enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25
enVVeno Medical (NASDAQ:NVNO) has reported its Q4 and full-year 2024 financial results, highlighting progress towards VenoValve FDA approval expected in H2 2025. The company ended 2024 with $43.2 million in cash and investments, sufficient to fund operations through VenoValve approval and enVVe pivotal trial initiation.
Key financial metrics include a Q4 cash burn of $5.2 million, with projected increases to $5-7 million per quarter in 2025. Net losses decreased 7% to $21.8 million in 2024 from $23.5 million in 2023.
Clinical highlights for VenoValve show strong two-year follow-up data with 78% of subjects maintaining significant clinical benefits, including 75% pain reduction. The SAVVE trial demonstrated 85% of patients experiencing meaningful improvement at one year. For enVVe, the company is on track for IDE application submission by mid-2025, pending GLP study completion in Q1 2025.
enVVeno Medical (NASDAQ:NVNO) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi verso l'approvazione della VenoValve da parte della FDA, prevista per il secondo semestre del 2025. L'azienda ha chiuso il 2024 con 43,2 milioni di dollari in contante e investimenti, sufficienti a finanziare le operazioni fino all'approvazione della VenoValve e all'inizio del trial fondamentale enVVe.
I principali indicatori finanziari includono un consumo di cassa nel Q4 di 5,2 milioni di dollari, con aumenti previsti a 5-7 milioni di dollari per trimestre nel 2025. Le perdite nette sono diminuite del 7%, a 21,8 milioni di dollari nel 2024, rispetto ai 23,5 milioni di dollari nel 2023.
I punti salienti clinici per la VenoValve mostrano dati di follow-up a due anni molto promettenti, con il 78% dei soggetti che mantiene benefici clinici significativi, inclusa una riduzione del dolore del 75%. Il trial SAVVE ha dimostrato che l'85% dei pazienti ha sperimentato un miglioramento significativo dopo un anno. Per enVVe, l'azienda è sulla buona strada per la presentazione della domanda IDE entro metà del 2025, in attesa del completamento dello studio GLP nel Q1 2025.
enVVeno Medical (NASDAQ:NVNO) ha informado sus resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances hacia la aprobación de la VenoValve por parte de la FDA, que se espera para el segundo semestre de 2025. La compañía finalizó 2024 con 43,2 millones de dólares en efectivo e inversiones, suficientes para financiar las operaciones hasta la aprobación de la VenoValve y el inicio del ensayo pivotal enVVe.
Los principales indicadores financieros incluyen un consumo de efectivo en el Q4 de 5,2 millones de dólares, con aumentos proyectados a 5-7 millones de dólares por trimestre en 2025. Las pérdidas netas disminuyeron un 7% a 21,8 millones de dólares en 2024, desde 23,5 millones de dólares en 2023.
Los aspectos clínicos destacados para la VenoValve muestran datos de seguimiento a dos años sólidos, con el 78% de los sujetos manteniendo beneficios clínicos significativos, incluida una reducción del dolor del 75%. El ensayo SAVVE demostró que el 85% de los pacientes experimentaron una mejora significativa al cabo de un año. Para enVVe, la compañía está en camino de presentar la solicitud IDE a mediados de 2025, a la espera de la finalización del estudio GLP en el Q1 de 2025.
enVVeno Medical (NASDAQ:NVNO)는 2024년 4분기 및 연간 재무 결과를 발표하며, 2025년 하반기에 예상되는 VenoValve FDA 승인에 대한 진전을 강조했습니다. 이 회사는 2024년을 4320만 달러의 현금 및 투자로 마감했으며, 이는 VenoValve 승인 및 enVVe 주요 시험 시작까지 운영 자금을 지원하기에 충분합니다.
주요 재무 지표에는 4분기 현금 소모가 520만 달러였고, 2025년에는 분기당 500만~700만 달러로 증가할 것으로 예상됩니다. 순손실은 2023년 2350만 달러에서 2024년 2180만 달러로 7% 감소했습니다.
