SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.htm

Chunk 41 of 87
Word Count: 1438
Character Count: 9709

Document Content:

on site initiation, recruitment rates, heart failure specialist referral rates, surgeon experience, and trial expense. The Revivent System is classified by the FDA as a Class III medical device and requires PMA approval. In the event we receive FDA PMA approval for our Revivent System, which we believe could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating in the trial to the top 336 United States cardiac surgery centers which represent approximately 30% of hospitals performing cardiac surgeries and 51% of cardiac surgery volume according to data published in The American Journal of Accountable Care. Ultimately, through the approximately 1,545 U.S. heart failure specialist and 1,120 U.S. cardiac surgery centers, our goal is to deploy the Revivent System in the market to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations.

While
our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may
build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses.
In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements.

There
is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional
trials for the Revivent System. See “Risk Factors – If our clinical trials are unsuccessful or significantly delayed,
or if we do not complete our clinical trials, our business may be harmed.” and “Risk Factors – The FDA regulatory
approval, clearance and license process is complex, time-consuming and unpredictable.”

Background
on ST Elevated Myocardial Infarction (“STEMI”)

Each year
in the U.S., approximately 805,000 patients experience an acute myocardial infarction, according to the American Heart Association’s
2025 Heart Disease and Stroke Statistics. Approximately 322,000 (or 40%) of these individuals experience a STEMI event according to 2010
data published in the Journal of the American College of Cardiology. About 35% of these patients who have experienced a STEMI event develop
anterior wall scarring according to data published in the Journal of the American Heart Association in 2020, and 25% of that group (approximately
28,000 patients) have severe scarring affecting greater than 30% of the anterior wall according to data published in the Journal of the
American College of Cardiology in 2016. These patients (who, as noted above, face the prognosis of 50-60% five-year mortality rates and
the prospect of frequent hospitalization due to their HFrEF) represent our primary target market for the Revivent System.

Based
on this information, and assuming a mid-point of 55% on five year survival rates (or 11% annual mortality rate), we estimate that approximately
192,000 patients in the U.S. live with heart failure induced by a large anterior scar. 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.

heart attack, also known as a myocardial infarction, occurs when blood flow to the heart is blocked, preventing the heart muscle from
getting enough oxygen. The amount of damage to the heart muscle due to lack of oxygen depends on The time between injury and
treatment and the size of the area supplied by the blocked artery. The risk of recurrent myocardial infarction, heart failure,
and death increases rapidly when the time between the heart attack and a PCI treatment exceeds one hour. Nearly half of U.S. patients
receive their PCI treatment an hour or more after their heart attack. Many patients have undiagnosed heart attacks and, therefore,
don’t receive treatment directly related to a heart attack. Despite ongoing advancements in cardiovascular risk management and
post-MI treatment, an estimated 20–60% of all MIs are undiagnosed in the acute phase, depending on the study population and diagnostic
technique employed. We have not included undiagnosed STEMIs in our market sizing estimates. Whether diagnosed or not, heart muscle
damaged by a heart attack heals by forming scar tissue. While PCI treatment in heart attack patients quickly restores heart blood flow
to the coronary artery and heart, a PCI procedure does not repair the already damaged tissue caused by the heart attack. As a result
of the scarred tissue, the heart enlarges and the left ventricle remodels. When the left ventricle remodels due to scar damage, it undergoes
structural changes in size, shape, and thickness, which can lead to impaired pumping ability and potentially progress to heart failure
if left untreated. Essentially, the left ventricle becomes enlarged and thinner (dilated), affecting its ability to efficiently pump
blood throughout the body.

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. 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. 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. Few patients (fewer than 10,000 out of 300,000 or 3%)
opt for these alternatives. 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, 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

believe that we are well-positioned to serve a substantial, underserved global addressable market of approximately $16 billion in eligible
and appropriate patients (prevalence) and once served, $2.4 billion of annually recurring patients (incidence). Assuming we achieve similar
reimbursement to Barostim and Impella devices, which we believe are similar treatment devices for HFrEF, the U.S. would represent
an approximate $10 billion addressable market. This addressable market based on our assumptions for U.S. prevalence in 2024 is 192,000,
U.S. incidence of 28,000. 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.

The
Revivent System