SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-05-15
Accession Number: 0001493152-26-023752
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226023752/forms-1a.htm

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MHS, whose combined expertise in less invasive cardiac surgery and advanced heart-failure research underpins the study’s oversight. We will maintain site principal investigators at www.clinicaltrials.gov and have already disclosed Andrew Kao, MD, Jessica Heimes, DO at Saint Luke’s Mid America Heart Institute, and John P. Boehmer, MD and Michael Pfeiffer, MD at Penn State College of Medicine. We are further supported by a group of clinical advisors with expertise spanning cardiac surgery, advanced heart failure, and cardiac imaging, including H. Kenith Fang, MD, FACS (Cardiac Surgeon), Thorsten Hanke, MD (Cardiac Surgeon), Patrick Klein, MD, PhD (Cardiac Surgeon), and Andrew Wechsler, MD (Cardiac Surgeon). Based on their clinical experience, these advisors provide input on procedural approaches, patient selection, and trial design, including the RELIVE trial protocol. Jerry Estep, MD, FACC, FASE (Advanced Heart Failure Specialist) and Gregg Stone, MD, FACC, MSCAI (Interventional Cardiologist) were National Co-Principal Investigators for the ALIVE trial.

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 or ischemic cardiomyopathy with clinically unrecognized myocardial infarction 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. 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, as reported in a systematic literature review by the Journal of Managed Care + Specialty Pharmacy (JMCP) in a January 2022
article. 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 Diagnosis-Related Group (DRG, the payment classification
system used by Medicare and many commercial payers to determine how much a hospital is reimbursed for an inpatient stay) code in the
United States under which hospitals would receive total reimbursement of approximately $50,000 per procedure and that we would receive
an average device selling price of approximately $35,000 per procedure; however, there can be no assurance that such a code will be obtained,
that the assumed reimbursement level or device pricing will be achieved, or that any reimbursement will be secured at all.

also note that other structural heart therapies, such as transcatheter aortic valve replacement (“TAVR”) and transcatheter
edge-to-edge repair (“TEER”), including MitraClip, experienced lower initial reimbursement levels during early commercialization,
followed by increases as dedicated coding, coverage and payment pathways were established. In these procedures, early device-related
economics were generally in the range of approximately $20,000 to $30,000 per procedure and increased over time to approximately $30,000
to $35,000 or more as reimbursement matured and adoption expanded. Pursuant to contractual arrangements with clinical trial sites participating
in the RELIVE trial, we receive reimbursement of $25,000 per procedure for certain procedure-related device expenses under substantially
all of our purchasing agreements.

While
payment rates for new procedures are determined by CMS and other payers
based on multiple factors, including the relative resource costs associated with the procedure, we expect that CMS will evaluate the
Revivent procedure in a manner consistent with its established methodologies for setting payment rates. We cannot guarantee that we will receive any coverage, nor can we guarantee that rates will be similar to those for
MitraChip or other similar products.

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.

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: