Results from first-in-human (FIH) clinical studies on 40 patients suffering from calcific aortic stenosis treated with Cardiawave’s non-invasive ultrasound therapy (NIUT) have been published in The Lancet.
The clinical studies series, enrolled 40 patients with severe symptomatic aortic valve stenosis at three clinical sites in France, The Netherlands and in Serbia. The patients were treated with Cardiawave’s NIUT investigational device in one session. Follow-ups were scheduled at one, three, six, 12, and 24 months. Six-month data are reported in the publication.
Investigators Emmanuel Messas (Hôpital Européen Georges Pompidou, Paris, France) et al report that the primary endpoints were met with no procedure-related mortality through 30 days and improved valve function. No procedure-related mortality occurred and no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed at six months, reflected by a 10% increase in mean aortic valve area and by quality-of-life improvements.
The New York Heart Association (NYHA) score improved or stabilized in 96% of patients (n=24), and the mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 33%.
“Results from this FIH series with a cohort of very frail patients suggest that the use of non-invasive ultrasound therapy is feasible and safe, and efficient with statistically significant improvements of hemodynamic and clinical parameters in high-risk patients with calcific aortic stenosis,” said Roxana Mehran (Mount Sinai Hospital, New York, USA) and member of Cardiawave scientific advisory board. “Clinically, the patients experienced a considerable improvement in their clinical status suggesting a better quality of life. These early findings can represent a change in the paradigm of calcified aortic stenosis treatment especially for patients who have no other options. I am encouraged by the momentum of these study results as I anticipate that this therapy potentially brings a new medical breakthrough to many patients suffering from calcified aortic stenosis in the world.”
The publication coincides with the completion of the enrolment of 60 patients at 11 clinical sites in France, Germany and The Netherlands in the Valvosoft pivotal study, which is investigating the use of the therapy in severe symptomatic aortic valve stenosis patients who refuse or were not recommended for valve replacement.
After the successful treatment of 100 patients at 12 investigational centres in four countries, Cardiawave is preparing a Series B financing round which will enable the company to prepare the scale-up, market access in Europe and the launch of its clinical developments in the USA as part of premarket approval by the Food and Drug Administration (FDA).