enVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update
enVVeno Medical (NASDAQ:NVNO) reported Q2 2025 financial results and provided updates on its deep venous disease treatment programs. The company ended Q2 with $35.1 million in cash and investments, sufficient to fund operations through Q3 2026. Q2 cash burn was $3.8 million, with net losses increasing to $6.7 million, up 35% year-over-year.
Key clinical updates include the VenoValve® PMA application under FDA review with a decision expected in 2H'2025, and the enVVe® program progressing toward IDE submission in 2H'2025. The company presented positive two-year interim data for VenoValve at the SVS 2025 Vascular Annual Meeting and completed pre-clinical studies for enVVe.
enVVeno Medical (NASDAQ:NVNO) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti sui programmi di trattamento delle malattie venose profonde. L'azienda ha chiuso il Q2 con 35,1 milioni di dollari in liquidità e investimenti, sufficienti a finanziare le operazioni fino al terzo trimestre 2026. Il consumo di cassa nel Q2 è stato di 3,8 milioni di dollari, con perdite nette in aumento a 6,7 milioni di dollari, con un incremento del 35% su base annua.
Tra gli aggiornamenti clinici principali, la domanda PMA per VenoValve® è in fase di revisione da parte della FDA, con una decisione prevista nella seconda metà del 2025, mentre il programma enVVe® sta avanzando verso la presentazione dell'IDE nella seconda metà del 2025. L'azienda ha presentato dati interim positivi a due anni per VenoValve al SVS 2025 Vascular Annual Meeting e ha completato gli studi pre-clinici per enVVe.
enVVeno Medical (NASDAQ:NVNO) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre sus programas de tratamiento de enfermedades venosas profundas. La compañía cerró el segundo trimestre con 35,1 millones de dólares en efectivo e inversiones, suficientes para financiar las operaciones hasta el tercer trimestre de 2026. El consumo de efectivo en el Q2 fue de 3,8 millones de dólares, con pérdidas netas que aumentaron a 6,7 millones de dólares, un incremento del 35% interanual.
Las actualizaciones clínicas clave incluyen la solicitud PMA de VenoValve® bajo revisión de la FDA, con una decisión esperada para la segunda mitad de 2025, y el programa enVVe® avanzando hacia la presentación del IDE en la segunda mitad de 2025. La compañía presentó datos interinos positivos a dos años para VenoValve en la Reunión Anual Vascular SVS 2025 y completó estudios preclínicos para enVVe.
enVVeno Medical (NASDAQ:NVNO)는 2025년 2분기 재무 실적을 발표하고 심부정맥 질환 치료 프로그램에 대한 최신 정보를 제공했습니다. 회사는 2분기 말에 3,510만 달러의 현금 및 투자 자산을 보유하고 있어 2026년 3분기까지 운영 자금을 충분히 확보했습니다. 2분기 현금 소진액은 380만 달러였으며, 순손실은 전년 대비 35% 증가한 670만 달러에 달했습니다.
주요 임상 업데이트로는 VenoValve® PMA 신청서가 FDA 심사 중이며 2025년 하반기에 결정이 예상되고, enVVe® 프로그램은 2025년 하반기에 IDE 제출을 향해 진행 중입니다. 회사는 SVS 2025 혈관 연례회의에서 VenoValve의 2년 중간 데이터를 긍정적으로 발표했으며, enVVe의 전임상 연구도 완료했습니다.
enVVeno Medical (NASDAQ:NVNO) a publié ses résultats financiers du deuxième trimestre 2025 et a fourni des mises à jour sur ses programmes de traitement des maladies veineuses profondes. La société a terminé le deuxième trimestre avec 35,1 millions de dollars en liquidités et investissements, suffisants pour financer ses opérations jusqu'au troisième trimestre 2026. La consommation de trésorerie au T2 s'est élevée à 3,8 millions de dollars, avec des pertes nettes en hausse à 6,7 millions de dollars, soit une augmentation de 35 % en glissement annuel.
