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

Chunk 2 of 94
Word Count: 1337
Character Count: 8963

Document Content:

new standard of care for these patients. We also have ownership rights to Alginate, a hydrogel-based device treatment for HFrEF patients without anterior scarring. Our Past and Current Clinical Trials in the United States November 2024, we received an investigational device exemption (“IDE”) from the U.S. Food and Drug Administration (the “FDA”) under a Breakthrough Device Designation (“BDD”) to begin a pivotal trial of the Revivent System (called the “RELIVE Trial”). We began enrolling patients in the RELIVE Trial in September 2025. An IDE authorizes the use of a significant-risk investigational medical device in a clinical study in order to collect safety and effectiveness data but does not constitute FDA clearance or approval to market or commercialize the device. The FDA grants BDD if preliminary clinical evidence suggests the procedure may improve substantially upon at least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Our
company, under prior management, previously conducted a clinical trial of the Revivent System (called the “ALIVE Trial”),
which ended in 2023. The ALIVE Trial achieved statistical significance upon secondary analysis on functional status and Quality-of-Life
(“QoL”) measures, three of the five measures in the trial’s primary efficacy endpoint. The functional status and QoL
endpoints included change in 6-minute walk test (“6MWT”), change in Minnesota Living with Heart Failure questionnaire score
(“MLHF”), and change in New York Heart Association (“NYHA”) functional classification assessed at 12 months.
However, as reported in the Journal of the American College of Cardiology (“JACC”) ALIVE Trial publication, the failure of
the other two measures, cardiovascular mortality and heart failure hospitalization, were in part a result of the comparison of our trial
results with a control group that was healthier than the treatment group. This was a result of prior management’s decision to not
randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (i) the control group was healthier than the treated
group as evidenced by heart failure treatments and hospitalizations in the twelve months prior 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.

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, 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.
We believe that hospitals are eager to increase elective surgeries, such as ours, to utilize the fixed costs of their surgical suites
and their surgeons and reduce bed utilization by deteriorating heart failure patients. Multiple studies highlight that untreated heart
failure imposes substantial burdens on hospitals and payers due to expensive hospitalization and declining patient health (Nair et al.
Impact of Outpatient Diuretic Infusion Therapy on Healthcare Cost and Readmissions, International Journal of Heart Failure 2022
Jan 11;4(1):29–41; Projecting Hospitals’ Profit Margins Under Several Illustrative Scenarios. Working Paper Series,
Congressional Budget Office. 2016; Milhailoff et al. The Effects of Multiple Chronic Conditions on Adult Patient Readmissions and
Hospital Finances: A Management Case Study. Inquiry. 2017 Sep 1).

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 (“ICM”) with Clinically
Unrecognized MI

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).

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 (the extent to which the scar extends across the thickness of
the heart wall), 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 (32,000/13.7%) 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.