enVVeno Medical Provides Update on FDA Premarket Approval Application Status for VenoValve(R)
enVVeno Medical has made significant progress in its FDA premarket approval (PMA) application for the VenoValve, a surgical replacement venous valve. The company has successfully submitted, and the FDA has approved, four out of five modules required for the PMA application. The fifth and final module, containing clinical data from the SAVVE U.S. pivotal trial, is expected to be filed in Q4 2024.
The VenoValve is being developed as a potential treatment for severe Chronic Venous Insufficiency (CVI), a debilitating disease affecting approximately 2.5 million new patients annually in the U.S. The SAVVE study, involving 75 CVI patients across 21 U.S. sites, is currently collecting one-year clinical data to support the final PMA module submission.
As of June 30, 2024, enVVeno Medical had $39.1 million in cash and investments, which is expected to fund operations through the FDA's decision on the VenoValve PMA application.
enVVeno Medical ha fatto significativi progressi nella sua richiesta di approvazione pre-commerciale (PMA) della FDA per il VenoValve, una valvola venosa sostitutiva chirurgica. L'azienda ha presentato con successo e la FDA ha approvato quattro dei cinque moduli richiesti per la domanda di PMA. Il quinto e ultimo modulo, contenente dati clinici dallo studio SAVVE negli Stati Uniti, è previsto per essere presentato nel quarto trimestre del 2024.
Il VenoValve è in fase di sviluppo come potenziale trattamento per la grave Insufficienza Venosa Cronica (CVI), una malattia debilitante che colpisce circa 2,5 milioni di nuovi pazienti ogni anno negli Stati Uniti. Lo studio SAVVE, che coinvolge 75 pazienti con CVI in 21 siti negli Stati Uniti, sta attualmente raccogliendo dati clinici di un anno per supportare la presentazione finale del modulo PMA.
Alla data del 30 giugno 2024, enVVeno Medical aveva 39,1 milioni di dollari in contante e investimenti, che si prevede finanzieranno le operazioni fino alla decisione della FDA sulla domanda di PMA per il VenoValve.
enVVeno Medical ha realizado progresos significativos en su solicitud de aprobación previa a la comercialización (PMA) ante la FDA para el VenoValve, una válvula venosa de reemplazo quirúrgico. La empresa ha presentado con éxito y la FDA ha aprobado cuatro de los cinco módulos requeridos para la solicitud de PMA. Se espera que el quinto y último módulo, que contiene datos clínicos del ensayo pivotal SAVVE en EE. UU., sea presentado en el cuarto trimestre de 2024.
El VenoValve se está desarrollando como un tratamiento potencial para la grave Insuficiencia Venosa Crónica (CVI), una enfermedad debilitante que afecta a aproximadamente 2.5 millones de nuevos pacientes anualmente en EE. UU. El estudio SAVVE, que involucra a 75 pacientes con CVI en 21 sitios de EE. UU., está recolectando actualmente datos clínicos de un año para apoyar la presentación final del módulo PMA.
Al 30 de junio de 2024, enVVeno Medical contaba con 39.1 millones de dólares en efectivo e inversiones, que se espera financien las operaciones hasta la decisión de la FDA sobre la solicitud de PMA para el VenoValve.
enVVeno Medical는 VenoValve, 수술적 판막 대체술에 대한 FDA 사전 마케팅 승인(PMA) 신청에서 중요한 진전을 이루었습니다. 이 회사는 PMA 신청에 필요한 다섯 개 모듈 중 네 개를 성공적으로 제출했으며 FDA의 승인을 받았습니다. 다섯 번째이자 최종 모듈은 SAVVE 미국 핵심 시험의 임상 데이터를 포함하고 있으며, 2024년 4분기에 제출될 것으로 예상됩니다.
VenoValve는 연간 약 250만 명의 새로운 환자에게 영향을 미치는 심각한 만성정맥부전(CVI)의 잠재적 치료법으로 개발되고 있습니다. 21개 미국 사이트에서 75명의 CVI 환자가 참여한 SAVVE 연구는 최종 PMA 모듈 제출을 지원하기 위해 현재 1년의 임상 데이터를 수집하고 있습니다.
2024년 6월 30일 기준, enVVeno Medical은 3천910만 달러의 현금 및 투자금을 보유하고 있으며, 이는 VenoValve PMA 신청에 대한 FDA의 결정까지 운영을 지원할 것으로 예상됩니다.
enVVeno Medical a réalisé des progrès significatifs dans sa demande d'approbation préalable à la commercialisation (PMA) auprès de la FDA pour le VenoValve, une valve veineuse de remplacement chirurgical. L'entreprise a réussi à soumettre et la FDA a approuvé quatre des cinq modules requis pour la demande de PMA. Le cinquième et dernier module, contenant des données cliniques de l'étude SAVVE aux États-Unis, devrait être soumis au quatrième trimestre de 2024.
Le VenoValve est en cours de développement comme un traitement potentiel pour une Insuffisance Veineuse Chronique (IVC) sévère, une maladie débilitante touchant environ 2,5 millions de nouveaux patients chaque année aux États-Unis. L'étude SAVVE, impliquant 75 patients atteints de IVC à travers 21 sites aux États-Unis, est actuellement en train de recueillir des données cliniques d'une durée d'un an pour soutenir la soumission finale du module PMA.
