enVVeno Medical Provides Update on FDA Premarket Approval Application Status for VenoValve(R)

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 5^th 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."