Theraclion, a company specializing in leading-edge medical equipment for echotherapy, has announced that the first patients were treated in the U.S. pivotal clinical trial to evaluate the safety and efficacy of Echopulse echotherapy as a non-invasive treatment of breast fibroadenomas (BFAs).
 
The prospective clinical trial will enroll approximately 100 patients at four centers in the U.S., University of Virginia School of Medicine, NYU Langone Bellevue, Montefiore Medical Center (NY) and New York-Presbyterian/Columbia University Medical Center and one in Europe with Tübingen University Hospital, Germany. Patients will receive a single high-intensity ultrasound treatment with Echopulse. The primary endpoint is a reduction of fibroadenoma volume, pain and anxiety. The first two cases were treated at the UVA site on January 20, 2017.
 
“High intensity focused ultrasound (HIFU) technology is exciting because it has the potential to provide patients with an alternative to surgery, avoiding a scar, with minimal interruption in their normal daily activity,” said David Brenin, M.D., chief of breast surgery, co-director of the University of Virginia Breast Care Program, associate professor of surgery at UVA’s School of Medicine, and principal investigator of the Echopulse U.S. trial.
 
David Caumartin, CEO of Theraclion concluded, “The U.S. market for non-invasive treatment alternatives for BFA is significant. There are approximately 400 thousand surgeries to remove BFAs in the U.S. each year. We believe that patients are searching for alternatives to invasive surgery that are outpatient, of short duration, generate minimal or no post-treatment pain and no scarring. This clinical trial is a significant step toward bringing our Echopulse echotherapy to U.S. patients.”