Cardiawave Announces the Success of Its Clinical Trial to Treat Aortic Stenosis Using VALVOSOFT, Its Disruptive, Non-Invasive, Ultrasound Treatment

The trial with VALVOSOFT its disruptive, non-invasive, ultrasound treatment was proven to:

• be safe and feasible

• provide a sustained repair of the aortic valve

• improve quality of life of the 34 patients treated

-Cardiawave SA, a deeptech medical device company that has developed VALVOSOFT a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, today announced the success of its First-In-Human I (FIH I) safety and feasibility clinical trial.

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“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.”

VALVOSOFT is a breakthrough technology that allows for the remote application of an extremely precise and focused therapeutic ultrasound beam to restore valve function in patients with aortic stenosis. This 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. This non-invasive therapy is a new treatment option for aortic stenosis, as the only current medical response is to replace the aortic valve with open heart surgery, or with a minimally invasive percutaneous valve (TAVI) for the most severely affected patients. Aortic stenosis has become a public health issue. This pathology affects between 2 and 12% of subjects over 65 years old (1.3 million patients in Europe).

The FIH 1 study

The purpose of the FIH I study was to assess the safety, and operating system of the first generation of VALVOSOFT as well as the clinical effects of softening calcific aortic valve tissues with a beating heart.

30 patients (average age 84yrs, with 9 patients over 90) have now been successfully treated in France and the Netherlands with the last being in Q4 2021. VALVOSOFT provided a sustained repair to the aortic vavlve for up to 12 months post treatment. The study has proven the safety and efficacy, as well as the ease of the procedure with a 60 minute non-invasive outpatient treatment. Following the successful VALVOSOFT treatment, two patients were able to have TAVI valve replacement.

“The positive results of the safety and feasibility clinical studies we observed in our First In Human trial are extremely encouraging. 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. Cardiawave’s VALVOSOFT has the potential to become a standard new treatment for this deadly disease,” said Benjamin Bertrand, CEO of Cardiawave. “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.” he added.

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VALVOSOFT’s non-invasive treatment brings great hope for patients with aortic stenosis and for their families. 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.” declared Professeur Emmanuel Messas the Georges Pompidou European Hospital (AP-HP), in Paris.

A second feasibility and safety FIH II study is underway with 10 further patients in Serbia. This includes brain MRI evaluation 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.

Next steps

On the back of these promising clinical results, Cardiawave has launched its Series B financing. This 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.

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

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