enVVeno Medical Announces the Issuance of a New Unique Category III CPT Code Covering the Insertion of a Bioprosthetic Valve into the Femoral Vein

• New Current Procedural Terminology (CPT®) III code establishes a reimbursement pathway for the VenoValve
• The VenoValve is a potential first-in-class treatment for patients suffering from Chronic Venous Insufficiency (CVI) of the deep veins of the leg
• There are currently no effective treatments for patients with deep venous CVI
• The VenoValve is currently being evaluated in leading hospitals throughout the U.S. in the ongoing SAVVE U.S. pivotal trial

IRVINE, CA / ACCESSWIRE / July 8, 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 the American Medical Association (AMA) has issued a new, unique CPT III code covering the insertion of a bioprosthetic valve into the femoral vein. The new CPT code, which becomes effective January 1, 2023, will potentially be used by providers performing the VenoValve® procedure on patients across the United States.

CPT codes are granted and regulated by the AMA CPT Editorial Panel and are widely used by government payers, including Medicare and Medicaid, and commercial health plans, to describe healthcare services and procedures for reimbursement. The release of this new code will enable hospitals and physicians across the U.S. to submit claims directly related to the VenoValve procedure.

“The absence of existing reimbursement codes to adequately cover the VenoValve speaks to ground-breaking, first-in-class nature of our technology,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “Coding, coverage, and reimbursement are three important factors that impact the commercial success of any medical device. The issuance of this new CPT code is an important first step towards creating the new reimbursement pathway that will be necessary to bring the VenoValve to the millions of U.S. patients that suffer from the debilitating impact of deep venous CVI.”

The VenoValve® is bioprosthetic valve that is surgically implanted into the femoral vein as a potential treatment for deep venous CVI. The device is currently being evaluated in the SAVVE U.S. pivotal trial for safety and effectiveness. 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 2.4 million people in the U.S. suffer from the debilitating impacts of deep venous CVI, with no currently effective treatment options.

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 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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