SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.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 Therapy Designation (“BTD”) 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 BTD 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 safer outcomes 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 1 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 its
more favorable safety profile.

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 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 survival rates (or 11% annual mortality rate), 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.)

Acute Myocardial Infarctions 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%) — 192,000

Reimbursement assumption $	50,000

Total U.S. Opportunity $	~10
billion

Leading cardiac surgery device companies average ~60% of revenue from the U.S. market 60	% $	~16
billion

Based on these data, we estimate a
U.S. prevalent target market of ~192,000 patients with severe scar-induced heart failure following STEMI, with an incremental 28,000
new patients added annually and a US and global total addressable market of $10 billion and $16 billion, respectively. However, these
estimates may not be accurate. See “Risk Factors –We
manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable market
for our product candidates. The sizes of the markets for our current product candidates have not been established with precision, and
may be smaller than we estimate.”

The
Revivent System

The
Revivent System is a less invasive surgical device designed to treat ischemic heart failure by excluding scarred anterior wall tissue
in the left ventricle. The Revivent System uses titanium anchors connected by PEEK tethers to plicate or fold non-functional myocardium
scarred tissue onto itself, reduce LV volume and restore cardiac function. The Revivent System can be implanted on a beating heart through
a mini-thoracotomy in under 90 minutes, offering a less invasive alternative to heart transplants, ventricular assist devices, and other
open-heart surgical approaches. CE Marked since 2016, the Revivent System is being evaluated in the U.S. through our
pivotal RELIVE Trial.

Our
Industry and Market Opportunity