SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS
Document Type: DRS
Date Filed: 2025-08-05
Accession Number: 0001641172-25-022123
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000164117225022123/filename1.htm

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this does so by increasing wall thickness. Alginate was CE-marked in Europe and had an approved IDE for the U.S. While we could resubmit and, subject to approval, start trials using a surgical approach to apply Alginate, we now believe the better procedure is to deliver Alginate via catheter. If and when the RELIVE trial is fully funded, we plan to use excess capital to fund catheter development, a new or revised IDE submission, and a new Alginate trial. The earliest we expect to commence an Alginate trial is 2028 and the earliest possible commercialization year is estimated to be 2032. We estimate that reimbursement for Alginate will be similar to the Revivent System, since the prognosis and therapeutic alternatives are similar to those eligible for the Revivent System. The addition of Alginate aligns with and complements our strategic objective to address broader heart failure populations through targeted, innovative therapies.

The
anticipated Alginate procedure, hydrogel beads are delivered percutaneously through a catheter to specific areas of the heart muscle
to prevent further LV enlargement. The presumed action of the beads, which are inert and believed to be well tolerated by the local tissue,
are designed to remain in the left ventricle muscle wall as a string of permanent implants that form a ring around the ventricle (hydrogel
beads implants in figure 3 below). The implant ring acts as a permanent prosthetic scaffold, is thought to increase wall thickness, and
changes the LV geometry to prevent further LV enlargement. If successful in our clinical trials, we believe that 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 its Revivent System CE mark, we ran a CE-mark study in 2016 and the 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 outcomes and rate of adverse events during and after implantation of the Revivent System were statistically significant when
analyzed against to the comparator, historical surgical ventricular reconstruction per the study design. 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 echocardiogram or a cardiac magnetic resonance (“CMR”) exam at six months and at one year. In the CE mark study, the left
ventricular end-systolic volume index (“LVESVi”) achieved a statistically significant 27% reduction. Additionally, left ventricular
ejection fraction (“LVEF”) showed a statistically significant relative increase of 16%, further underscoring the effectiveness
of the Revivent System in improving cardiac function.

an investigatory initiated study, in December 2019, Dr. Patrick Klein published a study titled, Single Center Long-Term Results with
LIVE Therapy, evaluating the Revivent System. A total of 89 patients were enrolled and 86 patients were successfully treated (97%).
At 12 months, a significant improvement in left ventricular ejection fraction and a reduction of left ventricular volumes were
observed. Survival at 12 months was 90.6% and improvements in quality-of-life measures were also significant. 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 (major adverse events 15/84 (17.9%); one-sided 97.5% upper confidence limit 27.7%;
p<0.0001). 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.