Positive 3-Year VenoValve(R) First-in-Human Data Presented at 49th Annual VEITH Symposium on Vascular and Endovascular Issues

Rhea-AI Summary

enVVeno Medical Corporation (NASDAQ:NVNO) announced promising results at the 49th Annual VEITH Symposium regarding its VenoValve clinical trial. Three years post-implantation, VenoValve recipients show no relapses of severe Chronic Venous Insufficiency (CVI) or venous ulcers. Average improvements in reflux, CVI manifestations, and pain are stable at 63%, 52%, and 84%, respectively. The trial involved eight patients with an average age of 68. The VenoValve aims to restore proper blood flow in patients with CVI, a condition affecting approximately 2.5 million people in the U.S.

Positive

• No relapses of severe CVI or venous ulcers reported three years post-surgery.
• Stable average improvements in reflux (63%), CVI severity (52%), and pain (84%).
• Demonstrates potential to help millions suffering from severe CVI.

Negative

• One thrombosis event after anti-coagulation medication was stopped.
• Only eight patients followed up, raising questions about sample size and data reliability.

• First-in-Human VenoValve recipients continue to benefit from VenoValve at average of 3 years post-surgery
• No venous ulcer recurrences or CVI relapses
• Stability in improvements for all study endpoints including reflux, disease severity (rVCSS), and pain (VAS)

IRVINE, CA / ACCESSWIRE / November 17, 2022 / 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 Principal Investigator Dr. Jorge Hernando Ulloa presented positive long-term, three-year observational data from a cohort of patients that participated in the previously concluded VenoValve first-in-human clinical trial.

The data, which was presented at the 49^th Annual VEITH Symposium in New York, showed that the VenoValve recipients, who are now an average of thirty-six (36) months post VenoValve implantation, continue to benefit from the VenoValve and have experienced no relapses of severe Chronic Venous Insufficiency (CVI) and no recurrences of venous ulcers. Safety events were limited to one (1) thrombosis after discontinuation of anti-coagulation medication.

Average improvements in reflux (the backwards flow of blood), CVI disease manifestations (rVCSS) and pain (VAS) remained stable at sixty three percent (63%), fifty two percent (52%), and eighty four percent (84%) respectively, when compared to pre-surgery levels, for the cohort of eight (8) patients that agreed to be followed at conclusion of the one year first-in-human trial. One patient experienced an increase in rVCSS due to dermatitis, which is unrelated to the VenoValve or vascular disease.

The average age of the patient group is sixty-eight (68), including one patient that is now eighty-nine (89) years old and another patient that is now eighty-five (85) years old.

"We are extremely pleased that our VenoValve first-in-human patients continue to benefit from the VenoValve surgeries that occurred three years ago and that these patients are no longer burdened by the debilitating impacts from severe CVI," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Our goal is to help millions of patients that suffer from debilitating CVI and currently have no effective treatment options."

The VenoValve is a first-in-class, surgically implanted replacement venous valve that is currently being evaluated in the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis U.S. pivotal trial, a prospective, non-blinded, single arm, multi-center study of 75 CVI patients.

The VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. CVI occurs when the natural valves inside of the veins fail, causing blood to flow in the wrong direction (reflux), and creating increased pressure inside of the veins of the leg (venous hypertension).

CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to heal. Patients with severe CVI have limited mobility and often experience difficulty standing, walking, and completing everyday tasks. The Company estimates that approximately 2.5 million people in the U.S. that suffer from the debilitating impacts of severe deep venous CVI would be candidates for the VenoValve.

Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration - who may also have leg pain when standing or walking - may be candidates for the SAVVE trial. Interested patients can learn more about the SAVVE trial and fill out a pre-qualification questionnaire by visiting www.VenoValve.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 first-in-human 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 (including, without limitation, with respect to our name change, our progress with the VenoValve and the expected timeline related to the SAAVE U.S. pivotal trial, including the timing of beginning patient enrollment, the VenoValve's ability to fill the unmet medical needs of CVI sufferers and our development of a second device for the treatment of venous disease) may differ significantly from those set forth or implied in the forward-looking statements. These 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
(833) 475-8247

SOURCE: enVVeno Medical Corporation

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FAQ

What were the results of the VenoValve clinical trial presented by NVNO?

The trial showed no relapses of severe Chronic Venous Insufficiency (CVI) or venous ulcer recurrences three years post-surgery, with stable improvements in reflux, disease severity, and pain.

What is the average follow-up period for VenoValve recipients according to NVNO's press release?

The average follow-up period for VenoValve recipients is three years post-surgery.

How many patients were involved in the VenoValve trial reported by enVVeno Medical?

Eight patients were involved in the follow-up study of the VenoValve trial.

What is the significance of the VenoValve for patients with CVI?

The VenoValve is intended to restore proper blood flow in patients with Chronic Venous Insufficiency (CVI), a condition affecting approximately 2.5 million people in the U.S.

What safety events were reported in the VenoValve clinical trial?

One thrombosis event occurred after the cessation of anti-coagulation medication.