SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-03-18
Accession Number: 0001493152-26-010642
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226010642/forms-1a.htm

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Medicare Services 2024 data release., the national average hospital for reimbursement for an Impella device under MS-DRG-215 in 2024 was approximately $71,520. Based on publicly disclosed information from CVRx, Inc., 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. CMS has a number of pathways to obtain written coverage, including “coverage with evidence development” and Transitional Coverage for Emerging Technologies. We will leverage the optimal pathway to seek coverage as we approach market launch. 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. According to a December 2019 article from the International Journal
of Academic Medicine, 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, according to a February 2025 study from Leonard Davis Institute of Health Economics (“Penn LDI”).
Based on a February 2019 survey conducted by the physician and consulting firm Merritt Hawkins. CTs drive approximately $3.7 million
in net revenue each year for a hospital system, the most among 18 physician specialties according to a February 2019 publication by
Cardiovascular Business. CTs average charge per provider is $32,599; the highest among specialties, according to a April
2025 publication by Definitive Healthcare. 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%),
according to The Society of Thoracic Surgeons Adult Cardiac Surgery Database. Additionally, over 60% of CABG procedures are urgent or
non-elective procedures with median hospital stays of 5 to 7 days post procedure according to a January 2020 from the European Journal
of Cardio-thoracic Surgery. Based on data from the Society of Thoracic Surgeons National Database, the American Heart Association, and
publications in the Journal of Thoracic and Cardiovascular Surgery, high volume cardiac surgery programs comprise 30% of hospitals
and represent 51% of procedures, according to data published in The American Journal of Accountable Care, 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. 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 $16 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

·	CorWave LVAD, a novel left ventricular
assist device designed for end-stage heart failure patients, competing in the advanced therapy
space alongside durable LVADs and transplant, rather than the NYHA class II–III space
where Revivent is positioned.

contrast, we believe that the Revivent System is unique in requiring the presence of severe anterior or apical scar with associated left
ventricular remodeling, which distinguishes it from devices that target non-ischemic or non-scar-related dilated cardiomyopathy. As of
the date of this prospectus, we are not aware of any other medical device in clinical development that directly
treats heart failure induced by scar-driven remodeling of the left ventricle. If there are companies with devices in development
that we are unaware of, they would need to conduct feasibility studies and pivotal clinical trials, typically a 6 to 9
year process, and demonstrate safety and efficacy equivalent to or superior to the Revivent System in the appropriate population.
In this case, we would retain a substantial timeline advantage, and given the size of the market, we believe we would
continue to have significant 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 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.