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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Population U.S. Annual Patients (approx.) AMI 100 % 805,000 STEMI (40%) 40 % 40 % 322,000 Anterior Wall Scarring (35% of STEMI) 35 % 14 % 112,000 Severe Anterior Scar (>30% wall involvement; 25%) 25 % 3.5 % 28,000 Prevalence (5-year survival midpoint, ~45%) 1 / 14.8% annual mortality rate suggests average life of 6.7 years for 28,000 patients indicating a prevalent population of approximately 192,000 — 192,000 Reimbursement assumption (based on reimbursement levels for comparable advanced heart failure device therapies, including implantable HFrEF interventions and mechanical circulatory support procedures) $ 50,000 Total U.S. Opportunity $ ~10 billion Leading cardiac surgery device companies (Based on 2024 Form 10-K disclosures for Boston Scientific and Edwards Lifesciences) US revenue as a percent of total revenue averages approximately 60% of revenue from the U.S. market, which we apply as a proxy to estimate implied global total addressable market. 60 % $ ~16 billion

Based on these data,
we estimate a U.S. prevalent target market of ~192,000 patients with severe scar-induced heart failure following STEMI and a US and global
total addressable market of $10 billion and $16 billion, respectively. Approximately 28,000 addressable patients, or an estimated
$1.4 billion of market opportunity are added each year due to a new AMI, and approximately 28,000 addressable patients are lost to mortality
each year. However, these estimates may not be accurate. See “Risk Factors –We manufacture and sell product candidates
that are used in a limited number of procedures and there is a 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.”

The
Revivent System

The
Revivent System is a less invasive surgical device designed to treat ischemic heart failure by excluding scarred anterior wall tissue
in the left ventricle. The Revivent System uses titanium anchors connected by PEEK tethers to plicate or fold non-functional myocardium
scarred tissue onto itself, reduce LV volume and restore cardiac function. The Revivent System can be implanted on a beating heart through
a mini-thoracotomy in under 90 minutes, offering a less invasive alternative to heart transplants, ventricular assist devices, and other
open-heart surgical approaches. CE Marked since 2016, the Revivent System is being evaluated in the U.S. through our
pivotal RELIVE Trial.

Our
Industry and Market Opportunity

We are
targeting what we believe is a large, underserved global heart failure population with anterior wall scarring post-STEMI. We
estimate the total addressable market for the Revivent System, following approval by the FDA, at approximately $16
billion globally and $9.6 billion in the U.S., based on prevalence and expected reimbursement levels, similar to Barostim and Impella,
which are both FDA-approved HFrEF devices being used in the market. Barostim is an implantable device that provides
baroreceptor stimulation to reduce sympathetic activity in patients with HFrEF, and Impella is a percutaneous ventricular assist
device that provides temporary mechanical circulatory support. By contrast, the Revivent System is designed to achieve durable left
ventricular volume reduction through exclusion of scar tissue in patients with ischemic cardiomyopathy.

In the U.S., the Revivent System
has the potential to address 28,000 new cases annually and 192,000 existing monitored patients, as noted above. Current treatments
like ventricular assist devices (known as VADs) and heart transplants are highly invasive, costly, and, according to the Society of
Thoracic Surgeons Intermacs 2025 Annual Report, are used in less than 3% of eligible patients, creating an unmet need for other options
such as the Revivent System. Innovative single commercial product medical device companies have historically been acquired around approval
or when revenue is meaningful and accelerating. We received reimbursement authorization in Germany, in the ALIVE trial, and the RELIVE
trial, however, we cannot guarantee that our product will receive reimbursement in the United States assuming an FDA approval, nor what
rate might be applied if reimbursement is granted. See “Risk Factors – We manufacture and sell product candidates that
are used in a limited number of procedures and there is a 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 2 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

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

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

Jun 2021 Boston Scientific Farapulse Pre-Approval Pulsed Field Ablation System 36 295 92 387

Dec 2018 Boston Scientific Millipede Pre-Approval Transcatheter Mitral Repair Ring 49 325 125 450

Jul 2018 Boston Scientific Claret Medical Early Revenue Cerebral Embolic Protection 51 220 50 270

Mar 2017 Boston Scientific Symetis Early Revenue Transcatheter Aortic Valve System 57 435 — 435

Nov 2016 Edwards Lifesciences Valtech Cardio Pre-Approval Transcatheter Mitral Valve Repair 70 340 350 690

Aug 2015 Medtronic Twelve Pre-Approval Transcatheter Mitral Valve Replacement — 408 50 458

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