enVVeno Medical Achieves Full Enrollment for VenoValve U.S. Pivotal Trial
- 18 VenoValve patients enrolled over the final two months of the study
- Surge in VenoValve demand exceeded the enrollment limit
- Topline safety and efficacy readout and PMA eligibility now expected to occur in Q4 2023, Q2 2024, and Q3 2024, respectively
IRVINE, CA / ACCESSWIRE / October 6, 2023 / 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 it has achieved full enrollment in SAVVE®️, the 75 person U.S. pivotal trial for the VenoValve®️ and the final precursor for seeking FDA pre-market approval of the VenoValve.
On July 5, 2023, the Company announced that it had 57 patients enrolled in SAVVE and that it expected to complete full enrollment by the end of 2023. With full enrollment occurring earlier than expected, initial topline safety data from SAVVE is now expected in Q4 of this year, initial topline efficacy data from SAVVE is now expected in Q2 of 2024, and PMA eligibility to file for FDA approval of the VenoValve is expected to occur in Q3 of 2024.
"We attribute the surge in demand in SAVVE to a combination of factors including the positive results that our primary investigators are experiencing, their familiarity and affinity for the VenoValve surgical procedure and the lack of effective treatment options for the large patient population that suffer from deep venous CVI," commented Robert Berman, CEO of enVVeno Medical. "Early completion of enrollment for a surgical study in the current challenging hospital environment is a testament to the dedication of our entire clinical team, which is led by Dr. Marc. Glickman, our Senior Vice President and Chief Medical Officer, and includes our in-house clinical specialists, site coordinators, and primary investigators."
Severe Chronic Venous Insufficiency (CVI) is a debilitating disease that most often occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such a sleeping, bathing, and walking, and is known to result 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.
In addition to the VenoValve, the Company is also developing enVVe®️, a non-surgical based replacement venous valve that is delivered by transcatheter via a minimally invasive procedure. The Company expects to be ready for the enVVe pivotal trial in Q3 of 2024.
For more information on the VenoValve and enVVe, 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 waiting for regulatory approval to begin the TAVVE early feasibility study 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.
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INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247
SOURCE: enVVeno Medical Corporation
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