enVVeno Medical Successfully Completes Final Wave of Implants in Pre-Clinical GLP Study for enVVe
enVVeno Medical (Nasdaq: NVNO) announced the successful completion of final implants in its six-month pre-clinical GLP study for enVVe, their transcatheter-delivered replacement venous valve. The company maintains its timeline for IDE application submission to FDA by mid-2025, pending successful study results. The enhanced enVVe crimping and delivery system has demonstrated consistent performance throughout the study.
The company recently submitted a PMA application for their lead product, VenoValve, seeking FDA approval for U.S. market distribution. They estimate approximately 2.5 million potential new patients annually in the U.S. could be candidates for VenoValve. Beginning early next year, enVVeno will transition from development to commercial stage for VenoValve while completing necessary testing for enVVe.
enVVeno Medical (Nasdaq: NVNO) ha annunciato il completamento con successo degli ultimi impianti nel suo studio pre-clinico GLP della durata di sei mesi per enVVe, la loro valvola venosa sostitutiva somministrata mediante catetere. L'azienda mantiene il suo piano per la domanda di IDE da presentare alla FDA entro la metà del 2025, in attesa di risultati positivi dello studio. Il sistema avanzato di crimpaggio e distribuzione di enVVe ha dimostrato prestazioni coerenti durante tutto lo studio.
L'azienda ha recentemente presentato una domanda PMA per il suo prodotto principale, VenoValve, cercando l'approvazione della FDA per la distribuzione nel mercato statunitense. Stimano che circa 2,5 milioni di nuovi potenziali pazienti all'anno negli Stati Uniti potrebbero essere candidati per VenoValve. A partire dall'inizio del prossimo anno, enVVeno passerà dalla fase di sviluppo a quella commerciale per VenoValve completando nel contempo i test necessari per enVVe.
enVVeno Medical (Nasdaq: NVNO) anunció la finalización exitosa de los últimos implantes en su estudio preclínico GLP de seis meses para enVVe, su válvula venosa de reemplazo entregada por catéter. La empresa mantiene su cronograma para la presentación de la solicitud de IDE a la FDA para mediados de 2025, a la espera de resultados positivos del estudio. El sistema mejorado de compresión y entrega de enVVe ha demostrado un rendimiento constante a lo largo del estudio.
Recientemente, la empresa presentó una solicitud de PMA para su producto principal, VenoValve, buscando la aprobación de la FDA para la distribución en el mercado de EE. UU. Estiman que aproximadamente 2,5 millones de nuevos pacientes potenciales al año en EE. UU. podrían ser candidatos para VenoValve. A partir de principios del próximo año, enVVeno pasará de la fase de desarrollo a la fase comercial para VenoValve mientras completa las pruebas necesarias para enVVe.
enVVeno Medical (Nasdaq: NVNO)는 enVVe, 그들의 카테터를 통해 전달되는 대체 정맥 밸브에 대한 6개월 간의 GLP 사전 임상 연구의 최종 임플란트를 성공적으로 완료했다고 발표했습니다. 회사는 성공적인 연구 결과를 기다리며 2025년 중반까지 FDA에 IDE 신청서를 제출할 계획을 유지합니다. 개선된 enVVe 압착 및 전달 시스템은 연구 기간 내내 일관된 성능을 보여주었습니다.
회사는 최근 자사 주력 제품인 VenoValve에 대한 PMA 신청서를 제출하여 미국 시장 배포를 위한 FDA 승인을 요청했습니다. 그들은 매년 약 250만 명의 새로운 잠재 환자가 VenoValve 후보가 될 수 있을 것으로 추정합니다. 내년 초부터 enVVeno는 VenoValve를 상용화 단계로 전환하는 한편 enVVe에 대한 필요한 테스트를 완료할 예정입니다.
enVVeno Medical (Nasdaq: NVNO) a annoncé l'achèvement réussi des derniers implants dans son étude préclinique GLP de six mois pour enVVe, leur valve veineuse de remplacement délivrée par cathéter. L'entreprise maintient son calendrier pour la soumission de la demande IDE à la FDA d'ici mi-2025, sous réserve de résultats d'étude positifs. Le système amélioré de compression et de délivrance d'enVVe a montré des performances constantes tout au long de l'étude.
