enVVeno Medical Announces New Expedited Development Plan for the enVVe(R) Transcatheter Based Replacement Venous Valve

Rhea-AI Summary

enVVeno Medical Corporation plans to expedite the development of its enVVe transcatheter based replacement venous valve, shortening the development cycle by approximately 6 months. The company aims to begin preparations for the enVVe pivotal trial and expects to seek an Investigational Device Exemption (IDE) by the end of 2024. enVVe is designed to treat severe Chronic Venous Insufficiency (CVI) and offers a non-surgical, minimally invasive procedure. The Company is also developing the VenoValve, a replacement venous valve implanted via open surgical procedure.

Positive

• enVVeno plans to expedite enVVe's development, shortening the cycle by approximately 6 months

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• None.

- enVVe development cycle to be reduced by 6 months

- Application for enVVe pivotal trial now expected to be ready by end of 2024

IRVINE, CA / ACCESSWIRE / October 6, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced a plan to expedite the development of enVVe^®, its transcatheter based replacement venous valve. The new plan should shorten the enVVe development cycle by approximately 6 months.

"Based upon the knowledge we gained from the VenoValve, our successful pre-clinical testing for enVVe, feedback that we recently received from the FDA, and our strong capital position, which is now sufficient to begin the enVVe pivotal study, we have decided to expedite enVVe's development and immediately begin preparations for the enVVe pivotal trial," commented Robert Berman, enVVeno's CEO. "enVVe is an important component of our strategy to be the leader in both surgical and non-surgical replacement venous valves for the millions of patients throughout the world that suffer with severe Chronic Venous Insufficiency."

The next step in the development of enVVe will be a six (6) month pre-clinical GLP study, which the Company expects to begin in early 2024 and which is an FDA prerequisite for the enVVe pivotal trial. The Company expects to be ready to seek an Investigational Device Exepmtion (IDE) for the enVVe pivotal trial at the end of 2024.

The enVVe is a non-surgical, replacement venous valve delivered via a minimally invasive procedure requiring no general anesthesia or overnight hospital stay. The valve is made from specially formulated biocompatible nickel and titanium alloy, which self-expands once deployed, and has a delivery profile of only 13 Fr when crimped. The enVVe valve is designed to accommodate the natural dilation and contraction of the vein and will be available in three sizes to ensure a proper fit across a broad range of vein sizes.

Severe Chronic Venous Insufficiency (CVI) is a debilitating disease that most often occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such a sleeping, bathing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence.

In addition to enVVe, the Company is also developing the VenoValve^®, a replacement venous valve that is implanted via an open surgical procedure. enVVeno recently announced completion of enrollment for the SAVVE^® U.S. pivotal trial for the VenoValve, with topline safety data expected in Q4 of this year, and topline efficacy data expected in Q2 of 2024. enVVeno expects to have sufficient data to be eligible to file a PMA seeking FDA approval for the VenoValve in Q3 of 2024.

For more information about enVVe and the VenoValve, please visit www.envveno.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 early feasibility study 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

View source version on accesswire.com:
https://www.accesswire.com/790660/envveno-medical-announces-new-expedited-development-plan-for-the-envver-transcatheter-based-replacement-venous-valve

FAQ

What is enVVe?

enVVe is a transcatheter based replacement venous valve developed by enVVeno Medical Corporation.

What is the purpose of enVVe?

enVVe is designed to treat severe Chronic Venous Insufficiency (CVI) and offers a non-surgical, minimally invasive procedure.

What is the next step in enVVe's development?

The next step is a six-month pre-clinical GLP study, expected to begin in early 2024.

When does enVVeno expect to seek an Investigational Device Exemption (IDE) for the enVVe pivotal trial?

enVVeno expects to seek an IDE by the end of 2024.

What is the VenoValve?

The VenoValve is a replacement venous valve implanted via an open surgical procedure, also being developed by enVVeno Medical Corporation.