SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm

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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 approximately half
of the 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 192,000 identifiable and 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”)

Each year in the U.S.,
approximately 805,000 patients experience an acute myocardial infarction (“AMI”), 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 face the prognosis of 50-60% five-year mortality rates (or 40-50% survival
rates), the prospect of frequent hospitalization due to their HFrEF and represent our primary target market for the Revivent System.

Based on this information,
and a 45% five year survival rate (implies 85.2% annual survival rate compounded over five years) (such mortality found in the 2002
Framingham Heart Study), 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.

Our Market Opportunity
and Key Assumptions

We estimate the U.S. addressable patient population
for our Revivent System as follows:

Step in Derivation Step Percent Percentage of Population U.S. Annual Patients (approx.)

AMI 100	% 805,000

STEMI (40%) 40	% 40	% 322,000

Anterior Wall Scarring (35% of STEMI) 35	% 14	% 112,000

Severe Anterior Scar (>30% wall involvement; 25%) 25	% 3.5	% 28,000

Prevalence (5-year survival midpoint, ~45%) 1 / 14.8% annual mortality
rate suggests average life of 6.7 years for 28,000 patients indicating a prevalent population
of approximately 192,000 — 192,000

Reimbursement assumption (based on reimbursement levels for comparable advanced heart failure device
therapies, including implantable HFrEF interventions and mechanical circulatory support procedures) $	50,000

Total U.S. Opportunity $	~10
billion

Leading cardiac surgery device companies (Based on 2024 Form 10-K disclosures for Boston Scientific
and Edwards Lifesciences) US revenue as a percent of total revenue averages approximately 60% of revenue from the U.S.
market, which we apply as a proxy to estimate implied global total addressable market. 60	% $	~16
billion