Cardiawave Announces Positive 12-Month Results from Its “Valvosoft® FIM Study” and "Valvosoft® Pivotal Study" for the Treatment of Severe Symptomatic Aortic Stenosis (sSAS)

At the EuroPCR 2025 Congress – Paris

Results confirm the promise of non-invasive ultrasound therapy (NIUT) previously observed in earlier clinical studies.

• 91% of patients were free of major adverse cardiac events (MACE) at 30 days (achieving the primary endpoint objective MACE ≤ 25%).
• 85% of patients experienced an improvement or stabilization in their NYHA class.
• An average 9-point improvement in the KCCQ (Kansas City Cardiomyopathy Questionnaire) score, indicating a significant gain in quality of life.
• A 43% increase in aortic valve area (AVA) at 12 months compared to the natural progression of the disease.

Cardiawave SA, medtech company specialized in valvular heart disease, presented today at the EuroPCR Congress the 12-month results from its "Valvosoft® FIM Study" and "Valvosoft® Pivotal Study" evaluating its innovative non-invasive ultrasound therapy (NIUT) device for the treatment of Severe Symptomatic Aortic Stenosis (sSAS).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250522089892/en/

Valvosoft® - Copyright Cardiawave

Following two First-in-Human studies (40 patients) that demonstrated the safety and feasibility of the therapy, and a multicenter, prospective, single-arm pivotal study (60 patients), conducted in total on 100 elderly patients with multiple comorbidities treated across 12 European centers in 4 countries, the treatment has shown feasibility, safety, and efficacy. Durable clinical benefits were observed one year after treatment, including improved cardiac function and significantly enhanced patient quality of life.

“These positive 12-month results confirm the ability of this innovative technology to significantly improve hemodynamics and patient quality of life in a completely non-invasive way. This device is emerging as a serious long-term therapeutic option for aortic stenosis. These results also open the door to additional indications, such as pre-TAVI preparation,” said Professor Hélène Eltchaninoff, Head of the Cardiology Department at Rouen University Hospital and principal investigator of the study, during her presentation at the EuroPCR Congress in Paris on May 22.

A New Option for Patients Without Therapeutic Alternatives

In 2024, approximately 2.5 million people over the age of 75 suffer from sSAS in the EU and the USA¹ . This therapy could become the first non-invasive therapeutic alternative to treat sSAS—a serious, degenerative, and fast-growing disease due to population aging—which remains without a solution for many patients.

“These results are very encouraging. They reinforce our determination to make this non-invasive therapy accessible to as many people as possible, including for complementary indications such as pre-TAVI preparation,” said Cardiawave’s leadership team. “We are excited to move forward with regulatory steps in Europe and the United States, aiming for a European market launch next year.”

Valvosoft® is an investigational medical device and is not yet approved for commercial use in the European Union or the United States.

About Cardiawave : www.cardiawave.com

¹ Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI: 10.1093/eurheartj/ehy107)

View source version on businesswire.com: https://www.businesswire.com/news/home/20250522089892/en/

91% of patients were free of major adverse cardiac events (MACE) at 30 days (achieving the primary endpoint objective MACE ≤ 25%).