One-Year Data from the VenoValve(R) U.S. Pivotal Trial Highlighting Impact on Patients' Quality of Life (QOL) to be Presented Today at the 37th Annual Meeting of the American Venous Forum
enVVeno Medical (NASDAQ:NVNO) announced one-year follow-up data from the VenoValve U.S. pivotal trial, showing sustained improvements in venous-specific quality-of-life indicators across 75 subjects. The data will be presented at the 37th Annual Meeting of the American Venous Forum.
The company has submitted a pre-market authorization (PMA) application for VenoValve to the FDA, with a decision expected in the second half of 2025. The VenoValve aims to be the first FDA-approved treatment for deep venous CVI, a debilitating disease affecting millions of patients with no effective treatment options.
Severe CVI, often caused by blood clots in deep leg veins, results in symptoms including leg swelling, pain, edema, and venous ulcers. The condition significantly impacts daily activities and costs the U.S. healthcare system over $4 billion annually.
enVVeno Medical (NASDAQ:NVNO) ha annunciato i dati di follow-up a un anno dello studio clinico VenoValve negli Stati Uniti, mostrando miglioramenti sostenuti negli indicatori di qualità della vita specifici per le vene in 75 soggetti. I dati saranno presentati al 37° Congresso Annuale del Forum Venoso Americano.
L'azienda ha presentato una domanda di autorizzazione pre-commerciale (PMA) per VenoValve alla FDA, con una decisione attesa nella seconda metà del 2025. VenoValve punta a essere il primo trattamento approvato dalla FDA per la CVI venosa profonda, una malattia debilitante che colpisce milioni di pazienti senza opzioni di trattamento efficaci.
La CVI grave, spesso causata da coaguli di sangue nelle vene profonde delle gambe, provoca sintomi come gonfiore delle gambe, dolore, edema e ulcere venose. La condizione impatta significativamente le attività quotidiane e costa al sistema sanitario statunitense oltre 4 miliardi di dollari all'anno.
enVVeno Medical (NASDAQ:NVNO) anunció datos de seguimiento a un año del ensayo clínico pivotal de VenoValve en EE. UU., mostrando mejoras sostenidas en los indicadores de calidad de vida específicos venosos en 75 sujetos. Los datos se presentarán en la 37ª Reunión Anual del Foro Venoso Americano.
La compañía ha presentado una solicitud de autorización previa a la comercialización (PMA) para VenoValve a la FDA, con una decisión esperada en la segunda mitad de 2025. VenoValve tiene como objetivo ser el primer tratamiento aprobado por la FDA para la CVI venosa profunda, una enfermedad debilitante que afecta a millones de pacientes sin opciones de tratamiento efectivas.
La CVI severa, a menudo causada por coágulos de sangre en las venas profundas de las piernas, resulta en síntomas que incluyen hinchazón de las piernas, dolor, edema y úlceras venosas. Esta condición impacta significativamente las actividades diarias y le cuesta al sistema de salud de EE. UU. más de 4 mil millones de dólares anuales.
enVVeno Medical (NASDAQ:NVNO)는 VenoValve 미국 주요 시험의 1년 추적 데이터를 발표하였으며, 75명의 피험자에서 정맥 관련 삶의 질 지표의 지속적인 개선을 보여주었습니다. 이 데이터는 미국 정맥 포럼의 제37회 연례 회의에서 발표될 예정입니다.
회사는 VenoValve에 대한 시장 출시 전 승인 신청(PMA)을 FDA에 제출했으며, 2025년 하반기에 결정이 예상됩니다. VenoValve는 심각한 정맥성 만성 정맥 insufficiency(CVI) 치료를 위한 첫 번째 FDA 승인 치료제가 되는 것을 목표로 하고 있으며, 이는 효과적인 치료 옵션이 없는 수백만 환자에게 영향을 미치는 쇠약한 질병입니다.
심각한 CVI는 종종 다리 깊은 정맥의 혈전으로 인해 발생하며, 다리 부기, 통증, 부종 및 정맥 궤양과 같은 증상을 초래합니다. 이 상태는 일상 활동에 상당한 영향을 미치며, 미국 의료 시스템에 연간 40억 달러 이상의 비용을 초래합니다.
enVVeno Medical (NASDAQ:NVNO) a annoncé des données de suivi d'un an de l'essai pivot VenoValve aux États-Unis, montrant des améliorations durables des indicateurs de qualité de vie spécifiques aux veines chez 75 sujets. Les données seront présentées lors de la 37e Réunion Annuelle du Forum Veineux Américain.
L'entreprise a soumis une demande d'autorisation de mise sur le marché (PMA) pour VenoValve à la FDA, avec une décision attendue dans la seconde moitié de 2025. VenoValve vise à être le premier traitement approuvé par la FDA pour la CVI veineuse profonde, une maladie débilitante touchant des millions de patients sans options de traitement efficaces.
