2006 American Urology Association Conference
Attendance by doctors from around the world indicated a strong interest in the Sonablate 500 (SB500), the medical device developed by Focus Surgery and manufactured and distributed in Europe by Misonix, which uses High Intensity Focused Ultrasound (HIFU) for the treatment of prostate cancer. Misonix also had visual and personal presentations on the SB500.
There were more than 80 physician users of the SB500 at the 6th Annual SB500 users group meeting at the AUA. There were eight separate presentations by urologists from the U.S., Canada, the U.K., Japan, Australia and Austria talking about the benefits of the SB500. Dr. Grunberger gave a presentation on the progress of the recurrent prostate clinical trial and Dr. Uchida presented 7 years of treatment data on 573 patients. Dr. Toyoaki Uchida concluded that the new software with faster treatment improved outcome. Dr. Mark Emberton presented on Visually Directed HIFU by the SB500 and demonstrated how to guide the Doctors controlled treatment using the Sonablate-500 HIFU that resulted in PSA of less than 0.2 ng/mL.
The new Version 4 software for the SB500, which provides for faster treatment times, 3D imaging with treatment planning color Doppler for Neuro Vascular Bundler (NVB) detection and other advancements, was also demonstrated. The doctors in attendance showed heightened interest in learning that the SB500 did not require Trans Urethral Resection of the Prostate (TURP) as required by other HIFU treatments. In addition, doctors noted that other HIFU treatments could only treat prostate heights of 25mm as compared to 45mm for the SB500 and without TURP procedures.
Dr. Michael A. Marberger, Chairman and Professor of the Department of Urology, Vienna, Austria who is a user of the Sonablate 500, taught an official Continuing Medical Education (CME) course on HIFU (organized by the AUA). During this course, he showed that HIFU has good modality with minimal side effects and showed the difference of the Sonablate using 4 MHz frequency that produced higher treatment temperatures and less cavitation.
Dr. Marberger presented facts relating to the difference between the Sonablate 500 HIFU device and the Ablatherm device. While the Ablatherm device requires a Trans-Urethral-Resection (TURP) and a maximum prostate height of 25mm Vs. 45mm and no required TURP for the Sonablate 500 device. In Dr Marberger's opinion, the requirement of a TURP procedure is in contrast to being a minimally invasive procedure.
Dr. Marberger's class on HIFU was a dedicated lecture on HIFU only and was well received by a total of 90 urology attendees. The basics of HIFU were presented with a pointed difference of why the 4 MHz frequency of Sonablate 500 device is a superior choice of operation. A movie of Doppler NVB detection using the SB500 was also presented. The 3D array of our work was presented in a second movie to show the technology of the future. Dr. Marberger also mentioned that the faster software now implemented on the SB500 and is very efficient. Dr. Marberger mentioned and demonstrated problems of extracorporeal HIFU device for the treatment of kidney and suggested that a laparoscopic approach has a higher probably of success. He said that prostate is the ideal organ for the HIFU application.
Michael A. McManus, Jr. President and CEO of Misonix noted, "I continue to be impressed by the number of prominent urologists expressing serious interest in adding to their practice the treatment of prostate cancer using HIFU with the Sonablate 500. We already have some of the most prominent urologists working with us in clinicals and procedures across Europe. It is a real pleasure to come to the AUA -- with momentum for our product increasing year after year -- and talk with some of the best urologists in the world. I consider doctors presently working with us, including Dr. Toyoaki Uchida from Japan and Dr. Mark Emberton from the U.K. to be among the very best. Our recent results show that 84% of patients were able to achieve success as measured by PSA nadirs dropping to 0.2 ng/ml or less without a TURP procedure.
"Later in 2006, we will be completing the first five site clinical done in Europe on the treatment of prostate cancer using the SB500, which includes procedures performed on 75 patients.
"We are also excited about our new Sonatherm product using HIFU in a laproscopic kidney procedure. At the AUA, Dr. Ari Shalov of the University of Chicago made a presentation of the benefits of the Sonatherm product. We will be starting clinicals in Europe using the Sonatherm at several sites.
"We are very pleased with our association with Focus Surgery as its European distributor of the SB500. The experts at Focus Surgery continue to provide us with new advanced technology, such as the new Visually Directed HIFU for the treatment of prostate cancer."