DELAND, Fla., May 13 USHIFU, LLC, the clinical trialmanagement provider for Focus Surgery, Inc. (Indianapolis, IN), is pleased toannounce conditional written approval pending minor changes to the protocolfrom the FDA to begin a pivotal trial for the treatment of recurrent prostatecancer with the Sonablate(R) 500 in men who have failed external beamradiation therapy.
Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine andmedical monitor for the trial said, "It is my pleasure to serve as the medicalmonitor for the prostate cancer clinical trial program evaluating the safetyand effectiveness of the Sonablate(R) 500 HIFU device."
"I have personally reviewed the preliminary data and observed theSonablate(R) 500 in action and I am impressed with this advanced technologyfor ablating the prostate. These rigorous clinical trials will help define theappropriate role of the Sonablate(R) 500 device in the treatment of prostatecancer," Lepor added.
This trial will be conducted at various sites across the U.S. and isexpected to enroll approximately 202 subjects and 10 clinical centers. Thisclinical trial is based on results from the feasibility trial completed inOctober 2007 which enrolled 11 subjects from two clinical research siteswithin the U.S. Ten of the eleven subjects had failed external beam radiationtherapy prior to participating in the clinical trial. The results of thisfeasibility trial provided a basis for the pivotal study. Additional studiesare still needed to satisfy the safety and effectiveness standards, includinglong term outcomes, set by the FDA for marketing approval.
The Sonablate(R) 500 is not approved for use in the U.S. The Sonablate(R)500 remains investigational in the U.S. and is being studied for the treatmentof prostate cancer in clinical trials in the U.S. FDA has made no decision asto the safety or efficacy of the Sonablate(R) 500 for the treatment ofprostate cancer.
The Sonablate(R) 500 was developed by Focus Surgery, Inc. and ismanufactured by Misonix, Inc. (Nasdaq: MSON) who also holds distributionrights in Europe. Takai Hospital Supply Ltd. and THS International distributethe Sonablate(R) 500 in Southeast Asia and the Middle East.
SOURCE USHIFU, LLC