enVVeno Medical Adds Sandy Prietto to its Executive Team as Vice President of Marketing
enVVeno Medical (Nasdaq: NVNO) has appointed Sandy Prietto as Vice President of Marketing, strengthening its commercial team ahead of key milestones. The company, focused on treating venous disease, is preparing for the VenoValve monetization and several Q4 2024 events, including:
1. Completion of PMA submission for FDA approval of VenoValve
2. Release of one-year data from VenoValve U.S. Pivotal Study
3. Initiation of GLP pre-clinical study for enVVe
Ms. Prietto brings extensive experience in medical device marketing and successful product launches. enVVeno's lead product, VenoValve, is a surgical replacement venous valve for severe Chronic Venous Insufficiency (CVI). The company is also developing enVVe, a non-surgical transcatheter-based replacement venous valve. With $39.1 million in cash and investments as of Q2, enVVeno is funded through 2025.
enVVeno Medical (Nasdaq: NVNO) ha nominato Sandy Prietto come Vice Presidente del Marketing, rafforzando il suo team commerciale in vista di importanti traguardi. L'azienda, focalizzata nel trattamento delle malattie venose, si sta preparando per la monetizzazione del VenoValve e vari eventi previsti per il quarto trimestre del 2024, tra cui:
1. Completamento della sottomissione del PMA per l'approvazione della FDA del VenoValve
2. Rilascio dei dati annuali dello Studio Pivotal VenoValve negli Stati Uniti
3. Inizio dello studio preclinico GLP per l'enVVe
La signora Prietto porta con sé una vasta esperienza nel marketing di dispositivi medici e nel lancio di prodotti di successo. Il prodotto principale di enVVeno, VenoValve, è una valvola venosa di sostituzione chirurgica per l'insufficienza venosa cronica severa (CVI). L'azienda sta anche sviluppando enVVe, una valvola venosa di sostituzione non chirurgica basata su un approccio transcatetere. Con 39,1 milioni di dollari in contante e investimenti al secondo trimestre, enVVeno è finanziata fino al 2025.
enVVeno Medical (Nasdaq: NVNO) ha nombrado a Sandy Prietto como Vicepresidenta de Marketing, fortaleciendo su equipo comercial antes de importantes hitos. La empresa, enfocada en el tratamiento de enfermedades venosas, se está preparando para la monetización del VenoValve y varios eventos del cuarto trimestre de 2024, incluyendo:
1. Finalización de la presentación del PMA para la aprobación de la FDA del VenoValve
2. Liberación de datos de un año del Estudio Pivotal del VenoValve en EE.UU.
3. Inicio del estudio preclínico GLP para el enVVe
La Sra. Prietto aporta una gran experiencia en marketing de dispositivos médicos y lanzamientos exitosos de productos. El producto principal de enVVeno, VenoValve, es una válvula venosa de reemplazo quirúrgico para la Insuficiencia Venosa Crónica severa (CVI). La compañía también está desarrollando el enVVe, una válvula venosa de reemplazo no quirúrgica basada en un enfoque transcatéter. Con 39,1 millones de dólares en efectivo e inversiones a partir del segundo trimestre, enVVeno está financiada hasta 2025.
enVVeno Medical (Nasdaq: NVNO)는 상무 마케팅 부사장으로 샌디 프리에토(Sandy Prietto)를 임명하여 주요 이정표를 앞두고 상업 팀을 강화했습니다. 정맥 질환 치료에 집중하는 이 회사는 베노밸브(VenoValve) 수익화 및 2024년 4분기 여러 이벤트를 준비하고 있습니다. 주요 일정은 다음과 같습니다:
1. VenoValve의 FDA 승인을 위한 PMA 제출 완료
2. VenoValve 미국 주도 연구의 1년 데이터 발표
3. enVVe에 대한 GLP 전임상 연구 시작
enVVeno Medical (Nasdaq: NVNO) a nommé Sandy Prietto au poste de vice-présidente du marketing, renforçant ainsi son équipe commerciale avant des jalons clés. L'entreprise, axée sur le traitement des maladies veineuses, se prépare à la monétisation de VenoValve et à plusieurs événements prévus pour le quatrième trimestre de 2024, notamment :
1. Achèvement de la soumission PMA pour l'approbation de la FDA de VenoValve
2. Publication des données d'un an de l'étude pivotale VenoValve aux États-Unis
3. Lancement de l'étude préclinique GLP pour enVVe
Mme Prietto apporte une vaste expérience dans le marketing de dispositifs médicaux et le lancement de produits réussis. Le produit phare d'enVVeno, VenoValve, est une valve veineuse de remplacement chirurgical pour l'insuffisance veineuse chronique sévère (CVI). L'entreprise développe également enVVe, une valve veineuse de remplacement non chirurgicale basée sur un système de cathéter. Avec 39,1 millions de dollars en espèces et investissements au deuxième trimestre, enVVeno est financée jusqu'en 2025.
