Health Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency
enVVeno Medical (NASDAQ:NVNO) has announced promising results from a health economic study of its VenoValve, a first-in-class surgical replacement venous valve for severe Chronic Venous Insufficiency (CVI). The study demonstrates significant cost-effectiveness, with $32,442 in savings per patient over 5 years compared to standard care.
Key clinical benefits include 2.2 ulcers avoided per patient and 0.33 additional quality-adjusted life years (QALYs) gained. The device could potentially save $5.9 billion annually in healthcare costs for approximately 2.5 million U.S. patients with severe CVI. The company has submitted a PMA application to the FDA, with a decision expected in H2 2025.
enVVeno Medical (NASDAQ:NVNO) ha annunciato risultati promettenti da uno studio economico-sanitario sul suo VenoValve, una valvola venosa chirurgica sostitutiva di prima classe per l'Insufficienza Venosa Cronica (CVI) grave. Lo studio evidenzia una significativa convenienza economica, con 32.442 dollari di risparmio per paziente in 5 anni rispetto alle cure standard.
I principali benefici clinici includono 2,2 ulcere evitate per paziente e 0,33 anni di vita aggiustati per qualità (QALYs) guadagnati. Il dispositivo potrebbe potenzialmente far risparmiare 5,9 miliardi di dollari all'anno in costi sanitari per circa 2,5 milioni di pazienti statunitensi con CVI grave. L'azienda ha presentato una domanda PMA alla FDA, con una decisione attesa nella seconda metà del 2025.
enVVeno Medical (NASDAQ:NVNO) ha anunciado resultados prometedores de un estudio económico sanitario sobre su VenoValve, una válvula venosa quirúrgica de reemplazo pionera para la Insuficiencia Venosa Crónica (CVI) severa. El estudio demuestra una rentabilidad significativa, con 32.442 dólares en ahorros por paciente durante 5 años en comparación con el tratamiento estándar.
Los beneficios clínicos clave incluyen 2,2 úlceras evitadas por paciente y 0,33 años adicionales de vida ajustados por calidad (QALYs) ganados. El dispositivo podría ahorrar potencialmente 5.900 millones de dólares anuales en costos de atención médica para aproximadamente 2,5 millones de pacientes estadounidenses con CVI grave. La compañía ha presentado una solicitud PMA a la FDA, con una decisión esperada en la segunda mitad de 2025.
enVVeno Medical (NASDAQ:NVNO)는 중증 만성 정맥 부전(CVI)을 위한 최초의 수술용 대체 정맥 판막인 VenoValve에 대한 건강 경제학 연구에서 유망한 결과를 발표했습니다. 연구 결과에 따르면 표준 치료 대비 환자당 5년간 32,442달러의 비용 절감 효과가 있음을 보여줍니다.
주요 임상 이점으로는 환자당 2.2개의 궤양 예방과 0.33년의 추가 삶의 질 조정 수명(QALYs) 확보가 포함됩니다. 이 기기는 중증 CVI를 가진 약 250만 명의 미국 환자에 대해 연간 59억 달러의 의료비 절감을 가능하게 할 수 있습니다. 회사는 FDA에 PMA 신청서를 제출했으며, 2025년 하반기에 결정이 예상됩니다.
enVVeno Medical (NASDAQ:NVNO) a annoncé des résultats prometteurs issus d'une étude économique de santé sur son VenoValve, une valve veineuse chirurgicale de remplacement innovante pour l'insuffisance veineuse chronique sévère (CVI). L'étude démontre une rentabilité significative, avec 32 442 $ d'économies par patient sur 5 ans par rapport aux soins standards.
Les principaux bénéfices cliniques incluent 2,2 ulcères évités par patient et 0,33 années de vie ajustées sur la qualité (QALYs) supplémentaires gagnées. Le dispositif pourrait potentiellement économiser 5,9 milliards de dollars par an en coûts de santé pour environ 2,5 millions de patients américains souffrant de CVI sévère. La société a soumis une demande PMA à la FDA, avec une décision attendue au second semestre 2025.
enVVeno Medical (NASDAQ:NVNO) hat vielversprechende Ergebnisse einer gesundheitsökonomischen Studie zu seinem VenoValve vorgestellt, einem erstklassigen chirurgischen Ersatz für venöse Klappen bei schwerer chronischer venöser Insuffizienz (CVI). Die Studie zeigt eine signifikante Kostenwirksamkeit mit 32.442 US-Dollar Einsparungen pro Patient über 5 Jahre im Vergleich zur Standardbehandlung.
Wesentliche klinische Vorteile umfassen 2,2 vermiedene Geschwüre pro Patient und 0,33 zusätzliche qualitätsadjustierte Lebensjahre (QALYs). Das Gerät könnte jährlich 5,9 Milliarden US-Dollar an Gesundheitskosten für etwa 2,5 Millionen US-Patienten mit schwerer CVI einsparen. Das Unternehmen hat einen PMA-Antrag bei der FDA eingereicht, eine Entscheidung wird für das zweite Halbjahr 2025 erwartet.
