Topline Efficacy Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024

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enVVeno Medical Corporation (NVNO) announces topline efficacy data from the VenoValve U.S. pivotal trial to be presented at the 2024 AVF Annual Meeting. The data will showcase clinical status improvements in severe Chronic Venous Insufficiency patients, addressing an unmet medical need.

IRVINE, CA / ACCESSWIRE / February 20, 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 topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 American Venous Forum (AVF) Annual Meeting being held March 3-6, 2024 in Tampa, Florida. The presentation will be made on Wednesday, March 6, 2024, by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial.

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 six (6) months compared to baseline, as measured by the revised Venous Clinical Severity Scores (rVCSS).

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 the subjects enrolled in the SAVVE study, the U.S. Food and Drug Administration (FDA) has indicated that an improvement in rVCSS of 3 points would be considered evidence of the VenoValve's clinical meaningful benefit.

Composite six (6) month rVCSS data will be presented including the overall percentage of patients enrolled in SAVVE that have shown clinical improvement (improvement in rVCSS), the percentage of SAVVE patients that have shown a clinical meaningful benefit from the VenoValve (rVCSS improvement of 3 or more points), and the average rVCSS improvement for those subjects showing clinical meaningful benefit.

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. Patients who are enrolled in the SAVVE study all failed at least three months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care for venous ulcer patients).

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 in the most severe cases, 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 malfunctioning valves and the Company estimates that there are approximately 2.5 new patients each year in the U.S. that could be candidates for the VenoValve.

The Annual Meeting of the American Venous Forum (AVF) is an international, scientific, academic and practical meeting for vascular surgeons as well as others dedicated to improving the care of patients with venous and lymphatic disease. The AVF fosters cutting edge research and clinical innovation and educates health care professionals, patients and policy makers about venous and lymphatic diseases.

For more information about the AVF Annual Meeting, please visit the VENOUS2024 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 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.

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INVESTOR CONTACT:

Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247

SOURCE: enVVeno Medical Corporation

View the original press release on accesswire.com

FAQ

What is the significance of the topline efficacy data from the VenoValve U.S. pivotal trial?

The data will showcase clinical status improvements in subjects enrolled in the SAVVE study for the VenoValve at six months compared to baseline, as measured by the revised Venous Clinical Severity Scores (rVCSS).

What is the rVCSS and its importance in the VenoValve study?

The rVCSS is an objective grading system used to report clinical outcomes and responses to treatments for venous diseases like Chronic Venous Insufficiency. It consists of 10 categories graded from 0 to 3, reflecting patient reported outcomes and physician assessments.

How does the FDA define a clinically meaningful benefit for the VenoValve?

The FDA considers an improvement in rVCSS of 3 points as evidence of the VenoValve's clinical meaningful benefit for severe Chronic Venous Insufficiency patients.

What symptoms are associated with severe Chronic Venous Insufficiency?

Symptoms include leg swelling, pain, edema, and venous ulcers. The disease can severely impact daily functions and result in high rates of depression and anxiety.

What is the estimated number of new patients in the U.S. that could benefit from the VenoValve each year?

The Company estimates approximately 2.5 new patients in the U.S. each year could be candidates for the VenoValve, addressing the unmet medical need for severe CVI.