VenoValve의 임상 하이라이트는 78%의 피험자가 중요한 임상적 이점을 유지하고 있으며, 이에는 75%의 통증 감소가 포함됩니다. SAVVE 시험은 1년 후 85%의 환자가 의미 있는 개선을 경험했다고 보여주었습니다. enVVe의 경우, 이 회사는 2025년 중반까지 IDE 신청서를 제출할 계획이며, 이는 2025년 1분기 GLP 연구 완료를 기다리고 있습니다.
enVVeno Medical (NASDAQ:NVNO) a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en évidence les progrès vers l'approbation de la VenoValve par la FDA, attendue au second semestre 2025. L'entreprise a terminé 2024 avec 43,2 millions de dollars en liquidités et investissements, suffisants pour financer ses opérations jusqu'à l'approbation de la VenoValve et le lancement de l'essai pivot enVVe.
Les principaux indicateurs financiers incluent une consommation de trésorerie au T4 de 5,2 millions de dollars, avec des augmentations projetées à 5-7 millions de dollars par trimestre en 2025. Les pertes nettes ont diminué de 7% à 21,8 millions de dollars en 2024, contre 23,5 millions de dollars en 2023.
Les points forts cliniques pour la VenoValve montrent des données de suivi sur deux ans solides, avec 78% des sujets maintenant des bénéfices cliniques significatifs, incluant une réduction de la douleur de 75%. L'essai SAVVE a démontré que 85% des patients ont connu une amélioration significative après un an. Pour enVVe, l'entreprise est sur la bonne voie pour soumettre une demande IDE d'ici la mi-2025, en attendant l'achèvement de l'étude GLP au T1 2025.
enVVeno Medical (NASDAQ:NVNO) hat seine Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und Fortschritte in Richtung der FDA-Zulassung für die VenoValve hervorgehoben, die im zweiten Halbjahr 2025 erwartet wird. Das Unternehmen schloss das Jahr 2024 mit 43,2 Millionen Dollar in bar und Investitionen, was ausreicht, um die Operationen bis zur Zulassung der VenoValve und dem Beginn der entscheidenden enVVe-Studie zu finanzieren.
Wichtige Finanzkennzahlen umfassen einen Cash-Burn im Q4 von 5,2 Millionen Dollar, mit prognostizierten Erhöhungen auf 5-7 Millionen Dollar pro Quartal im Jahr 2025. Die Nett Verluste verringerten sich um 7% auf 21,8 Millionen Dollar im Jahr 2024, verglichen mit 23,5 Millionen Dollar im Jahr 2023.
Die klinischen Höhepunkte für die VenoValve zeigen starke Zweijahres-Nachverfolgdaten, wobei 78% der Probanden signifikante klinische Vorteile aufrechterhalten, einschließlich einer Schmerzlinderung von 75%. Die SAVVE-Studie zeigte, dass 85% der Patienten nach einem Jahr eine bedeutende Verbesserung erfuhren. Für enVVe ist das Unternehmen auf dem richtigen Weg, um bis Mitte 2025 einen IDE-Antrag einzureichen, abhängig vom Abschluss der GLP-Studie im Q1 2025.
- Net loss decreased 7% year-over-year to $21.8M
- $43.2M cash position sufficient for operations through FDA approval
- 78% of VenoValve patients showed sustained clinical benefits at 24 months
- 85% of SAVVE trial patients showed meaningful improvement at one year
- 87% median reduction in venous ulcer area in CEAP C6 patients
- Cash burn expected to increase to $5-7M quarterly in 2025 from $4-5M
- 12 target vein thromboses reported in SAVVE trial
- 7 deep wound infections reported in trial results
- Continued net losses of $21.8M in 2024
Insights
enVVeno's Q4 2024 report shows a company in a critical pre-commercialization phase with $43.2 million in cash reserves and a stable quarterly burn rate of $5.2 million. This cash position is strategically significant as management projects it will fund operations through three important milestones: VenoValve FDA approval, initial commercialization efforts, and the commencement of the enVVe pivotal trial.
The projected increase in quarterly cash burn to $5-7 million in 2025 indicates planned scaling of operations, likely for commercial preparations. With the VenoValve FDA decision expected in H2 2025, this represents a calculated acceleration in spending to prepare for market entry.
The 7% reduction in annual net losses (from $23.5 million to $21.8 million) demonstrates improving operational efficiency despite being in a capital-intensive development phase. For a pre-revenue medical device company with two potentially first-in-class products advancing through regulatory pathways, this financial discipline is noteworthy.
