Potential relief to approximately 3.5 million CVI sufferers
Designed to be used by an expansive network of physicians
Initial bench testing and animal testing successfully completed
Awaiting regulatory approval to begin first-in-human testing, which is expected by end of 2022
Company to host conference call with live audio webcast today, Wednesday, September 21st at 4:30 PM ET
IRVINE, CA / ACCESSWIRE / September 21, 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 development of a non-surgical transcatheter based replacement venous valve called enVVe™, for the treatment of Chronic Venous Insufficiency (CVI) of the deep veins of the leg. Preliminary bench testing and animal testing for enVVe have already been successfully completed and the Company has filed an application seeking approval to begin first-in-human (FIH) testing, which it expects to receive by the end of 2022. The Company's surgical replacement venous valve, called the VenoValve®️, is currently being evaluated in the SAVVE U.S. pivotal trial. As previously announced, enVVeno will host a conference call and webcast today, Wednesday, September 21, 2022 at 4:30 PM ET (details below).
"In addition to potentially appealing to an even larger pool of CVI patients, our plan is to eventually make enVVe available through a substantially larger number of doctors, which includes the thousands of physician interventionalists across the world," said Robert Berman, enVVeno Medical's Chief Executive Officer. "As the replacement venous valve market develops over time, we want to be the leader for both surgical valves, and non-surgical valves, and by developing both the VenoValve and enVVe, we will have the products that we need to help establish and maintain enVVeno Medical as the preeminent company for the treatment of venous disease."
The enVVe first-in-human trial, which will take place in Colombia, will be known as the Transcatheter Anti-reflux, Venous Valve Endoprosthesis (TAVVE) FIH study. The initial phase of the TAVVE-FIH study will seek to enroll 3 to 5 patients across multiple sites. Several parameters will be evaluated over the course of the study including safety and technical success of the enVVe venous valve delivery system, and the safety and clinical performance of the enVVe venous valve. With its potential appeal to a broader patient population, enVVeno estimates the total U.S. market for enVVe to be approximately 3.5 million patients.
The Company recently reported cash and cash equivalents of $47.2 million at the end of the second quarter of 2022. The budget for the TAVVE-FIH study has already been included in the Company's financial guidance, which includes cash resources expected to fund operations through the end of 2024.
Key features of enVVe include:
Minimally invasive procedure requiring no general anesthesia and no overnight hospital stay;
Procedure to be performed in an Angio Suite as opposed to an operating room;
Self-expanding frame made from a specially formulated biocompatible nickel and titanium alloy;
Frame geometry that accommodates the natural dilation and contraction of the vein, and provides a proper fit across a broad range of vein sizes;
Mono-cusp leaflet that is laser cut from porcine pericardium tissue;
Delivery profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system; and
Delivery via an over-the-wire, coaxial, single-stage pull system for ease of use.
The enVVe valve 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.
For more information on enVVe, please visit envveno.com/envve.
Conference Call and Webcast Details
As previously announced, the Company will host a conference call and webcast today, Wednesday, September 21, 2022 at 4:30 PM ET. Interested participants and investors may access the conference call by dialing (877) 407-9708 (domestic) or (201) 689-8259 (international) and referencing conference ID: 13732870. The live webcast will be accessible on the Events page of the Investors section of the enVVeno website, envveno.com, and will be archived for 90 days.
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 (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.
Jenene Thomas, JTC Team, LLC
SOURCE: enVVeno Medical Corporation
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