enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)
enVVeno Medical (NASDAQ:NVNO) has received a not-approvable letter from the FDA for its VenoValve® PMA application, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). The FDA determined that the clinical improvement data was insufficient to establish a favorable benefit-risk profile.
The FDA cited concerns about the lack of specific hemodynamic measurements correlating with patient improvement and raised safety issues related to the surgical procedure requiring re-hospitalizations. Despite showing improvements in revised Venous Clinical Severity Score (rVCSS), pain scores, and quality of life indicators, the FDA suggested potential study bias.
The company is evaluating options, including potential FDA discussions for resubmission or appeal, while continuing development of enVVe, its non-surgical replacement venous valve alternative.
enVVeno Medical (NASDAQ:NVNO) ha ricevuto una lettera di non approvazione dalla FDA per la sua domanda PMA relativa a VenoValve®, una valvola venosa sostitutiva chirurgica progettata per trattare l'insufficienza venosa cronica (CVI) grave. La FDA ha ritenuto che i dati di miglioramento clinico fossero insufficienti per dimostrare un profilo beneficio-rischio favorevole.
L'agenzia ha sollevato dubbi per la mancanza di misurazioni emodinamiche specifiche che si correlino con il miglioramento dei pazienti e ha evidenziato problemi di sicurezza legati alla procedura chirurgica, incluse re-ospedalizzazioni. Nonostante i miglioramenti riportati nel revised Venous Clinical Severity Score (rVCSS), nei punteggi del dolore e negli indicatori di qualità della vita, la FDA ha suggerito la possibilità di bias nello studio.
La società sta valutando le opzioni disponibili, compresa la possibilità di discutere con la FDA per una nuova presentazione o un ricorso, mentre prosegue lo sviluppo di enVVe, la sua alternativa valvolare venosa non chirurgica.
enVVeno Medical (NASDAQ:NVNO) ha recibido una carta de no aprobación por parte de la FDA para su solicitud PMA de VenoValve®, una válvula venosa de reemplazo quirúrgico diseñada para tratar la insuficiencia venosa crónica (CVI) severa. La FDA determinó que los datos de mejoría clínica eran insuficientes para establecer un perfil beneficio-riesgo favorable.
La agencia señaló preocupaciones por la falta de medidas hemodinámicas específicas que se correlacionen con la mejoría del paciente y planteó cuestiones de seguridad relacionadas con el procedimiento quirúrgico, que requiere reingresos hospitalarios. A pesar de las mejorías en el revised Venous Clinical Severity Score (rVCSS), en las puntuaciones de dolor y en los indicadores de calidad de vida, la FDA sugirió la posibilidad de sesgos en el estudio.
La compañía está evaluando opciones, incluida la posibilidad de entablar conversaciones con la FDA para una nueva presentación o una apelación, mientras continúa el desarrollo de enVVe, su alternativa valvular venosa no quirúrgica.
enVVeno Medical (NASDAQ:NVNO)는 중증 만성 정맥부전(CVI)을 치료하기 위해 설계된 외과적 대체 정맥판막인 VenoValve®의 PMA 신청에 대해 FDA로부터 불승인(not-approvable) 통지를 받았습니다. FDA는 임상 개선 데이터가 충분하지 않다고 판단하여 유익성-위험성 프로파일을 입증하지 못했다고 밝혔습니다.
FDA는 환자 개선과 상관관계가 있는 구체적인 혈역학적 측정치의 부재를 문제로 지적하고, 재입원을 초래할 수 있는 외과적 시술 관련 안전성 우려를 제기했습니다. revised Venous Clinical Severity Score(rVCSS), 통증 점수 및 삶의 질 지표에서 개선이 나타났음에도 불구하고 FDA는 연구에 편향 가능성이 있다고 언급했습니다.
회사는 재제출 또는 항소를 위한 FDA와의 논의 가능성을 포함한 선택지를 검토 중이며, 비외과적 대체 정맥판막인 enVVe 개발은 계속 진행하고 있습니다.
enVVeno Medical (NASDAQ:NVNO) a reçu une lettre de non-approbation de la FDA concernant sa demande PMA pour VenoValve®, une valve veineuse de remplacement chirurgical conçue pour traiter l'insuffisance veineuse chronique (CVI) sévère. La FDA a estimé que les données d'amélioration clinique étaient insuffisantes pour établir un profil bénéfice-risque favorable.
L'agence a cité des inquiétudes quant à l'absence de mesures hémodynamiques spécifiques corrélées à l'amélioration des patients et a soulevé des questions de sécurité liées à la procédure chirurgicale nécessitant des réhospitalisations. Malgré des améliorations du revised Venous Clinical Severity Score (rVCSS), des scores de douleur et des indicateurs de qualité de vie, la FDA a évoqué un possible biais dans l'étude.
