EDAP TMS announces regulatory clearance of ExactVu Micro-Ultrasound in Japan

EDAP TMS provided a regulatory and clinical update. The Company has received approval from the Pharmaceutical and Medical Devices Agency, PMDA, for the commercialization of the ExactVu micro-ultrasound biopsy platform in Japan. "We are pleased to announce the approval of the ExactVu system in Japan," said Marc Oczachowski, Chief Executive Officer and Chairman of the Board of EDAP TMS. "The Japanese market is the second largest market for advanced medical device technology in the world, and prostate cancer is the most common cancer diagnosis in Japanese men. Each year, there are over 100,000 newly diagnosed cases of prostate cancer. Our established commercial team in Japan is well positioned to engage clinical sites to offer their patients precise prostate biopsies utilizing this groundbreaking technology."