Making heart valve treatment non-invasive
Cardiawave develops Valvosoft®, a non-invasive focused ultrasound therapy for calcific aortic stenosis – the most prevalent heart valve disease in adults. Born from French academic research, CE-marked in 2025.
Founded from INSERM, CNRS, ESPCI and HEGP research
Patients treated in clinical studies
European countries in clinical investigation
People in Levallois-Perret
EN ISO 13485:2016 certified
Valvosoft® CE marked
Born from world-class French research
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.
Our mission is to improve the quality of patient care by offering medical devices for non-invasive therapies.
Our values
Quality
- Offer reliable and efficient products to physicians and patients
- Constantly improve the quality of our products
Innovation u0026 Progress
- Develop breakthrough innovations for patients with unmet clinical needs in the cardiovascular field
- Contribute to reducing healthcare cost
Diversity u0026 Gender Equality
- Equity
- Respect
- Tolerance Multiculturalism
- Openness to the world and to collaborations
Solidarity u0026 Team Spirit
- Attention to the human and to the accessibility of care
- Altruism
- Favouring the group over the individual
Care
- Well-being of the patient at all stages of therapy
- The well-being of the patient is at the heart of our activity
Ethics u0026 Integrity
- Be transparent and communicate about risks
- Act in an honest and pragmatic way
- Do what we say and say what we do
- Build confidence
Milestones
Clinical Deployment of Valvosoft® in Europe
First patients treated in routine clinical practice across several European centers following CE mark approval.
CE Mark Approval for Valvosoft®
Valvosoft® became the first non-invasive ultrasound therapy for severe symptomatic aortic stenosis to receive CE marking.
Publication in The Lancet
Clinical results from the First-in-Human studies were published in The Lancet, demonstrating the safety and efficacy of the therapy.
Completion of Pivotal Study Enrollment
Completed enrollment of the Valvosoft® pivotal study, bringing the total clinical experience to 100 treated patients.
Completion of First-in-Human Studies
Successfully treated 40 patients, demonstrating the feasibility and safety of the technology.
Founded
Cardiawave was established through a collaboration between leading French academic laboratories specializing in therapeutic ultrasound and the Georges Pompidou European Hospital (HEGP).
20 awards and honours since 2014
Recognised by the French government, BPI France, Inserm, the European Commission and the MedTech community.
Our team
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Maurice Delplanque
COO
François Desmarest
CFO
Dirk Pauwels
Clinical Director
Clémence Pupier
QARA SR Manager
Jonathan Freeman
Board Chairman
Nicolas Boulay
UI Investor
Jacques Duquesne
Investor
Jean de Gunzburg
Investor
François Levé
Investor
Hardip Thakerar
Independent Director
Michael Zaoui
Investor
Emmanuel Messas
Co-founder, Cardiologist, HEGP
Mathieu Pernot
Physicist, Physics for Medicine Paris
Mickaël Tanter
Physicist, Physics for Medicine Paris
Andreas Baumbach
MD, Prof. of Interventional Cardiology at Barts Heart
Hélène Eltchaninoff
Cardiologist, Rouen University Hospital
Edwin Ho
Director Structural Heart Imaging at Montefiore
Won-Keun Kim
MD, Cardiologist & Deputy Director at UKSH Campus Kiel
Azeem Latib
Head of Interventional Cardiology at Montefiore Health
Roxana Mehran
Prof. of Medicine, Mount Sinai Hospital
Ehud Schwammenthal
Cardiologist at Sheba Medical Center
Join Cardiawave
Help us build the future of non-invasive cardiac therapy. We are a passionate team of engineers, scientists and clinicians based in Levallois-Perret, near Paris.