enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval
enVVeno Medical has submitted its PMA application to the FDA for the VenoValve, seeking marketing and sales approval in the United States. Four out of five modules have been approved, with the final module containing clinical data from the SAVVE pivotal trial and proposed labeling. The FDA-designated breakthrough device aims to treat severe deep venous Chronic Venous Insufficiency (CVI), targeting an estimated 2.5 million U.S. candidates annually. A decision is expected in the second half of 2025. The company is also developing enVVe, a next-generation transcatheter-based replacement venous valve, with pivotal trials expected mid-2025.
enVVeno Medical ha presentato la sua richiesta di PMA alla FDA per il VenoValve, cercando l'approvazione per la commercializzazione e le vendite negli Stati Uniti. Quattro moduli su cinque sono stati approvati, con l'ultimo modulo contenente dati clinici dalla sperimentazione SAVVE e l'etichettatura proposta. Il dispositivo designato come breakthrough dalla FDA mira a trattare una grave Insufficienza Venosa Cronica (CVI), rivolgendo l'attenzione a circa 2,5 milioni di candidati annuali negli Stati Uniti. Una decisione è attesa nella seconda metà del 2025. L'azienda sta inoltre sviluppando enVVe, una valvola venosa sostitutiva basata su catetere di nuova generazione, con sperimentazioni pivotal previste per metà 2025.
enVVeno Medical ha presentado su solicitud de PMA a la FDA para el VenoValve, buscando la aprobación para comercialización y ventas en los Estados Unidos. Cuatro de los cinco módulos han sido aprobados, siendo el módulo final el que contiene datos clínicos del ensayo pivotal SAVVE y el etiquetado propuesto. El dispositivo designado como breakthrough por la FDA tiene como objetivo tratar la Insuficiencia Venosa Crónica (CVI) severa, dirigiéndose a aproximadamente 2.5 millones de candidatos en los EE. UU. anualmente. Se espera una decisión en la segunda mitad de 2025. La empresa también está desarrollando enVVe, una válvula venosa de reemplazo basada en catéter de próxima generación, con ensayos pivotal esperados para mediados de 2025.
enVVeno Medical는 VenoValve에 대한 PMA 신청서를 FDA에 제출하여 미국 내 마케팅 및 판매 승인을 요청하였습니다. 다섯 개 모듈 중 네 개가 승인되었으며, 마지막 모듈에는 SAVVE 주요 시험의 임상 데이터와 제안된 라벨링이 포함되어 있습니다. FDA가 지정한 돌파구 장치는 중증 심부 정맥 만성 정맥 부전 (CVI)을 치료하는 것을 목표로 하며, 매년 약 250만 명의 미국 후보자를 제안합니다. 2025년 하반기에 결정이 예상됩니다. 회사는 또한 차세대 경피적 기반의 대체 정맥 밸브인 enVVe를 개발 중이며, 주요 시험은 2025년 중반에 예정되어 있습니다.
enVVeno Medical a soumis sa demande de PMA à la FDA pour le VenoValve, recherchons l'approbation de commercialisation et de vente aux États-Unis. Quatre des cinq modules ont été approuvés, le dernier module contenant des données cliniques issues de l'essai pivot SAVVE et l'étiquetage proposé. Le dispositif désigné comme dispositif novateur par la FDA vise à traiter l'Insuffisance Veineuse Chronique (CVI) sévère, ciblant environ 2,5 millions de candidats américains chaque année. Une décision est attendue dans la seconde moitié de 2025. L'entreprise développe également enVVe, une valve veineuse de remplacement de nouvelle génération basée sur un cathéter, avec des essais pivots prévus pour la mi-2025.
enVVeno Medical hat seinen PMA-Antrag bei der FDA für das VenoValve eingereicht und strebt die Genehmigung für Vermarktung und Verkauf in den Vereinigten Staaten an. Vier von fünf Modulen wurden genehmigt, wobei das letzte Modul klinische Daten aus der SAVVE-Hauptstudie und die vorgeschlagene Kennzeichnung enthält. Das von der FDA als Durchbruch bezeichnete Gerät zielt darauf ab, schwere Chronische Venenschwäche (CVI) zu behandeln, und richtet sich jährlich an schätzungsweise 2,5 Millionen Kandidaten in den USA. Eine Entscheidung wird für die zweite Hälfte des Jahres 2025 erwartet. Das Unternehmen entwickelt auch enVVe, ein transkatheterbasiertes Ersatzvenenventil der nächsten Generation, für das Mitte 2025 wichtige Studien erwartet werden.
- FDA breakthrough device designation grants priority review status
- Four out of five PMA modules already approved by FDA
- Large market potential with 2.5 million annual U.S. candidates
- Development of next-generation non-surgical valve (enVVe) expanding market reach
- FDA approval decision not expected until second half of 2025
- No current revenue from main product pending approval
Insights
The VenoValve PMA submission marks a significant regulatory milestone. With 4 out of 5 modules already approved and FDA breakthrough device designation, this submission carries substantial weight. The breakthrough status grants priority review, potentially expediting the typical 180-day PMA review timeline. The final module, containing pivotal trial data and proposed labeling, is important for market approval.
The 2.5 million annual U.S. candidates represents a substantial market opportunity, especially given the current lack of effective treatments for deep venous CVI. The projected H2 2025 decision timeline aligns with standard FDA review processes for complex medical devices. The parallel development of enVVe, their transcatheter device, demonstrates strategic pipeline planning to capture both surgical and minimally invasive market segments.
This PMA submission positions enVVeno to potentially capture a significant untapped market in CVI treatment. The addressable market of 2.5 million annual U.S. candidates represents substantial revenue potential. The dual-product strategy with VenoValve and enVVe demonstrates smart market positioning - targeting both surgical and minimally invasive approaches could maximize market penetration and physician adoption.
For a company with a
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium
Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access
IRVINE, CA / ACCESSWIRE / November 19, 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 it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA. The fifth and final module of the application contains the clinical data from the SAVVE pivotal trial as well as proposed labeling for the device.
"We are thrilled to get this last step of the PMA review process underway and look forward to further interactions with the FDA," said Robert Berman, enVVeno Medical's Chief Executive Officer. "It is difficult to predict precisely how long the PMA process will take, but we expect to learn more and potentially have a decision in the second half of 2025."
The VenoValve, which has been designated as a breakthrough device by the FDA and is therefore subject to priority review, is intended to treat severe deep venous Chronic Venous Insufficiency (CVI), 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 deep venous CVI and the company estimates that there are approximately 2.5 million candidates each year in the U.S. for the VenoValve.
The Company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe, which could appeal to an even larger market in terms of both patients and physicians. The Company expects enVVe to be ready for its own pivotal trial during the middle of 2025.
Definitive data that supports the VenoValve PMA application will be presented Wednesday, November 20, 2024, at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. Following Wednesday's presentation, the Company will host a live video conference call with the PI Presenters at 2:00 PM Eastern Time. To access the call visit the Events page on the Investor section of the Company's website or 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 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
View the original press release on accesswire.com
FAQ
When does enVVeno Medical (NVNO) expect FDA approval for VenoValve?
How many modules of NVNO's VenoValve PMA application have been approved?
What is the market size for NVNO's VenoValve in the US?
When will NVNO begin pivotal trials for their enVVe device?