- Significant cost savings of $32,442 per patient over 5 years
- Clinical effectiveness with 2.2 venous ulcers avoided per patient
- Quality of life improvement with 0.33 additional QALYs gained
- Break-even achieved between years 2-3
- Large addressable market of 2.5 million potential U.S. candidates
- Potential annual healthcare cost savings of $5.9 billion
- FDA approval still pending with decision in H2 2025
- Results based on model simulations rather than real-world data
Insights
VenoValve's strong health economic data shows cost-effectiveness and significant savings potential, strengthening its commercial case ahead of FDA decision.
The health economic study for enVVeno's VenoValve demonstrates compelling cost-effectiveness for treating severe Chronic Venous Insufficiency (CVI), a critical milestone for medical device commercialization. The data shows
These economic benefits position the VenoValve favorably with commercial payers, as the device achieved dominance over standard care treatments (lower costs with better outcomes) and reached cost break-even within 2-3 years. With robust results across multiple sensitivity analyses, the economic case appears solid.
The addressable market is substantial—approximately 2.5 million potential patients in the U.S. alone, including 1.5 million diagnosed with venous ulcers. The projected system-wide savings of
This economic validation complements the previously reported clinical data from the VenoValve's pivotal trial, creating a dual-pronged case for adoption. For a first-in-class medical device, demonstrating both clinical effectiveness and economic value is crucial for securing insurance coverage and physician adoption.
With the FDA decision on the pending Pre-Market Authorization (PMA) application expected in H2 2025, these health economic findings significantly strengthen enVVeno's commercialization prospects by addressing one of the major hurdles to widespread adoption—payer willingness to cover costs.
Clinical data and cost-effectiveness analysis demonstrates the VenoValve would provide both better health outcomes and lower costs compared to current standard of care treatments
The VenoValve could potentially save
Company to host live webcast with lead author of the cost-analysis manuscript, today, August 6th, at 12:00 PM ET; Access the Webcast Here
IRVINE, CA / ACCESS Newswire / August 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announcedpreliminary findings from a VenoValve health economic study, which indicate that the VenoValve would be a cost-effective treatment option for patients with severe Chronic Venous Insufficiency (CVI) caused by deep valvular incompetency. The Company announced it will host a live webcast to discuss the cost-effectiveness analysis results today, Wednesday, August 6th at 12:00 PM ET (details below).
Key Findings from the Study Include:
VenoValve was dominant relative to standard of care (i.e., lower costs, higher quality-adjusted life years):
Cost savings:
$32,442 per patient over 5 yearsClinical benefit: 2.2 ulcers avoided per patient
Quality of life: 0.33 additional QALYs gained per patient
Additional economic value associated with use of the VenoValve:
$14,912 saved per each venous ulcer avoided$4,101 cost per each rVCSS point improvementBreak-even achieved between years 2-3
Results remained consistent across multiple sensitivity analyses and scenarios (different age populations, various assumptions), confirming the model's reliability.
Mark H. Meissner M.D., surgeon at the Vascular and Endovascular Surgery Clinic at University of Washington (UW) Medical Center, a UW professor of Surgery, and the lead author of the manuscript added, "There remains a significant need for better treatment options for patients with severe, deep venous CVI, an advanced disease that affects millions of Americans annually and accounts for 1
"There are several factors that need to align in order to promote wide adoption of a first-in-class medical device. Two of the more important factors are good clinical results, and a willingness to pay for the device and the procedure. This health economic study provides evidence that the VenoValve would be extremely cost-effective, resulting in substantial health cost savings over time. This cost-effectiveness data, together with the strong clinical evidence from the pivotal trial, make a compelling package for commercial payors such as private health insurance providers and employers, that often make coverage decisions based upon both clinical and cost-effectiveness data", added Robert Berman, enVVeno Medical's Chief Executive Officer.
While private payors generally make coverage decisions based upon clinical evidence and cost effectiveness, Medicare makes coverage decisions based upon clinical effectiveness to support reasonable and necessary criteria for the Medicare population.
As part of the health economic study, a de novo cost-effectiveness model was developed to simulate clinical and economic outcomes for patients with deep venous CVI caused valvular incompetence. The model structure was based on health states defined by the revised Venous Clinical Severity Score (rVCSS), which were derived from a post-hoc analysis of the one-year results from the VenoValve U.S. pivotal trial. Key input values for transition probabilities, clinical events, costs of care, and utilities were sourced from the pivotal trial and publicly available sources. Six-month cycles were assumed for the first year, to match the VenoValve pivotal trial, followed by annual cycles; outcomes were compared over a 5-year time horizon.A manuscript describing the full methodology and findings has been submitted for peer review and publication.
The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that approximately 2.5 million people in the United States could be candidates for the VenoValve, including approximately 1.5 million diagnosed with venous ulcers. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.
Webcast Details
The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, August 6, 2025, at 12:00 PM ET. Joining enVVeno management for the event will be Dr. Meissner. The live webcast will be accessible on the Events page of the enVVeno website, envveno.com, and will be archived for 90 days.
About CVI
Severe deep venous CVI is a serious and debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension).
Symptoms of CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments that repair deep venous valve dysfunction, the #1 cause of severe CVI-a disease estimated to cost the U.S. healthcare system in excess of
About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous CVI. The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVIcalled enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(908) 824-0775
MEDIA CONTACT:
Glenn Silver, FINN Partners
Glenn.Silver@finnpartners.com
(973) 818-8198
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire
FAQ
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