EDAP TMS Announces 510K Filing with the FDA for Its Sonolith Praktis Lithotriptor; Antoine Tetard Appointed C.O.O. of EDAP TMS S.A.

Medical/Health Writers

VAULX-EN-VELIN, France--(BW HealthWire)--Nov. 28, 2000

EDAP TMS S.A. (Nasdaq: EDAPY and EASDAQ: EDAP), announced today that it has filed a submission to obtain a 510K approval with the FDA for the introduction in the US of its Sonolith Praktis Lithotriptor. Standard FDA review time for a 510K submission is usually ninety days.

Eric Simon, Chief Executive Officer of EDAP TMS, commented, "Based upon the success of our Sonolith Praktis in Europe and Asia, we believe that this device should perfectly address the US market needs for an efficient, compact and cost effective lithotriptor. The Sonolith Praktis, which combines the high efficacy rate of the electroconductive shockwave technology with a unique modular concept, clearly represents the newest generation of lithotriptors."

EDAP TMS S.A. also announced today the appointment of Antoine Tetard, to Chief Operating Officer for the Company. Mr. Tetard, 36, joined EDAP in 1990 as Senior Sales Manager for Asia. He was promoted to President of the Japanese Operations in 1996 and President of the U.S. Operations in January 2000.

Mr. Simon concluded, "Antoine has played a critical role in the recent developments within the Company. His experience, management skills and depth of knowledge in our environment will further help us to enhance our technology platform, our commitment to the Urology community and our overall performance."

Founded in 1979, EDAP TMS S.A., is the global leader in the development, production, marketing and distribution of a portfolio of minimally invasive medical devices primarily for the treatment of urological diseases. The Company currently produces and markets devices for the minimally invasive treatment of localized prostate cancer, using High Intensity Focused Ultrasound (HIFU) and the treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL). The Company also produces and markets in Japan devices for the non-surgical treatment of benign Prostate Hyperplasia (BPH) using Microwave Thermotherapy (TUMT). The Company is also developing HIFU for the treatment of certain other types of tumors. For more information, contact EDAP TMS on the Web at: www.edaptechnomed.com.