enVVeno Medical Successfully Passes Preliminary FDA Safety Review for the VenoValve U.S. Pivotal Study
enVVeno Medical Corporation announced the successful preliminary safety review by the FDA for its VenoValve, as part of the ongoing SAVVE U.S. pivotal study. The first 20 patients enrolled showed minimal adverse events, allowing the trial to proceed without changes. Currently, 33 patients are enrolled, with full enrollment expected by Q2 2023. The company reported $42.7 million in cash to sustain operations through 2024, including the upcoming release of pivotal trial data.
- FDA cleared the SAVVE study to continue without modification or interruption.
- Only three mild adverse events reported in the first 20 patients, indicating a positive initial safety profile.
- Sufficient cash reserves of $42.7 million to sustain operations through 2024.
- None.
The Company submitted safety data for the first 20 patients enrolled in the ongoing SAVVE U.S. pivotal study for the VenoValve
Following the initial safety data review by the FDA, the SAVVE study is cleared to continue without modification or interruption
The Company currently has 33 patients enrolled in the study and expects to be fully enrolled by the end of Q2 of 2023
With
IRVINE, CA / ACCESSWIRE / November 7, 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 Company has successfully passed a preliminary safety review by the U.S. Food and Drug Administration (FDA) for the first twenty (20) patients enrolled in the ongoing SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal study for the VenoValve.
The FDA had requested that enVVeno submit preliminary safety data at thirty (30) days post VenoValve implantation for the first twenty (20) patients enrolled in the study. The preliminary safety data submitted by the Company included one (1) device related (mild) and two (2) procedure related (moderate) adverse events. After review by the FDA, the study was cleared to continue without modification or interruption.
The Company currently has thirty-three (33) patients enrolled in the trial and based upon the current pace of enrollment, expects to be fully enrolled by the end of the second quarter of 2023. With
"It is not unusual for the FDA to request to closely monitor safety data for an initial group of patients in a study for a first-in-class device such as the VenoValve," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We are encouraged by the safety profile of the VenoValve for this initial group of patients and are pleased that the FDA permitted the study to continue without any changes due to safety concerns."
The SAVVE Trial is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients. The trial's primary safety endpoint is based on the number of major adverse events (MAEs) at 30 days post implantation. MAEs are defined as mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis or pulmonary embolism.
The VenoValve® is surgical replacement venous valve that is being evaluated as a potential treatment for deep venous CVI. 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 2.5 million people in the U.S. suffer from the debilitating impacts of severe deep venous CVI who would be candidates for the VenoValve.
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 (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.
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INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247
SOURCE: enVVeno Medical Corporation
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FAQ
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