enVVeno Medical Updates Regulatory Status of VenoValve(R)
enVVeno Medical (NASDAQ:NVNO) announced plans to file a supervisory appeal following FDA's not-approvable letter for its VenoValve® Premarket Approval (PMA) application. The appeal must be filed by September 18, 2025, challenging the FDA's August 19 decision regarding this surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
The company maintains a positive outlook based on its previous Breakthrough Device Designation and collaborative history with the FDA. The appeal process will involve formal requests, in-person meetings, and multiple interactions. A decision is expected by end of 2025. The VenoValve targets 2.5 to 3.5 million U.S. patients suffering from severe deep venous CVI who currently lack effective treatment options.
enVVeno Medical (NASDAQ:NVNO) ha annunciato piani di presentare un appello di supervisione dopo la lettera della FDA non approvata per la sua domanda di VenoValve® Premarket Approval (PMA). L’appello deve essere presentato entro il 18 settembre 2025, contestando la decisione della FDA del 19 agosto riguardo questa valvola venosa sostitutiva chirurgica per trattare una grave insufficienza venosa profonda (CVI).
L’azienda mantiene una prospettiva positiva sulla base della precedente Breakthrough Device Designation e della storia di collaborazione con la FDA. Il processo di ricorso comprenderà richieste formali, incontri di persona e molte interazioni. Una decisione è prevista entro la fine del 2025. Il VenoValve è destinato a 2,5–3,5 milioni di pazienti negli USA che soffrono di grave CVI venosa profonda e che attualmente non hanno opzioni di trattamento efficaci.
enVVeno Medical (NASDAQ:NVNO) anunció planes de presentar un recurso de supervisión tras la carta de no aprobación de la FDA para su solicitud de VenoValve® Premarket Approval (PMA). El recurso debe presentarse antes del 18 de septiembre de 2025, desafiando la decisión de la FDA del 19 de agosto respecto a esta válvula venosa de reemplazo quirúrgico para tratar la insuficiencia venosa crónica profunda grave (CVI).
La compañía mantiene una perspectiva positiva basada en su anterior Designación de Dispositivo Innovador y su historial de colaboración con la FDA. El proceso de apelación incluirá solicitudes formales, reuniones en persona y múltiples interacciones. Se espera una decisión para fin de 2025. El VenoValve está dirigido a 2,5 a 3,5 millones de pacientes estadounidenses que padecen CVI venosa profunda grave y que actualmente carecen de opciones de tratamiento efectivas.
enVVeno Medical (NASDAQ:NVNO)는 FDA의 비승인 서한 이후 VenoValve® 프리마켓 승인(PMA) 신청에 대한 감독 상소 계획을 발표했습니다. 상소는 2025년 9월 18일까지 제기되어야 하며, 심부 만성 정맥 기능 부전(CVI)을 치료하는 이 수술용 정맥판막의 FDA 8월 19일 결정에 이의를 제기합니다.
회사는 이전의 Breakthrough Device Designation 및 FDA와의 협력 이력을 바탕으로 긍정적인 전망을 유지합니다. 상소 절차에는 공식 요청, 대면 회의 및 다수의 상호 작용이 포함됩니다. 2025년 말까지 결정이 예상됩니다. VenoValve는 현재 효과적인 치료 옵션이 없는 미국 내 250만~350만 명의 심부 정맥 CVI 환자를 대상으로 합니다.
enVVeno Medical (NASDAQ:NVNO) a annoncé son intention de déposer un recours de supervision après que la FDA a émis une lettre de non‑approbation pour sa demande de VenoValve® Premarket Approval (PMA). L’appel doit être déposé d’ici le 18 septembre 2025, pour contester la décision de la FDA du 19 août concernant cette valve veineuse de remplacement chirurgicale destinée à traiter une grave insuffisance veineuse profonde (CVI).
La société demeure optimiste grâce à sa précédente Breakthrough Device Designation et à son historique de collaboration avec la FDA. Le processus d’appel comprendra des demandes formelles, des réunions en personne et de multiples échanges. Une décision est attendue d’ici fin 2025. Le VenoValve cible 2,5 à 3,5 millions de patients américains souffrant d’une CVI veineuse profonde grave qui n’ont actuellement pas d’options de traitement efficaces.
enVVeno Medical (NASDAQ:NVNO) kündigte Pläne an, eine Aufsichtsberufung nach einem von der FDA ausgestellten Nicht‑Zulassungsbrief (Non‑Approvable Letter) für den PMA-Antrag von VenoValve® einzureichen. Die Berufung muss bis zum 18. September 2025 eingereicht werden, um die Entscheidung der FDA vom 19. August bezüglich dieses chirurgisch ersetzen Venenaustrittsventils zur Behandlung einer schweren tieferen venösen Insuffizienz (CVI) anzugreifen.
Das Unternehmen bleibt zuversichtlich basierend auf der vorherigen Breakthrough Device Designation und der Zusammenarbeit mit der FDA. Der Berufungsprozess wird formelle Anträge, persönliche Treffen und mehrere Interaktionen umfassen. Eine Entscheidung wird bis Ende 2025 erwartet. Das VenoValve zielt auf 2,5 bis 3,5 Millionen US‑Patienten ab, die an schwerer tief venöser CVI leiden und derzeit keine wirksamen Behandlungsoptionen haben.
