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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walk test (“6MWT”), and New York Heart Association Heart Failure Stage Classification (“NYHA”). It will then proceed through the procedure phase and culminate in follow-up assessments at 6 and 12 months, with annual evaluations extending up to five years (Proposed Timeline and Phases of the RELIVE Trial are shown in figure 8 below). Site enrollment and patient recruitment rates will be based on ALIVE Trial empirical experience. First patient treatment is currently expected in the third quarter of 2025 and the last patient enrolled is currently expected in the second quarter of 2027. Six-month data is expected by the first quarter of 2028 and FDA Premarket Approval (“PMA”) approval is anticipated mid-year 2028. The FDA typically completes its review of a PMA submission within 180 days of the filing date, with BTD designed to accelerate this review process. We have budgeted six months for the RELIVE Trial PMA submission review.

Figure
8. Proposed Timeline and Phases of the RELIVE Trial: The procedural and follow-up phases include key assessment milestones and safety
and efficacy evaluations.

Our
Industry and Market Opportunity

Heart
failure following STEMI events remains a significant cause of morbidity and mortality worldwide, particularly for patients who suffer
from severe left ventricular remodeling due to scarring in the anterior wall. Approximately 322,000 initial STEMI events occur in the
United States annually, with over 28,000 of these cases developing into advanced heart failure due to anterior LV scarring. Our incidence
and prevalence figures exclude undiagnosed STEMI events which are approximately 20-60% of all myocardial infarctions based on literature
reviews. Whether diagnosed or not, scarred myocardium leads to heart failure which places a substantial economic burden on the healthcare
system, with estimated costs exceeding $30 billion per year, driven by hospitalizations, readmissions and long-term cardiac management.
Upon FDA approval, we can apply for a procedure-specific code and seek a new reimbursement rate. For the purposes of estimating our
potential addressable market, we have assumed that the Revivent System could obtain a procedure-specific code in the United States with
an average reimbursement of approximately $50,000 per procedure; however, there can be no assurance that such a code will be obtained,
that the assumed rate will be achieved, or that any reimbursement will be secured at all. Due to the bleak prognosis of non treatment
(50-60% mortality over 5 years), the high cost of alternative treatments, low profitability to hospitals for care of heart failure
inpatients, the high cost to heart failure patients to payers, and the expected efficacy of the Revivent System therapeutic procedure,
and based on our management team’s experience, we expect over time that we can obtain similar reimbursement to the Impella and
Barostim devices, which we believe are similar treatment devices for HFrEF. Heart transplants cost $1.6 million on average with
a 15-20% mortality within a year and 4% annual mortality for the next 18 years. Ventricular assist devices, such as Impella, which are
small, catheter-based heart pumps that help the heart circulate blood when the heart is not functioning properly serve as a bridge to
a heart transplant and cost $221,313 over an average of 9.5 months. The national average hospital for reimbursement for an Impella
device under MS-DRG-215 in 2024 was approximately $71,250. The Barostim device (an implantable system designed to treat heart failure
by stimulating baroreceptors, which are pressure sensors in the body) obtained average payment between $40,000 and $50,000 with a 1.26
win ratio in its pivotal trial on a healthier and less costly HFrEF patient population. Re-hospitalization is a major driver of the win
ratio in HFrEF trials, of patient cost, and of reimbursement. The Centers for Medicare and Medicaid Services (“CMS”) offer
parallel review and coverage with evidence development (“CED”) 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. For Barostim
and Impella, the approval for the permanent Category I CPT codes came 4 to 5 years after FDA approval.

The
Revivent System procedure is performed by cardiothoracic surgeons. Most cardiovascular device innovations in the last few decades have
enabled many new procedures performed by interventional cardiologists (“IC”) and electrophysiologists (“EP”).
Despite significant innovation for procedures performed by ICs and EPs, cardiothoracic surgery departments and cardiothoracic surgeons
(“CTs”) still lead hospital metrics in revenue and profitability. CTs drive approximately $3.7 million in net revenue each
year for a hospital system, the most among 18 physician specialties. CTs average charge per provider is $34,757; the highest among specialties.
While CTs have high surgical workloads, their work is increasingly concentrated (approximately 61%) on coronary arterial bypass grafts
(“CABGs”) and surgical aortic and mitral valve replacement (approximately 16%). Additionally, over 60% of CABG procedures
are urgent or non-elective procedures with median hospital stays of 5 to 7 days post procedure. High volume cardiac surgery programs
comprise 30% of hospitals and represent 51% of procedures though they are 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 heart failure specialists and CTs from its trial sites into many of the remaining heart failure
specialists and 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 designed to serve
the target patient population in a differentiated manner, there are other product candidates, treatments or devices that may now or in
the future compete directly or indirectly 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.

Several
devices under development or in commercialization address related populations of patients with heart failure with reduced ejection fraction
(HFrEF). For example, Barostim (CVRx) is a neuromodulation device approved for 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