enVVeno Medical Successfully Initiates 6-Month Pre-Clinical GLP Study Evaluating enVVe(R)
enVVeno Medical has successfully initiated its six-month pre-clinical GLP study for enVVe, their transcatheter-delivered replacement venous valve. The first wave of implants was completed successfully, with final wave scheduled for December. The company is on track to file for IDE approval for the enVVe pivotal trial by mid-2025. The updated delivery system performed well, with improvements to crimping and delivery systems resulting in consistent valve deployment. The company plans to file its PMA application for VenoValve and release supporting data in Q4 2024, marking its transition from development to commercial stage.
enVVeno Medical ha avviato con successo il suo studio pre-clinico GLP di sei mesi per enVVe, la loro valvola venosa sostitutiva impiantabile per via transcatetere. La prima ondata di impianti è stata completata con successo, con la fase finale programmata per dicembre. L'azienda è sulla buona strada per presentare la domanda di approvazione IDE per il trial pivotale enVVe entro la metà del 2025. Il sistema di consegna aggiornato ha mostrato buone prestazioni, con miglioramenti nei sistemi di crimpatura e consegna che hanno portato a un deployment della valvola coerente. L'azienda prevede di presentare la sua domanda PMA per il VenoValve e di rilasciare dati di supporto nel Q4 2024, segnando la sua transizione dallo sviluppo alla fase commerciale.
enVVeno Medical ha iniciado con éxito su estudio preclínico GLP de seis meses para enVVe, su válvula venosa de reemplazo administrada por catéter. La primera ola de implantes se completó con éxito, y la ola final está programada para diciembre. La compañía está en camino de presentar su solicitud de aprobación IDE para el ensayo pivotal de enVVe a mediados de 2025. El sistema de entrega actualizado funcionó bien, con mejoras en los sistemas de crimpado y entrega que resultaron en un despliegue constante de la válvula. La compañía planea presentar su solicitud PMA para VenoValve y liberar datos de soporte en el cuarto trimestre de 2024, marcando su transición de la etapa de desarrollo a la etapa comercial.
enVVeno Medical는 enVVe, 그들의 트랜스캐테터 방식의 대체 정맥 판막에 대한 6개월 간의 GLP 전임상 연구를 성공적으로 시작했습니다. 첫 번째 임플란트 파동이 성공적으로 완료되었으며, 마지막 파동은 12월로 예정되어 있습니다. 회사는 2025년 중반까지 enVVe 주요 시험에 대한 IDE 승인 신청을 제출할 예정입니다. 업데이트된 전달 시스템은 잘 작동하였고, 크림핑과 전달 시스템의 개선으로 인해 일관된 판막 배치가 이루어졌습니다. 회사는 VenoValve에 대한 PMA 신청서를 제출하고 2024년 4분기 동안 지원 데이터를 공개할 계획이며, 이는 개발 단계에서 상업 단계로의 전환을 나타냅니다.
enVVeno Medical a réussi à lancer son étude préclinique GLP de six mois pour enVVe, leur valve veineuse de remplacement délivrée par cathéter. La première vague d'implants a été complétée avec succès, la dernière vague étant prévue pour décembre. L'entreprise est sur la bonne voie pour déposer une demande d'approbation IDE pour l'
enVVeno Medical hat erfolgreich die sechsmonatige präklinische GLP-Studie für enVVe, ihr transkatheterverabreichbares Ersatzvenenventil, eingeleitet. Die erste Welle von Implantationen wurde erfolgreich abgeschlossen, die letzte Welle ist für Dezember geplant. Das Unternehmen ist auf dem besten Weg, bis Mitte 2025 einen IDE-Antrag für die enVVe Hauptstudie einzureichen. Das aktualisierte Liefer-System hat gut funktioniert, wobei Verbesserungen bei Crimp- und Liefersystemen zu einer konsistenten Ventilplatzierung geführt haben. Die Firma plant, ihren PMA-Antrag für VenoValve einzureichen und unterstützende Daten im vierten Quartal 2024 zu veröffentlichen, was den Übergang von der Entwicklungsphase zur kommerziellen Phase markiert.
- Successfully completed first wave of pre-clinical GLP study implants
- On schedule for IDE approval application by mid-2025
- Improved delivery system showing consistent performance
- Large market potential with estimated 2.5 million U.S. candidates annually for VenoValve
- PMA application and definitive data release planned for Q4 2024
- Currently no revenue-generating products
- Pending regulatory approvals create uncertainty
- Extended timeline to market with multiple regulatory steps ahead
Insights
The successful initiation of the GLP study for enVVe marks a important milestone in the development of this transcatheter venous valve. The study's positive start with successful first-wave implants and improved delivery system performance significantly derisks the path toward IDE approval. Key developments include:
- Successful implementation of refined crimping and delivery systems, addressing a major technical challenge of fitting a functional valve into a 0.17-inch diameter catheter
- The potential market is substantial, with 2.5 million annual candidates in the US for venous valve replacement
- Two parallel developments strengthen the company's position: imminent VenoValve PMA submission in Q4 2024 and preparation for enVVe IDE submission by mid-2025
The technical achievements in valve miniaturization and delivery system optimization demonstrate significant progress toward a minimally invasive solution for severe CVI, potentially transforming treatment options for this underserved market.
First wave of implants successfully completed with updated delivery system performing very well
Company on schedule to be in position to apply for approval for enVVe pivotal trial mid-2025
IRVINE, CA / ACCESSWIRE / October 28, 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 start to its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The first wave of implants, for the long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December. The GLP study is a prerequisite to enVVeno seeking IDE approval from the U.S. Food and Drug Administration to begin the enVVe U.S. pivotal study. The Company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-next year.
"There is no question that we could not have developed enVVe without the knowledge gained from the VenoValve over the past six years," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Engineering a transcatheter replacement venous valve that will fit into a catheter of only .17 inches in diameter and that will consistently and successfully deploy once it reaches the target vein is not easy. The final adjustments that we made to the crimping and delivery systems over the past few months resulted in easy, consistent and accurate delivery of the enVVe valves in the GLP study and now we wait to confirm that the deployed enVVe valves work as well as the rest of the system."
enVVeno's lead product is the VenoValve®, a first-in-class, surgical replacement venous valve for patients suffering from severe Chronic Venous Insufficiency (CVI) caused by incompetent valves in the deep venous system. The Company estimates that there are approximately 2.5 million candidates each year in the U.S. for the VenoValve. enVVe, a next-generation, transcatheter based replacement venous valve, would appeal to an even larger market in terms of both patients and physicians.
Severe deep venous 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, 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.
enVVeno expects to file its PMA application seeking approval from the U.S. Food and Drug Administration to market and sell the VenoValve, and to release the definitive data that supports the PMA application in Q4 of this year. Beginning early next year, the Company will begin to implement its plans to transition from being a development stage company to a commercial entity, and to complete all of the additional non-clinical testing for enVVe that is necessary to file for IDE approval.
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 enVVe pivotal trial.
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
SOURCE: enVVeno Medical Corporation
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FAQ
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