أعلنت شركة enVVeno Medical (بورصة ناسداك: NVNO) عن خطط لتقديم استئناف إشرافي عقب رسالة FDA التي لم تقبل طلبها (PMA) لمنتج VenoValve® المسبوق بالتسويق. يجب تقديم الاستئناف قبل 18 سبتمبر 2025 للطعن في قرار FDA الصادر في 19 أغسطس بشأن هذه الصمام الوريدي البديل الجراحي لعلاج فشل الصِمّامات الوريدية العميقة الخطير (CVI).
تتمسك الشركة بتوقعات إيجابية استناداً إلى Designation جهاز اختراق السابق وتاريخها من التعاون مع FDA. ستشمل إجراءات الاستئناف طلبات رسمية، اجتماعات حضورياً، وتفاعلات متعددة. من المتوقع صدور قرار بحلول نهاية 2025. يهدف VenoValve إلى 2.5 إلى 3.5 مليون مريض في الولايات المتحدة يعانون من CVI الوريدية العميقة الخطيرة الذين يفتقدون حالياً لخيارات علاج فعّالة.
enVVeno Medical (NASDAQ:NVNO) 宣布计划在 FDA 发出的不予批准函之后，对其 VenoValve® 的 Premarket Approval (PMA) 申请提起监管上诉。上诉必须在 2025 年 9 月 18 日 前提交，以挑战 FDA 于 2025 年 8 月 19 日 就这款用于治疗严重深部慢性静脉功能不全（CVI）的外科替代静脉瓣的决定。
公司基于其先前的 突破性设备指定 与与 FDA 的合作历史，保持乐观展望。上诉过程将包括正式请求、面对面会谈以及多轮互动。预计在 2025 年底 作出决定。VenoValve 的目标是美国境内 250万至350万名患有严重深部静脉 CVI 且目前缺乏有效治疗选项的患者。
- None.
- FDA issued not-approvable letter for VenoValve PMA application
- Regulatory approval timeline extended due to appeal process
- Uncertainty in appeal outcome despite company's confidence
Insights
enVVeno appealing FDA rejection of VenoValve PMA, significant regulatory hurdle for first-in-class device treating millions with chronic venous insufficiency.
enVVeno Medical's announcement regarding their supervisory appeal strategy reveals a significant regulatory setback for their VenoValve device. The FDA's not-approvable letter for this first-in-class surgical venous valve replacement represents a substantial obstacle in their commercialization pathway. Despite having previously secured both Breakthrough Device Designation and Investigational Device Exemption, the company now faces a critical challenge in the final PMA review stage.
The supervisory appeal process they're pursuing is a formal escalation mechanism within the FDA hierarchy, moving the decision to higher-level officials. This approach has a tight timeline - their 30-day window for filing expires September 18, 2025. The company appears to be banking on their previously established collaborative relationship with the agency to help overcome this hurdle.
What's particularly notable is that enVVeno isn't planning to submit new clinical data, but rather will focus on reframing and emphasizing existing data from their pivotal study that's already in the administrative file. This suggests they believe the issue may be one of interpretation rather than insufficient evidence. The company's optimism about a positive outcome by year-end 2025 appears to be based on their confidence in the strength of both physician-reported and patient-reported outcomes.
The stakes are exceptionally high, as the company notes the VenoValve targets a population of
IRVINE, CA / ACCESS Newswire / September 15, 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 it will file 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 FDA provides several internal informal and formal mechanisms to challenge lower review staff decisions, including scientific controversies. One mechanism is a request for supervisory review in which an appeal is made to the next line of supervision. Supervisory appeals are required to be filed within 30 days of the decision being appealed, which is on or before September 18, 2025. These appeals involve a formal substantive request, an in-person meeting, and a decision. It also often includes multiple interactions even after an initial appeal decision is made.
"Due to our interaction with FDA to obtain our Breakthrough Device Designation (BDD), in which the FDA determined that the VenoValve will meet an unmet clinical need, and our clinical trial negotiations to obtain our Investigational Device Exemption (IDE), as well as during our PMA submission interactions, we have established a productive and collaborative working relationship with the FDA over the past several years. We view this supervisory appeal as an opportunity to extend that relationship," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Bringing a true first-in-class device through the PMA regulatory process raises unique challenges, and it is not unusual to have sequential collaborative discussions with the Agency to address issues that arise during the review process. We are committed to our continuing interactions with the FDA and to the goal of bringing the VenoValve to the 2.5 to 3.5 million patients suffering from severe deep venous CVI in the U.S. and who have no effective treatment options."
Internal Agency reviews are based on information already in the administrative file. Due to the variety of both physician reported and patient reported data generated by the VenoValve pivotal study and which is already a part of the file, the Company is confident that explaining this data to supervisory management in a focused appeal setting will lead to a positive outcome, with a decision expected by the end of 2025.
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.
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, but not limited to that such FDA appeal is unsuccessful and other risks 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
FAQ
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