FDA approves start of U.S. clinical study for fourth generation lithotripter.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 25, 1996--EDAP Technomed, Inc. announced today that the United States Food and Drug Administration (FDA) has granted approval of the Investigational Device Evaluation (IDE) request for their Sonolith 4000+(r) lithotripter.

The IDE approval sets in motion the U.S introduction of a new generation lithotripsy device, Sonolith 4000+, and enables EDAP Technomed to select five hospitals as study centers.

Sonolith 4000+, a non-surgical device for the treatment of kidney stone disease, uses an advanced, patented electroconductive process developed to fragment kidney stones completely and without the need for anesthesia. It is the first lithotripter to offer Digital Slit Scan X-Ray delivering a crisp digital image of the stone, and minimizing radiation exposure. These advances are the result of over 10 years of research and development by EDAP Technomed, the third largest manufacturer of lithotripers.

"The use of electroconductivity in lithotripsy truly defines a next generation in the technologies available for treating kidney stones," said Eric Poincelet, Chief Executive Officer of EDAP Technomed, Inc. "In studies throughout the world, we have found that our electroconductive process significantly outperforms the standard electrohydraulic process in terms of efficacy, accuracy, and reliability. For the patient, this means reduced pain, and faster outpatient treatment."

Sonolith 4000+ differs from standard electrohydraulic systems by incorporating a revolutionary shockwave generator that forms the shockwave in an electrode filled with an electrolyte solution. Studies have found that this results in consistently reproducible shockwaves, hence fewer shocks needed for treatment.

EDAP Technomed plans to present clinical results for Sonolith 4000+ at the May 1996 American Urological Association (AUA) meeting in Orlando, FL. As an investigational device, Sonolith 4000+ is available for $650,000 and should benefit from the recent FDA/Health Care Financing Administration policy allowing Medicare reimbursement for Class B investigational devices.

While Sonolith 4000+ has been commercially available outside the US since 1995, a full compliment of lithotripers is currently available in the U.S. including EDAP Technomed's Sonolith 3000(r), Pulsolith(r), and LT.01(r). Today with more than 400 lithotripters installed, EDAP Technomed controls approximately 20% of the world lithotripsy market.

In addition to lithotripsy, EDAP Technomed is pioneering thermotherapy with the Prostatron(r) for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH), and High Intensity Focused Ultrasound (HIFU) for cancer treatment. Prostatron represents a breakthrough in the treatment of BPH, or enlarged prostate, especially over traditional surgery. It is the first device for non-surgical BPH treatment to receive FDA panel approval. Prostatron will be showcased at the 1996 AUA meeting. HIFU with Ablatherm(tm) and Pyrotech(tm) is currently being studied at leading European oncology centers.

EDAP Technomed, headquartered in France, is the result of a strategic merger of two well-established medical companies, EDAP and Technomed. The privately-held company maintains a strong international presence with subsidiaries in Italy, Japan, Russia and Korea. The U.S. headquarters, EDAP Technomed, Inc., are located in Cambridge, MA. The Company is committed to developing, manufacturing and marketing minimally invasive medical devices.

CONTACT: Christine Meehan

Vice President Marketing

EDAP Technomed, Inc.

179 Sidney Street

Cambridge, MA 02139

617.441.9212