Cardiawave Confirms the Safety of VALVOSOFT® its Non-Invasive Ultrasound Treatment for Aortic Stenosis

Cardiawave Confirms the Safety of VALVOSOFT® its Non-Invasive Ultrasound Treatment for Aortic Stenosis




Cardiawave Confirms the Safety of VALVOSOFT® its Non-Invasive Ultrasound Treatment for Aortic Stenosis

No cerebral vascular anomaly before and after treatment observed

Successful completion of the FIM II clinical study prior to the pivotal study, that will pave the way for CE marking

PARIS–(BUSINESS WIRE)–Cardiawave SA, a deeptech medical device manufacturer that has developed VALVOSOFT® a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, today announced positive MRI scans before and after therapeutic ultrasound treatment to assess the risk of stroke.

This final phase of the clinical study “VALVOSOFT® FIM STUDY” (FIM II) showed no signs of any cerebral vascular anomaly in the 10 patients treated. This marks the completion of two successful First-In-Human clinical studies involving a total of 40 patients treated in France, the Netherlands and Serbia.

“This confirmation of the safety of VALVOSOFT® bodes well for the launch of patient recruitment for our European pivotal study which will commence shortly in France, and extended to Germany and the Netherlands, with the aim of obtaining CE Marking.” said Benjamin Bertrand, CEO of Cardiawave.

VALVOSOFT®’s non-invasive treatment brings great hope for patients with aortic stenosis and for their families. Having the absence of any abnormality before and after treatment being confirmed by MRI scans is major clinical step forward” declared Professeur Emmanuel Messas the Georges Pompidou European Hospital (AP-HP), in Paris.

Learn more: www.cardiawave.com

Contacts

Cardiawave
Benjamin Bertrand – CEO

mailto: blbertrand@cardiawave.com
+33 (0)1 55 26 82 17

AFL Conseil – Press Relations
Annie-Florence Loyer

aflwoodside@gmail.com
+33 (0)6 88 20 35 59

Stéphanie Lentini

slentini@gmail.com
+33 (0)7 62 62 51 21

Agile Capital Markets
Sophie Baratte

sophie.baratte@agilecapitalmarkets.com
+33 (0)6 38 33 15 02

Orpheon Finance
James Palmer

j.palmer@orpheonfinance.com
+33 (0)7 60 92 77 74