VenoValve PMA Approval Application Process Consists of the Submission of 5 Modules to the FDA
4 Modules Have Now Been Submitted, Reviewed, and Approved by the FDA
Company on Track to File the 5th and Final Module in Q4 2024
IRVINE, CA / ACCESSWIRE / August 14, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided an update on the U.S. Food and Drug Administration (FDA) premarket approval (PMA) application status for its lead product, a surgical replacement venous valve called the VenoValve. Four (4) out of five (5) modules that comprise the VenoValve PMA application have now been submitted, reviewed and approved by the FDA, with the fifth and final module containing the clinical data from the SAVVE U.S. pivotal trial for the VenoValve expected to be filed in the fourth quarter of this year.
The enVVeno Medical PMA application seeking FDA approval for the VenoValve consists of five sections (modules) including:
Module 1 -- Sterilization, Packaging, and Packaging Shelf-Life Testing
Module 2 -- Non-clinical and Device Shelf-Life Testing
Module 3 -- Biocompatibility, Animal Study, and Tissue Sourcing
Module 4 -- Manufacturing Information
Module 5 - Clinical Data and Proposed Labeling
The first four (4) modules have now been submitted, reviewed, and approved by the FDA.
"While approval of all five modules by the FDA is required to market the VenoValve, I am extremely proud of the progress that we have made and the tremendous amount of effort by our team in securing approval from the FDA for the first four modules of our PMA application," said Robert Berman, enVVeno Medical's CEO. "Our strategy was to capitalize on the opportunity that the FDA provides to submit sections of the PMA application in advance of the clinical data, in order to improve the efficiency of our application process and to resolve any deficiencies earlier in the review process. We have successfully executed that strategy and look forward to submitting the final PMA module later this year."
In a traditional PMA application, the applicant submits all PMA data at the same time, regardless of when the testing is completed, and the FDA begins its PMA review only upon receipt of all of the required information. In 1998, the FDA implemented a new policy to increase the efficiency of the PMA review process by allowing applicants to submit discrete sections (modules) of the PMA application to the FDA soon after completing testing and analysis for that section of the application. A modular PMA is a compilation of sections or "modules" submitted at different times that together become a complete PMA application. A PMA module is a discrete section of the PMA that can be submitted and reviewed independently and that addresses a selected aspect of a device application. On average, the PMA review process takes approximately six (6) to nine (9) months.
The VenoValve is a potential treatment for severe Chronic Venous Insufficiency (CVI) and is currently being evaluated in The Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study, a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients enrolled at twenty-one (21) U.S. sites.
CVI is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as 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 and the Company estimates that there are approximately 2.5 million new patients each year in the U.S. that could be candidates for the VenoValve.
The Company is in the process of collecting one-year clinical data for each patient in the SAVVE study, to support the filing of the fifth and final module of the PMA application for the VenoValve, which the Company expects to file in Q4 of this year. As of June 30, 2024, the Company had cash and investments of $39.1 million on hand, which the Company expects to be sufficient capital to fund operations through an FDA decision on the PMA application for the VenoValve.
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 trial and the company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial.
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.
