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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with the Revivent TC group having more active HF at baseline (greater proportion of patients treated for HF in the prior year and more HF hospitalizations) and evidence of worse LV function, which complicates interpretation of the results of the study.” Additionally, we noted that the Internal Anchor approach was more difficult to perform for the IC and CT, more expensive for the hospital and less safe for the patient than the External Anchor approach, based on number of serious adverse events (though any safety determination will ultimately be made by the FDA). Therefore, we have elected, and the FDA has agreed, to exclude the Internal Anchor approach in the RELIVE Trial. We believe that the External Anchor approach is also appropriate for all patients in which the Internal Anchor approach was previously used in the ALIVE Trial and thus will not disqualify such eligible patients for the RELIVE Trial.

terms of Quality of Life and Functional Outcomes (“QoL”), the 23 subjects in the External Anchor group outperformed the control
group on the six-minute walk test (6MWT), the Minnesota Living with Heart Failure Questionnaire (MLHF), and the NYHA Heart Failure Stage
Classification. The QoL outcomes for the 23 treated External Anchor subjects showed a win ratio of 1.78 and achieved statistical significance
(p-value=0.034). This win-ratio and statistical significance with 23 treated subjects suggest that the RELIVE trial may have a similar
or greater win-ratio when compared to a control group that is equally sick (unlike the ALIVE trial, the RELIVE trial will be randomized,
which may provide a balance so that the control group is as sick as the intervention group). We believe that the design of the RELIVE
trial, with both randomization as well as use of what we believe is the safer External Anchors-only approach may improve
the chance of a successful trial which could lead to FDA approval, thought any safety determination will ultimately be made by the
FDA.

Figure
7. Composite Hierarchy Endpoint – Quality of Life (QoL) and Functional Outcomes. The QoL outcomes for the 23 treated External
Anchor patients showed a win ratio of 1.78 and achieved statistical significance (p-value=0.034). This is the same efficacy endpoint
that will be the basis for approval in the RELIVE trial. *Internal Anchor = Internal RV-LV plus External Anchors (Hybrid Procedure)

RELIVE
Trial

The
RELIVE Trial aims to build on the insights and lessons from the ALIVE Trial by demonstrating efficacy and safety through randomization
and sole use of the External Anchor approach (though any safety determination will ultimately be made by the FDA). While the inclusion
and exclusion criteria largely mirrors those established in the ALIVE Trial, the RELIVE Trial allows the inclusion of patients
with prior sternotomy and open-heart surgery. This adjustment reflects our evolving understanding of the patient population that could
benefit from the Revivent System. Inclusion criteria is designed to ensure that only patients with significant LV aneurysm or
scar, accompanied by viable myocardium in non-scar segments, are selected. Additionally, patients must have an LVEF of 40% or less and
an LVESVI of 60 mL/m² or greater, among other specific conditions. In the RELIVE Trial, investigators will randomize the control
group to ensure a balanced comparison with the treated group.

The
RELIVE Trial is expected to capitalize on the infrastructure, sites and expertise established during the ALIVE Trial. We believe that
we understand the required procedures, training, and documentation from the ALIVE Trial, with only minor modifications needed to align
with RELIVE Trial protocol. The RELIVE Trial is designed to adhere to a well-defined treatment timeline, beginning with the pre-implantation
phase, which includes baseline assessments (Computed Tomography (CT) and Magnetic Resonance Imaging (“MRI”), Transthoracic
Echocardiogram (“TTE”), Kansas City Cardiomyopathy Questionnaire (“KCCQ”), 6-minute walk test (“6MWT”),
and New York Heart Association Heart Failure Stage Classification (“NYHA”). It will then proceed through the procedure phase
and culminate in follow-up assessments at 6 and 12 months, with annual evaluations extending up to five years (Proposed Timeline and
Phases of the RELIVE Trial are shown in figure 8 below). Site enrollment and patient recruitment rates will be based on ALIVE Trial empirical
experience. First patient treatment is currently expected in the third quarter of 2025 and the last patient enrolled is currently expected
in the second quarter of 2027. Six-month data is expected by the first quarter of 2028 and FDA Premarket Approval (“PMA”)
approval is anticipated mid-year 2028. The FDA typically completes its review of a PMA submission within 180 days of the filing date,
with BDD designed to accelerate this review process. We have budgeted six months for the RELIVE Trial PMA submission review.

