enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
enVVeno Medical (NASDAQ:NVNO) announced an unfavorable FDA supervisory appeal decision dated November 13, 2025, upholding a not-approvable letter issued on August 19, 2025 for its surgical VenoValve device because it did not meet the standard of reasonable assurance of safety and effectiveness.
The company said it will shift focus to its next-generation transcatheter valve, enVVe, which it views as having a different safety profile and as ready for human testing pending alignment with the FDA on endpoints. The company reported $31.5 million in cash and investments at Q3-end and a quarterly cash burn of $4–5 million, which it says funds operations into 2027.
enVVeno Medical (NASDAQ:NVNO) ha annunciato una decisione sfavorevole dell'appello di supervisione FDA datata 13 novembre 2025, che sostiene una lettera non approvabile emessa il 19 agosto 2025 per il suo dispositivo chirurgico VenoValve perché non ha raggiunto lo standard di ragionevole sicurezza ed efficacia.
L'azienda ha detto che concentrerà l'attività sul suo prossiomo generazione di valvola transcatetere, enVVe, che considera avere un profilo di sicurezza diverso e pronta per i test sull'uomo in attesa di allineamento con la FDA sugli endpoint. L'azienda ha riportato $31.5 milioni in contanti e investimenti al termine del terzo trimestre e un consumo di cassa trimestrale di $4–5 milioni, che secondo quanto detto finanzia le operazioni fino al 2027.
enVVeno Medical (NASDAQ:NVNO) anunció una decisión desfavorable de la apelación de supervisión de la FDA fechada el 13 de noviembre de 2025, que mantiene una carta no aprobable emitida el 19 de agosto de 2025 para su dispositivo quirúrgico VenoValve porque no cumplió con el estándar de una seguridad y eficacia razonablemente aseguradas.
La compañía dijo que cambiará su enfoque a su válvula transcatéter de nueva generación, enVVe, que considera que tiene un perfil de seguridad diferente y está lista para pruebas en humanos a la espera de la alineación con la FDA sobre los endpoints. La empresa reportó $31.5 millones en efectivo e inversiones al cierre del tercer trimestre y un gasto de efectivo trimestral de $4–5 millones, lo que dice financia las operaciones hasta 2027.
enVVeno Medical (NASDAQ:NVNO)는 2025년 11월 13일자 FDA 관리 항소 결정의 불리한를 발표했으며 이는 2025년 8월 19일에 발행된 승인 불가 서한을 유지하고, 수술용 VenoValve 기기가 안전성과 효과에 대한 합리적 보장을 충족하지 못했기 때문입니다.
회사는 차세대 경피성 밸브인 enVVe로 초점을 옮길 것이며, 이는 안전성 프로파일이 다르고 엔드포인트에 대한 FDA의 조정이 완료되면 인간 시험이 준비될 것이라고 봅니다. 회사는 3분기 말 현금 및 투자액이 $31.5 million이고 분기당 현금 소모가 $4–5 million으로 2027년까지 운영 자금을 확보했다고 전했습니다.
enVVeno Medical (NASDAQ:NVNO) a annoncé une décision défavorable de l'appel de supervision par la FDA datée du 13 novembre 2025, confirmant une lettre non approuvable émise le 19 août 2025 pour son dispositif VenoValve chirurgical, car il n'a pas atteint le standard d'une sécurité et d'une efficacité raisonnablement assurées.
L'entreprise a déclaré qu'elle orienterait son attention vers sa valve transcatéter de nouvelle génération, enVVe, qu'elle considère comme ayant un profil de sécurité différent et prête pour des essais chez l'homme en attendant l'alignement avec la FDA sur les endpoints. L'entreprise a rapporté $31.5 millions en liquidités et investissements à la clôture du T3 et une consommation de trésorerie trimestrielle de $4–5 millions, ce qui, selon elle, finance les opérations jusqu'en 2027.
enVVeno Medical (NASDAQ:NVNO) gab eine ungünstige FDA-Aufsichtsbeschwerdeentscheidung bekannt, datiert auf den 13. November 2025, die ein nicht genehmigungsfähiges Schreiben bestätigte, das am 19. August 2025 für sein chirurgisches VenoValve-Gerät ausgestellt wurde, weil es nicht das Maß an vertretbarer Sicherheit und Wirksamkeit erfüllt.
