Recent Updates
Recently added Catalysts
NVNO Neutral Sentiment

enVVeno Medical (NASDAQ:NVNO) Participates in Virtual Investor “What This Means” Segment

Key Takeaway: enVVeno Medical Corporation recently participated in a Virtual Investor segment where CEO Robert Berman discussed the company's request for a supervisory appeal regarding a not-approvable letter from the FDA. This letter was related to their Premarket Approval application for the VenoValve, a device aimed at treating severe chronic venous insufficiency. The company continues to develop its products, including the enVVe valve, which is in the final testing phase for IDE approval.
Price reaction · baseline $33.495 (2025-09-25 close) · hit pre-market · clean, no other NVNO news in the window
day 0 close
+1.2%

Market Sentiment Analysis

POSITIVE FACTORS

  • CEO Robert Berman discussed recent developments in a virtual segment.
  • The company is advancing innovative solutions for deep venous disease.
  • Final testing for the enVVe valve is underway, moving towards IDE approval.

CONCERNS & RISKS

  • The company received a not-approvable letter from the FDA.
  • The PMA application for VenoValve was not approved.

Full Press Release Details

Watch the “What This Means” video here
IRVINE, CA / ACCESS Newswire / September 26, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of deep venous disease, today announced that Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor “What This Means” segment .
As part of the segment, Mr. Berman discussed the Company’s recent news announcing it filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve ® , a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
The Virtual Investor “What This Means” segment featuring enVVeno Medical is now available here .
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 deep venous disease. The Company’s lead product, the VenoValve ® , is a first-in-class surgical replacement venous valve being developed for the treatment of severe deep 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 ® . 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 Company is currently performing the final testing necessary to seek IDE approval from the FDA to begin the U.S. pivotal trial for enVVe.
INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC NVNO@jtcir.com (908) 824-0775
MEDIA CONTACT: Glenn Silver, FINN Partners Glenn.Silver@finnpartners.com (973) 818-8198
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire

Frequently Asked Questions

What did enVVeno Medical announce recently?

enVVeno Medical announced a request for a supervisory appeal regarding an FDA not-approvable letter.

Who participated in the Virtual Investor segment?

CEO Robert Berman participated in the Virtual Investor 'What This Means' segment.

What is the VenoValve used for?

The VenoValve is a surgical replacement valve for treating severe chronic venous insufficiency.

What is the status of the enVVe valve?

The enVVe valve is undergoing final testing to seek IDE approval for a pivotal trial.

Last updated: Sep 26, 2025