Les principales mises à jour cliniques incluent la demande PMA de VenoValve® en cours d'examen par la FDA, avec une décision attendue au second semestre 2025, et le programme enVVe® progressant vers la soumission de l'IDE au second semestre 2025. La société a présenté des données intérimaires positives sur deux ans pour VenoValve lors du SVS 2025 Vascular Annual Meeting et a achevé les études précliniques pour enVVe.
enVVeno Medical (NASDAQ:NVNO) berichtete über die Finanzergebnisse des zweiten Quartals 2025 und gab Updates zu seinen Behandlungsprogrammen für tiefe Venenerkrankungen bekannt. Das Unternehmen schloss das zweite Quartal mit 35,1 Millionen US-Dollar in Barbeständen und Investitionen ab, was ausreicht, um den Betrieb bis zum dritten Quartal 2026 zu finanzieren. Der Cash-Burn im zweiten Quartal betrug 3,8 Millionen US-Dollar, wobei der Nettoverlust um 35 % auf 6,7 Millionen US-Dollar im Jahresvergleich anstieg.
Wichtige klinische Updates umfassen den VenoValve® PMA-Antrag, der von der FDA geprüft wird und dessen Entscheidung für die zweite Hälfte des Jahres 2025 erwartet wird, sowie das enVVe®-Programm, das auf die IDE-Einreichung in der zweiten Hälfte 2025 zusteuert. Das Unternehmen präsentierte positive Zwischenberichte nach zwei Jahren für VenoValve auf dem SVS 2025 Vascular Annual Meeting und schloss präklinische Studien für enVVe ab.
- None.
- Net losses increased by 35% to $6.7 million year-over-year
- Operating expenses increased by $1.6 million due to personnel costs and other expenses
- Cash burn rate expected to increase once VenoValve commercialization begins
Insights
enVVeno maintains $35.1M cash position with regulatory decisions for novel CVI treatments expected in late 2025, keeping runway through Q3'26.
enVVeno Medical's Q2 results reveal
The net loss of
What's particularly significant is the development timeline convergence in 2H'2025, when both the FDA decision on VenoValve's PMA application and the IDE submission for enVVe are expected. The VenoValve program has already produced positive two-year interim data presented at the prestigious Society for Vascular Surgery Annual Meeting, while the enVVe program has completed critical pre-clinical testing required for the upcoming IDE filing.
For severe chronic venous insufficiency (CVI) patients lacking effective treatment options, these potential first-in-category products represent significant medical breakthroughs. The company's strategic positioning through national media appearances following high-profile CVI diagnoses demonstrates effective market awareness building before potential product launches.
With sufficient capital to fund operations through regulatory milestones and initial commercialization activities, enVVeno appears well-positioned for the critical transition from clinical-stage to commercial-stage operations, assuming favorable regulatory decisions.
- Cash burn of
- Cash and investments are sufficient to fund operations through Q3'2026 at current cash burn rate
- Commercial readiness activities underway for a phased launch of VenoValve® subject to FDA decision expected in 2H'2025
- IDE submission for enVVe® on track for 2H'2025
IRVINE, CA / ACCESS Newswire / August 1, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the second quarter 2025.
"As the recent headlines around CVI confirmed, CVI is a pervasive and a progressive disease that is especially debilitating once it becomes severe. Our participation in several of the recent national news stories about CVI fits with our strategy of establishing enVVeno Medical as the world-wide leader in treatments for severe, deep venous disease. With several value driving milestones on the horizon, including FDA decisions on potential approval for the VenoValve and the pivotal study for enVVe, we continue to make strong progress in our mission to bring first-in-category, effective treatments to patients with severe CVI, and are well positioned to lead the ongoing national dialogue about CVI as further events are reported," commented Robert Berman, CEO of enVVeno Medical.
Summary of Financial Results for the Second Quarter 2025
The Company ended the quarter with
Cash burn for the quarter was
The Company reported net losses of
Clinical Program Progress
VenoValve®: Novel, First-In-Class Surgical Replacement Venous Valve
Amended VenoValve PMA application in response to formal questions from U.S. Food and Drug Administration (FDA)
Continue to respond to FDA questions and inquiries as they arise
Presented positive interm, two-year data at Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
PMA decision from FDA expected 2H'2025
enVVe®: Novel, First-In-Class Non-Surgical Transcatheter-Based Replacement Venous Valve
Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study
Awaiting final pathology form the GLP study
Successfully completed other testing necessary for IDE filing
IDE filing for enVVe pivotal trial on track for 2H'2025
President Trump CVI Diagnosis
Following President Trump's recent diagnosis of what appears to be moderate CVI, Dr. Marc Glickman, Senior Vice President and Chief Medical Officer of enVVeno Medical was featured in several national television news segments, podcasts, radio reports, and news articles, including Fox News, NewsMax, Morning Wire, and the N.Y. Post. To view this media, click 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 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®. 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 VenoValve U.S. pivotal study and 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.
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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
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