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

Chunk 43 of 89
Word Count: 1325
Character Count: 8451

Document Content:

treated patients may benefit from improved LV systolic function without negatively impacting LV relaxation or filling. Figure 5. Illustration of Alginate Implant Mechanism. The image shows the placement of alginate implants on a heart model strategically positioned to support the ventricular walls and improve overall heart function. Historical and Planned Clinical Trials have made considerable advancements in the clinical development of the Revivent System through a structured sequence of trials aimed at establishing the safety and efficacy of this minimally invasive intervention for heart failure patients with severe left ventricular scarring. We obtained our CE mark, the regulatory approval necessary for European commercial sales, in 2016 and followed up with a long term results study in 2019. We completed the ALIVE trial in 2023 and based on its findings and FDA granting the IDE in November 2024 are now expecting to launch the RELIVE trial in 2025. Mark in Europe

obtain our Revivent System CE mark, we conducted a CE-mark study evaluating the Revivent System, the results of which were published
by Dr. Patrick Klein in 2019 (the publication was titled Less invasive ventricular reconstruction for ischemic heart failure)).
This study successfully met its primary safety endpoint of serious adverse events (“SAEs”) during a 12-month follow-up period
as compared to historical surgical ventricular reconstruction (SVR). The table below provides Major Adverse Events by treatment approach
for the CE Mark Study. In the 86-patient study, major adverse events occurred in 7 patients (8.1%) within 30 days, with an in-hospital
mortality rate of 4.5% (4 patients). Ventricular arrhythmias were the most frequently observed peri-procedural complication but were
generally manageable with standard therapies. Emergent surgical conversion was required in a small number of patients, most often due
to bleeding or perforation; importantly, no patient requiring emergent surgery died within 12 months of follow-up. The observed 12-month
survival of 90.6% was also comparable to SVR outcomes. The study met the primary efficacy endpoint of a measurable decrease in LV volume
by either an echocardiography or a cardiac magnetic resonance (“CMR”) imaging at six months and one year. Specifically, the
left ventricular end-systolic volume index (“LVESVi”) was reduced by a statistically significant 27% reduction and left ventricular
ejection fraction (“LVEF”) was increased by 16% on a relative basis, 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.

Mark Study Major
adverse events Sternotomy approach (n = 51) Hybrid approach (n = 35) All (n = 86) P-value

Tricuspid valve insufficiency increase 1 2.0	% 4 11.4	% 5 5.8	% 0.0734

Mitral valve insufficiency increase 1 2.0	% 1 2.9	% 1 1.2	% 0.79

Pulmonary valve insufficiency increase 3 5.9	% 0 0.0	% 3 3.5	% 0.15

Ventricular septal defect 1 2.0	% 1 2.9	% 2 2.3	% 0.79

Bleeding 3 5.9	% 4 11.4	% 7 8.1	% 0.36

Renal dysfunction 3 5.9	% 1 2.9	% 4 4.7	% 0.52

Respiratory failure 1 2.0	% 1 2.9	% 2 2.3	% 0.79

Stroke 3 5.9	% 1 2.9	% 4 4.7	% 0.52

Late cardiac arrest 0 0.0	% 2 5.7	% 2 2.3	% 0.09

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. 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.