enVVeno Medical Successfully Initiates 6-Month Pre-Clinical GLP Study to Test enVVe(R) Via Investing.com
The first wave of transplants has been successfully completed with a new, more efficient delivery system
The company is on schedule to be in a position to apply for enVVe pivotal trial approval by mid-2025
IRVINE, CA / ACCESSWIRE / October 28, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care in the treatment of venous disease, today announced the successful start of its six-month preclinical GLP study of enVVe. , a transcatheter-delivered replacement venous valve. The first wave of transplants, for long-term studies, was successfully completed, with the final wave of short-term studies scheduled for December. The GLP study is a prerequisite for enVVeno to seek IDE approval from the US Food and Drug Administration to begin enVVe US pivotal research. The company expects to be in a position to file for IDE approval for enVVe’s pivotal trial by the middle of next year.
“There is no doubt that we could not have developed enVVe without the knowledge we have gained from VenoValve over the past six years,” said Robert Berman, Chief Executive Officer of enVVeno Medical. “Engineering a venous valve replacement transcatheter that will fit into a catheter that is only .17 inches in diameter and that will be used continuously and effectively once it reaches the target vein is not easy. The final improvements we made to the infusion and delivery systems over the past few months have resulted in easy, consistent and accurate delivery of the enVVe valves in the study -GLP and now we are waiting to confirm that the enVVe valves used are working as well as the whole system.”
enVVeno’s flagship product is the VenoValve ®, a first-in-class, surgical venous valve for patients with severe Chronic Venous Insufficiency (CVI) caused by inoperable valves in the deep venous system. The company estimates that there are approximately 2.5 million people each year in the US on VenoValve. enVVe, the next generation, transcatheter based valve replacement, could appeal to an even larger market in terms of both patients and physicians.
Deep venous CVI is a debilitating disease usually caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When the valves inside the leg veins fail, blood flows in the wrong direction and pools in the lower leg, causing the pressure inside the leg veins to increase (venous hypertension).
Symptoms of severe CVI include leg swelling, pain, edema, and in more severe cases, repeated open ulcers known as venous ulcers. The disease can have a negative impact on daily activities such as sleeping, bathing, and walking, and is known to lead to high levels of stress and anxiety. There are currently no effective treatments for severe CVI of the deep venous system caused by valvular dysfunction.
enVVeno expects to submit its PMA application seeking approval to the US Food and Drug Administration to market and sell the VenoValve, and to release definitive data supporting the PMA application in Q4 of this year. Starting early next year, the Company will begin implementing its plans to transition from a development stage company to a commercial enterprise, and complete all of the non-clinical testing of enVVe required to apply for IDE approval.
About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California, late-stage medical device company focused on the development of innovative (tissue-based) bioprosthetic solutions to improve the standard of care in the treatment of venous disease. The Company’s lead product, VenoValve ® , is a first-in-class venous valve being developed for the treatment of chronic venous insufficiency (CVI). The Company has also developed a non-surgical, transcatheter-based venous valve for the treatment of deep venous CVI called enVVe ® . CVI occurs when the valves inside the leg veins are damaged, leading to backflow of blood (reflux), blood pooling in the lower leg, increased pressure in the leg veins (venous hypertension) and in severe cases, venous. wounds that are difficult to treat and become chronic diseases. Both the VenoValve and the enVVe are designed to function as one-way valves, helping to direct blood from the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE US pivotal study and the company is currently conducting the final tests required to obtain approval for the enVVe pivotal study.
Cautionary Note on Forward-Looking Statements
This press release and any related statements of the shareholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the “Company”) contain, or may constitute, among other things, “forward-looking statements” within the meaning of the Private Securities Act. Litigation 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,” “may,” “should,” “must,” “believe,” “expect,” “anticipate,” “expect ,” “anticipates,” “expects,” “anticipates,” “anticipates,” “expects,” “estimates,” “intends,” “plans,” “may” or similar expressions. These statements are based on 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 Industry and Trade Commission. Actual results and timing (may differ materially from those stated or implied in forward-looking statements. Forward-looking statements involve certain risks and uncertainties that may 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, either as a result of new information , future representations or otherwise, unless required by applicable law.
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SOURCE: Veno Medical Corporation
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