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 (32000/13.7%) 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 a 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 40% to 50% of individuals
who develop heart failure, according to data published in The Lancet in 2025, suggesting an ischemic heart failure population of approximately
1.95 to 2.30 million patients in the U.S. Applying our clinical assumptions regarding symptom severity (New York Heart Association Class
III or greater) and the presence of significant transmural anterior scar, we estimate that approximately 4% or 80,000 patients in the
United States 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.
There is no precise epidemiologic dataset that directly quantifies the incidence and 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 Induced 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 total 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 entry into
this population.

Left
Ventricle Remodeling

While
percutaneous coronary interventions (“PCIs”), such as stents, restore blood flow post-MI, they do not prevent scar formation
in necrotic heart muscle damaged prior to blood flow restoration. As a result of the scarred tissue, the heart enlarges, the left ventricle
remodels, pumping ability becomes impaired, and heart failure progresses – even with guideline directed medical therapy.

Figure
1. Cardiovascular Post-MI Remodeling Imaging

remodeled heart pumps blood poorly, and as a result can cause heart failure, including associated symptoms, which include fatigue
and shortness of breath, leg swelling, fluid buildup in the lungs, rapid and irregular heartbeat, coughing, weight gain, nausea and
decreased alertness. According to a study published by the American College of Cardiology in August 2024, approximately 25%
of New York Heart Association (“NYHA”) Class II patients (patients who have suffered a previous heart attack and
experience mild shortness of breath, angina, fatigue, or palpitations during ordinary physical activity) experience cardiovascular
(“CV”) death or Heart Failure (“HF”) hospitalization within 27 months of follow-up, underscoring the severe
nature of this condition.

New
York Heart Association (NYHA) Functional Classification

Class Patient
Symptoms

limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

II Slight
limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath
or chest pain.

III Marked
limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath
or chest pain.

IV Symptoms
of heart failure at rest. Any physical activity causes further discomfort.

Heart
failure patients suffer worsening heart failure symptoms marked by occasional acute events, which often drive hospitalization and well-being
deterioration rates as depicted in Figure 2 below and according to a research paper in the Journal of Pain and Symptom Management October
2007. Guideline directed medical therapy and cardiac resynchronization therapy (noted as Pharma and CRT, respectively, in Figure 2 below)
slow progression of heart failure; however, heart failure progression nonetheless continues. STEMI patients with severe anterior scarring
and heart failure have only advanced surgical options, such as ventricular assist devices (“VADs”), heart transplants, and
artificial hearts, as alternatives. According to the Society of Thoracic Surgeons Intermacs 2025 Annual Report: Focus on Outcomes in
Older Adults, 6,000 - 7,000 (<3%) out of the 250,000 prevalent US patients with advanced heart failure (<30% ejection fraction,
NYHA class III or IV) have received an LVAD and/or a heart transplant each year in the 2018 – 2024 period. Heart transplants are
not prevalent due to matching organ availability, the procedure complexity procedure expense, and the lifelong immunosuppressant medication
required. Syncardia’s Total Artificial Heart (“TAH”), the only FDA approved artificial heart, is used primarily as
a bridge to transplant solution. Syncardia was approved in 2004 and has performed 2,000 implants over the last 20 years. The TAH extends
life for patients to become eligible for heart transplants. VADs are not prevalent due to significant surgical risks, device site bleeding,
site infection risks, sensitive device settings, monitoring requirements, lifelong anticoagulation therapy, stroke complications, and
right heart failure complications. They are therefore reserved for patients with very advanced heart failure. The Revivent System is
aimed at improving the prognosis of appropriate patients with heart failure so that their condition does not progress to require VADs
and transplantation. The goal of the RELIVE Trial is to demonstrate that the Revivent System is safe (which will ultimately be determined
by the FDA), beneficial to the patient, within the capabilities of most CT surgeons, and lower cost than the alternatives. Patients who
receive the Revivent System procedure are expected, based on the trial endpoints, to have lower hospitalization rates, better quality-of-life,
and extended survival outcomes. These factors position our Revivent System as a compelling option for patients, who currently face 50-60%
mortality rates over five years.

Figure
2. Typical HF Patient Progression and Treatment Options

We believe that we are well-positioned to serve a substantial, underserved
global addressable market of approximately $18 billion in eligible and appropriate patients (prevalence including ICM patients) and once
served, $1.9 billion of annually recurring patients (incidence; excluding new ICM patients). Assuming we achieve similar reimbursement
similar to other high-acuity structural heart and advanced heart failure procedures, the U.S. would represent an approximate $11 billion
addressable market. This addressable market based on our assumptions for U.S. prevalence in 2024 is 315,000, U.S. incidence of 32,000
(excluding ICM). To obtain the global addressable market, we divide the U.S. market by 60% based on the average U.S. revenue share of
Boston Scientific and Edwards Lifesciences, companies whose revenue is primarily cardiovascular medical devices, as the Revivent System
is. Reimbursement pathways in the United States are complex, and we cannot
guarantee we will be successful in securing Medicare or private third-party payor coverage for our Revivent System now or in the future.

The
Revivent System

The
Revivent System is a novel and proprietary medical device engineered to exclude non-functional scar tissue in the left ventricular (“LV”),
make the left ventricle smaller, restore shape, lower wall stress, increase ejection fraction, and restore efficient cardiac function.
Cardiothoracic surgeons can perform the procedure on a beating heart in under ninety minutes through a mini-thoracotomy incision, making
it significantly less invasive than open heart surgery. As a point of comparison, a similar procedure using open heart surgery requires
a sternotomy (cutting through the breastbone to access the heart and lungs), cardiopulmonary bypass, cardioplegic arrest, frequent procedural
complications, as well as long recovery times.