Cardiawave’s Valvosoft Ultrasound Treatment for Aortic Stenosis Evaluated in FIH Trial

March 14, 2022—Cardiawave SA, a Paris, France-based medical device company, announced findings from its first-in-human (FIH) I safety and feasibility clinical trial of Valvosoft. Valvosoft uses the remote application of a precise and focused therapeutic ultrasound beam to restore valve function in patients with aortic stenosis.

According to the company, Valvosoft uses a new and unique ultrasound technology with a remote repair procedure on the aortic valve. The treatment combines therapeutic ultrasound, robotics, and ultrasound imaging. Ultrasound softens the tissue, restores leaflet mobility, and enables a wider opening of the valve. This noninvasive therapy is intended to be an alternative treatment versus surgical or transcatheter aortic valve replacement.

Valvosoft’s intense beam decreases the stiffness of the aortic valve and improves its functional opening to allow sufficient oxygenated blood to reach the brain and the rest of the body. All software and most hardware components have been developed in-house by Cardiawave, building on the work of the Institut Langevin and Laboratoire Physique pour la Médecine in Paris, France.

Cardiawave stated that the purpose of the FIH I study was to assess the safety, and operating system of the first-generation Valvosoft technology as well as to evaluate the clinical effects of softening calcific aortic valve tissues with a beating heart.

In the study, 30 patients (average age, 84 years, with nine patients age > 90 years) have been successfully treated in France and the Netherlands with the latest treatment in Q4 2021.

The company reported that Valvosoft provided a sustained repair to the aortic valve for up to 12 months post treatment. The study demonstrated the safety and efficacy of the therapy. The ease of the procedure was a 60-minute noninvasive outpatient treatment. Two patients were able to have transcatheter valve replacement after Valvosoft treatment.

“Valvosoft’s noninvasive treatment brings great hope for patients with aortic stenosis and for their families,” commented study's principal investigator, Professor Emmanuel Messas, MD, in the company’s press release. “It offers the possibility of an efficient outpatient treatment for fragile patients, for whom valve replacement is too risky. In the longer term, treating patients with less severe stenosis would be a major step forward.” Prof. Messas is from Georges Pompidou European Hospital in Paris.

A second feasibility and safety study, FIH II, is underway, enrolling 10 patients in Serbia. This includes evaluating MRI of the brain both before and after treatment to assess the risk of a stroke. Four patients were safely treated by the end of December 2021. None of the MRIs detected an abnormality. Six further patients will be treated during H1 2022.

Additionally, Cardiawave advised it has launched its Series B financing, which is expected to be completed in the second half of 2022. These funds will be used to finance the next phase of clinical trials in Europe and the United States.

Cardiawave plans to enroll around 50 aortic stenosis patients across 10 hospitals in France, the Netherlands, and Germany between April and December 2022. The clinical trial protocol includes patient monitoring at 1, 6, and 12 months. This new European clinical trial targets the granting of CE Mark approval, advised the company.

“The positive results of the safety and feasibility clinical studies we observed in our FIH trial are extremely encouraging,” commented Cardiawave CEO Benjamin Bertrand in the company’s press release. “We have shown that Valvosoft can treat patients who are exceedingly fragile and sick for whom no medical solution exists today. This represents a new treatment solution for aortic stenosis, over and above aortic valve replacement from which only a small minority of patients can benefit.”

Mr. Bertrand continued, “Cardiawave’s Valvosoft has the potential to become a standard new treatment for this deadly disease. We are currently working on receiving the necessary authorizations in Europe for further clinical trials over the next few months. I am confident that these will once again confirm the therapeutic benefits of Valvosoft.”