Misonix has announced the acceleration of patient enrollment relating to the FDA clinical trials for the Sonablate 500 (SB500), a medical device using high intensity focused ultrasound (HIFU) for non-invasive treatment of prostate cancer. The Sonablate 500 is approved by the FDA as an investigational device for clinical trials in the US. The increased enrollment pace pertains to the ongoing FDA approved pivotal study for the treatment of prostate cancer. Over 16 patients in the pivotal study have been treated using the SB500 device at two clinical study sites. A third clinical study site started treatments in June 2007.
Drs Michael Alabaster and Walter Rayford recently released preliminary data from the first US clinical trials for the treatment of de novo localised prostate cancer using the SB500. Based on their positive results, the doctors report that interest in participating in the FDA clinical trials has been extremely heavy, with calls received from all over the country requesting patient entrance into the trials.
Alabaster, managing partner with Southeast Urology Network (SUN) of Memphis, TN, had been performing HIFU procedures outside of the US for approximately two years prior to his participation in the FDA clinical studies using the SB500. He stated that the demand for this procedure is great, with scores of American citizens going for HIFU treatment every month in Europe, Canada, Mexico, and the Dominican Republic where the SB500 is presently being used. HIFU treatment with the SB500 only became available in the US as part of the next phase of FDA approval process which commenced in March 2007.
