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In Brief: Edap TMS S.A

This article was originally published in The Gray Sheet

Executive Summary

Edap TMS S.A: FDA approval of a premarket approval application supplement for the firm's Prostatron version 2.5 transurethral microwave thermotherapy (TUMT) device for treatment of moderate to severe benign prostatic hyperplasia obstruction is expected "in the coming weeks," Edap's Eric Simon, CEO, stated Oct. 27 at the Oppenheimer conference in New York City. The PMA supplement was filed in April. Edap's Prostatron version 2.0 was approved in May 1996 for treatment of symptomatic BPH ("The Gray Sheet" May 13, 1996, I&W-1). Edap's product pipeline also includes a compact, mobile version of the Prostatron and high-intensity focused ultrasound technology for the minimally-invasive destruction of certain types of tumors ("The Gray Sheet" May 19, I&W-3)...

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