CARDIAWAVE

ABOUT CARDIAWAVE

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.

1 Messas E, Ijsselmuiden A, Trifunović-Zamaklar D, et al. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. The Lancet(10419). 2023;402(10419):2317-2325. doi:10.1016/S0140-6736(23)01518-0

Our mission is to improve the quality of patient care by offering medical devices
for non-invasive therapies.

AWARDS & HONOURS

Cardiawave has won several awards and honours since its inception.

2025

Prize-winner Trophées de l’Embarqué

Trophées de l’Embarqué 2025

2024

ICI Innovation Awards finalists

ICI Meeting 2024

2024

Certificate of Recognition for Dr Trifunovic’s oral presentation: “Cerebral safety evaluation using MRI of the Valvosoft® Non-Invasive Ultrasound Therapy for 10 patients with severe symptomatic aortic valve stenosis”

Cardio World Congress 2024

2024

Finalist of Fonds FHF’s Espace Innovation, in the “Radiology & Imaging” category

French Hospital Federation

2024

Cardiawave’s founders Mickaël Tanter, Mathieu Pernot and Emmanuel Messas winners of Le Point’s Palmarès des Inventeurs 2024

French weekly news magazine published in Paris, Le Point is one of the three major French news magazines

2024

Cardiawave’s technology has been recognized by Inserm as one of its 5 major breakthroughs of 2023

French National Institute of Health and Medical Research

2023

Winner of the first French Tech Health20 promotion

French government

2022

Prize-winner I-nov Contest

French government / BPI France

2021

Accelerator & Showcase Cohort

MedTech Innovator

2021

HealthTech Award, best concept / invention

Nobel Project – MedTech Forum 2021

2020

Tech Tour finalists

Tech Tour

2019

“Best Fit to the US market”, pitch contest in Boston

Care Tour

2019

Prize-winner of the International Symposium on Therapeutic Ultrasound: Student Award

ISTU / Barcelona

2018

Prize-winner of Gallien MedStart’Up, in the category: Best Collaboration with Academia Leading to a Breakthrough Solution, partnering with Mount Sinai Medical Center New York

USA

2018

Prize-winner of SME Instrument, Phase 2

European Union

2017

Prize-winner of Worldwide Innovation Contest (CMI), 3rd phase

French government / BPI France

2015

Prize-winner of Worldwide Innovation Contest (CMI), 2nd phase

French government / BPI France

2015

Prize winner of Fondation pour l’Innovation Thérapeutique Béatrice Denys

Turenne Capital (French Investment Fund)

2014

Prize-winner of Worldwide Innovation Contest (CMI), 1st phase

French government / BPI France

2014

Prize-winner of the French National Contest for Innovative Technologies Companies

French government / BPI France