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enVVeno Medical Successfully Initiates 6-Month Pre-Clinical GLP Study Evaluating enVVe(R)
First wave of implants successfully completed with updated delivery system performing very well
Company on schedule to be in position to apply for approval for enVVe pivotal trial mid-2025
IRVINE, CA / ACCESSWIRE / October 28, 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 the successful start to its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The first wave of implants, for the long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December. The GLP study is a prerequisite to enVVeno seeking IDE approval from the U.S. Food and Drug Administration to begin the enVVe U.S. pivotal study. The Company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-next year.
"There is no question that we could not have developed enVVe without the knowledge gained from the VenoValve over the past six years," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Engineering a transcatheter replacement venous valve that will fit into a catheter of only .17 inches in diameter and that will consistently and successfully deploy once it reaches the target vein is not easy. The final adjustments that we made to the crimping and delivery systems over the past few months resulted in easy, consistent and accurate delivery of the enVVe valves in the GLP study and now we wait to confirm that the deployed enVVe valves work as well as the rest of the system."
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 estimates that there are approximately 2.5 million candidates each year in the U.S. for the VenoValve. enVVe, a next-generation, transcatheter based replacement venous valve, would appeal to an even larger market in terms of both patients and physicians.
Severe deep venous 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.
enVVeno expects to file its PMA application seeking approval from the U.S. Food and Drug Administration to market and sell the VenoValve, and to release the definitive data that supports the PMA application in Q4 of this year. Beginning early next year, the Company will begin to implement its plans to transition from being a development stage company to a commercial entity, and to complete all of the additional non-clinical testing for enVVe that is necessary to file for IDE approval.
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.
