enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium
enVVeno Medical presented one-year data from the VenoValve U.S. pivotal trial at the 51st Annual VEITH Symposium, supporting their recent FDA pre-market authorization application. Key findings include: 85% of subjects achieved clinically meaningful benefit with a 3+ point improvement in revised Venous Clinical Severity Score (rVCSS), 7.91 point average rVCSS improvement among responders, 97% target vein patency rate, 75% median pain reduction, and 87% median ulcer area reduction.
The VenoValve demonstrated effectiveness across all CEAP diagnostic classes, with positive correlation between rVCSS improvement and systemic reflux time. The safety profile showed minimal adverse events, with 94% of subjects experiencing adverse events still achieving clinical meaningful benefit at one year.
enVVeno Medical ha presentato i dati a un anno del trial pivotale VenoValve negli Stati Uniti al 51° Simposio Annuale VEITH, supportando la loro recente richiesta di autorizzazione pre-market presso la FDA. I principali risultati includono: 85% dei soggetti ha ottenuto un beneficio clinicamente significativo con un miglioramento di oltre 3 punti nel punteggio di gravità clinica venosa rivisto (rVCSS), un miglioramento medio di 7.91 punti nel rVCSS tra i rispondenti, un tasso di pervietà della vena obiettivo del 97%, una riduzione mediana del dolore del 75%, e una riduzione mediana dell'area dell'ulcera del 87%.
Il VenoValve ha dimostrato efficacia in tutte le classi diagnostiche CEAP, con una correlazione positiva tra il miglioramento del rVCSS e il tempo di reflusso sistemico. Il profilo di sicurezza ha mostrato eventi avversi minimi, con il 94% dei soggetti che, pur avendo sperimentato eventi avversi, ha comunque ottenuto un beneficio clinicamente significativo dopo un anno.
enVVeno Medical presentó los datos de un año del ensayo pivotal VenoValve en EE.UU. en el 51er Simposio Anual VEITH, apoyando su reciente solicitud de autorización previa al mercado ante la FDA. Los hallazgos clave incluyen: 85% de los sujetos lograron un beneficio clínicamente significativo con una mejora de más de 3 puntos en el puntaje de gravedad clínica venosa revisado (rVCSS), una mejora promedio de 7.91 puntos en el rVCSS entre los respondedores, una tasa de permeabilidad de la vena objetivo del 97%, una reducción media del dolor del 75% y una reducción media del área de la úlcera del 87%.
El VenoValve demostró efectividad en todas las clases diagnósticas CEAP, con una correlación positiva entre la mejora del rVCSS y el tiempo de reflujo sistémico. El perfil de seguridad mostró eventos adversos mínimos, con el 94% de los sujetos que, a pesar de experimentar eventos adversos, aún lograron un beneficio clínicamente significativo al cabo de un año.
enVVeno Medical는 51회 VEITH 심포지엄에서 VenoValve 미국 주요 시험의 1년 데이터를 발표하며 최근 FDA 사전 시장 승인 신청을 뒷받침했습니다. 주요 결과로는: 85%의 피험자가 수정된 정맥 임상 중증도 점수(rVCSS)에서 3점 이상의 개선으로 임상적으로 의미 있는 혜택을 얻었고, 응답자들 사이에서 평균 7.91점의 rVCSS 개선, 97%의 목표 정맥 개통률, 75%의 중간 통증 감소, 87%의 중간 궤양 면적 감소가 포함됩니다.
VenoValve는 모든 CEAP 진단 클래스에서 효과성을 입증했으며, rVCSS 개선과 전신 역류 시간 간의 긍정적인 상관관계를 보였습니다. 안전성 프로필은 최소한의 부작용을 나타내었으며, 94%의 피험자가 부작용을 경험했음에도 불구하고 1년 후에도 임상적으로 의미 있는 혜택을 얻었습니다.
enVVeno Medical a présenté des données d'un an de l'essai pivot VenoValve aux États-Unis lors du 51e Symposium Annuel VEITH, soutenant ainsi leur récente demande d'autorisation préalable au marché auprès de la FDA. Les résultats clés incluent : 85% des sujets ont atteint un bénéfice cliniquement significatif avec une amélioration de plus de 3 points dans le score de gravité clinique veineuse révisé (rVCSS), une amélioration moyenne de 7.91 points du rVCSS parmi les répondants, un taux de perméabilité de la veine cible de 97%, une réduction médiane de la douleur de 75%, et une réduction médiane de la surface de l'ulcère de 87%.
