Positive Long-Term VenoValve(R) First-in-Human Data Presented at 34th Annual Meeting of the American Venous Forum

Rhea-AI Summary

enVVeno Medical Corporation (NASDAQ:NVNO) reported favorable thirty-month outcomes for its VenoValve in first-in-human trials, presented at the 34th Annual Meeting of the American Venous Forum. Key findings include no relapses of Chronic Venous Insufficiency (CVI) or venous ulcers, with significant improvements in reflux (55%), CVI disease manifestations (61%), and pain (81%). The CEO expressed optimism about ongoing trials that may lead to further advancements in treating CVI. As the company gears up for pivotal trials, data showcasing effective solutions for CVI patients continues to grow.

Positive

• 30 months post-surgery, VenoValve recipients show no relapses of CVI or venous ulcers.
• Average improvements: 55% in reflux, 61% in VCSS, and 81% in pain.
• Ongoing U.S. pivotal trial for VenoValve positioned for success.

Negative

• None.

- First-in-Human VenoValve recipients continue to benefit from VenoValve at average of 30 months post-surgery
- No venous ulcer recurrences, relapses of CVI, or safety issues
- Improvements in average Reflux, disease manifestations (VCSS), and pain (VAS) endpoints continue to be encouraging

IRVINE, CA / ACCESSWIRE / February 25, 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 positive thirty-month VenoValve first-in-human data was presented at the 34^th Annual Meeting of the American Venous Forum (AVF) being held February 23-26, 2022 in Orlando, Florida.

The presented data showed that VenoValve recipients, who are now an average of 30 months post VenoValve implantation, continue to benefit from the VenoValve and have experienced no relapses of severe Chronic Venous Insufficiency (CVI), no recurrences of venous ulcers, and no material adverse safety events. Average improvement in reflux (the backwards flow of blood) was 55%, average improvement in VCSS (CVI disease manifestations) was 61%, and average improvement in VAS (pain) was 81%, all compared to pre-VenoValve levels for the eight first-in-human patients that agreed to be followed for the data, including one patient that is now 3 years post VenoValve implantation. A copy of the presentation from AVF is available on the Scientific Publications and Presentations page of the enVVeno Medical Website.

"We continue to be extremely encouraged by the performance of the VenoValve to date and its ability to bring relief to a group of severely debilitated CVI patients that have no other effective treatment options," commented Robert Berman, Chief Executive Officer of enVVeno Medical. "With the growing body of data demonstrating efficacy and safety in the first-in-human trial, we believe our ongoing U.S. pivotal trial evaluating the same version of the device for a very similar patient population and with the same study endpoints, is well positioned for success."

The VenoValve is a first-in-class surgically implanted solution being developed for the treatment of deep venous CVI. Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve to help restore proper blood flow up the leg, to return sufficient blood back to the heart and lungs for re-oxygenation. The VenoValve is currently being evaluated in the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial. The primary safety endpoint for the pivotal trial is the absence of material adverse safety events in twenty six percent (26%) or less of the patients at one (1) month post implantation, and the primary effectiveness endpoint for the pivotal trial is improvement in reflux of at least thirty percent (30%), measured at six (6) months post VenoValve implantation. Interested patients can learn more about the SAVVE trial and find a study center near them by visiting www.venovalve.com.

About the Annual Meeting of the American Venous Forum

The Annual Meeting of the American Venous Forum (AVF) is an international, scientific, academic and practical meeting for vascular surgeons as well as other AVF is 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.

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

SOURCE: enVVeno Medical Corporation

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FAQ

What are the latest results for NVNO's VenoValve?

The latest results show no relapses of CVI and significant improvements in reflux, disease manifestations, and pain.

When was the VenoValve data presented?

The VenoValve data was presented at the 34th Annual Meeting of the American Venous Forum on February 25, 2022.

What improvements were reported for VenoValve patients?

Patients experienced a 55% improvement in reflux, a 61% improvement in VCSS, and an 81% improvement in pain.

What is NVNO's plan moving forward?

NVNO is focusing on ongoing U.S. pivotal trials to further evaluate the effectiveness and safety of the VenoValve.