Clinical
leadership for the RELIVE Trial is anchored by national co-Principal Investigators Vinod H. Thourani, MD and Marat Fudim, MD, MHS, whose
combined expertise in less invasive cardiac surgery and advanced heart-failure research underpins the study’s oversight. We will
maintain site principal investigators at www.clinicaltrials.gov and have already disclosed Andrew Kao, MD and Jessica Heimes, DO at Saint
Luke’s Mid America Heart Institute and John P. Boehmer, MD and Michael Pfeiffer, MD at Penn State College of Medicine.

Figure
8. Proposed Timeline and Phases of the RELIVE Trial: The procedural and follow-up phases include key assessment milestones and safety
and efficacy evaluations.

Our
Industry and Market Opportunity

Heart
failure following STEMI events remains a significant cause of morbidity and mortality worldwide, particularly for patients who suffer
from severe left ventricular remodeling due to scarring in the anterior wall. 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, with over 28,000
of these cases developing into advanced heart failure due to anterior LV scarring. Our incidence and prevalence figures exclude undiagnosed
STEMI events which are approximately 20-60% of all myocardial infarctions based on systematic review and meta-analysis published by
Cardiovascular Research in October 2024. Whether diagnosed or not, scarred myocardium leads to heart failure which places a substantial
economic burden on the healthcare system, with estimated costs exceeding $30 billion per year, driven by hospitalizations, readmissions
and long-term cardiac management, as reported in a systematic literature review by the Journal of Managed Care + Specialty Pharmacy
(JMCP) in a January 2022 article. Upon FDA approval, we can apply for a procedure-specific code and seek a new reimbursement rate.
For the purposes of estimating our potential addressable market, we have assumed that the Revivent System could obtain a procedure-specific
code in the United States with an average reimbursement of approximately $50,000 per procedure; however, there can be no assurance that
such a code will be obtained, that the assumed rate will be achieved, or that any reimbursement will be secured at all. Due to the high
cost of alternative treatments, the high cost to heart failure patients to payers, and the expected efficacy of the Revivent System therapeutic
procedure, and based on our management team’s experience, we expect over time that we can obtain similar reimbursement to the Impella
and Barostim devices, which we believe are similar treatment devices for HFrEF. According to the 2020 Milliman Research Report, heart
transplantation incurs average costs of approximately $1.6 million per patient and has 15–20% mortality within the first year
post-transplant, followed by an estimated 4% annual mortality over the subsequent 18 years. Ventricular assist devices, such as Impella,
which are small, catheter-based heart pumps that help the heart circulate blood when the heart is not functioning properly serve as a
bridge to a heart transplant and cost $235,727 as documented in the preprint May 2025 article from Health Sciences. Based on a Center
for Medicaid and Medicare Services 2024 data release., the national average hospital for reimbursement for an Impella device under MS-DRG-215
in 2024 was approximately $71,520. Based on publicly disclosed information from CVRx, Inc., the Barostim device (an implantable system
designed to treat heart failure by stimulating baroreceptors, which are pressure sensors in the body) obtained average payment between
$40,000 and $50,000 with a 1.26 win ratio in its pivotal trial on a healthier and less costly HFrEF patient population. Re-hospitalization
is a major driver of the win ratio in HFrEF trials, of patient cost, and of reimbursement. CMS has a number of pathways to obtain
written coverage, including “coverage with evidence development” and Transitional Coverage for Emerging Technologies.
We will leverage the optimal pathway to seek coverage as we approach market launch. For Barostim and Impella, the approval for the
permanent Category I CPT codes came 4 to 5 years after FDA approval.