SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS
Document Type: DRS
Date Filed: 2025-08-05
Accession Number: 0001641172-25-022123
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000164117225022123/filename1.htm

Chunk 39 of 82
Word Count: 1381
Character Count: 9453

Document Content:

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. 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 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% (“US
Share”) 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 plicate (fold) and exclude non-functional scar tissue
in the left ventricular (“LV”), enabling healthy myocardial tissue to restore efficient cardiac function. Cardiothoracic
surgeons can perform the procedure on a beating heart in under two hours 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. Revient 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.

Alginate

addition to the Revivent System, we also own an unapproved and investigatory alginate-based hydrogel product (“Alginate”)
to potentially treat heart failure patients with reduced ejection fraction (“HFrEF”) who may not be appropriate for the Revivent
System due to a non-anterior scar or non-ischemic cardiomyopathy. U.S. prevalence of HRrEF in 2024 was approximately 3.3
million adults. Presumed labeling would include an indication that therapeutic procedures would be limited to those with moderate symptoms
(NYHA III; 25-35%) or severe symptoms (NYHA IV; 5-10%). We anticipate 1.0 to 1.5 million of moderate to severe HFrEF adults less the
322,000 appropriate for Revivent, suggests 0.7 million to 1.2 million adults may be appropriate for Alginate. Further clinical work will
provide greater precision in determining the target market size. Like the Revivent System, Alginate is theorized to reduce LV wall stress
to enhance heart performance and we believe this does so by increasing wall thickness. Alginate was CE-marked in Europe and had an
approved IDE for the U.S. While we could resubmit and, subject to approval, start trials using a surgical approach to apply Alginate,
we now believe the better procedure is to deliver Alginate via catheter. If and when the RELIVE trial is fully funded, we plan to
use excess capital to fund catheter development, a new or revised IDE submission, and a new Alginate trial. The earliest we expect to
commence an Alginate trial is 2028 and the earliest possible commercialization year is estimated to be 2032. We estimate that reimbursement
for Alginate will be similar to the Revivent System, since the prognosis and therapeutic alternatives are similar to those eligible for
the Revivent System. The addition of Alginate aligns with and complements our strategic objective to address broader heart failure
populations through targeted, innovative therapies.