enVVeno Medical (NASDAQ:NVNO) Participates in Virtual Investor "What This Means" Segment
enVVeno Medical (NASDAQ:NVNO) announced its CEO Robert Berman's participation in a Virtual Investor "What This Means" segment. During the presentation, Berman discussed the company's recent supervisory appeal request to the FDA following a not-approvable letter for their VenoValve® device.
The not-approvable letter was received on August 19, 2025 from the FDA's Center for Devices and Radiological Health (CDRH) regarding the Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI).
enVVeno Medical (NASDAQ:NVNO) ha annunciato la partecipazione del CEO Robert Berman a un segmento Virtual Investor "What This Means". Durante la presentazione, Berman ha discusso la recente richiesta di ricorso di supervisione presso la FDA dell'azienda a seguito di una lettera non approvabile per il dispositivo VenoValve®.
La lettera non approvabile è stata ricevuta il 19 agosto 2025 dal Center for Devices and Radiological Health (CDRH) della FDA riguardo all'applicazione di Premarket Approval (PMA) per VenoValve®, una valvola venosa sostitutiva chirurgica progettata per trattare una grave insufficienza venosa cronica profonda (CVI).
enVVeno Medical (NASDAQ:NVNO) anunció la participación de su CEO Robert Berman en un segmento virtual de inversores "What This Means". Durante la presentación, Berman habló sobre la reciente solicitud de apelación supervisora a la FDA tras una carta de no aprobación para su dispositivo VenoValve®.
La carta de no aprobación fue recibida el 19 de agosto de 2025 del Center for Devices and Radiological Health (CDRH) de la FDA respecto a la solicitud de Premarket Approval (PMA) para VenoValve®, una válvula venosa quirúrgica de reemplazo diseñada para tratar la grave insuficiencia venosa crónica profunda (CVI).
enVVeno Medical (NASDAQ:NVNO)는 CEO 로버트 버만의 가상 투자자 "What This Means" 세그먼트 참가를 발표했습니다. 발표 중 버만은 VenoValve® 기기에 대한 비승인 서신 후의 최근 FDA에 대한 감독 상소 요청에 대해 논의했습니다.
비승인 서신은 2025년 8월 19일에 FDA의 의료기기 및 방사선 건강 센터(CDRH)로부터 VenoValve®의 프리마켓 승인(PMA) 신청에 대해 접수되었다고 합니다. 이는 심각한 심부 만성 정맥 기능부전(CVI)을 치료하기 위해 고안된 수술용 대체 정맥 밸브입니다.
enVVeno Medical (NASDAQ:NVNO) a annoncé la participation de son PDG, Robert Berman, à un segment virtuel d'investisseurs "What This Means". Lors de la présentation, Berman a évoqué la récente demande d'appel de supervision à la FDA suite à une lettre de non-acceptation pour leur dispositif VenoValve®.
La lettre de non-acceptation a été reçue le 19 août 2025 du Center for Devices and Radiological Health (CDRH) de la FDA concernant la demande de Premarket Approval (PMA) pour VenoValve®, une valve veineuse chirurgicale de remplacement conçue pour traiter une insuffisance veineuse chronique profonde sévère (CVI).
enVVeno Medical (NASDAQ:NVNO) hat die Teilnahme seines Geschäftsführers Robert Berman an einem virtuellen Investoren-Segment "What This Means" angekündigt. Während der Präsentation sprach Berman über die jüngste Anfechtung bei der FDA durch Aufsichtsbeschwerde nach einem ablehnenden Schreiben für ihr VenoValve®-Gerät.
Der ablehnende Brief wurde am 19. August 2025 vom Center for Devices and Radiological Health (CDRH) der FDA im Zusammenhang mit dem Premarket Approval (PMA)-Antrag für VenoValve® erhalten, einer chirurgischen Ersatz-Venenklappe zur Behandlung einer schweren tiefen chronischen Venenschwäche (CVI).
enVVeno Medical (NASDAQ:NVNO) أعلنت مشاركة المدير التنفيذي روبرت بيرمان في فقرة افتراضية للمستثمرين بعنوان "What This Means". خلال العرض، ناقش بيرمان طلب الاستئناف الإشرافي لدى FDA بعد رسالة عدم الموافقة لجهــاز VenoValve®.
تم استلام رسالة عدم الموافقة في 19 أغسطس 2025 من مركز الأجهزة والصحة الإشعاعية لدى FDA (CDRH) بخصوص طلب الموافقة المسبقة (PMA) لـ VenoValve®، وهو صمام وريدي جراحي بديل مصمم لعلاج فشل الصمامات الوريدية العميقة المزمن الشديد (CVI).
enVVeno Medical (NASDAQ:NVNO)宣布首席执行官罗伯特·伯曼将参加一个名为“这意味着什么”的虚拟投资者环节。在演示中，伯曼讨论了公司最近的向FDA提出的监督申诉请求，这是在其VenoValve®设备收到不予批准信后所提。
这一不予批准信于2025年8月19日由FDA的医疗器械与放射健康中心（CDRH）发出，涉及VenoValve®的 Premarket Approval (PMA) 申请，这是一种外科替代静脉瓣，旨在治疗严重的深部慢性静脉功能不全(CVI)。
- None.
- Received FDA not-approvable letter for VenoValve® PMA application
- Required to file supervisory appeal for product approval
Watch the "What This Means" video here
IRVINE, CA / ACCESS Newswire / September 26, 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 Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor "What This Means" segment.
As part of the segment, Mr. Berman discussed the Company's recent news announcing it filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
The Virtual Investor "What This Means" segment featuring enVVeno Medical is now available 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 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 severe deep 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®. 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 Company is currently performing the final testing necessary to seek IDE approval from the FDA to begin the U.S. 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
What was the FDA's decision on enVVeno Medical's VenoValve® PMA application?
What is enVVeno Medical's VenoValve® designed to treat?
What action did enVVeno Medical (NVNO) take after receiving the FDA not-approvable letter?
Who discussed enVVeno Medical's FDA appeal in the Virtual Investor segment?
