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 痴别苍辞痴补濒惫别庐 PMA application under FDA review with a decision expected in 2H'2025, and the 别苍痴痴别庐 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 liquidit脿 e investimenti, sufficienti a finanziare le operazioni fino al terzo trimestre 2026. Il consumo di cassa nel Q2 猫 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 痴别苍辞痴补濒惫别庐 猫 in fase di revisione da parte della FDA, con una decisione prevista nella seconda met脿 del 2025, mentre il programma 别苍痴痴别庐 sta avanzando verso la presentazione dell'IDE nella seconda met脿 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) inform贸 los resultados financieros del segundo trimestre de 2025 y proporcion贸 actualizaciones sobre sus programas de tratamiento de enfermedades venosas profundas. La compa帽铆a cerr贸 el segundo trimestre con 35,1 millones de d贸lares 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 d贸lares, con p茅rdidas netas que aumentaron a 6,7 millones de d贸lares, un incremento del 35% interanual.
Las actualizaciones cl铆nicas clave incluyen la solicitud PMA de 痴别苍辞痴补濒惫别庐 bajo revisi贸n de la FDA, con una decisi贸n esperada para la segunda mitad de 2025, y el programa 别苍痴痴别庐 avanzando hacia la presentaci贸n del IDE en la segunda mitad de 2025. La compa帽铆a present贸 datos interinos positivos a dos a帽os para VenoValve en la Reuni贸n Anual Vascular SVS 2025 y complet贸 estudios precl铆nicos para enVVe.
enVVeno Medical (NASDAQ:NVNO)電� 2025雲� 2攵勱赴 鞛 鞁れ爜鞚� 氚滍憸頃橁碃 鞁秬鞝曤Д 歆堩櫂 旃橂 頂勲攴鸽灗鞐� 雽�頃� 斓滌嫚 鞝曤炒毳� 鞝滉车頄堨姷雼堧嫟. 須岇偓電� 2攵勱赴 毵愳棎 3,510毵� 雼煬鞚� 順勱笀 氚� 韴瀽 鞛愳偘鞚� 氤挫湢頃橁碃 鞛堨柎 2026雲� 3攵勱赴旯岇 鞖挫榿 鞛愱笀鞚� 於╇秳頌� 頇曤炒頄堨姷雼堧嫟. 2攵勱赴 順勱笀 靻岇鞎§潃 380毵� 雼煬鞓�鞙茧┌, 靾滌啇鞁れ潃 鞝勲厔 雽�牍� 35% 歃濌皜頃� 670毵� 雼煬鞐� 雼枅鞀惦媹雼�.
欤检殧 鞛勳儊 鞐呺嵃鞚错姼搿滊姅 痴别苍辞痴补濒惫别庐 PMA 鞁犾箔靹滉皜 FDA 鞁偓 欷戩澊氅� 2025雲� 頃橂皹旮办棎 瓴办爼鞚� 鞓堨儊霅橁碃, 别苍痴痴别庐 頂勲攴鸽灗鞚� 2025雲� 頃橂皹旮办棎 IDE 鞝滌稖鞚� 頄ロ暣 歆勴枆 欷戩瀰雼堧嫟. 須岇偓電� SVS 2025 順堦磤 鞐半須岇潣鞐愳劀 VenoValve鞚� 2雲� 欷戧皠 雿办澊韯半ゼ 旮嶌爼鞝侅溂搿� 氚滍憸頄堨溂氅�, enVVe鞚� 鞝勳瀯靸� 鞐瓣惮霃� 鞕勲頄堨姷雼堧嫟.
enVVeno Medical (NASDAQ:NVNO) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 et a fourni des mises 脿 jour sur ses programmes de traitement des maladies veineuses profondes. La soci茅t茅 a termin茅 le deuxi猫me trimestre avec 35,1 millions de dollars en liquidit茅s et investissements, suffisants pour financer ses op茅rations jusqu'au troisi猫me trimestre 2026. La consommation de tr茅sorerie au T2 s'est 茅lev茅e 脿 3,8 millions de dollars, avec des pertes nettes en hausse 脿 6,7 millions de dollars, soit une augmentation de 35 % en glissement annuel.
Les principales mises 脿 jour cliniques incluent la demande PMA de 痴别苍辞痴补濒惫别庐 en cours d'examen par la FDA, avec une d茅cision attendue au second semestre 2025, et le programme 别苍痴痴别庐 progressant vers la soumission de l'IDE au second semestre 2025. La soci茅t茅 a pr茅sent茅 des donn茅es int茅rimaires positives sur deux ans pour VenoValve lors du SVS 2025 Vascular Annual Meeting et a achev茅 les 茅tudes pr茅cliniques pour enVVe.
enVVeno Medical (NASDAQ:NVNO) berichtete 眉ber die Finanzergebnisse des zweiten Quartals 2025 und gab Updates zu seinen Behandlungsprogrammen f眉r tiefe Venenerkrankungen bekannt. Das Unternehmen schloss das zweite Quartal mit 35,1 Millionen US-Dollar in Barbest盲nden 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 痴别苍辞痴补濒惫别庐 PMA-Antrag, der von der FDA gepr眉ft wird und dessen Entscheidung f眉r die zweite H盲lfte des Jahres 2025 erwartet wird, sowie das 别苍痴痴别庐-Programm, das auf die IDE-Einreichung in der zweiten H盲lfte 2025 zusteuert. Das Unternehmen pr盲sentierte positive Zwischenberichte nach zwei Jahren f眉r VenoValve auf dem SVS 2025 Vascular Annual Meeting und schloss pr盲klinische Studien f眉r 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 痴别苍辞痴补濒惫别庐 subject to FDA decision expected in 2H'2025
- IDE submission for 别苍痴痴别庐 on track for 2H'2025
IRVINE, CA / / 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
: 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
: 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, .
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 痴别苍辞痴补濒惫别庐, 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 别苍痴痴别庐. 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.
###
INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
[email protected]
(908) 824-0775
MEDIA CONTACT:
Glenn Silver, FINN Partners
[email protected]
(973) 818-8198
SOURCE: enVVeno Medical Corporation
View the original on ACCESS Newswire
FAQ
What were enVVeno Medical's (NVNO) Q2 2025 financial results?
When is the FDA decision expected for enVVeno Medical's VenoValve?
How long can enVVeno Medical fund operations with current cash?
What is the status of enVVeno Medical's enVVe program?
What caused the increase in enVVeno Medical's net losses in Q2 2025?
