enVVeno Medical Provides Enrollment Update for Ongoing VenoValve(R) U.S. Pivotal Study and Announces Upcoming Investor and KOL Events

Rhea-AI Summary

enVVeno Medical Corporation provided an update on enrollment for its SAVVE U.S. pivotal study for the VenoValve. To date, 57 patients have been enrolled in the study, and full enrollment is expected by the end of 2023. The company will be participating in an investor event on July 13 and a KOL event on July 18.

• 57 patients enrolled to date in the SAVVE® study
• Full SAVVE enrollment expected by year-end
• July 13 - Company to participate in investor event to further discuss enrollment
• July 18 - KOL event with two SAVVE study Principal Investigators

IRVINE, CA / ACCESSWIRE / July 5, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided an update on enrollment for its ongoing SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal study for the VenoValve and announced two upcoming investor events (details below).

The SAVVE pivotal study is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients. To date, the Company has enrolled 57 patients in the study and expects enrollment to be completed before the end of 2023.

"We are very encouraged by the enrollment momentum we have created over the past few months, including the number of new patients currently being considered for SAVVE, and are confident that we will reach full enrollment by the end of the year," commented Robert Berman, CEO of enVVeno Medical. "The new patient enrollment initiatives that we implemented over the course of the study have resulted in significant progress in what is still a somewhat unpredictable and challenging hospital environment."

Investor Event: Virtual Investor Summer Spotlight Series

The Company will be participating in the Virtual Investor Summer Spotlight Series on Thursday, July 13, 2023 at 12:00 PM ET, sharing additional information about SAVVE enrollment and the initiatives implemented by enVVeno Medical. The format will feature a one-on-one question and answer session and investors will have the opportunity to submit questions. To participate in the event, a live video webcast link will be available on the Events page of the Company's website (www.envveno.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

KOL Event: "VenoValve® - A New Potential Treatment Paradigm for Vascular Disease"

On July 18, 2023, at 3:00 PM ET, the Company will host a KOL event featuring two Principal Investigators from its ongoing VenoValve U.S. pivotal trial; Dr. David Dexter, Sentara Healthcare, Associate Professor Surgery, Eastern Virginia Medical School and Dr. Eric Hager, Co-Director Venous Services and Associate Professor Surgery, University of Pittsburgh Medical Center.

Topics for the event will include: ongoing need for a replacement venous valve technology for approximately 2.5 million patients in the U.S; unanswered questions about the deep venous system; first-hand impressions of the VenoValve after performing several surgical procedures, including patient feedback; VenoValve study enrollment; and prospects for VenoValve commercial adoption.

To register for the KOL event, visit the event link here. A live question and answer session will follow the roundtable discussion. If you would like to ask a question during the live Q&A, please submit your request to questions@lifesciadvisors.com.

"With several of our principal investigators now having completed multiple VenoValve procedures, the time is right to provide a platform to hear their insights. The PI's participating in the KOL event have sufficient, first-hand experiences to form their own opinions on the viability of the VenoValve and its prospects for success. We are excited to host the upcoming KOL discussion to bring these experts' opinions regarding VenoValve to the investment community," added Mr. Berman.

With $34.2 million in cash and investments reported at the end of the first quarter, and a modest burn rate of between $4 million and $5 million per quarter, the Company has sufficient resources to fund its current operations past the release of topline safety and efficacy data from the SAVVE study and through the end of 2024.

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 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.

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

SOURCE: enVVeno Medical Corporation

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FAQ

What is the update from enVVeno Medical Corporation?

enVVeno Medical Corporation provided an update on enrollment for its SAVVE U.S. pivotal study for the VenoValve.

How many patients have been enrolled in the SAVVE study?

To date, 57 patients have been enrolled in the SAVVE study.

When is full enrollment expected?

Full enrollment is expected by the end of 2023.

What investor events will enVVeno Medical Corporation participate in?

enVVeno Medical Corporation will be participating in a Virtual Investor Summer Spotlight Series on July 13 and a KOL event on July 18.