Le VenoValve a démontré son efficacité dans toutes les classes de diagnostic CEAP, avec une corrélation positive entre l'amélioration du rVCSS et le temps de reflux systémique. Le profil de sécurité a montré des événements indésirables minimes, avec 94% des sujets ayant présenté des événements indésirables tout en atteignant tout de même un bénéfice clinique significatif après un an.
enVVeno Medical präsentierte die einjährigen Daten der VenoValve-Studie in den USA auf dem 51. jährlichen VEITH-Symposium und unterstützte damit ihren kürzlichen Antrag auf Marktzulassung bei der FDA. Zu den wichtigsten Ergebnissen gehören: 85% der Probanden erzielten einen klinisch bedeutenden Vorteil mit einer Verbesserung von mehr als 3 Punkten im überarbeiteten venösen klinischen Schweregrad-Scores (rVCSS), einer durchschnittlichen Verbesserung des rVCSS von 7.91 Punkten bei den Antwortenden, einer Zielvenen-Wiedereröffnungsrate von 97%, einer mittleren Schmerzreduktion von 75% und einer mittleren Reduktion der Ulkusfläche von 87%.
Der VenoValve zeigte über alle CEAP-Diagnoseklassen hinweg Wirksamkeit, mit einer positiven Korrelation zwischen der Verbesserung des rVCSS und der systemischen Refluxzeit. Das Sicherheitsprofil wies minimale unerwünschte Ereignisse auf, wobei 94% der Probanden, die unerwünschte Ereignisse erlitten hatten, trotzdem nach einem Jahr einen klinisch bedeutenden Vorteil erzielten.
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7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort
Improvement in All Patient Reported Quality-of-Life Indicators
Company to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time - Click Here to Access
IRVINE, CA / ACCESSWIRE / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S.
Among the data being presented at VEITH are:
Eighty five percent (
85% ) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS).7.91 point average rVCSS improvement among the rVCSS responder cohort.
Clinical meaningful benefit was shown across all CEAP diagnostic classes of subjects (C4(b), C4(c), C5, C6) enrolled in the study.
Ninety seven percent (
97% ) Target Vein Patency rate at one year.Hemodynamic data from the study showed a positive correlation between rVCSS improvement and systemic reflux time improvement.
rVCSS is a clinically validated scoring system used to track the regression or progression of venous diseases. The FDA previously indicated to the Company that a 3 or more-point improvement in rVCSS would be evidence of the VenoValve's clinical meaningful benefit.
Subjects in the VenoValve pivotal study also experienced a median reduction in pain of seventy-five percent (
"The number one concern for clinicians and where other attempts to replace venous valves have failed in the past is that they have occluded or completely blocked blood flow in the targeted refluxing vein. With a ninety seven percent (
The Company will also update the pivotal trial safety profile of the VenoValve at VEITH, reporting Major Adverse Events (MAEs) through one year of: one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) Target Vein Thromboses, ten (10) Surgical Pocket Hematomas, four (4) Other Bleeds, and seven (7) Deep Wound Infections. Of the subjects that experienced an MAE, there was no long-term negative impact on clinical improvement as ninety-four percent (
Severe, deep venous Chronic Venous Insufficiency (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 VenoValve® is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company is also developing enVVe®, a next-generation, transcatheter based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians.
The Company will host a video conference call today at 2:00 PM Eastern Time following the VEITH presentation, with the presenting Primary Investigators. To access the call visit the Events page on the Investor section of the Company's website or click here.
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.
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INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(908) 824-0775
SOURCE: enVVeno Medical Corporation
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