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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plicating the anterior wall onto itself in the case of LV-LV anchors, thereby excluding the nonviable anteroseptal scar. Plicated Non-Functional Scar Revivent System Anchors Figure 3. Plicated Non-Functional Scar (Left) and Revivent System Anchors (Right). Figure 4. Comparison of Healthy Heart, Dilated & Scarred Heart post-MI scarring, and Revivent Heart Post-Procedure. reducing LV volume and wall tension, the Revivent System is designed to hopefully enhance the performance of the remaining functional myocardium (or heart muscle), if successful, this may effectively address the core pathology of heart failure in patients with substantial LV scarring. The principles of Laplace’s Law guide the remodeling process. Based on Laplace’s Law, wall tension in the LV is proportional to the chamber’s size and inversely proportional to wall thickness. The Revivent System will potentially exclude scarred tissue from the functional myocardium, and we anticipate this reduces LV size, decreasing wall tension and thereby improving cardiac function.

believe the Revivent System’s less invasive, controlled-access approach may make the procedure a suitable future candidate for
robot-assisted surgical support, consistent with how robotics have been incorporated into robot-assisted coronary artery bypass graft
procedures.

Alginate

addition to the Revivent System, we also own an unapproved and investigatory alginate-based hydrogel product (“Alginate”)
to potentially treat heart failure patients with reduced ejection fraction (“HFrEF”) who may not be appropriate for the Revivent
System due to a non-anterior scar or non-ischemic cardiomyopathy. According to the Heart Failure Society of America HF Stats 2025: Heart
Failure Epidemiology and Outcomes Statistics, approximately 6.7 million Americans over 20 years of age have heart failure, and the prevalence
is expected to rise to 8.7 million in 2030, 10.3 million in 2040, and 11.4 million by 2050. We estimate that the U.S. prevalence of HRrEF
is approximately 3.3 million adults, based on HFrEF being an estimated 50% of heart failure as found in the Journal of American Medicine
Association publication “Heart Failure With Reduced Ejection Fraction: A Review”. Presumed labeling would include an indication
that therapeutic procedures would be limited to those with moderate symptoms (NYHA III; 25-35%) or severe symptoms (NYHA IV; 5-10%).
30-45% of 3.3 million HFrEF adults would suggest 1.0 to 1.5 million have moderate to severe HFrEF less the 322,000 appropriate for
Revivent, suggesting 0.7 million to 1.2 million adults may be appropriate for Alginate

Further
clinical work will provide greater precision in determining the target market size. Like the Revivent System, Alginate is theorized to
reduce LV wall stress to enhance heart performance and we believe this does so by increasing wall thickness. Alginate was CE-marked in
Europe and had an approved IDE for the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the
FDA regarding a proposed plan). 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.

The
regulatory and clinical path forward for Alginate via catheter is not yet fully defined. The device previously held an approved IDE in
the United States, which gives us confidence that a feasible path forward exists. To determine the most appropriate regulatory and clinical
strategy, we will need to engage with the FDA to clarify whether we should resubmit under the existing IDE using prior testing data,
or whether a new submission with updated testing will be required. Such a meeting would provide essential guidance on the regulatory
pathway, additional testing or data needs (if any), and the impact on product development timelines. As of the date of this prospectus, no such meetings have been requested to date and it is not currently apparent
when we will be ready to re-engage with the FDA regarding Alginate.

and when the RELIVE trial is fully funded, we plan to use any excess capital to fund catheter development, a new or revised IDE submission
(as the prior IDE for Alginate has lapsed), 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,
launched 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

Post
CE Mark Clinical Study Results in Europe