enVVeno Medical Appoints Kevin Belteau as Vice President of Clinical Operations
enVVeno Medical Corporation (NASDAQ: NVNO) has appointed Kevin Belteau as Vice President of Clinical Operations. Belteau brings over 23 years of experience from Medtronic, where he managed clinical operations for significant studies. enVVeno expects to engage in multiple clinical trials to support the adoption of its VenoValve device, aimed at treating Chronic Venous Insufficiency (CVI). The VenoValve is currently under evaluation in the SAVVE U.S. pivotal trial for safety and effectiveness, addressing a condition affecting around 2.4 million U.S. individuals.
- Appointment of experienced Kevin Belteau may strengthen clinical operations and leadership.
- Engagement in multiple clinical trials expected to drive product adoption and market penetration.
- No current effective treatment options for CVI may indicate competitive challenges.
- Dependence on ongoing clinical trial results creates uncertainty in future operational success.
IRVINE, CA / ACCESSWIRE / August 16, 2022 / 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 appointment of Kevin Belteau as Vice President of Clinical Operations. Mr. Belteau joins enVVeno Medical following a twenty-three-year career in clinical operations at Medtronic.
Mr. Belteau joined Medtronic as a field engineer upon graduation from college and has progressed through various clinical operations roles over the course of his tenure there. Most recently he managed his own team of clinical operations professionals and has been directly involved is more than 75 clinical studies for class III medical devices seeking PMA approval.
"Our expectation is to be engaged in multiple clinical trials over the next several years in order to support the worldwide adoption of our products," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We will look to Kevin to immediately contribute to our existing clinical activities and to build a world-class clinical operations team over time".
"Opportunities to change the treatment paradigm with a first-in-class device like the VenoValve for a disease like Chronic Venous Insufficiency (CVI) do not come around very often, said Mr. Belteau. "This opportunity is one that I could not pass up and I am excited to join the talented team at enVVeno and to contribute the expertise that I have gained over my career in planning and executing successful clinical trials for world-class products".
Mr. Belteau received a Masters in Business Administration from University of South Florida and a Bachelor of Science in Biomedical Engineering from Texas A&M University.
The VenoValve® is bioprosthetic valve that is surgically implanted into the femoral vein as a potential treatment for deep venous CVI. The device is currently being evaluated in the SAVVE U.S. pivotal trial for safety and effectiveness. The VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. CVI occurs when the natural valves inside of the veins fail, causing blood to flow in the wrong direction (reflux), and creating increased pressure inside of the veins of the leg (venous hypertension).
CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to heal. Patients with severe CVI have limited mobility and often experience difficulty standing, walking, and completing everyday tasks. The Company estimates that approximately 2.4 million people in the U.S. suffer from the debilitating impacts of deep venous CVI, with no currently effective treatment options.
Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration - who may also have leg pain when standing or walking - may be candidates for the SAVVE trial. Interested patients can learn more about the SAVVE trial and fill out a pre-qualification questionnaire by visiting www.VenoValve.com.
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 in the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). In healthy patients, valves inside the veins of the leg assist in propelling blood up the leg, and back to the heart and lungs. Affecting approximately 2.4 million people in the United States, 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. Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve, to help restore proper blood flow in the leg. The VenoValve is currently being evaluated in the SAVVE pivotal study.
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
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