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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to the trial and better baseline left-ventricle function; and (ii) the external anchor placement (surgical only approach) produced fewer major adverse events than the internal right ventricle-left ventricle (RV-LV) anchor placement (hybrid procedure). The composite primary safety endpoint through 30 days was met. Major adverse events occurred in 15 of 84 patients (17.9%) of which 12 out of 60 patients (20%) were in the hybrid procedure and 3 out of 23 (13.0%) were in the surgical only approach. In one patient, the device procedure was attempted but aborted before device anchor placement. While the ALIVE trial met its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided to test the surgical only approach only in the RELIVE trial due to the fact that fewer major adverse events could indicate that it has a more favorable safety profile, which would ultimately be determined by the FDA.

Revivent procedures have been performed to date in the following 13 countries: Germany (109), Czech Republic (38), USA (47 - ALIVE),
USA (2 - RELIVE), Netherlands (35), China (34), Belarus (30), Italy (17), Greece (9), United Kingdom (5), Lithuania (5), Spain (3), Austria
(3), and Switzerland (1). Of the 338 Revivent procedures, 145 were performed commercially outside of the United States and 193 were performed
as part of our clinical trials.

Our
current management team is following the JACC article authors’ recommendations by designing a randomized control trial using the
external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients
and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition)
to support our Revivent Therapy Pre-Market Approval (“PMA”) application. We are actively engaged with 18 sites needed
for the RELIVE Trial, providing confidence to management on their estimates 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 315,000 potentially 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”) and Ischemic Cardiomyopathy with Clinically Unrecognized MI

Disease
Pathways

A 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. A ST Elevated
Myocardial Infarction (“STEMI”) is a prolonged blockage of the coronary artery, characterized by ST-segment elevation on an
electrocardiogram (ECG) and damage to the heart muscle. 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. Contemporary U.S. registry data from the National
Cardiovascular Data Registry (NCDR) and American Heart Association programs indicate that approximately 10% of non-transferred and 83%
of transferred STEMI patients undergoing primary PCI do not meet the guideline-recommended door-to-balloon time of 90 minutes. Approximately
25% of patients require transfer suggesting 25 – 30% of patients don’t meet guideline recommended door-to-ballon times. In
addition, total ischemic time from symptom onset to reperfusion frequently extends several hours in real-world practice, underscoring
persistent gaps in timely treatment (total ischemic time includes time prior to arrival in the hospital, with patients typically waiting
1-2 hours prior to calling 911 or presenting to the emergency department). While PCI treatment in heart attack patients is successful
in the majority of cases in restoring patency of the coronary artery, a PCI procedure does not repair the already damaged tissue caused
by the heart attack. Additionally, even with successful opening of the artery, myocardial salvage is often incomplete due to microvascular
obstruction, the no reflow phenomenon, and reperfusion injury. As a result of the scarred tissue, the heart enlarges and the left ventricle
remodels, leading to heart failure.

ICM represents a second disease pathway to a large scar and left ventricle remodeling. ICM patients have
no documented history of myocardial infarction, often due to clinically unrecognized (“silent”) myocardial infarctions or
prolonged periods of untreated ischemia. An estimated 20–60% of all MIs are undiagnosed in the acute phase, depending on the study
population and diagnostic technique employed. In these patients, myocardial injury occurs without timely diagnosis or intervention, allowing
damaged heart muscle to progressively be replaced by non-contractile scar tissue. Because these events are not clinically recognized
at the time of occurrence, patients frequently present later in the disease course with symptomatic heart failure, at which point structural
changes are well established and difficult to reverse.

Whether
diagnosed or not, heart muscle damaged by a heart attack heals by forming scar tissue. 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. In STEMI and ICM populations with large scars remodeling of the left ventricle occurs in a
similar manner as a result of the scar.

Prevalence
and Incidence

We found approximately 805,000 patients
experience an acute myocardial infarction (“AMI”) each year based on the 2025 American Heart Association’s Heart Disease and Stroke Statistics. Epidemiological data published in 2010 in the Journal of
the American College of Cardiology predict 40% of AMI patients or 322,000 are STEMI patients (the remainder termed Non-STEMI and
have less extensive scarring). Our estimates using Cosmos Data resulted in approximately the same 322,000 STEMI
patients.

About 42% of STEMI patients or approximately 135,000 have anterior wall
involvement (caused by occlusion of the “Left Anterior Descending” or “LAD” artery) according to epidemiological
data published in the Journal of the American Heart Association in 2014.

Approximately
48% of the 135,000 in the STEMI LAD group or approximately 64,000 patients have severe scarring affecting greater than 31.7% of the
anterior wall according to data published in the Journal of the American Heart Association in 2024. Not all patients included in our
epidemiologic estimate would be anatomically or clinically suitable for treatment. Suitability depends on factors such as scar
location, transmurality, presence of contiguous anterior/septal scar, viability and function of remote myocardium, LV geometry,
comorbidities, frailty, renal function, and surgical risk. Applying an estimated 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.