center, Baptist Health South Florida, Banner University Medical Center Phoenix, Duke University
Hospital, University of Chicago Medical Center, and Tampa General Hospital.

●	Experienced Clinical Trial and Manufacturing Management across
Cardiovascular Devices and Specifically Running the Needed Trial : Our Chief Medical Officer and Co-CEO have played major
roles in running many cardiovascular trials. 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.

●	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.

●	Robust IP Portfolio : Multiple U.S. and international
patents, some of which extend through 2041.

Management