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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this nonrandomized study, there was an imbalance in the severity of illness between the device and control groups, with the Revivent TC group having more active HF at baseline (greater proportion of patients treated for HF in the prior year and more HF hospitalizations) and evidence of worse LV function, which complicates interpretation of the results of the study.” Additionally, we noted that the Internal Anchor approach was more difficult to perform for the IC and CT, more expensive for the hospital and less safe for the patient than the External Anchor approach. Therefore, we have elected, and the FDA has agreed, to exclude the Internal Anchor approach in the RELIVE Trial. We believe that the External Anchor approach is also appropriate for all patients in which the Internal Anchor approach was previously used in the ALIVE Trial and thus will not disqualify such eligible patients for the RELIVE Trial.

terms of Quality of Life and Functional Outcomes (“QoL”), the 23 subjects in the External Anchor group outperformed the control
group on the six-minute walk test (6MWT), the Minnesota Living with Heart Failure Questionnaire (MLHF), and the NYHA Heart Failure Stage
Classification. The QoL outcomes for the 23 treated External Anchor subjects showed a win ratio of 1.78 and achieved statistical significance
(p-value=0.034). This win-ratio and statistical significance with 23 treated subjects suggest that the RELIVE trial may have a similar
or greater win-ratio when compared to a control group that is equally sick (unlike the ALIVE trial, the RELIVE trial will be randomized,
which may provide a balance so that the control group is as sick as the intervention group). The design of the RELIVE trial, with both
randomization as well as use of the safer External Anchors only approach, which we believe may improve the chance of a successful trial
which could lead to FDA approval.

Figure
7. Composite Hierarchy Endpoint – Quality of Life (QoL) and Functional Outcomes. The QoL outcomes for the 23 treated External
Anchor patients showed a win ratio of 1.78 and achieved statistical significance (p-value=0.034). This is the same efficacy endpoint
that will be the basis for approval in the RELIVE trial. *Internal Anchor = Internal RV-LV plus External Anchors (Hybrid Procedure)

RELIVE
Trial

The
RELIVE Trial aims to build on the insights and lessons from the ALIVE Trial by demonstrating efficacy and safety through randomization
and sole use of the External Anchor approach. While the inclusion and exclusion criteria will largely mirror those established in the
ALIVE Trial, the RELIVE Trial will allow the inclusion of patients with prior sternotomy and open-heart surgery. This adjustment reflects
our evolving understanding of the patient population that could benefit from the Revivent System. Inclusion criteria will ensure that
only patients with significant LV aneurysm or scar, accompanied by viable myocardium in non-scar segments, are selected. Additionally,
patients must have an LVEF of 40% or less and an LVESVI of 60 mL/m² or greater, among other specific conditions. In the RELIVE Trial,
investigators will randomize the control group to ensure a balanced comparison with the treated group.

The
RELIVE Trial is expected to capitalize on the infrastructure, sites and expertise established during the ALIVE Trial. We believe that
we understand the required procedures, training, and documentation from the ALIVE Trial, with only minor modifications needed to align
with RELIVE Trial protocol. The RELIVE Trial is designed to adhere to a well-defined treatment timeline, beginning with the pre-implantation
phase, which includes baseline assessments (Computed Tomography (CT) and Magnetic Resonance Imaging (“MRI”), Transthoracic
Echocardiogram (“TTE”), Kansas City Cardiomyopathy Questionnaire (“KCCQ”), 6-minute 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. This condition
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. Due to the bleak prognosis of non treatment (50-60% mortality over 5 years), the high cost of alternative treatments 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 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 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%). 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 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.