Das Unternehmen sagte, es werde seinen Fokus auf die nächste Generation des transkatheter Ventilprodukts (enVVe) legen, das aus seiner Sicht ein anderes Sicherheitsprofil aufweist und für Tierversuche am Menschen bereit sei, vorausgesetzt, die FDA stimmt die Endpunkte ab. Das Unternehmen berichtete $31.5 Millionen an Bargeld und Investitionen zum Ende des dritten Quartals und einen quartalsweisen Cash-Burn von $4–5 Millionen, was laut dem Unternehmen die Operationen bis 2027 finanziert.
enVVeno Medical (NASDAQ:NVNO) أعلنت عن قرار سلبي في الاستئناف الإشرافي من FDA مؤرخ 13 نوفمبر 2025، يؤيد رسالة غير قابلة للاعتماد صدرت في 19 أغسطس 2025 لجهاز VenoValve الجراحي لأنه لم يستوفِ معيار ضمان السلامة والفعالية المعقول.
وقالت الشركة إنها ستركز في جيلها التالي من صمام عبر الأوردة enVVe، والذي تعتبره يمتلك ملف سلامة مختلف وجاهز للاختبار البشري بانتظار التنسيق مع FDA بشأن النهايات النهائية. وأفادت الشركة بأن لديها $31.5 مليون من النقد والاستثمارات في نهاية الربع الثالث وبمصروف نقدي ربع سنوي قدره $4–5 مليون، والذي تقول إنه يمول العمليات حتى عام 2027.
- Cash and investments of $31.5M at Q3-end
- Quarterly cash burn of $4–5M, runway into 2027
- Plan to advance enVVe toward human testing pending FDA alignment
- FDA supervisory appeal upheld not-approvable decision for VenoValve
- VenoValve failed to meet FDA standard for reasonable assurance of safety and effectiveness
Insights
FDA upheld a not-approvable decision for VenoValve; company pivots to transcatheter enVVe and reports cash runway into
enVVeno's supervisory appeal outcome confirms the FDA found the VenoValve did not meet the agency's standard of reasonable assurance of safety and effectiveness, which represents a clear regulatory setback for the PMA pathway for the surgical device. The company states it will shift focus to a next‑generation transcatheter valve, enVVe, and seek alignment with the FDA on achievable clinical endpoints before human testing.
The company reported
IRVINE, CA / ACCESS Newswire / November 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 it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). The supervisory appeal upheld the review staff decision in the not-approvable letter that the VenoValve did not meet the standard of reasonable assurance of safety and effectiveness.
"Although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe, our next generation transcatheter based replacement venous valve," said Robert Berman, enVVeno Medical's Chief Executive Officer. "enVVe should have a different safety profile than an open surgical device and is ready for human testing. Assuming that we can reach alignment with the Agency on achieveble endpoints for enVVe, it makes sense to turn our attention and devote our resources to enVVe. We will continue to interact with the FDA on enVVe and will provide periodic updates on our progress."
The Company reported
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. 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 there are approximately 2.5 million to 3.5 million patients with severe deep venous CV I in the U.S. including approximately 1.5 million patients that develop venous leg ulcers (C6 patients). The average patient seeking treatment of a venous ulcer spends as much as
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 is developing surgical and non-surgical replacement venous valves for the treatment of deep venous CVI.
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
FAQ
What did enVVeno (NVNO) announce on November 13, 2025 about the VenoValve?
How much cash did enVVeno (NVNO) report and how long is the runway?
What is enVVeno's next regulatory plan after the FDA decision on VenoValve (NVNO)?
Did the FDA approve VenoValve for severe deep chronic venous insufficiency (NVNO)?
What clinical unmet need does enVVeno (NVNO) target with its valves?
Will enVVeno (NVNO) provide updates on enVVe development?
