Cardiawave Granted Three New Patents

Cardiawave SA has added three new U.S. patents to its IP portfolio. The patents protect Valvosoft’s ultrasound imaging and therapy device and its medical applications and strengthen Cardiawave’s U.S. patent portfolio for its non-invasive treatment of heart valve diseases and other cardiovascular applications.

“We are thrilled to receive these new patents for our innovative solution to treat non-invasively aortic stenosis and other cardiovascular diseases,” Cardiawave CEO Benjamin Bertrand said. “Our IP portfolio is a key asset for our future development. We will continue to build high barriers to entry to protect our market from competition. Our team has worked tirelessly to bring this innovative technology to life, and we are proud to bring it soon to the market to help patients who suffer from this life-threatening condition.”
 
The first U.S. patent protects Cardiawave’s ultrasound imaging and therapy device, and more specifically the system that allows an optimal imaging for safety and performance purposes by keeping the ultrasound imaging probe stationary and in direct with the patient’s chest while the ultrasound therapeutical transducer treats different target zones.
 
The second U.S. patent protects the technology and the means to detect and monitor with ultrasound imaging the cavitation bubbles which create the therapeutic effect generated by the emission of focused ultrasound.
 
The third U.S. patent protects the entire apparatus for treating deep vein thrombosis with focused ultrasounds.
 
Cardiawave intends to bring its medical device to the American market to treat aortic stenosis, which remains an immense unmet medical need despite the development of TAVR. A large number of patients diagnosed with severe aortic stenosis in their 80s are not treated in the United States: about 78% aged 70-79 and 84% aged 80-89, which represent approximately 200,000 patients in their 80s, are untreated (2022 TCT presentation, 2021 figures). Patients affected with severe symptomatic AS who do not undergo treatment have limited lifespans and cost Medicare as much as $1.3 billion each year due to rehospitalization, prolonged stays, admissions to skilled nursing facilities, and use of hospice care (Clark et al. 2012).
 
Cardiawave is currently carrying out a pivotal clinical study in Europe, in order to obtain the CE marking and launch the commercialization of its device.
 
Valvosoft is a non-invasive ultrasound therapy medical device for the treatment of calcific aortic stenosis. 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 developed its technology following the work of the French academic laboratories Institut Langevin and Physics for Medicine Paris. This non-invasive treatment of aortic stenosis combines therapeutic ultrasound, robotics, and ultrasound imaging. 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.
 
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 and symptomatic stenosis). Aortic stenosis has become a public health issue, as the pathology affects between 2% and 12% of people over age 65. With age, the aortic valve calcifies, becomes more rigid and narrow, and no longer opens properly leading to poor blood circulation. Aortic stenosis can be mild, moderate, and severe. Two million people are estimated to suffer from severe AS in Europe and in the United States, of whom 500,000 benefit from Transcatheter Aortic Valve Replacement (TAVI) or open-heart surgery. Another 1.5 million patients remain untreated and face a low life expectancy of two to five years. Around 3 million other patients suffer from moderate AS, for which there is no early treatment.
 
Based near Paris, Cardiawave is a member of the national research consortium RHU Stop-AS, and has had ISO 13485:2016 certification since 2019. Cardiawave employs 30 people and has secured more than €22 million in funding since its 2014 creation.