The key value driver remains regulatory approval of VenoValve, which would unlock a significant market opportunity in severe deep venous Chronic Venous Insufficiency - a condition with no current viable solutions. With sufficient capital to reach these inflection points, enVVeno has effectively de-risked much of its financial execution.
enVVeno's clinical progress represents potential breakthrough therapy development in venous disease - an area with significant unmet needs. The VenoValve's PMA submission marks the final regulatory hurdle before potential commercialization, with compelling clinical data supporting its case for approval.
The interim two-year SAVVE trial data demonstrates remarkable durability of effect, with 78% of subjects maintaining clinically meaningful benefits in revised Venous Clinical Severity Score (rVCSS). The 8.2-point average improvement among responders and 75% median pain reduction at 24 months indicates robust and sustained clinical impact.
Particularly impressive is the 87% median reduction in ulcer area for CEAP C6 patients, addressing one of the most debilitating manifestations of venous disease. The safety profile appears manageable with 94% of patients experiencing adverse events still achieving clinical benefit, suggesting favorable risk-benefit balance.
Meanwhile, enVVe's progression toward IDE application by mid-2025 builds a compelling pipeline. As a transcatheter device, enVVe could significantly expand the addressable market beyond surgical candidates. The sequential development strategy minimizes regulatory risk by leveraging learnings from the VenoValve program while creating potential for a product portfolio serving different patient populations.
Cash Burn of
Cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial
PMA application for the VenoValve submitted, with FDA decision expected in the second half of 2025
On track for enVVe IDE application submission by mid-2025, pending GLP study results
IRVINE, CA / ACCESS Newswire / February 28, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2024.
"Throughout 2024, we executed on our primary objectives - the successful submission of our PMA application for the VenoValve®, and the advancement of enVVe towards its U.S. pivotal trial, both critical milestones for enVVeno Medical," commented Robert Berman, CEO of enVVeno Medical. "We also added two key members to our Executive team in order to begin preparations for the commercialization of the VenoValve and will continue to add to our team following a positive decision from the FDA."
Mr. Berman added, "We are on the precipice of achieving what no other company has been able to achieve, a viable solution for the millions of patients that suffer from severe deep venous Chronic Venous Insufficiency."
Summary of Financial Results for the Full Year 2024
The Company ended the year with
Cash burn for the quarter was
The Company reported net losses of
Clinical Program Highlights
VenoValve®: Surgical Replacement Venous Valve
VenoValve PMA application seeking U.S. Food and Drug Administration (FDA) approval submitted; Decision expected in H2 2025.
Interim two-year follow-up data from 34 subjects in the SAVVE U.S. pivotal trial for the VenoValve demonstrated sustained clinical improvement and continued patient benefit, from 12 months to 24 months.
78% of subjects maintained a clinically meaningful benefit of more than 3 points in rVCSS at 24 months, with an average improvement of 8.2 points among the responder cohort.Subjects continued to experience a median
75% reduction in pain at 24 months.Interim follow-up data indicate sustained improvements across all venous specific quality-of-life (QoL) indicators.
Reported one-year efficacy and safety data from the SAAVE U.S. pivotal trial at the 51st Annual VEITH Symposium. The data indicated:
85% of the patients enrolled in SAVVE experienced a clinical meaningful benefit from the VenoValve, defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline.The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points.
Patients in the SAVVE study also experienced a seventy-five percent (
75% ) median reduction in pain and improvements in quality-of-life indicators.For patients with venous ulcers (CEAP C6 patients), ulcer area was reduced a median average of eighty-seven percent (
87% ).Over the course of the 1-year period, there was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket hematomas, four (4) other bleeds, and seven (7) deep wound infections. Ninety four percent (
94% ) of the patients that experienced a material safety event also went on to experience a clinically meaningful benefit from the VenoValve. Also, the reported target vein patency rates at thirty (30) days and one (1) year were ninety one percent (91% ) and ninety seven percent (97% ), respectively.
enVVe®:Non-Surgical Transcatheter Based Replacement Venous Valve
Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study. Completion of GLP study expected in Q1 2025.
The GLP study should be the final step necessary before filing the Investigational Device Exemption (IDE) seeking FDA approval to start the enVVe pivotal study.
The Company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-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 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®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. 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 SAVVE 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
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire
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