SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-03-18
Accession Number: 0001493152-26-010642
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226010642/forms-1a.htm

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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 Post CE Mark Clinical Study Results in Europe

Between
October 2016 and September 2021 30 patients (5 females; mean age 62 ± 12 years) were operated on in a single Dutch center. Procedural
success was 100%. On average 2.3 ± 0.8 anchor-pairs were used to reconstruct the LV. Comparing echocardiographic data pre- and
directly postoperatively, LVEF increased from 33 ± 8% to 44 ± 10% (p < 0.0001). LV end-systolic volume index decreased
from 58 ± 24 mL/m2 to 34 ± 19 mL/m2 (p < 0.0001) and LV end-diastolic volume index decreased from 84 ± 32 mL/m2
to 58 ± 25 mL/m2 (p < 0.0001). Hospital mortality was 0%. Median duration of ICU–stay was 2 days (IQR 1-48 days) and
median length of hospital stay was 7 days (IQR 5-61 days). Survival at 8 years was 69.2%. At latest follow-up, 64.7% of surviving patients
had improved to NYHA class I-II as compared to 70% in NYHA class III-IV preoperatively. Expected 8 year survival rates would be 32.8%
based on an interpolation of 5 year mortality rates of 54.5% and 10 year mortality rates of 75.5% as found in the British Medical Journal 2019. Standard of care outcomes
are improving, albeit slowly, as the 2002 Framingham Heart Study had expected 8 year survival rates of 24% based on an interpolation of
5 year mortality rates of 70% and 10 year mortality rates of 80%. Patients with large anterior scars have
higher mortality rates based on a 2016 Journal of the American College of Cardiology publication which showed infarct size is strongly
associated with all-cause mortality and hospitalization for heart failure within 1 year. We historically recorded product revenue primarily
from the sale of our Revivent TC™ TransCatheter Ventricular Enhancement System. All such sales of product in Europe ceased at the
end of 2023 when the decision to cease operations to preserve capital was made.

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.

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.