
-
US anti-disinformation guardrails fall in Trump's first 100 days
-
Dick Barnett, two-time NBA champ with Knicks, dies at 88
-
PSG hope to have Dembele firing for Arsenal Champions League showdown
-
Arteta faces Champions League showdown with mentor Luis Enrique
-
Niemann wins LIV Mexico City to secure US Open berth
-
Slot plots more Liverpool glory after Premier League triumph
-
Novak and Griffin win PGA pairs event for first tour titles
-
Inter Miami unbeaten MLS run ends after Dallas comeback
-
T'Wolves rally late to beat Lakers, Knicks edge Pistons amid controversy
-
Japan's Saigo wins playoff for LPGA Chevron title and first major win
-
Trump tells Putin to 'stop shooting' and make a deal
-
US says it struck 800 targets in Yemen, killed 100s of Huthis since March 15
-
Conflicts spur 'unprecedented' rise in military spending
-
Gouiri hat-trick guides Marseille back to second in Ligue 1
-
Racing 92 thump Stade Francais to push rivals closer to relegation
-
Inter downed by Roma, McTominay fires Napoli to top of Serie A
-
Usyk's unification bout against Dubois confirmed for July 19
-
Knicks edge Pistons for 3-1 NBA playoff series lead
-
Slot praises Klopp after Liverpool seal Premier League title
-
FA Cup glory won't salvage Man City's troubled season: Guardiola
-
Bumrah, Krunal Pandya star as Mumbai and Bengaluru win in IPL
-
Amorim says 'everything can change' as Liverpool equal Man Utd title record
-
Iran's Khamenei orders probe into port blast that killed 40
-
Salah revels in Liverpool's 'way better' title party
-
Arsenal stun Lyon to reach Women's Champions League final
-
Slot 'incredibly proud' as Liverpool celebrate record-equalling title
-
Israel strikes south Beirut, prompting Lebanese appeal to ceasefire guarantors
-
Smart Slot reaps rewards of quiet revolution at Liverpool
-
Krunal Pandya leads Bengaluru to top of IPL table
-
Can Trump-Zelensky Vatican talks bring Ukraine peace?
-
Van Dijk hails Liverpool's 'special' title triumph
-
Five games that won Liverpool the Premier League
-
'Sinners' tops N.America box office for second week
-
Imperious Liverpool smash Tottenham to win Premier League title
-
Man City sink Forest to reach third successive FA Cup final
-
Toll from Iran port blast hits 40 as fire blazes
-
Canada car attack suspect had mental health issues, 11 dead
-
Crowds flock to tomb of Pope Francis, as eyes turn to conclave
-
Inter downed by Roma, AC Milan bounce back with victory in Venice
-
Religious hate has no place in France, says Macron after Muslim killed in mosque
-
Last day of Canada election campaign jolted by Vancouver attack
-
Barcelona crush Chelsea to reach women's Champions League final
-
Nine killed as driver plows into Filipino festival in Canada
-
Germany marks liberation of Bergen-Belsen Nazi camp
-
Hojlund strikes at the death to rescue Man Utd in Bournemouth draw
-
Zelensky says Ukraine not kicked out of Russia's Kursk
-
Zverev, Sabalenka battle through in Madrid Open, Rublev defence over
-
Ruthless Pogacar wins Liege-Bastogne-Liege for third time
-
Bumrah claims 4-22 as Mumbai register five straight IPL wins
-
No place for racism, hate in France, says Macron after Muslim killed in mosque

enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium
Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access
Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium
Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, November 20th at 2:00 PM Eastern Time - Click Here to Access
enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA. The fifth and final module of the application contains the clinical data from the SAVVE pivotal trial as well as proposed labeling for the device.
"We are thrilled to get this last step of the PMA review process underway and look forward to further interactions with the FDA," said Robert Berman, enVVeno Medical's Chief Executive Officer. "It is difficult to predict precisely how long the PMA process will take, but we expect to learn more and potentially have a decision in the second half of 2025."
The VenoValve, which has been designated as a breakthrough device by the FDA and is therefore subject to priority review, is intended to treat severe deep venous Chronic Venous Insufficiency (CVI), 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 deep venous CVI and the company estimates that there are approximately 2.5 million candidates each year in the U.S. for the VenoValve.
The Company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe, which could appeal to an even larger market in terms of both patients and physicians. The Company expects enVVe to be ready for its own pivotal trial during the middle of 2025.
Definitive data that supports the VenoValve PMA application will be presented Wednesday, November 20, 2024, at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. Following Wednesday's presentation, the Company will host a live video conference call with the PI Presenters at 2:00 PM Eastern Time. To access the call visit the Events page on the Investor section of the Company's website or click 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 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 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.
###
INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
[email protected]
(908) 824-0775
SOURCE: enVVeno Medical Corporation
Y.Kobayashi--AMWN