New Topline Efficacy Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the 46th Annual Charing Cross Symposium on April 24, 2024
IRVINE, CA / ACCESSWIRE / April 16, 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 additional topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 Charing Cross International Symposium being held April 23rd - 25th in London, England. The presentation, entitled "Efficacy Results of the SAVVE Trial: Long-term Results for Use of a Bioprosthetic Valve for Patients with Chronic Deep Venous Reflux," will be made on Wednesday, April 24, 2024 by primary investigator Dr. David Dexter, Sentara Hospital, Norfolk, Virginia and Associate Professor of Surgery, Eastern Virginia Medical School.
The data to be presented will review the comparative clinical status for subjects enrolled in the Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve at a composite weighted average of eleven (11) months post VenoValve implantation, comparing the clinical results from subjects' most recent clinical visit to baseline, as measured by the revised Venous Clinical Severity Score (rVCSS). The composite eleven (11) month weighted average rVCSS data will include nine (9) subjects that have passed the twenty-four (24) month milestone, thirty-one (31) subjects that have passed the twelve (12) month milestone, and twenty-nine (29) subjects that have passed the six (6) month milestone, representing an aggregate of 64 patient-years of follow-up.
The rVCSS is an objective grading system used by vascular specialists throughout the world to report clinical outcomes and responses to treatments for venous diseases such as Chronic Venous Insufficiency (CVI). The score consists of 10 categories graded from 0 to 3 and includes patient reported outcomes and physician assessments. For severe CVI patients, such as subjects enrolled in the SAVVE study, an improvement in rVCSS of 3 or more points would be considered evidence of the VenoValve's Clinical Meaningful Benefit.
Weighted average composite eleven (11) month rVCSS data will be presented during the presentation including the average rVCSS improvement for those subjects showing ≥ 3 point rVCSS improvement (Clinical Meaningful Benefit), sub-analyses of the Clinically Meaningful Benefit cohort by most recent clinical visit grouping (24 months, 12 months, and 6 months) and CEAP classification, as well as the overall percentage of SAVVE subjects that have shown a Clinical Meaningful Benefit, and the overall percentage of subjects enrolled in SAVVE that have shown clinical improvement ( ≥ 1 point improvement in rVCSS).
In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the FDA considers whether a medical device provides a clinically meaningful benefit compared to existing technologies. Subjects who were enrolled in the SAVVE study all failed at least three (3) months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care for venous ulcer subjects).
Severe Chronic Venous Insufficiency 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.
Now in its 46th year, the Charing Cross International Symposium (CX), which first took place in 1978 at Charing Cross Hospital, Hammersmith, London, and has gone on to become the leading global vascular symposium, expects to welcome an audience of over 4,000 attendees. For more information about the AVF Annual Meeting, please visit the CX Symposium website.
The SAVVE data presented at the CX Symposium will be made available to the public via a press release and a copy of the VenoValve CX Symposium slides will be made available after the presentation on Company's website.
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 working toward the launch of a 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.
