Full Press Release Details
Interviews with participating patients from the VenoValve® U.S. Pivotal Trial
Webcast replay from with the presenting Primary Investigators
Presentation with data from the VenoValve U.S. Pivotal Trial
Access the Recap Website Here!
IRVINE, CA / November 27, 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 launch of a recap website which highlights the Company’s participation at the recently held 51 st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium. Materials accessible on the recap website include interviews with two patients and two Principal Investigators who participated in the VenoValve U.S. Pivotal Trial as well as data presented at the symposium.
“While our data is compelling, we think it is equally important to hear the stories behind the data from both physicians and patients who have first-hand experience with the VenoValve,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “It is physicians and patients that will ultimately drive our commercial success following FDA approval. This is the second group of patients and third group of primary investigators whose perspectives we have made available. It takes an organic network of physician and patient advocates for a new device to succeed and anyone who takes the time to engage with these materials will recognize the strong foundation we’ve established.”
Access the enVVeno Medical VEITH Symposium Recap Site at envveno.com/veith-2024
Severe, deep venous Chronic Venous Insufficiency (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, dressing, 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. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year.
The VenoValve ® is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company is also developing enVVe ® , a next-generation, transcatheter based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians.
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 pivotal trial for enVVe.
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.
INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC NVNO@jtcir.com (908) 824-0775
SOURCE: enVVeno Medical Corporation
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