SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.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.”

Additionally,
the cardiovascular medical treatment industry has experienced consolidation in recent years, which indicates that large medical
device companies are willing to pay for newly approved devices and treatments. For example cardiovascular medical device
transactions companies that have been acquired shortly following their FDA approval include Bolt (acquired by Boston Scientific),
V-Wave (acquired Johnson & Johnson), JenaValve (acquired by Edwards Lifesciences), Endotronix (acquired by Edwards
Lifesciences), Innovalve (acquired by Edwards Lifesciences), Laminar (acquired Johnson & Johnson), Farapulse (acquired by Boston
Scientific), Claret (acquired by Boston Scientific), Symetis (acquired by Boston Scientific), Valtech (acquired by Edwards
Lifesciences), and Twelve (acquired by Medtronic).

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 : No alternative device
addresses severe anterior LV scarring post-STEMI. We believe this represents a $16 billion market available based on prevalence
and a $2 to 3 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 more
than half of the potential sites needed for our RELIVE Trial and have activated six sites which are actively screening
subjects.

●	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.