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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NYHA class II–III HFrEF patients. Unlike our Revivent System, Barostim does not address the underlying structural remodeling of the ventricle but instead modulates sympathetic and parasympathetic activity to improve symptoms and function. Impella (Abiomed, a Johnson & Johnson company) is a percutaneous ventricular assist device designed to provide temporary hemodynamic support in advanced decompensated heart failure or high-risk PCI. Impella serves a different segment of the market than Revivent, as it is not intended for durable ventricular remodeling or long-term heart failure stabilization, but we believe that Impella is relevant as a comparator in reimbursement and resource utilization discussions. Other investigational heart therapy devices include: · AccuCinch (Ancora Heart), which reduces ventricular dilation in HFrEF patients but is not specific to scar-driven remodeling; · V-Wave interatrial shunt and Alleviant interatrial decompression therapy, which target both HFrEF and HFpEF populations by reducing left atrial pressure rather than addressing ventricular mechanics; and

·	CorWave LVAD, a novel left ventricular
assist device designed for end-stage heart failure patients, competing in the advanced therapy
space alongside durable LVADs and transplant, rather than the NYHA class II–III space
where Revivent is positioned.

contrast, we believe that the Revivent System is unique in requiring the presence of severe anterior or apical scar with associated left
ventricular remodeling, which distinguishes it from devices that target non-ischemic or non-scar-related dilated cardiomyopathy. As of
the date of this prospectus, we are not aware of any other medical device in clinical development that directly
treats heart failure induced by scar-driven remodeling of the left ventricle. If there are companies with devices in development
that we are unaware of, they would need to conduct feasibility studies and pivotal clinical trials, typically a 6 to 9
year process, and demonstrate safety and efficacy equivalent to or superior to the Revivent System in the appropriate population.
In this case, we would retain a substantial timeline advantage, and given the size of the market, we believe we would
continue to have significant revenue opportunities.

We do not believe that biopharmaceutical solutions can be an effective
therapy for heart remodeling. Scarred tissue has less vascularization than healthy issue, reduced vascularization impedes biopharmaceutical
delivery to scarred areas, and biological and mechanical properties of mature scar tissue are typically resistant to change – even
by antifibrotic agents.

Our Strategy

Our
business strategy focuses on heart failure surgical device research & development, manufacturing, and clinical trial management. Since
inception, we have focused on advancing clinical and regulatory milestones to demonstrate the safety, effectiveness, and novel benefits
of the Revivent System for treating heart failure in patients with severe LV scarring post-myocardial infarction. Our clinical studies
have shown positive outcomes in LV remodeling and patient survival, underscoring the potential of our technology to provide a valuable
alternative to traditional heart failure treatments.

support our regulatory pathway, we are in the process of developing and executing a series of clinical trials, including the recently
completed ALIVE Trial, which informed protocol improvements for our pivotal RELIVE Trial. Our RELIVE Trial is expected to begin in the
second half of 2025 and is designed to meet FDA requirements for full market approval. By adhering to rigorous trial designs and collaborating
with experienced clinical sites, we aim to accelerate regulatory approvals and establish a robust evidence base for the Revivent System.

receive reimbursement from our hospital customers as payment for our Revivent System for patients treated during the trial. We expect
this reimbursement level to remain relatively constant during earlier commercialization, which we believe will provide an opportunity
for gross margins to be accretive to our business. In parallel with FDA PMA review or based upon FDA approval, we intend to work with
CMS to obtain a new procedure code and seek to increase reimbursement consistent with the approach taken by the Impella and Barostim
devices, which we believe are similar treatment devices for HFrEF. For therapies with BTD, CMS offers parallel review and coverage
with evidence development to support faster access to promising therapies. BTD does not automatically qualify a therapy for these programs,
but it can increase the likelihood that CMS will prioritize its review.

Our
development pipeline also includes expanding the capabilities of our product portfolio with the development of Alginate, a complementary
device that addresses heart failure patients that have not experienced significant scarring. Alginate was CE-marked in Europe and
had an approved IDE for the U.S. As we advance the RELIVE Trial, we are also planning further research and development for Alginate,
including a catheter-based delivery system to improve accessibility for additional heart failure patient segments.

Becoming
a public company is an important step in advancing our long-term strategy. We believe access to the public capital markets will provide
us with an opportunity to enhance our ability to fund ongoing clinical development, support potential commercialization of the Revivent
System, and expand our operating infrastructure. In addition, public company status may increase our visibility among physicians, partners,
and patients, helping to accelerate adoption of our therapy if approved.

Through
these focused development initiatives, we are strategically positioned to deliver high-impact therapies for heart failure, capture
significant market share, and drive long-term growth in the cardiovascular device market. Our ongoing investments in clinical validation,
product refinement, and commercial readiness are designed to meet the needs of healthcare providers and improve outcomes for patients
worldwide.

Our
Competitive Strengths

believe that we possess several competitive strengths that position us favorably in the medical device industry for heart failure
treatments:

●	Serving
Large Unmet Medical Need : The Revivent System targets an identifiable U.S. patient population of approximately 192,000
monitored individuals suffering from STEMI-induced heart failure, with an additional 28,000 patients added and 28,000 patients lost
each year, creating relatively stable patient base. Currently, we believe that no alternative therapies specifically address the
needs of this patient population, which faces deteriorating well-being and a five-year mortality rate of approximately 50-60%.

●	Providing
Hospitals and CTs a High-Volume and High Value Procedure within Their Capabilities : Most cardiac surgery device innovation
over the last two to three decades supports catheter based procedures performed by interventional cardiologists, not surgeries performed
by CTs. CTs are, nonetheless, among the highest earners among physicians and for hospitals.

●	Utilizing
Breakthrough Therapy Designation to Obtain Accelerated FDA Review : Based on certain positive signals from the ALIVE trial
(where quality of life and functional status improved in the Revivent group despite lack of randomization and a healthier control
group at baseline), as well as the exclusive use of external anchors in the upcoming RELIVE trial (the external only approach has
shown better safety compared with the hybrid approach, as measured by number of SAEs), we expect the RELIVE trial to demonstrate
both adequate safety and efficacy and hopes to receive accelerated FDA review under BTD of its RELIVE trial safety and efficacy data
. However, the process of medical device development is inherently uncertain and there is no guarantee that this designation will
accelerate the timeline for approval or make it more likely that the Revivent System will be approved.

Efficacious and Patent Protected Less Invasive Therapy : We believe our Revivent System procedure offers a novel, less invasive
procedure for left ventricular reconstruction in patients with severe anterior wall scarring following myocardial infarction. If
the RELIVE Trial meets its endpoints and the Revivent System is approved by the FDA, we believe that it will demonstrate that
the Revivent System procedure is safer, easier to perform, faster to recover from, and more beneficial to patient quality-of-life
than current advanced therapy alternatives, such as heart transplant and left ventricular assist devices.

●	Prospect
for Achieving the Same or Better
Safety and Efficacy Outcomes in Our RELIVE Trial that we Demonstrated with Statistical Significance in the ALIVE trial : The
ALIVE Trial demonstrated statistically significant safety and efficacy outcomes with 23 External Anchor patients and provided valuable
data to inform the pivotal RELIVE Trial. While the FDA requires an additional trial with at least 84 treated patients and 42 control
patients, we expect to achieve the safety and efficacy endpoints based on the ALIVE Trial evidence and potentially achieve better
results than the non-randomized ALIVE Trial given that the treated and control patient populations in the RELIVE Trial should have
equal health characteristics due to randomization. In the ALIVE Trial the control patients were demonstrably healthier than the treated
patients.