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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dividend yield - We have not previously issued dividends and do not anticipate paying dividends in the foreseeable future. Therefore, we used a dividend rate of zero based on our expectation of additional dividends. ● Expected term -The expected term of the options was estimated using the simplified method. Shares of common stock issued to third parties for services provided are valued at fair value of our common stock. Recently Adopted Accounting Pronouncements The Financial Accounting Standards Board (FASB) has issued several new accounting standards that are not yet effective for the Company, including ASU 2023-06 (Disclosure Improvements), ASU 2023-07 (Income Statement—Reporting Comprehensive Income), ASU 2023-09 (Income Taxes), ASU 2024-03 (Expense Disaggregation Disclosures), and ASU 2025-03 (VIE Business Combinations). The Company has evaluated these new standards and does not expect them to have a material impact on its financial position, results of operations, or cash flows upon adoption. BUSINESS Overview

are a medical device company focused on developing, manufacturing and commercializing proprietary devices to restore left ventricular
function in heart failure patients with reduced ejection fraction (“HFrEF”).

Our
lead device program, the Revivent System, has a CE mark in Europe and is in its pivotal trial in the United States. In Europe
(where we have obtained approval but are currently not commercially operating in order to preserve capital) or through an authorized
U.S. clinical site (as we have not received FDA approval), heart failure specialists refer HFrEF patients with left ventricular dilation
due to large anterior heart attack scars to cardiac surgeons who elect to utilize our product to restore left ventricular function by
reducing the size of the left ventricle. The Revivent System accomplishes this reduction by folding the scar onto itself and fastening
it together in a less invasive mini-thoracotomy procedure.

Based on our analysis of publicly available data and according to a 2016
New England Journal of Medicine article, patients with heart failure with HFrEF continue to face poor outcomes under the current standard
of care, with multiple studies reporting an approximately 50–60% five-year mortality. Our goal is for the Revivent System to be
the new standard of care for these patients.

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.

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, 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 (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.