EDAP Receives Japanese Approval for Quanta Litho Laser; Secures Exclusive Distribution Rights in Japan

EDAP TMS SA

, the global leader in therapeutic ultrasound, today announced that its Japanese subsidiary, Edap Technomed Japan, has secured Japanese PMDA approval for the Quanta Litho Laser. By gaining this approval, Edap Technomed Japan has been granted exclusive marketing and distribution rights in Japan by Quanta System SpA. Jean-François Bachelard, General Manager of EDAP Technomed Japan, commented: "We are very pleased with the grant of this approval by the Japanese PMDA as it allows EDAP to immediately and exclusively distribute the Litho Laser in the Japanese Territory. This laser is a clear complement to our existing range of urology products and technologies, further expands our comprehensive therapeutic offering in the management of stone diseases." Paolo Salvadeo, Chief Executive Officer of Quanta System SpA, added: ''This regulatory approval is a milestone achievement for both EDAP and Quanta, which we believe will further strengthen the global cooperation between our companies. The economy of Japan is the third largest in the world by nominal GNP, the fourth largest by purchasing power parity and is the second largest developed economy. Based on this large market opportunity, we are pleased to have EDAP play an even more significant role in the continued development of our urology business by marketing our gold standard Litho Laser in Japan." Marc Oczachowski, EDAP TMS Chief Executive Officer, concluded: "This is an important step forward in our productive, worldwide collaboration with Quanta System. Moreover, this clearance further validates EDAP's ability to work through international regulatory processes and guidance to successfully achieve marketing approvals for innovative technologies and devices. We look forward to bringing the Litho Laser technology to the Japanese market."