Appointment bolsters Company's transition from being a clinical stage to a commercial entity planning for the monetization of the VenoValve?
PMA application seeking FDA approval for the VenoValve on track to be filed in Q4 of 2024
IRVINE, CA / ACCESSWIRE / April 9, 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 Andrew Cormack has been hired as the Company's Chief Commercial Officer. Mr. Cormack, who joined enVVeno Medical on April 8, comes to enVVeno following a career at both start-up and large medical device companies including WallabyPhenox, Medtronic, Covidien, and ev3.
"Andrew's experience in formulating and executing strategies for new product launches will be invaluable as we begin to plan for the commercialization of the VenoValve," said Robert Berman, enVVeno Medical's Chief Executive Officer. "I look forward to working closely with Andrew on our U.S. product launch strategy for the VenoValve and in recruiting a world-class sales and marketing team to execute that strategy."
"I have been involved with several innovative products throughout my career and would put the VenoValve at the top of the list in terms of its potential to fulfill the unmet medical need for the millions of patients that suffer from severe, deep venous Chronic Venous Insufficiency (CVI)," added Mr. Cormack. "I am excited to work on the VenoValve commercialization strategy and to lead the commercial team to ensure that the VenoValve reaches its full potential."
Mr. Cormack has held numerous regional, national, and international sales and marketing positions throughout his almost 25-year career in med-tech and holds a Bachelor of Arts degree in Kinesiology from The University of Western Ontario, where he graduated with honors.
enVVeno is advancing the VenoValve, a first-in-class, surgical replacement venous valve for patients suffering from severe CVI caused by incompetent valves in the deep venous system. 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 recently released initial, topline six-month efficacy data from the Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve, which is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled at 21 U.S. sites. The data indicated that 97% of the patients in SAVVE have shown clinical improvement in revised venous clinical severity score (rVCSS) since receiving the VenoValve, and 74% have experienced a clinically meaningful benefit (≥ 3 point improvement in rVCSS), when comparing rVCSS at baseline, to six months following VenoValve implantation. The average rVCSS improvement for SAVVE patients experiencing a clinical meaningful benefit was 8 points. The rVCSS is an objective grading system used by vascular specialists throughout the world to measure the severity of venous diseases, such as CVI, and to report clinical outcomes and responses to treatments for venous diseases.
The U.S. Food and Drug Administration (FDA) has asked the Company to collect a minimum of one-year of data on all SAVVE patients prior to filing a PMA application seeking FDA approval for the VenoValve. With full enrollment in SAVVE having occurred in September of 2023, the Company will be in a position to file the PMA application in the fourth quarter of 2024. The VenoValve has been granted breakthrough device designation by the FDA.
To hear from patients in the SAVVE study, see examples of venous ulcer healing caused by the VenoValve, and to learn more about the SAVVE pivotal trial, please visit enVVeno.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 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.