enVVeno Medical (Nasdaq: NVNO) hat Sandy Prietto zur Vizepräsidentin für Marketing ernannt, um sein Vertriebsteam vor wichtigen Meilensteinen zu stärken. Das Unternehmen, das sich auf die Behandlung venöser Erkrankungen spezialisiert hat, bereitet sich auf die Monetarisierung des VenoValve und mehrere Ereignisse im vierten Quartal 2024 vor, darunter:
1. Abschluss der PMA-Einreichung zur FDA-Zulassung des VenoValve
2. Veröffentlichung der Ein-Jahres-Daten aus der US-Pivotal-Studie zum VenoValve
3. Beginn der GLP-vorclinical Studie für enVVe
Frau Prietto bringt umfassende Erfahrung im Marketing von Medizinprodukten und erfolgreichen Produkteinführungen mit. Das Hauptprodukt von enVVeno, VenoValve, ist ein chirurgisches Ersatzventil für schwerwiegende chronische venöse Insuffizienz (CVI). Das Unternehmen entwickelt auch das enVVe, ein nicht-chirurgisches, transkatheterbasiertes Ersatzvenenventil. Mit 39,1 Millionen Dollar in bar und Investitionen zum zweiten Quartal ist enVVeno bis 2025 finanziert.
- Appointment of experienced marketing executive Sandy Prietto as VP of Marketing
- Completion of PMA submission for FDA approval of VenoValve expected in Q4 2024
- One-year data from VenoValve U.S. Pivotal Study to be released in Q4 2024
- Initiation of GLP pre-clinical study for enVVe planned for Q4 2024
- $39.1 million in cash and investments reported at the end of Q2, sufficient to fund operations through 2025
- None.
MedTech Marketing Leader with Significant New Product Launch Experience for Cardiovascular Devices
Key Addition to Commercial Team as Company Begins Planning for the VenoValve Monetization
Several Upcoming Company Milestones Planned for Q4 of 2024 Including:
Completion of PMA Submission Seeking FDA Approval for the VenoValve
Release of One Year Data from VenoValve U.S. Pivotal Study
Beginning of GLP Pre-clinical Study for enVVe in Preparation for enVVe Pivotal Trial
IRVINE, CA / ACCESSWIRE / September 3, 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 that Sandy Prietto has joined the Company as Vice President of Marketing. Ms. Prietto brings many years of medical device marketing experience including successful new product launches at Endologix and Edwards Lifesciences.
"In addition to the wealth of marketing experience and success with innovative new product launches that is directly relevant to the commercial launch of the VenoValve, Sandy brings an infectious enthusiasm that will permeate throughout the commercial team and elsewhere across our Company," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We will continue to add talented people like Sandy to our executive team who can help us achieve our goal of building enVVeno Medical into the world's preeminent company for replacement venous valves and the treatment of venous disease."
"Throughout my career, I have developed a passion for driving Medtech innovations that have the potential to transform patients' lives. The opportunity to lead the marketing team at enVVeno represents the culmination of all my past work experiences," added Ms. Prietto. "First-in-class medical devices like the VenoValve and enVVe that have the potential to change the treatment paradigm for a pervasive disease like severe Chronic Venous Insufficiency do not occur very often and I am excited to help bring relief to the millions of patients that suffer from this disease."
Most recently, Ms. Prietto served as head of worldwide marketing at Endologix, where she oversaw the launch of the DETOURä System, a percutaneous transmural arterial bypass therapy which was designated as a breakthrough device by the U.S. Food and Drug Administration (FDA). Prior to that, Ms. Prietto spent six (6) years with Edwards Lifesciences, where she held key marketing roles within the Surgical and TAVR divisions. In her last position at Edwards, she was instrumental in leading U.S. therapy development initiatives for the SAPIEN 3 transcatheter heart valve system. Ms. Prietto joins enVVeno with seventeen (17) years of medical device experience since graduating from the California State University at Fullerton.
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 is also developing enVVe®, a non-surgical transcatheter based replacement venous valve. 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.
enVVeno has several significant upcoming milestones planned throughout the remainder of 2024, including: the filing of the fifth and final PMA module with the FDA, seeking regulatory approval to market and sell the VenoValve in the U.S. (the first four modules for the VenoValve PMA application have already been filed, and approved by the FDA), the release of one (1) year data from the VenoValve pivotal trial; and the start of a GLP pre-clinical study for enVVe, the last step needed before seeking FDA approval to start the enVVe pivotal study. As of the end of the second quarter of this year, the Company reported 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 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.
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INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247
SOURCE: enVVeno Medical Corporation
View the original press release on accesswire.com
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