(Incorporated in Delaware)

We 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% (percent) five-year mortality. Our goal is for the Revivent System to be the 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.

In 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.

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. In the event we receive FDA PMA 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% (30 percent) of hospitals performing cardiac surgeries and 51% (51 percent) 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.

Note: Net loss is for the year that ended Dec. 31, 2025. The company does not have revenue, according to the prospectus.

(Note: BioVentrix, Inc. filed its S-1 for its small IPO on Feb. 12, 2026, without disclosing the terms. Estimated proceeds are $17 million.)