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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underscoring the effectiveness of the Revivent System while maintaining a favorable safety profile. Based on these results, the study authors concluded that treatment with the Revivent System in the enrolled patients with symptomatic heart failure resulted in statistically significant and sustained reduction of LV volumes and improvement of LV function, symptoms, and quality-of-life. While a Single Center investigator initiated study and non-randomized, the study findings appear to suggest that the therapy could extend life and improve the quality-of-life that is extended. currently have “NUB Status” in Germany, which is the German acronym for „Neue Untersuchungs-und Behandlungsmethode” which can be translated as “new examination and treatment method.” It provides a mechanism for reimbursement for innovative devices and procedures. While our priority is the RELIVE Trial, we plan to build a small European commercial organization if funding from our initial public offering in excess of our trial expenses becomes available. ALIVE Trial

completed our ALIVE Trial in 2023, enrolling 126 patients (84 device; 42 control) at 28 sites in a prospective, multi-center,
non-randomized study. The trial included heart failure patients with severe anterior scarring from a previous STEMI event. Patients showed
NYHA Class III-IV symptoms, indicating advanced heart failure with significant activity limitations, and had LVEF of 45%, reflecting
reduced pumping efficiency. Additionally, patients had LVESVI of at least 50 ml/m², indicating high residual blood volume post-contraction,
and a transmural anterior LV scar, meaning full-thickness scarring in the left ventricular wall, which further limits heart function.
Patients with inadequate scar or previous sternotomy served as the control group. The primary safety endpoint was the percent of patients
with major adverse events in the device arm being less than an upper bound performance goal of 40.5%, as agreed with the FDA based on
a database analysis of expected events in similar procedures. In other words, the FDA required a result of no more major adverse events
than expected with similar procedures. The primary efficacy endpoint was the hierarchical composite of cardiovascular mortality, HF hospitalization,
change in 6-minute walk test, change in Minnesota Living with Heart Failure questionnaire score, and change in NYHA classification assessed
at 12 months as the win ratio in the device group compared with the control group.

The
ALIVE Trial had two surgical approaches. The Internal Anchor (“Internal Anchor”) approach required a hybrid surgical suite
involving an interventional cardiologist (“IC”) and a cardiothoracic (“CT”) surgeon using a more complex technique
and experienced more SAEs. The External Anchor (“External Anchor”) approach required only a cardiac surgeon in a standard
surgical suite using a simpler technique and experienced comparatively fewer SAEs. The main difference between the two approaches is
that the External Anchor Approach places anchors on the outside of the heart (epicardial surface) through a standard and less invasive
thoracotomy by a CT surgeon while the Internal Anchor Approach places anchors inside the left ventricular cavity directly in contact
with the blood flow through a complex procedure needing IC and CT surgeons working in collaboration.

External
Anchor Approach
/ Standard Surgical Suite Internal
Anchor Approach
and IC / Hybrid Surgical Suite

Figure
6. Comparison of the External Anchor Approach versus Internal Anchor Approach.

30 days, the safety performance goal endpoint was met. 17.9% of subjects had major adverse events (15/84 subjects. (The performance
goal was 40.5% (one-sided 97.5% upper confidence limit 27.7%; p<0.0001). A total of 30 major adverse events occurred in these
15 patients. The hybrid procedure had 23 major adverse events occur in 12 of 60 patients (20.0%), while the surgical only approach subgroup
had 7 major adverse events occur in 3 of 23 patients (13.0%). There were 7 cardiac deaths in the Revivent arm (6 of which were caused
by heart failure) occurring between days 5 and 357. A total of 4 patients required mechanical circulatory support (2 Impella and 2 intra-aortic
balloon pumps), whereas 7 patients required emergent cardiac surgery: 1 for an incidental finding of LV thrombus, 5 for perforations,
and 1 for bleeding. No patient requiring emergent cardiac surgery died within 1 year of follow-up. 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.

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. 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 the safer External Anchors only approach may improve the chance
of a successful trial which could lead to FDA approval.

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. 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.