La société examine ses options, y compris d'éventuelles discussions avec la FDA en vue d'une nouvelle soumission ou d'un appel, tout en poursuivant le développement d'enVVe, son alternative veineuse non chirurgicale.
enVVeno Medical (NASDAQ:NVNO) hat von der FDA ein Not-Approavable-Schreiben für den PMA-Antrag seiner chirurgischen Ersatz-Venenklappe VenoValve® erhalten, die zur Behandlung schwerer chronischer Venenschwäche (CVI) entwickelt wurde. Die FDA stellte fest, dass die klinischen Verbesserungsdaten unzureichend seien, um ein günstiges Nutzen-Risiko-Verhältnis nachzuweisen.
Die Behörde äußerte Bedenken hinsichtlich des Fehlens spezifischer hämodynamischer Messwerte, die mit der Patientverbesserung korrelieren, und hob Sicherheitsfragen im Zusammenhang mit dem chirurgischen Eingriff hervor, der zu Wiederaufnahmen ins Krankenhaus führen kann. Trotz Verbesserungen im revised Venous Clinical Severity Score (rVCSS), bei Schmerzwerten und Lebensqualitätsindikatoren deutete die FDA auf mögliche Studienverzerrungen hin.
Das Unternehmen prüft Optionen, darunter mögliche Gespräche mit der FDA zur erneuten Einreichung oder Berufung, und setzt gleichzeitig die Entwicklung von enVVe fort, einer nicht-chirurgischen Alternative zur venösen Ersatzklappe.
- Clinical trials showed significant improvement in patients who previously failed standard treatments
- Company has a non-surgical alternative (enVVe) in development
- Potential market of 2.5-3.5 million CVI patients in the U.S.
- FDA rejected VenoValve PMA application
- Clinical data deemed insufficient to prove benefit-risk profile
- Safety concerns identified with surgical procedure
- Required re-hospitalizations reported in trials
- Lack of specific hemodynamic measurements to correlate with patient improvement
Insights
FDA rejection of enVVeno's VenoValve represents a significant regulatory setback requiring new efficacy evidence and safety improvements.
The FDA's not-approvable letter for enVVeno's VenoValve represents a significant regulatory setback for the company's lead product. The rejection centers on two critical issues: insufficient evidence of efficacy and safety concerns. Despite improvements in revised Venous Clinical Severity Score (rVCSS), pain metrics, and quality of life indicators, the FDA determined these outcomes were inadequate without correlating hemodynamic measurements to objectively validate patient improvement. The agency expressed concerns about potential study bias affecting reported clinical improvements.
Additionally, the FDA highlighted safety issues requiring re-hospitalizations related to the open surgical procedure. This rejection significantly impacts enVVeno's commercialization timeline as the company must now either appeal the decision or develop new clinical evidence that meets the FDA's standards for both efficacy and safety. While management appears to remain committed to the technology, they face substantial challenges in demonstrating the risk-benefit profile necessary for approval.
Looking forward, enVVeno indicates it will apply lessons from this rejection to its enVVe device development, a non-surgical replacement valve currently in earlier development stages. However, the company now faces extended timelines, additional development costs, and uncertain regulatory prospects for both products. For a company targeting the 2.5-3.5 million U.S. patients with severe deep venous CVI, this regulatory barrier significantly delays potential market entry and revenue generation.
IRVINE, CA / ACCESS Newswire / August 20, 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 a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
The letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form. In particular, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve. Without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as a result of the patients being enrolled in a study.
The FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure, and that required re-hospitalizations. The Company would not expect to see similar safety events with a non-surgical replacement valve.
"We are obviously disappointed by the FDA's decision. The results showed that a high percentage of the patients in the SAVVE study, who all previously failed standard of care treatments, showed significant clinical improvement after receiving the VenoValve. With the VenoValve being the only difference in their care, it is hard to not attribute the improvement to the VenoValve," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We remain committed 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 and will continue to work with the FDA on new criteria to demonstrate the safety and effectiveness of our devices."
enVVeno Medical is reviewing the feedback from the FDA and is assessing all options, which may include a meeting to discuss requirements for a potential resubmission of the VenoValve or appeal of the decision along with appropriate next steps. The Company also expects to apply the key learnings from this FDA approval process as it advances enVVe, its non-surgical replacement venous valve for which it is preparing an IDE application.
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 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
FAQ
Why did the FDA reject enVVeno's VenoValve (NVNO) PMA application?
What are enVVeno's (NVNO) next steps after the FDA rejection?
What safety concerns did the FDA raise about enVVeno's VenoValve?
How many patients could potentially benefit from enVVeno's VenoValve treatment?
What clinical improvements did enVVeno's VenoValve show in trials?