La CVI sévère, souvent causée par des caillots sanguins dans les veines profondes des jambes, entraîne des symptômes tels que le gonflement des jambes, la douleur, l'œdème et les ulcères veineux. Cette condition impacte significativement les activités quotidiennes et coûte au système de santé américain plus de 4 milliards de dollars par an.
enVVeno Medical (NASDAQ:NVNO) hat Daten zur einjährigen Nachverfolgung der entscheidenden VenoValve-Studie in den USA veröffentlicht, die nachhaltige Verbesserungen der venenspezifischen Lebensqualitätsindikatoren bei 75 Probanden zeigen. Die Daten werden auf dem 37. Jahresmeeting des American Venous Forum präsentiert.
Das Unternehmen hat einen Antrag auf Marktzulassung (PMA) für VenoValve bei der FDA eingereicht, mit einer Entscheidung, die für die zweite Hälfte von 2025 erwartet wird. VenoValve soll die erste von der FDA zugelassene Behandlung für die tiefe venöse CVI sein, eine belastende Erkrankung, die Millionen von Patienten betrifft und für die es keine effektiven Behandlungsoptionen gibt.
Schwere CVI, die oft durch Blutgerinnsel in den tiefen Beinvenen verursacht wird, führt zu Symptomen wie Schwellungen der Beine, Schmerzen, Ödemen und venösen Geschwüren. Diese Erkrankung hat erhebliche Auswirkungen auf die täglichen Aktivitäten und kostet das US-Gesundheitssystem jährlich über 4 Milliarden Dollar.
- Clinical trial data shows statistically significant QoL improvements at 12 months
- PMA application submitted to FDA, with decision expected in H2 2025
- Potential to be first FDA-approved treatment for deep venous CVI
- Addresses $4 billion+ annual U.S. healthcare market
- FDA approval still pending and not guaranteed
- Product not yet generating revenue
Insights
The presentation of VenoValve's one-year follow-up data at the prestigious American Venous Forum marks a pivotal moment in the treatment landscape for deep venous CVI. The statistically significant improvements in VEINES-QoL/Sym scores at 12 months are particularly compelling, as quality-of-life metrics increasingly influence both regulatory decisions and insurance coverage determinations.
The timing of this data presentation is strategically significant, coming shortly after the November 2024 PMA submission. The FDA's review timeline, with a decision expected in H2 2025, positions enVVeno for potential market entry in early 2026. Being potentially the first FDA-approved treatment for deep venous CVI would give the company significant first-mover advantages in physician adoption and payer negotiations.
The $4 billion annual healthcare cost burden of CVI in the U.S. provides strong economic justification for payer coverage. The lack of effective treatments for severe deep venous CVI, combined with its debilitating impact on daily activities and high rates of depression, creates a compelling value proposition for the VenoValve. The device's potential to reduce long-term healthcare costs through improved patient outcomes could support favorable reimbursement decisions.
The continued presentation invitations at leading vascular conferences indicate growing awareness and interest within the medical community. This pre-market physician engagement is important for building a strong initial adopter base. However, the company will need to demonstrate readiness in manufacturing scale-up and clinical training programs to capitalize on potential approval.
One-year follow-up data demonstrates sustained improvements across venous specific quality-of-life (QoL) indicators.
PMA application for the VenoValve submitted in November 2024, with an FDA decision expected in the second half of 2025.
IRVINE, CA / ACCESS Newswire / February 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that one-year follow-up data on 75 subjects from the VenoValve U.S. pivotal trial will be presented by Dr. Cassius Iyad Ochoa Chaar, Associate Professor Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, Principal Investigator, and lead enroller for the trial, at the 37th Annual Meeting of the American Venous Forum (VENOUS2025) being held February 16-19, 2025 in Atlanta, GA. The presentation is scheduled for today at 9:47 AM ET.
The data show that trial subjects who had the SAVVE procedure experienced statistically significant improvements in QoL metrics related to venous disease at 12 months compared to baseline as demonstrated by the VEINS-SYM/QOL scores. To view results from the trial, please visit www.venovalve.com. 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.
"We continue to be asked to present our data at leading vascular conferences throughout the world as news of the potential for the VenoValve spreads among vascular surgeons whose practices include the treatment of venous diseases," said Robert Berman, enVVeno Medical's Chief Executive Officer. "The VenoValve has the potential to be the first FDA approved treatment for deep venous CVI, and we are attempting to reach the top of a mountain that nobody has successfully climbed and with many failed attempts over the past several decades. With the summit of the mountain finally in sight, this is an exciting time for our company and for the millions of patients with severe deep venous CVI who have no effective treatment options."
Severe, deep venous CVI is a 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 severe 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 for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of
The Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaire is a validated, disease-specific instrument to measure patient-reported quality of life and symptom severity in individuals with chronic venous disease. By assessing factors such as pain, functional limitations, and psychosocial impacts, VEINES-QoL/Sym provides a standardized framework for evaluating treatment outcomes and guiding clinical decision-making.
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 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 Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. 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 SAVVE 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
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire
FAQ
When will the FDA decide on NVNO's VenoValve PMA application?
What are the one-year clinical results for NVNO's VenoValve trial?
What market opportunity does NVNO's VenoValve address?
What medical condition does NVNO's VenoValve treat?
