Major Milestones Announced For Sonablate 500 HIFU Treatment Of Prostate Cancer
Farmingdale, NY - Misonix, Inc. recently announced major milestones for the Sonablate 500 ("SB500"), a medical device using high intensity focused ultrasound ("HIFU") for non-invasive treatment of prostate cancer, at the American Urological Association's Annual Conference, held from May 19-24 in Anaheim, CA. Medical experts in the field of urology from around the world attended the conference and celebrated the milestones achieved by the SB500 which has now been used in 6,000 treatments in over 100 clinics over the past six years.
The American Urological Association's (AUA) Annual Conference is the world's largest meeting of urologic professionals. With more than 10,000 urologists and health care professionals and 5,000 exhibitors in attendance and over 350 exhibitors showcasing their urological products or services, there is no better place to learn about the latest advances in urology, such as those introduced for the SB500.
The SB500 was developed by Focus Surgery, Inc. and is manufactured by Misonix. Misonix also has the exclusive European distribution rights for the product. Misonix is an investor in privately-held Focus Surgery, one of the most prominent developers of HIFU technology in the world. Other investors in Focus include Takai Hospital Supply, Inc. (www.thsinternational.com), which has the exclusive distribution rights to market the SB500 in Asia, Australia, Japan and part of the Middle East, and US HIFU, LLC, the exclusive distributor in the Americas region and South Africa.
Focus Surgery and its international distribution partners showcased the SB500 at the annual AUA event to a groundswell of support. Momentum has been accelerating for the SB500, with adoption rates rapidly growing among urologists and other medical professionals. "We are seeing a shift among international as well as domestic physicians toward HIFU technology for the treatment of prostate cancer and other soft tissue cancers," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "As witnessed at the AUA conference this month and the annual European Association of Urology conference in March, medical professionals are signing up for training workshops, joining our information network and contemplating therapeutic applications with HIFU medical devices as part of their every day practices. These are clear indications that the global medical community is embracing HIFU technology -- and the SB500 in particular -- as one of the most significant scientific advances in years."
Urologists and other international users of the SB500 convened at the 7th Annual User Group Meeting on May 21, 2007, held simultaneously with the AUA conference. The user group meeting was chaired by Dr. Mark Emberton, a member of the Clinical Effectiveness Unit of the Royal College of Surgeons of England, London, UK, and Dr. T. Uchida, of Tokai University, Tokyo, Japan. Technological advancements in the software that powers the SB500 was the primary topic of discussion by Dr. Uchida, one of the world's most experienced users of the medical device. Results achieved by Dr. Uchida using the latest software, version 4.0 with enhanced 3-dimensional imaging capabilities, delivered improved efficacy and a success rate of 94% for the SB500, an increase of 50% as compared to earlier results with the prior software version. Dr. Uchida also stated that the technology upgrades enabled more efficient treatment cycles with procedure times reduced by an average of 48%. Treatments by Dr. Uchida, which based on his experience have been performed increasingly on patients with higher risk profiles as determined by age of patient and size of prostate, among other factors, are now in a range of under an hour to approximately 1.5 hours, a substantial decrease from a range of approximately 1.5 hours to over 2.5 hours prior to using the latest software package.
The annual user group meetings are intended to encourage dialogue among medical professionals currently or considering treating patients with the SB500. The event was a success as urology experts from Australia, Japan, Canada, the United Kingdom and the Dominican Republic shared clinical data. Dr. Emberton, another leading user of the SB500 who performs treatments on patients with higher risk profiles, was among the speakers who noted the favorable results and highly reduced morbidity for patients enrolled in an ongoing hemiablation study using the SB500. The results to date for the study showed that the hemiablation procedures were successfully completed with positive ablation of cancerous tissue in the effected area of the prostate gland, and patients showed 100% continence and 100% potency in follow-up examinations. Unlike many of the traditional prostate cancer surgeries which treat or remove the entire gland, HIFU hemiablation using the SB500 involves ablation of cancer in patients who have had biopsy-proven prostate cancer limited to one side of the prostate. It has been noted that patients undergoing radical prostatectomy treatment of the prostate gland experience erectile dysfunction between 20%-90% of the time and incontinence between 20%-30% of the time. These treatment options presented significant shortcomings for patients, until the new HIFU hemiablation technique was introduced.
Medical professionals from four continents participated in discussions at the user group meeting. Among other featured speakers, noteworthy contribution was made by a respected Canadian-based professor and chief of urology, who emphasized low morbidity and excellent results achieved in studies recently undertaken using the SB500 in his clinic.
A final milestone for the SB500 announced at the AUA meeting was the inauguration of the first Medical Advisory Board for the Americas. The purpose of the Board is to provide expert opinion and guidance to assist with the growth and adoption of current and future technologies, versus the Medical Review Committee which was established to provide oversight of the HIFU procedures and to provide a basis for standardization of treatment methods.
"We are gratified by the growing global interest in and success of the Sonablate 500," continued Mr. McManus. "Between Focus Surgery, US HIFU, Takai and Misonix, we are combining the strengths of four companies to elevate what increasingly is being understood as the world's most important medical device using unique technology for the treatment of prostate cancer. Through our collective endeavors, we have seen the performance of the SB500 steadily improve. Some of our more recent accomplishments for prostate cancer treatment include what we believe to be the most efficacious HIFU results documented and a substantial reduction in procedure time resulting from our continued investment in research and development. In the six years that the SB500 has been available for use, we have worked with surgeons from around the world with various backgrounds and professional practices. We have culminated a myriad of protocols and have advanced from treating low risk patients to successfully handling more aggressive cases. We believe our efforts with the SB500 will result in further progression of the impressive results announced to date, including optimal patient outcomes, minimization of negative quality of life issues and reduced health care costs as compared with surgical and other treatment methods for prostate cancer."
SOURCE: Misonix, Inc.