Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery
enVVeno Medical (NASDAQ:NVNO) has published promising three-year data from its first-in-human VenoValve® trial in the Annals of Vascular Surgery. The VenoValve, a surgical replacement venous valve for severe deep venous CVI, demonstrated continued safety and effectiveness after three years of implantation. Key findings from the study of 11 subjects include:
- 79% primary patency rate at three years
- 7-point improvement in Venous Clinical Severity Score
- 84% reduction in pain on the Visual Analog Scale
The company estimates 2.5 million potential new U.S. patients annually could benefit from VenoValve. A PMA application has been submitted to the FDA, with a decision expected in H2 2025.
enVVeno Medical (NASDAQ:NVNO) ha pubblicato dati promettenti a tre anni dal suo primo trial VenoValve® nell'uomo sulla rivista Annals of Vascular Surgery. Il VenoValve, una valvola venosa sostitutiva chirurgica per la grave insufficienza venosa profonda (CVI), ha dimostrato sicurezza ed efficacia continuative dopo tre anni dall'impianto. I risultati principali dello studio su 11 soggetti includono:
- Tasso di pervietà primaria del 79% a tre anni
- Miglioramento di 7 punti nel Venous Clinical Severity Score
- Riduzione del dolore del 84% nella scala analogica visiva
L'azienda stima che 2,5 milioni di nuovi pazienti potenziali negli Stati Uniti ogni anno potrebbero beneficiare del VenoValve. È stata presentata una domanda PMA alla FDA, con una decisione prevista nella seconda metà del 2025.
enVVeno Medical (NASDAQ:NVNO) ha publicado datos prometedores a tres años de su primer ensayo en humanos con VenoValve® en la revista Annals of Vascular Surgery. El VenoValve, una válvula venosa quirúrgica de reemplazo para insuficiencia venosa profunda grave (CVI), demostró seguridad y eficacia continuas tras tres años de implantación. Los hallazgos clave del estudio con 11 sujetos incluyen:
- Tasa de permeabilidad primaria del 79% a los tres años
- Mejora de 7 puntos en el Venous Clinical Severity Score
- Reducción del dolor del 84% en la Escala Visual Analógica
La compañía estima que 2,5 millones de nuevos pacientes potenciales en EE.UU. podrían beneficiarse anualmente del VenoValve. Se ha presentado una solicitud PMA a la FDA, con decisión prevista para la segunda mitad de 2025.
enVVeno Medical (NASDAQ:NVNO)가 Annals of Vascular Surgery에 첫 인간 대상 VenoValve® 임상시험 3년 데이터를 발표했습니다. 중증 심부정맥 만성정맥부전(CVI)을 위한 외과적 대체 정맥판막인 VenoValve는 이식 후 3년 동안 안전성과 효과가 지속됨을 입증했습니다. 11명의 대상자를 대상으로 한 연구의 주요 결과는 다음과 같습니다:
- 3년 후 기본 개통률 79%
- 정맥 임상 중증도 점수 7점 개선
- 시각 아날로그 척도에서 통증 84% 감소
회사는 매년 미국 내 250만 명의 신규 환자가 VenoValve의 혜택을 받을 수 있을 것으로 추산합니다. FDA에 PMA 신청서를 제출했으며, 2025년 하반기에 결정이 예상됩니다.
enVVeno Medical (NASDAQ:NVNO) a publié des données prometteuses à trois ans issues de son premier essai VenoValve® chez l'humain dans les Annals of Vascular Surgery. Le VenoValve, une valve veineuse chirurgicale de remplacement pour une insuffisance veineuse chronique profonde sévère (CVI), a démontré une sécurité et une efficacité durables après trois ans d'implantation. Les résultats clés de l'étude menée sur 11 sujets sont :
- Taux de perméabilité primaire de 79% à trois ans
- Amélioration de 7 points au score de gravité clinique veineuse
- Réduction de 84% de la douleur sur l'échelle visuelle analogique
L'entreprise estime que 2,5 millions de nouveaux patients potentiels aux États-Unis pourraient bénéficier chaque année du VenoValve. Une demande PMA a été soumise à la FDA, avec une décision attendue au second semestre 2025.
enVVeno Medical (NASDAQ:NVNO) hat vielversprechende Dreijahresdaten aus seiner ersten klinischen Studie mit dem VenoValve® im Menschen in den Annals of Vascular Surgery veröffentlicht. Das VenoValve, ein chirurgischer Ersatz der Venenklappe bei schwerer tiefer venöser chronischer Insuffizienz (CVI), zeigte auch nach drei Jahren Implantation weiterhin Sicherheit und Wirksamkeit. Wichtige Ergebnisse aus der Studie mit 11 Probanden sind:
- Primäre Offenheitsrate von 79% nach drei Jahren
- Verbesserung um 7 Punkte im Venous Clinical Severity Score
- 84% Schmerzreduktion auf der Visuellen Analogskala
Das Unternehmen schätzt, dass jährlich 2,5 Millionen potenzielle neue Patienten in den USA vom VenoValve profitieren könnten. Ein PMA-Antrag wurde bei der FDA eingereicht, eine Entscheidung wird für die zweite Hälfte 2025 erwartet.
- Strong clinical trial results with 79% primary patency rate after 3 years
- Significant pain reduction of 84% demonstrated on Visual Analog Scale
- Large market potential with 2.5 million annual potential new patients in the U.S.
- FDA decision on PMA application expected in H2 2025
- Small trial size with only 11 subjects initially and 8 completing follow-up
- Three subjects dropped out during the three-year follow-up period
Insights
VenoValve shows strong 3-year data with FDA decision pending in 2025, potentially addressing 2.5 million U.S. patients annually.
The newly published three-year outcomes for enVVeno Medical's VenoValve demonstrate remarkable durability and effectiveness for treating deep venous reflux. With 79% primary patency at the three-year mark according to Kaplan-Meier analysis, the device is showing promising longevity in the vascular system—a critical factor for permanent implants.
The 7-point improvement in Venous Clinical Severity Score and 84% reduction in pain on the Visual Analog Scale represent substantial clinical benefits for patients suffering from severe chronic venous insufficiency (CVI). These metrics are particularly significant as they translate to meaningful quality-of-life improvements for patients who previously had limited treatment options.
Perhaps most important from a regulatory and commercial perspective is that enVVeno has submitted their Pre-Market Authorization application to the FDA, with a decision expected in H2 2025. This timing suggests the company has completed their pivotal trials and compiled what they believe is sufficient evidence for approval.
The potential market impact is substantial—enVVeno estimates 2.5 million new potential U.S. patients annually could be candidates for this device. If approved, the VenoValve would be a first-in-class surgical replacement valve, potentially establishing enVVeno as the leader in a previously untapped segment of the vascular device market.
While the three-year study included a small sample (only 8 subjects completed three-year follow-up), the results are nonetheless compelling for this severe patient population with healed or active venous ulcers (CEAP C5-C6), who typically have few effective treatment options.
Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefits
Company has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025
IRVINE, CA / ACCESS Newswire / May 13, 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 announced that its manuscript titled, "Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux1," has been published in the in the peer-reviewed journal, Annals of Vascular Surgery.
The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6). Eight subjects completed three years of follow-up, with key findings including:
Primary patency:
79% (Kaplan-Meier curve) at three yearsSymptom relief: 7 point improvement Venous Clinical Severity Score;
84% reduction in pain on the Visual Analog Scale (VAS)
The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits
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 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.
About CVI
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
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 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
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
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