SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm

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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 began in 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 BDD, CMS offers parallel review and coverage
with evidence development to support faster access to promising therapies. BDD 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. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a
proposed plan). 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. Hospitals typically seek
to increase high-revenue elective surgeries, like ours, and reduce bed utilization by deteriorating heart failure patients, like
our eligible patients.

●	Utilizing Breakthrough Device
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 ongoing 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 BDD 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.

●	Access
to a Large Market Driven by Potential Healthcare Savings and Quality of Life Improvements : If the RELIVE trial indeed demonstrates
a significant improvement in the hierarchical composite endpoints which include death, heart failure hospitalization, quality of
life, and functional measures and meets its safety endpoint (as it did in the ALIVE trial), we expect the FDA to approve the Revivent
System thus allowing us to provide a significant new treatment for patients. However, the results of the ALIVE trial may not be replicated
or ultimately accepted by the FDA as part of our PMA submission. We believe, based on our completed and current studies, that we
will have sufficient evidence to show significant savings for payors, largely driven by reduced hospitalizations, and improved quality
adjusted life years. Given recent experience with heart failure devices, such as Impella (Abiomed/J&J) and Barostim (CVRx), it
is reasonable to expect that CMS will assign appropriate MS_DRG groups to the Revivent procedure. Based on similar reimbursement
to the Impella and Barostim devices and an estimated $2-3 billion global total addressable market, we believe that the Revivent System
offers attractive revenue potential.

●	Demonstrated Trial Progress : We
are engaged with more than half of the potential sites needed for our RELIVE Trial and have activated
six sites which are actively screening subjects.

●	Expanding
Product Portfolio and Product Synergies : In addition to the Revivent System, we hold ownership rights to Alginate, a therapeutic
device designed to treat heart failure patients without myocardial scarring. This device was CE-marked in Europe, had received an
IDE in the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a proposed plan), and represents a significant opportunity for expanding our addressable
market and diversifying our product offerings.

●	Experienced Clinical Trial and Manufacturing Management across Cardiovascular Devices and Specifically Running the Needed Trial :
Our Chief Medical Officer has played a major role in running many cardiovascular trials, including Gilead Sciences (TERISA, RIVER-PCI),
Abbott (COAPT), Edwards (PARTNER 3, TAVR-UNLOAD), Cardiovalve (TARGET), Medinol (Bionics, BLADE-PCI), Heartflow (PRECISE), Microport
(Target IV-NA), and BuMA (PIONEER III). Our Co-CEO has played a significant role in running many clinical trials, including BioVentrix
(ALIVE, RELIVE), PROSPECT 2, PROSPECT Absorb, ORACLE - NIRS Registry, PREVENT), Sirtex (DOORwaY90, MIDwaY90, LAVA), CCSF (ATHEM-HFrEF),
Anika Therapeutics (Cingal 16-02, Cingal 17-02). Complemented by a team of industry consultants, our leadership team brings deep
medical affairs, clinical trial management, regulatory, and manufacturing expertise and established relationships with leading clinical
investigators and trial sites. Complemented by a team of industry consultants, our leadership team brings deep medical affairs, clinical
trial management, regulatory, and manufacturing expertise and established relationships with leading clinical investigators and trial
sites.