VenoValve to be Featured During Presentation at the 47th Annual Charing Cross Symposium
enVVeno Medical (NASDAQ:NVNO) announced that its VenoValve® will be featured at the 47th Annual Charing Cross Symposium in London from April 23-25, 2025. Dr. David Dexter from Sentara Hospital and Eastern Virginia Medical School will present on 'Progress to date and future prospects for invasive correction of deep venous reflux' on April 24.
The VenoValve is positioned as a first-in-class surgical replacement venous valve for severe deep venous CVI patients, with an estimated 2.5 million potential new patients annually in the U.S. The company has submitted a pre-market authorization (PMA) application to the FDA, with a decision expected in the second half of 2025.
enVVeno Medical (NASDAQ:NVNO) ha annunciato che il suo VenoValve® sarà presentato al 47° Simposio Annuale di Charing Cross a Londra, dal 23 al 25 aprile 2025. Il dott. David Dexter, del Sentara Hospital e della Eastern Virginia Medical School, terrà una presentazione dal titolo 'Progresso ad oggi e prospettive future per la correzione invasiva del reflusso venoso profondo' il 24 aprile.
Il VenoValve si presenta come una valvola venosa chirurgica sostitutiva di prima classe per pazienti con insufficienza venosa cronica profonda grave, con un bacino stimato di 2,5 milioni di nuovi potenziali pazienti ogni anno negli Stati Uniti. L'azienda ha presentato una domanda di autorizzazione pre-mercato (PMA) alla FDA, con una decisione prevista nella seconda metà del 2025.
enVVeno Medical (NASDAQ:NVNO) anunció que su VenoValve® será presentado en el 47º Simposio Anual de Charing Cross en Londres, del 23 al 25 de abril de 2025. El Dr. David Dexter, del Hospital Sentara y la Escuela de Medicina de Eastern Virginia, presentará una ponencia titulada 'Progresos hasta la fecha y perspectivas futuras para la corrección invasiva del reflujo venoso profundo' el 24 de abril.
El VenoValve se posiciona como una válvula venosa quirúrgica de primera clase para pacientes con insuficiencia venosa crónica profunda severa, con un estimado de 2.5 millones de nuevos pacientes potenciales anualmente en EE.UU. La compañía ha presentado una solicitud de autorización previa al mercado (PMA) a la FDA, con una decisión esperada para la segunda mitad de 2025.
enVVeno Medical (NASDAQ:NVNO)는 2025년 4월 23일부터 25일까지 런던에서 열리는 제47회 연례 Charing Cross 심포지엄에서 VenoValve®를 선보인다고 발표했습니다. Sentara 병원과 Eastern Virginia 의과대학의 David Dexter 박사가 4월 24일 '심부 정맥 역류의 침습적 교정에 대한 현재까지의 진전과 미래 전망'에 대해 발표할 예정입니다.
VenoValve는 중증 심부 정맥 만성 정맥 부전(CVI) 환자를 위한 최초의 수술용 대체 정맥 판막으로 자리 잡고 있으며, 미국에서 연간 약 250만 명의 신규 잠재 환자가 있을 것으로 추산됩니다. 회사는 FDA에 사전 시장 승인(PMA) 신청서를 제출했으며, 2025년 하반기에 결정이 예상됩니다.
enVVeno Medical (NASDAQ:NVNO) a annoncé que son VenoValve® sera présenté lors du 47e Symposium annuel de Charing Cross à Londres, du 23 au 25 avril 2025. Le Dr David Dexter de l'hôpital Sentara et de l'École de médecine de Virginie de l'Est présentera une conférence intitulée « Progrès à ce jour et perspectives futures pour la correction invasive du reflux veineux profond » le 24 avril.
Le VenoValve est positionné comme une valve veineuse chirurgicale de première classe destinée aux patients atteints d'insuffisance veineuse chronique profonde sévère, avec un potentiel estimé à 2,5 millions de nouveaux patients chaque année aux États-Unis. La société a déposé une demande d'autorisation préalable à la mise sur le marché (PMA) auprès de la FDA, une décision étant attendue pour le second semestre 2025.
enVVeno Medical (NASDAQ:NVNO) gab bekannt, dass sein VenoValve® auf dem 47. jährlichen Charing Cross Symposium in London vom 23. bis 25. April 2025 vorgestellt wird. Dr. David Dexter vom Sentara Hospital und der Eastern Virginia Medical School wird am 24. April zum Thema 'Fortschritte bis heute und zukünftige Aussichten für die invasive Korrektur des tiefen venösen Refluxes' referieren.
Das VenoValve wird als erstklassiges chirurgisches Ersatz-Venenklappenimplantat für Patienten mit schwerer chronischer tiefer Venenerkrankung (CVI) positioniert, mit geschätzten 2,5 Millionen potenziellen neuen Patienten jährlich in den USA. Das Unternehmen hat einen Antrag auf vorläufige Marktzulassung (PMA) bei der FDA eingereicht, eine Entscheidung wird für die zweite Hälfte des Jahres 2025 erwartet.
- Large addressable market with 2.5 million potential new U.S. patients annually
- FDA decision on PMA application expected in H2 2025
- Potential first-in-class product for deep venous CVI treatment
- Product not yet FDA approved
- Revenue generation dependent on successful FDA approval
IRVINE, CA / ACCESS Newswire / April 23, 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 the VenoValve® will be featured during a presentation at the Annual Charing Cross Symposium being held April 23-25, 2025 in London, England.
As part of the Symposium, Dr. David Dexter, Sentara Hospital, Norfolk, Virginia and Associate Professor of Surgery, Eastern Virginia Medical School, and a Principal Investigator for the VenoValve U.S. pivotal trial, will present, "Progress to date and future prospects for invasive correction of deep venous reflux" onThursday, April 24, 2025 at 11:10 AM BST.
The VenoValveis 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.
For more information, visit the Annual Charing Cross Symposium website here.
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.
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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