enVVeno Medical Reports Successful Completion of First VenoValve Surgery for U.S. Pivotal Trial
- 75 Patient Trial Underway to Evaluate Safety and Efficacy of the VenoValve as a Potential Treatment for Severe Deep Venous Chronic Venous Insufficiency (CVI)
- Severe CVI Impacts Approximately 2.4 million U.S. Patients with No Current Effective Treatment Options
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 first VenoValve surgery in the Company’s SAVVE U.S. pivotal trial for the VenoValve® has been successfully completed. The surgery was performed by Dr. Adriana Laser, associate professor of surgery at Albany Medical College and a vascular surgeon with Albany Med Vascular Surgery. The patient has been discharged from the hospital.
“It is an honor to be the first surgeon in the U.S. to implant a device which has the potential to help the millions of people that suffer from the debilitating impacts of Chronic Venous Insufficiency,” said Dr. Laser. “Although the name Chronic Venous Insufficiency may not be familiar to the general public, deep venous CVI has been frustrating the vascular community and our CVI patients for decades, and we are hopeful that the VenoValve will be the first safe and effective treatment option for the disease.”
The VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. CVI occurs when 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 treat.
“Today marks a historical milestone for our Company, having had the first patient treated in the SAVVE U.S. pivotal trial for the VenoValve”, said enVVeno Medical CEO Robert Berman. “We would like to thank Dr. Laser for agreeing to be a part of our study and for treating the first patient”.
The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial is a prospective, non-blinded, single arm, multi-center trial designed to evaluate the safety and efficacy of the VenoValve to improve lower leg blood flow, alleviate symptoms and improve quality of life for patients suffering from CVI caused by dysfunctional valves in the deep veins of the lower leg. The Company expects to enroll 75 patients at up to 20 centers throughout the U.S.
The device used for the pivotal trial is the same as was used in the successful VenoValve first-in-human trial. Primary endpoints for the U.S. pivotal trial include: the absence of Material Adverse Events (MAEs) in 26% or less of the patients at 30 days post-VenoValve implantation, for the primary safety endpoint; and improvement of reflux of at least 30% at six months following VenoValve surgery, as the primary effectiveness endpoint. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis (DVT), or pulmonary embolism. Improvement of VCSS and VAS scores are also included in the SAVVE study as secondary endpoints. The Company hopes to have topline safety and/or efficacy data from the SAVVE study by the end of 2022.
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 find a study center near them by visiting www.venovalve.com.
CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping and walking extremely difficult. The Company estimates that approximately 2.4 million people in the U.S. have the type of CVI for which the VenoValve is being studied. There are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.
The Company recently announced that the U.S. Food and Drug Administration granted Breakthrough Device Designation status to enVVeno Medical for the VenoValve.
About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based medical device company focused on the development 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.
Jenene Thomas, JTC Team, LLC
Michelle McAdam, Chronic Communications, Inc.
SOURCE: enVVeno Medical Corporation