SA: Non Invasive Prostate Cancer Treatment Available Soon
Published: May 23, 2005
U.S. HIFU, a development company headquartered in Charlotte, NC, announced today it has acquired exclusive distribution rights for the Sonablate® 500 in South Africa. U.S. HIFU has committed to purchase a minimum number of Sonablate® 500 units each year from Focus Surgery, Inc., of Indianapolis, IN, to place in the South African market.
The Sonablate® 500, developed and manufactured by Focus Surgery, is a non invasive medical device that uses High Intensity Focused Ultrasound (HIFU) to destroy tissue within the prostate without affecting surrounding tissue. In the past two-and-a-half years, nearly 3,500 total patients with prostate disease have been treated with the Sonablate® 500.
U.S. HIFU’s Chief Executive Officer, Steve Puckett Jr., sees significant growth potential in South Africa. “We have already initiated conversations with both prominent academic and private practice urologists in South Africa who will be the first physicians to perform HIFU with the Sonablate® on the African continent,” Puckett said.
U.S. HIFU is confident in an expeditious rollout of the Sonablate® 500, having already seen a consistent acceleration in demand for the HIFU procedure and a quick adoption of the technology by cutting-edge urologists.
“Stemming from the positive responses we’ve received from urologists viewing the procedure in our international clinics, we highly recommend that South African urologists contact U.S. HIFU directly for information about training and clinical trial opportunities,” Puckett added.
U.S. HIFU plans on conducting multiple clinical trials with the Sonablate® 500 including trials that will treat benign prostatic hyperplasia (BPH), localized prostate cancer and locally recurrent prostate cancer from failed external beam radiation or brachytherapy.
In approved countries, HIFU with the Sonablate® 500 has been successful as both a primary treatment for prostate disease and as a salvage treatment when radiation or surgery has failed and the cancer has returned. HIFU gives men experiencing recurrence a treatment option when few others remain.
“This South African expansion plan is in line with our mission to make HIFU with the Sonablate® 500 available worldwide, so that all men facing prostate disease will have access to the first completely non invasive treatment modality for prostate cancer and BPH,” Puckett said.
HIFU with the Sonablate® 500 is a non surgical procedure that uses focused ultrasound waves to raise the temperature of the targeted tissue in the prostate to more than 90 degrees Celsius in a matter of seconds, effectively destroying the tissue.
Treatment is performed using a transrectal ultrasound probe on an outpatient basis with an epidural anesthetic. The one-time treatment lasts two to three hours and, unlike radiation therapy, it can be applied repeatedly if needed. HIFU with the Sonablate® 500 does not require any additional surgeries, such as a transurethral resection of the prostate (TURP), making it the only entirely non invasive HIFU device.
The Sonablate® 500 is treating patients in Europe, including the United Kingdom, as well as parts of China, Japan, Mexico, Russia and the Dominican Republic. Five-year results from a Japanese study by Dr. Toyoaki Uchida reported an 88 percent clinical success rate at one year. Additionally, a multi-center study by Dr. George M. Suarez reports that 80 percent of patients had a prostate specific antigen (PSA) of less than one after one year with no incidence of urinary incontinence and minimal reports of erectile dysfunction.
Prostate cancer is one of the leading cancers in men worldwide. Incidence rates among South African males rank among the highest in the world and are second to those reported in the United States.
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