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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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 (or 40-50% survival 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 mortality rates, 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. According to an October 2024 research article
from the International Journal of Cardiology, 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. 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

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

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.

The
Revivent System procedure places external left-ventricle to left-ventricle (“LV-LV”) anchors with or without external
right ventricle to left ventricle anchors (“RV-LV”). The anchoring system is composed of two polyester covered titanium anchors
(5 x 25 mm) mounted on a polyethylene ether ether ketone (PEEK) tether. The anchors are drawn together to appose the LV free wall to
the septum in the case of RV anchors as well as plicating the anterior wall onto itself in the case of LV-LV anchors, thereby excluding
the nonviable anteroseptal scar.

Plicated
Non-Functional Scar Revivent
System Anchors

Figure
3. Plicated Non-Functional Scar (Left) and Revivent System Anchors (Right).

Figure
4. Comparison of Healthy Heart, Dilated & Scarred Heart post-MI scarring, and Revivent Heart Post-Procedure.

reducing LV volume and wall tension, the Revivent System is designed to hopefully enhance the performance of the remaining functional
myocardium (or heart muscle), if successful, this may effectively address the core pathology of heart failure in patients with substantial
LV scarring. The principles of Laplace’s Law guide the remodeling process. Based on Laplace’s Law, wall tension in the LV
is proportional to the chamber’s size and inversely proportional to wall thickness. The Revivent System will potentially
exclude scarred tissue from the functional myocardium, and we anticipate this reduces LV size, decreasing wall tension and thereby improving
cardiac function.