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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50% procedural-eligibility adjustment (which is based on management assessments, though actual adjustment numbers may be higher or lower than 50%) to our estimated U.S. incidence population of approximately 64,000 patients would imply a serviceable eligible population of approximately 32,000 patients. Based on 2024 published research in the Journal of the American Heart Association, STEMI LAD patients have 6.2% one-year mortality and that each 1% increase in infarct size is associated with a 4% increase in adjusted mortality risk. We estimate that the highest quartile of anterior infarct size may experience approximately 12–15% one-year mortality and approximately 45–55% five-year mortality. Assuming an average annual mortality rate of approximately 13.7% (derived from the midpoint of a five-year mortality range of 45-55%), we estimate that approximately 235,000 patients (32,000/13.7%) in the U.S. live with heart failure induced by a large STEMI induced anterior scar and may be clinically appropriate for the Revivent procedure.

In addition to patients with clinically recognized myocardial infarction,
there is increasing recognition of the population of ICM patients who do not have a documented history of myocardial infarction. Approximately
6.7 million adults in the United States had heart failure in 2020 with projections of approximately 8.7 million by 2030, according to
HF Stats 2025: Heart Failure Epidemiology and Outcomes Statistics published in the Journal of Cardiac Failure. Based on a linear interpolation
of these data, we estimate that approximately 7.7 million adults in the United States had heart failure in 2025. Approximately 50% - 60%
of patients with heart failure have reduced ejection fraction (generally defined as a left ventricular ejection fraction of 40% or less)
according to studies published in European Heart Journal in 2013 and Circulation in 2012, implying approximately 3.9 – 4.6 million
patients with heart failure with reduced ejection fraction. Ischemic heart disease is present in approximately 50% of individuals who develop
heart failure, according to data published in The Lancet in 2025, suggesting an ischemic heart failure population of approximately 1.8
to 2.1 million patients in the U.S. Applying our clinical assumptions regarding symptom severity (New York Heart Association Class III
or greater), the presence of significant transmural anterior scar, and clinical suitability, we estimate that approximately 4% or 80,000
patients in the U.S. may have disease characteristics suitable for treatment with the Revivent System. This prevalent population is dynamic,
with patient attrition over time due to disease progression and mortality generally offset by the ongoing identification and clinical
progression of additional patients into this disease state, although no single discrete clinical event defines entry into this population.
Additionally, there is no precise epidemiologic dataset that directly quantifies the prevalence of this population, and certain assumptions
used in this estimate, including the proportion of patients with advanced symptoms and anterior transmural scar, are based on our clinical
experience rather than published literature. Accordingly, this estimate is inherently uncertain and should be considered a directional
estimate of a potential incremental prevalent patient population beyond our primary STEMI disease pathway.

Combining an estimated prevalence of approximately 235,000 patients associated
with the STEMI disease pathway and approximately 80,000 ICM patients, we estimate a potential addressable prevalent population of approximately
315,000 patients in the U.S. The STEMI pathway contributes approximately 32,000 new patients annually, while the ICM population represents
a dynamic cohort in which patient attrition due to disease progression and mortality is generally offset by the ongoing identification
and clinical progression of additional patients into this disease state, although no single discrete clinical event defines classification into
this population.

Our Market Opportunity
and Key Assumptions

We estimate the U.S. addressable patient population
for our Revivent System as follows:

Step in Derivation Step Percent Percentage of Population U.S. Annual Patients (approx.)

STEMI Disease Pathway

AMI 100	% 805,000

STEMI (40%) 40	% 40	% 322,000

Anterior Wall Scarring (42% of STEMI) 42	% 17	% 135,000

Severe Anterior Scar (>30% wall involvement; 48%) 48	% 8	% 64,000

Clinical
Suitability 50	% 4	% 32,000

Prevalence (5-year survival midpoint, ~50%)
1 / 13.7% annual mortality rate suggests average life of 7.3 years for 32,000 patients indicating a prevalent population of approximately

ICM with Clinically Unrecognized MI Disease Pathway

Interpolated Heart Failure Patients in 2025 based on 6.7 million patients
in 2020 and 8.7 million patients in 2030 7,700,000

HFrEF Patients 50 - 60	% ~3,900,000

Ischemic heart failure population 50	% ~1,950,000 to 2,300,000

Severe symptoms + anterior transmural scar + clinical suitability (ICM Prevalence) 4	% ~80,000

STEMI + Ischemic Cardiomyopathy (Prevalence) ~315,000

STEMI + ICM (Incidence; excluding ICM) ~32,000

Device pricing assumption (based on our estimated portion of hospital reimbursement levels for comparable
advanced heart failure device therapies) $	35,000

Total U.S. Opportunity $	~11 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	% $	~18 billion

Based on these data, we
estimate a U.S. prevalent target market of ~315,000 patients with severe scar-induced heart failure following STEMI or ICM and a US
and global total addressable market of $11 billion and $18 billion, respectively. Approximately 32,000 U.S. addressable patients
(excluding ICM), or an estimated $1.1 billion of U.S. market opportunity (excluding ICM) are added each year due to a new AMI, and
approximately 32,000 addressable patients are lost to mortality each year. A 1% penetration of the current prevalent untreated
population represents 3,150 patients and the potential for $110 million of revenue. 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 scarred
myocardial 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 large anterior wall scarring post-STEMI or clinically unrecognized
ICM. We estimate the total addressable market for the Revivent System, following approval by the FDA, at approximately
$18 billion globally and $11 billion in the U.S., based on prevalence and expected reimbursement levels similar to other high-acuity
structural heart and advanced heart failure procedures.

In the U.S., the Revivent
System has the potential to address 32,000 new cases annually (excluding ICM) and 315,000 appropriate patients in total. 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.