One-Year VenoValve(R) Data Published in Peer-Reviewed Journal, Vascular and Endovascular Surgery

Rhea-AI Summary

enVVeno Medical Corporation (NASDAQ: NVNO) announced positive results from its first-in-human study of the VenoValve, showing sustained safety and effectiveness one year post-implantation. The study included 11 patients with severe deep venous Chronic Venous Insufficiency (CVI), revealing a 54% improvement in reflux, 56% in disease manifestations, and 76% in pain. The VenoValve aims to address the shortcomings of existing treatments and is currently under evaluation in the ongoing SAVVE U.S pivotal trial, having received Breakthrough Device Designation from the FDA.

Positive

• Significant improvements noted in patient outcomes: 54% reduction in reflux, 56% in disease manifestations, and 76% in pain.
• The VenoValve has received Breakthrough Device Designation from the FDA, expediting its clinical path.
• Ongoing SAVVE U.S pivotal trial may lead to wider adoption if results confirm safety and effectiveness.

Negative

• None.

- Previously announced promising results from the first-in-human study demonstrated sustained safety and effectiveness of the VenoValve at 1-year post-implantation

- The VenoValve is currently being evaluated in ongoing SAVVE U.S pivotal trial as a potential treatment for severe deep venous Chronic Venous Insufficiency (CVI)

IRVINE, CA / ACCESSWIRE / March 9, 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 the publication of its research paper, One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency[1], in the peer-reviewed Journal, Vascular and Endovascular Surgery.

This first-In-human (FIH) trial was a non-randomized, single-center, prospective study. The study enrolled 11 patients with severe deep venous CVI (CEAP C5 and C6 disease patients). Patients enrolled in the VenoValve FIH trial demonstrated significant improvement in all study endpoints including an aggregate 54% improvement in reflux (the backwards flow of blood), a 56% improvement in disease manifestations, as measured by venous clinical severity scores ("rVCSS"), and a 76% improvement in pain, as measured on a visual analog scale ("VAS"), all at the conclusion of the one-year study when compared to pre-surgery levels. There were no device related safety events.

"While we recently presented thirty (30) month, longer term data at the American Venous Forum conference in Orlando, it is important to have the VenoValve data published in well-respected, peer reviewed journals as part of the paradigm shift that we are leading for the treatment of deep venous CVI," commented Robert Berman, Chief Executive Officer of enVVeno Medical. "The current standard of care for deep venous CVI has significant shortcomings and we believe the VenoValve could be the effective solution that frustrated doctors and their patients have been seeking for decades."

The published paper can be accessed on the Journal website and on the Scientific Publications and Presentations page of the Company's website.

The VenoValve is the Company's first-in-class surgically implanted solution, currently undergoing the SAVVE U.S. pivotal trial for safety and effectiveness as a treatment of deep venous Chronic Venous Insufficiency (CVI). Patient enrollment at study sites across the U.S. is underway. The surgically implanted VenoValve is designed to act as a one-way valve to help restore proper directional blood flow up the leg, to return sufficient blood back to the heart. The VenoValve has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration.

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 find a study center near them 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 in the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). In healthy patients, valves inside the veins of the leg assist in propelling blood up the leg, and back to the heart and lungs. Affecting approximately 2.4 million people in the United States, 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. Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve, to help restore proper blood flow in the leg. The VenoValve is currently being evaluated in the SAVVE pivotal study with data expected in late 2022.

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
[1]https://doi.org/10.1177/15385744211073730

SOURCE: enVVeno Medical Corporation

View source version on accesswire.com:
https://www.accesswire.com/692151/One-Year-VenoValveR-Data-Published-in-Peer-Reviewed-Journal-Vascular-and-Endovascular-Surgery

FAQ

What are the results of the VenoValve study announced by NVNO?

The VenoValve study showed a 54% improvement in reflux, 56% in disease manifestations, and 76% in pain after one year.

What is the VenoValve and its significance for NVNO?

The VenoValve is a first-in-class implant designed to treat severe deep venous Chronic Venous Insufficiency (CVI), currently undergoing pivotal trials.

What designation has the VenoValve received from the FDA?

The VenoValve has received Breakthrough Device Designation from the FDA.

When was the VenoValve study published?

The study results were published on March 9, 2022.

What is the ongoing trial related to the VenoValve?

The ongoing trial is the SAVVE U.S pivotal trial evaluating the VenoValve for safety and effectiveness.