Paris, France, May 2, 2022 – 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 the authorization by the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a new clinical study in France.

“Following the recent announcement of positive results from our First In Human (FIH) clinical studies which validated the safety and feasibility of treating aortic stenosis with our non-invasive ultrasound therapy device on 34 patients, the ANSM approval confirms the successful progress of our clinical development. This announcement is a major milestone for Cardiawave, and we look forward to demonstrating through this new pivotal study the performance and efficacy of our non-invasive ultrasound therapy to treat a greater number of patients with aortic valve stenosis.” said Benjamin Bertrand, CEO of Cardiawave.

France is the first country to authorize this European clinical study, which will also be rolled out in Germany and the Netherlands. Cardiawave will enroll c.60 patients with aortic stenosis in 11 hospitals between May and December 2022, with the aim of obtaining CE Marking. The clinical protocol involves patient follow up at 1, 6 and 12 months after treatment. The aim of this study is to ensure, on the one hand, the absence of serious adverse events related to the device or the procedure and, on the other hand, the efficacy of the treatment, which will be measured by the improvement of the patients’ quality of life and an improved opening of the aortic valve after the treatment.

“VALVOSOFT® represents a breakthrough non-invasive therapeutic solution, complementary to TAVI, which will not only allow the treatment of the most fragile patients for whom TAVI is not an option, but also, in the longer term, open the way for new patients with calcified aortic stenosis. We are very pleased to be participating in the pivotal study and have the opportunity to treat patients with a very promising new French technology,” said Professor Hélène Eltchaninoff, Cardiologist at the Rouen University Hospital and national coordinator of the pivotal study in France and the STOP-AS research program.