CARDIAWAVE

Cardiawave was founded in late 2014 through a longstanding collaboration between the academic laboratories Physics for Medicine Paris and Langevin Institute (INSERM/CNRS/ESPCI), leaders in ultrasound imaging and therapy, and the Georges Pompidou European Hospital (HEGP AP-HP), a leading center in valve disease and cardiac ultrasound imaging.

The project received support from the “Investissements d’Avenir” Program as part of the World Innovation Contest and I-Nov program, funding from the French National Research Agency (ANR-16-RHUS-0003_STOP-AS and ANR-17-CE19-0019-03), and the European Commission’s Horizon 2020 SME Instrument (grant no. 829492). Cardiawave was named a winner of French Tech Health 20, joined La French Care in 2023, and became a member of Medtech in France and France Biotech in 2024, as well as the Medicen competitiveness cluster.

Certified EN ISO 13485:2016 since 2019, Cardiawave developed Valvosoft®, a non-invasive focused ultrasound therapy (NIUT) medical device for the treatment of calcific Aortic Stenosis (AS), the most prevalent heart valve disease in adults and a major cause of cardiovascular mortality worldwide.

Cardiawave’s breakthrough therapy was published in The Lancet in November 2023 (DOI: 10.1016/S0140-6736(23)01518-0), confirming the safety and efficacy of the therapy in severe Symptomatic AS (sSAS) patients who were not eligible for an immediate valve replacement.

Cardiawave’s clinical program included two First-in-Human (FIH) studies  (30 and 10 patients, total of 40 patients) (NCT03779620, NCT04665596) and a pivotal study (60 patients)(NCT05235568).

Six-month results of pivotal study were presented at TCT 2024, showing 91.7% of patients free from major adverse cardiovascular events (MACE) at 30 days and at 6 months follow-up 80.5% presented a stabilized or improved cardiac condition (New York Heart Association class).

Twelve-month results (covering all 3 studies or 100 patients) were presented at EuroPCR 2025: 91.0% free from MACE at 30 days and at 12 months an 85.8% NYHA class improvement or stabilization, an 8.6-point increase in KCCQ score, and a 42.8% average increase in aortic valve area (AVA) compared to natural progression of the disease[1]

Valvosoft® has obtained CE marking in November 2025 (when intended for the treatment of patients with severe symptomatic calcific Aortic Stenosis (AS) by non-invasive ultrasound therapy (NIUT). Cardiawave is preparing for commercialization, with initial treatment centers yet to be announced.

[1] AVA increases by 0.1cm²/year. Prosperi-Porta, et.al, Arch Cardiovasc Dis, 2023.