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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highly influential on the remaining 784 lower volume programs. We believe that CTs, hospitals, and industry need new cardiac surgical procedures, like the Revivent System procedure, that are surgical in nature, not complex, minimally invasive, address large unmet needs, extend patients’ quality adjusted life years, and have the potential to generate high revenue/profit. The RELIVE Trial is expected to be conducted in up to twenty five of the top 30% cardiac surgery hospitals. Given that our trial will be conducted in 7-8% of the top 30% of or approximately 336 U.S. cardiac surgery centers, we believe that a relatively small salesforce can take the Revivent System to CTs from its trial sites into many of the remaining top cardiac surgery hospitals during its initial commercial launch and expand to the remaining approximately 838 cardiac surgery hospitals once the Revivent System procedure is accepted at the nation’s leading cardiac surgery hospitals.

Given
(1) the concentrated call point, (2) the statistically significant 1.78 win ratio achieved in the External Anchor treated population
in the ALIVE Trial versus a healthy control, (3) the expected similar or better win ratio in the RELIVE Trial, (4) an expected attractive
facility and physician fee similar to what is achieved with the CABG procedure, and (5) the opportunity for CTs to diversify their concentrated
procedure mix, we believe that we are well-positioned for rapid adoption by CTs and a significant penetration into the
prevalent patient population. As noted above, the Revivent System would serve a substantial, underserved addressable market of $12.2
billion in eligible and appropriate patients (prevalence) and once served, a $2.4 billion market of annually recurring patients (incidence).

Competition

operate in the highly competitive medical device industry. While our product candidates are patent-protected and could serve the
target patient population in a differentiated manner, there are other product candidates, treatments or devices that may indirectly
now or in the future compete with our product candidates. We expect to compete with various companies that operate in the medical device
industry. Among these companies are Edwards Lifesciences, Johnson & Johnson, Boston Scientific, and Medtronic. Many of these competitors
have substantially greater technological, financial, research and development, manufacturing, personnel and marketing resources than
we do. We believe that we have competitive strengths that will position us favorably in our markets. However, our industry is evolving
rapidly and is becoming increasingly competitive. Larger and more established companies may acquire or in-license devices and could directly
compete with us. Additionally, certain of our competitors may be able to develop competing or superior technologies and processes and
compete more aggressively and sustain that competition over a longer period of time than we are able. Our technologies and devices may
be rendered obsolete or uneconomical by technological advances or entirely different approaches developed by one or more of our competitors,
which could result in limited demand for our product candidates.

are not aware of a medical device in development or conducting a clinical trial which treats heart failure induced by severe scarring
in the anterior wall of the left ventricle. If there are companies with medical devices in development which we are unaware of, they
would need to conduct feasibility studies and clinical trials, typically a 6 to 9 year process, with protocols similar to the RELIVE
Trial and show safety and efficacy equivalent to or superior to the Revivent System for the Revivent System appropriate population. In
this unlikely case, we would have a substantial timeline advantage, share the market with the new entrant, and we believe would still
have substantial 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 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.

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, 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.