L'entreprise a récemment soumis une demande PMA pour son produit phare, VenoValve, en recherchant l'approbation de la FDA pour la distribution sur le marché américain. Elle estime qu'environ 2,5 millions de nouveaux patients potentiels chaque année aux États-Unis pourraient être des candidats pour VenoValve. Dès le début de l'année prochaine, enVVeno passera de la phase de développement à la phase commerciale pour VenoValve tout en complétant les tests nécessaires pour enVVe.
enVVeno Medical (Nasdaq: NVNO) gab bekannt, dass die endgültigen Implantationen in seiner sechsmonatigen präklinischen GLP-Studie für enVVe, sein transkatheterfähiges Ersatzvenenventil, erfolgreich abgeschlossen wurden. Das Unternehmen hält an seinem Zeitplan fest, die IDE-Antragsstellung bei der FDA bis Mitte 2025 vorzunehmen, vorbehaltlich positiver Studienergebnisse. Das verbesserte Crimp- und Liefersystem von enVVe hat während der gesamten Studie eine konsistente Leistung gezeigt.
Das Unternehmen hat kürzlich einen PMA-Antrag für sein Hauptprodukt, VenoValve, eingereicht und bittet um die Genehmigung der FDA für die Verteilung auf dem US-Markt. Sie schätzen, dass jährlich etwa 2,5 Millionen potenzielle neue Patienten in den USA für VenoValve in Frage kommen könnten. Anfang nächsten Jahres wird enVVeno von der Entwicklungs- in die kommerzielle Phase für VenoValve übergehen, während die notwendigen Tests für enVVe abgeschlossen werden.
- Successful completion of all planned implants in the GLP study for enVVe
- On track for IDE application submission by mid-2025
- PMA application submitted to FDA for VenoValve commercialization
- Large market potential with 2.5 million annual potential patients in U.S.
- None.
Insights
The successful completion of all planned implants in the GLP (Good Laboratory Practice) study for enVVe marks a significant pre-clinical milestone. The enhanced crimping and delivery system's consistent performance is particularly noteworthy, as it addresses one of the key technical challenges in transcatheter valve deployment. With an estimated
The dual-product strategy with VenoValve (surgical) and enVVe (transcatheter) positions the company to address different patient populations and physician preferences. The recent PMA submission for VenoValve, combined with the progress on enVVe, demonstrates a well-structured pipeline approach targeting the 2.5 million potential annual patients in the U.S. market alone.
This development represents a important de-risking event for enVVeno Medical's product pipeline. The successful completion of GLP study implants, combined with the earlier PMA submission for VenoValve, positions the company for two potential revenue streams targeting a significant market opportunity. The transition from development to commercialization phase for VenoValve, while advancing enVVe's development, indicates strong execution of the company's strategic roadmap.
With a market cap of
Successful Completion of All Planned Implants in GLP Study
enVVe Delivery System Demonstrates Consistent Performance
Company Maintains Timeline for IDE Application Submission by Mid-2025, Pending GLP Study Results
IRVINE, CA / ACCESSWIRE / December 16, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the successful completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve.
The successful completion of all planned implants in the GLP study, including both long-term and short-term subjects, completes a critical phase of the study. The follow-up period, which began with the first wave of implants, is ongoing as scheduled. Pending successful completion of the GLP study, the Company anticipates submitting its IDE application to the FDA in mid-2025. The submission, if approved, would allow the Company to initiate the pivotal clinical trial for enVVe.
"With the successful completion of all planned implants in the enVVe GLP study, we have achieved the last of our milestones for 2024," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Our enhanced enVVe crimping and delivery system has performed very well throughout the study and is ready for the pivotal trial. We will continue to monitor the performance of the enVVe valves throughout the remainder of the study and with successful data and pathology, should be in a position to file the IDE on schedule in mid 2025. We remain focused on our goal of becoming the established leader in both the surgical and non-surgical replacement venous valve markets for patients with severe deep venous CVI."
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. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. 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 CVI costs the U.S. healthcare system in excess of
The Company's lead product is the VenoValve,® a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. In November, the Company submitted a PMA application with the U.S. Food and Drug Administration seeking approval to market and sell the VenoValve in the U.S. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company is also developing enVVe®, a next-generation, transcatheter based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians.
Beginning early next year, the Company will begin to implement its strategy to transition from a development stage to a commercial entity for the VenoValve, while completing the necessary non-clinical and GLP testing for enVVe in preparation for its 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 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
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