French start-up Cardiawave has developed a non-invasive medical device for the treatment of aortic stenosis using an ultrasound technology, and has secured €8 million in funding.
In 2019, Cardiawave conducted a clinical study of non-invasive treatment in ten elderly patients with severe symptomatic aortic stenosis at the HEGP in Paris (France) and the Amphia Hospital in Breda (The Netherlands). These patients had no therapeutic solution as they were ineligible for valve replacement. The absence of serious adverse events related to Cardiawave’ medical device or to the procedure has proven the safety and the feasibility of the treatment. The neurological assessment performed in all patients was satisfactory. With regard to the efficacy, an improvement in the hemodynamic and anatomical parameters was observed in the majority of patients treated, as assessed by an independent certified core-lab. Based on the promising results of this first clinical trial, Cardiawave has been selected to present its preliminary results at prestigious international cardiology conferences.
The new financing will allow the company to continue the clinical development of its therapy for aortic stenosis by improving the first generation of the Valvosoft medical device and by conducting more clinical trials in Europe and in the United States.
Benjamin Bertrand, CEO of Cardiawave, said: “Our therapy offers tremendous hope for many patients affected by aortic stenosis because, to this day, 16% of them are not eligible for aortic valve replacement. We are very pleased to have secured the necessary funding to maintain our development despite the current COVID-19 pandemic. We have achieved a significant milestone with the success of our first clinical trial. It rewards the great commitment of our teams and partners. Further studies with long-term follow-up and a larger population are required to confirm the safety and performance of our non-invasive therapy. We look confidently ahead to the next steps.”