Au 30 juin 2024, enVVeno Medical disposait de 39,1 millions de dollars en espèces et en investissements, ce qui devrait financer les opérations jusqu'à la décision de la FDA concernant la demande de PMA pour le VenoValve.
enVVeno Medical hat bedeutende Fortschritte bei seinem Antrag auf Marktzulassung (PMA) bei der FDA für das VenoValve, ein chirurgisches Ersatzvenenklappensystem, erzielt. Das Unternehmen hat erfolgreich vier der fünf für den PMA-Antrag erforderlichen Module eingereicht, die von der FDA genehmigt wurden. Das fünfte und letzte Modul, das klinische Daten aus der SAVVE-Hauptstudie in den USA enthält, wird voraussichtlich im vierten Quartal 2024 eingereicht.
Das VenoValve wird als potenzielle Behandlung für schwere Chronische Venenzirkulationsinsuffizienz (CVI) entwickelt, eine schwächende Krankheit, die jährlich etwa 2,5 Millionen neue Patienten in den USA betrifft. Die SAVVE-Studie, an der 75 CVI-Patienten an 21 Standorten in den USA teilgenommen haben, sammelt derzeit einjährliche klinische Daten, um die endgültige PMA-Modul-Einreichung zu unterstützen.
Am 30. Juni 2024 hatte enVVeno Medical 39,1 Millionen Dollar in bar und Investitionen, was voraussichtlich die Operationen bis zur Entscheidung der FDA über den PMA-Antrag für das VenoValve finanzieren wird.
- Four out of five PMA application modules approved by FDA
- On track to file final PMA module in Q4 2024
- $39.1 million in cash and investments as of June 30, 2024
- Sufficient capital to fund operations through FDA decision on PMA application
- Final PMA module approval still pending
- No current effective treatments for severe CVI of the deep vein system
Insights
The FDA's approval of 4 out of 5 modules for enVVeno's VenoValve PMA application is a significant milestone. This modular approach has allowed for early identification and resolution of potential issues, potentially streamlining the final approval process. With the final module submission expected in Q4 2024, the company is on track for a potential FDA decision in mid-2025, assuming a 6-9 month review period.
The VenoValve addresses a critical unmet need in treating severe Chronic Venous Insufficiency (CVI), a condition affecting an estimated
With
enVVeno's progress on the VenoValve PMA application is a positive indicator for potential market entry. The company's
However, investors should note that regulatory approval doesn't guarantee commercial success. The company will need to navigate reimbursement challenges, build a sales force and compete for market share. The large addressable market of
While the news is promising, the company remains pre-revenue and significant risks persist. Investors should closely monitor the final module submission and subsequent FDA interactions.
VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA
4 Modules Have Now Been Submitted, Reviewed, and Approved by the FDA
Company on Track to File the 5th and Final Module in Q4 2024
IRVINE, CA / ACCESSWIRE / August 14, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided an update on the U.S. Food and Drug Administration (FDA) premarket approval (PMA) application status for its lead product, a surgical replacement venous valve called the VenoValve. Four (4) out of five (5) modules that comprise the VenoValve PMA application have now been submitted, reviewed and approved by the FDA, with the fifth and final module containing the clinical data from the SAVVE U.S. pivotal trial for the VenoValve expected to be filed in the fourth quarter of this year.
The enVVeno Medical PMA application seeking FDA approval for the VenoValve consists of five sections (modules) including:
Module 1 -- Sterilization, Packaging, and Packaging Shelf-Life Testing
Module 2 -- Non-clinical and Device Shelf-Life Testing
Module 3 -- Biocompatibility, Animal Study, and Tissue Sourcing
Module 4 -- Manufacturing Information
Module 5 - Clinical Data and Proposed Labeling
The first four (4) modules have now been submitted, reviewed, and approved by the FDA.
"While approval of all five modules by the FDA is required to market the VenoValve, I am extremely proud of the progress that we have made and the tremendous amount of effort by our team in securing approval from the FDA for the first four modules of our PMA application," said Robert Berman, enVVeno Medical's CEO. "Our strategy was to capitalize on the opportunity that the FDA provides to submit sections of the PMA application in advance of the clinical data, in order to improve the efficiency of our application process and to resolve any deficiencies earlier in the review process. We have successfully executed that strategy and look forward to submitting the final PMA module later this year."
In a traditional PMA application, the applicant submits all PMA data at the same time, regardless of when the testing is completed, and the FDA begins its PMA review only upon receipt of all of the required information. In 1998, the FDA implemented a new policy to increase the efficiency of the PMA review process by allowing applicants to submit discrete sections (modules) of the PMA application to the FDA soon after completing testing and analysis for that section of the application. A modular PMA is a compilation of sections or "modules" submitted at different times that together become a complete PMA application. A PMA module is a discrete section of the PMA that can be submitted and reviewed independently and that addresses a selected aspect of a device application. On average, the PMA review process takes approximately six (6) to nine (9) months.
The VenoValve is a potential treatment for severe Chronic Venous Insufficiency (CVI) and is currently being evaluated in The Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study, a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled at twenty-one (21) U.S. sites.
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 and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve.
The Company is in the process of collecting one-year clinical data for each patient in the SAVVE study, to support the filing of the fifth and final module of the PMA application for the VenoValve, which the Company expects to file in Q4 of this year. As of June 30, 2024, the Company had cash and investments of
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 trial 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
(833) 475-8247
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SOURCE: enVVeno Medical Corporation
View the original press release on accesswire.com
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