Cardiawave was created at the end of 2014 as a result of a partnership of several years between the academic laboratories Physics for Medicine Paris (INSERM/CNRS/ESPCI/PSL) and Langevin Institute (CNRS/INSERM/ESPCI), world leaders in ultrasound imaging and therapy, and the Georges Pompidou European Hospital (HEGP AP-HP), a leader in the field of valve disease and cardiac ultrasound imaging.
This project was supported by the Program “Investissements d’Avenir” as part of the World Innovation Competition. It also benefited from state aid managed by the National Research Agency under the references ANR-16-RHUS-0003_STOP-AS and ANR-17-CE19- 0019-03 and the Horizon 2020 SME instruments program of the European Commission (reference no. 829492). Cardiawave is a winner of the French Tech Health 20 program, a member of La French Care since 2023, Medtech in France and France Biotech since 2024, and also a member of the competitiveness cluster Medicen.
With a quality management system, EN ISO 13485:2016 certified since 2019, Cardiawave has developed a non-invasive ultrasound therapy (NIUT) medical device for the treatment of calcific Aortic Stenosis (AS), an investigational device. Calcific AS is the most prevalent heart valve disease in adults and one of the most common causes of cardiovascular mortality worldwide. Early 2019, Cardiawave was granted approval to perform a first-in-human feasibility and safety clinical study (FIH‑I) in France and the Netherlands to enrol 10 patients. A second study (FIH-II) has been approved in Serbia and started at the end of 2019. In 2020, Cardiawave obtained approval for an extension of its FIH-I, increasing the study population up to 30 patients. First results of the data up to 6 months follow-up of both studies have been published in The Lancet (1).
In June 2022, following the positive preliminary results of our FIH clinical studies, Cardiawave started a pivotal confirmatory study on severe symptomatic aortic valve stenosis patients who were for immediate aortic valve replacement or refused such an intervention (note: last indication not approved in France by ANSM).
In July 2023, Cardiawave successfully enrolled 60 patients in 11 clinical sites in France, Germany and the Netherlands and marks a significant milestone in the development of Cardiawave’s medical advances, paving the way for CE marking of the device. The 6 months results were presented at the TCT 2024 in Washington DC by Professor Hélène Eltchaninoff.
Cardiawave has won several awards and honours since its inception.
Trophées de l’Embarqué 2025
ICI Meeting 2024
Cardio World Congress 2024
French Hospital Federation
French weekly news magazine published in Paris, Le Point is one of the three major French news magazines
French National Institute of Health and Medical Research
French government
French government / BPI France
MedTech Innovator
Nobel Project – MedTech Forum 2021
Tech Tour
Care Tour
ISTU / Barcelona
USA
European Union
French government / BPI France
French government / BPI France
Turenne Capital (French Investment Fund)
French government / BPI France
French government / BPI France