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 $39.1 million, which should be sufficient capital to fund operations through the end of 2025.
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
[email protected]
(833) 475-8247
SOURCE: enVVeno Medical Corporation