About VALVOSOFT®
Valvosoft® is a non-invasive ultrasound therapy medical device for the treatment of calcific aortic stenosis developed by Cardiawave. It is currently undergoing clinical investigations for safety and efficacy. It has not yet received CE Marking or marketing authorization and its use is limited to clinical investigations.
Cardiawave has developed its new breakthrough technology following the work of the prestigious French academic laboratories Institut Langevin (INSERM/CNRS/ESPCI) and Physics for Medicine Paris (INSERM/CNRS/ESPCI/PSL). This non-invasive treatment of aortic stenosis combines therapeutic ultrasound, robotics, and ultrasound imaging. All software and most hardware components have been developed in-house thanks to the unique know-how of Cardiawave and its academic partners. This device uses a new and unique ultrasound technology with a remote repair procedure on the aortic valve. Ultrasound softens the tissue, restores leaflet mobility, and enables a wider opening of the valve.
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About CALCIFIC AORTIC STENOSIS
Calcific aortic stenosis is a degenerative and potentially life-threatening condition, caused by calcium buildup which prevents the aortic valve from fully opening. Aortic Stenosis evolves over time leading to heart failure and increases the risk of sudden death during its final stage (severe & symptomatic stenosis). Aortic stenosis has become a public health issue as the pathology affects between 2 and 12% of subjects over 65 years old. With age, the aortic valve calcifies, becomes more rigid and narrow, and no longer opens properly leading to poor blood circulation.
Aortic Stenosis (AS) can be mild, moderate, and severe. 2 million people are estimated to suffer from severe AS in Europe and in the USA, of whom 500,000 benefit from Transcatheter Aortic Valve Replacement (TAVI) or open-heart surgery. 1.5 million patients remain untreated and face a low life expectancy of 2 to 5 years. Around 3 million further patients suffer from moderate AS for whom there is no early treatment.
About CARDIAWAVE
Cardiawave has developed a non-invasive ultrasound therapy medical device for the treatment of valvular heart diseases, and in particular, Aortic Stenosis, the most prevalent heart valve disease in adults and one of the most common causes of cardiovascular mortality worldwide. Based near Paris, Cardiawave is a member of the national research consortium RHU Stop-AS, and has EN ISO 13485:2016 certification since 2019. Cardiawave employs 30 people and has secured over €22M in funding since its creation in 2014.
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