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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was completed in 2023 (the “ALIVE Trial”), achieved statistical significance upon secondary analysis on functional status and Quality-of-Life (“QoL”) measures, three of the five measures in our primary efficacy endpoint. However, as reported in the Journal of the American College of Cardiology (“JACC”) ALIVE Trial publication, the failure of the other two measures were in part a result of the comparison of our trial results with a control group that was healthier than the treatment group. This was a result of prior management’s decision to not randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (1) the control group was healthier than the treated group as evidenced by heart failure treatments and hospitalizations in the twelve months prior to the trial and better baseline left-ventricle function; and (2) the external anchor placement (surgical only approach) was safer than the internal RV-LV anchor placement (hybrid procedure).

Our
current management team is following the JACC article authors’ recommendations by designing a randomized control trial using the
external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients
and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition)
to support our Revivent Therapy Pre-Market Approval (“PMA”) application for approval. We are actively engaged with approximately
half of the sites needed for the RELIVE Trial, providing confidence to management on their estimates on site initiation, recruitment
rates, surgeon experience, and trial expense. We currently anticipate first subject treatment in August 2025. In the event we
receive FDA PMA approval for our Revivent System, which we anticipate could be by mid-2028, we intend to expand from the 20 or more cardiac
surgery centers participating in the trial to the top 340 United States cardiac surgery centers which represent 30% of hospitals performing
cardiac surgeries and 51% of cardiac surgery volume. Ultimately, through the approximately 1,120 U.S. cardiac surgery centers,
we will seek to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S.
Based on leading cardiac surgery device companies averaging 60% of their total revenue in the U.S., we estimate an additional
213,000 identifiable and appropriate patients which have similar unmet needs outside the U.S. Approximately 28,000 and 32,000
Revivent System-eligible patients are added each year to U.S. and ex-U.S. prevalence, respectively, and a similar number
are lost each year to mortality.

Background
on ST Elevated Myocardial Infarction (“STEMI”)

Each
year in the U.S., approximately 322,000 individuals experience a STEMI event. About 35% of these patients develop anterior wall
scarring, and 25% of that group (approximately 28,000 patients) have severe scarring affecting greater than 30% of the anterior
wall. These patients face approximately a 50-60% five-year mortality rate and frequent hospitalizations. In aggregate approximately
192,000 patients in the U.S. and 213,000 outside the U.S. are monitored with similar scarring and prognosis. While percutaneous
coronary interventions (“PCI”), like stents, restores blood flow post-MI, they do not prevent scar formation in necrotic
heart muscle damaged prior to blood flow restoration. As a result of the scarred tissue, the heart enlarges, the left ventricle
remodels, pumping ability becomes impaired, and heart failure progresses – even with guideline directed medical
therapy.

The
Revivent System

The
Revivent System is a less invasive surgical device designed to treat ischemic heart failure by excluding scarred anterior wall tissue
in the left ventricle. The Revivent System uses titanium anchors connected by PEEK tethers to plicate or fold non-functional myocardium
scarred tissue onto itself, reduce LV volume and restore cardiac function. The Revivent System can be implanted on a beating heart through
a mini-thoracotomy in under 90 minutes, offering a safer and less invasive alternative to heart transplants, ventricular assist devices,
and open-heart surgical approaches. CE Marked since 2016 the device is being evaluated in the U.S. through the pivotal RELIVE trial.

Our
Industry and Market Opportunity

BioVentrix
targets a large, underserved global heart failure population with anterior wall scarring post-STEMI. The total addressable market is
estimated at $16 billion globally and $7 billion in the U.S., based on prevalence and expected reimbursement levels, similar to
Barostim and Impella. In the U.S., the Revivent System has the potential to address 28,000 new cases annually and 192,000 existing
monitored patients. Current treatments like VADs and heart transplants are highly invasive, costly, and used in <3% of eligible
patients, creating an unmet need for safer, cost-effective options like Revivent.  Innovative single commercial product medical
device companies get acquired around approval or when revenue is meaningful and accelerating.  However, we cannot guarantee
that our product will receive reimbursement at all, nor what rate might be applied if reimbursement is granted. See “If
hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for
procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they
will gain further acceptance.

Additionally,
the cardiovascular medical treatment industry has experienced consolidation in recent years, which indicates that large medical
device companies are willing to pay for newly approved devices and treatments. For example cardiovascular medical device
transactions companies that have been acquired shortly following their FDA approval include Bolt (acquired by Boston Scientific),
V-Wave (acquired Johnson & Johnson), JenaValve (acquired by Edwards Lifesciences), Endotronix (acquired by Edwards
Lifesciences), Innovalve (acquired by Edwards Lifesciences), Laminar (acquired Johnson & Johnson), Farapulse (acquired by Boston
Scientific), Claret (acquired by Boston Scientific), Symetis (acquired by Boston Scientific), Valtech (acquired by Edwards
Lifesciences), and Twelve (acquired by Medtronic).

Competition

The
medical device industry is highly competitive, with major players including Medtronic, Boston Scientific, Edwards Lifesciences, and Johnson
& Johnson. However, BioVentrix believes no currently marketed or investigational device targets patients with severe anterior wall
LV scarring. Potential biopharmaceutical competitors face delivery challenges in scar tissue which has little or no blood flow. Larger
companies may develop competing devices, but BioVentrix benefits from early-mover advantage, breakthrough therapy design (“BTD”),
published multi-year cohort studies, and CE Mark approval.

Our
Strategy

BioVentrix’s
strategy focuses on clinical validation, regulatory approval, and targeted commercialization of the Revivent System. We are advancing
the pivotal RELIVE trial using only the External Anchor approach and intends to seek pre-market approval (“PMA”) by mid-2028.
Upon approval, BioVentrix will market to its clinical sites and the top 30% or approximately 330 cardiac surgery hospitals which provide
over half of cardiac surgery procedures. Bioventrix will seek new procedure codes and reimbursement rates. It also plans to expand its
portfolio with Alginate, a CE-marked hydrogel treatment for HFrEF patients without anterior scarring. Bioventrix intends to access public capital
markets as needed to support clinical, regulatory, and commercial expansion.

Our
Competitive Strengths

●	Serving Large Unmet Medical Need : No alternative device addresses
severe anterior LV scarring post-STEMI. $16 billion market available based on prevalence and $2-3 billion market based on incidence.

●	Providing Hospitals and Cardiothoracic Surgeons 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.

●	Utilizing Breakthrough Therapy Designation to Obtain Accelerated
FDA Review : We expect the RELIVE trial to demonstrate both adequate safety and efficacy and hope to receive accelerated FDA review
under Breakthrough Therapy Designation of its RELIVE trial safety and efficacy data.

●	An 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.

●	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 : 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.

●	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.

●	Demonstrated Trial Progress : We are engaged with
half the sites needed, have received approval from two sites which are already screening subjects, and anticipate our first human
subject in August 2025