SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-12-12
Accession Number: 0001493152-25-027406
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225027406/filename1.htm

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of follow-up. The table below provides Major Adverse Events by treatment approach for the ALIVE Trial. ALIVE Trial Material Adverse Events at 30 Days Revivent + GDMT Patients (%) (N = 84) 1-Sided 97.5% Upper Confidence Bound, % (Pass if Upper Confidence Bound <40.5%) Composite MAE at 30 d 15 17.9 % 27.7 All-cause death 3 3.6 % Placement of mechanical support device intraoperatively or postoperatively 4 4.8 % Emergent cardiac surgery 7 8.3 % Prolonged mechanical ventilation 8 9.5 % Renal failure 3 3.6 % Clinically important stroke (Rankin score of ≥ 4) 0 0.0 % 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 what we believe is a more favorable safety profile, though any safety determination will ultimately be made by the FDA.

While
the ALIVE Trial met its primary safety endpoints, it did not achieve its efficacy endpoints. The Journal of American College of Cardiology
published article on the ALIVE trial noted that “in this nonrandomized study, there was an imbalance in the severity of illness
between the device and control groups, 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 will largely mirror those established in the ALIVE Trial, the RELIVE Trial will allow 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 will 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 BTD 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.

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