CHARLOTTE, N.C., Aug. 3 /PRNewswire/ -- On July 26, 2004 the Mexican Ministry of Health granted approval to U.S. HIFU, a development company based in Charlotte, NC, for the use of the Sonablate(R) 500 in Mexico for the treatment of prostate cancer with High Intensity Focused Ultrasound, or HIFU, technology. This is the first HIFU technology officially approved in Mexico.
The Sonablate 500(R), developed by Focus Surgery Inc. of Indianapolis, IN, is a noninvasive therapy device that uses the power of ultrasound to destroy deep seated tissue without affecting healthy surrounding tissue. Ultrasound energy is non-ionizing "clean energy" that does not affect tissue surrounding the target zone, as opposed to radiation therapies.
Steve Puckett, Jr., chief executive officer of U.S. HIFU, said, "Mexican approval for the Sonablate(R) 500 marks a new chapter in the fight against prostate cancer in the region. Mexican patients now have access to the most advance prostate cancer treatment available today."
In 2001, the Sonablate(R) 500 received approval in Europe and Japan. The device is also approved for use in the Dominican Republic.
Although the Sonablate(R) 500 is only approved for investigational use within the United States, U.S. HIFU is eager to offer HIFU to as many people as possible. "U.S. HIFU will not rest until this treatment option is available throughout all of the Americas," Puckett said.
The American Cancer Society reported in 2000 that 16.6 men out of 100,000 will die of prostate cancer in Mexico. The mortality rating is only slightly higher in the United States where on average 17.9 of 100,000 men will die of prostate cancer. Early prostate cancer has few symptoms and the only risk factors are age, ethnicity and family history of the disease.
U.S. HIFU is the distributor of the Sonablate 500 in North, Central and South America and the funding source for Phase II-III U.S. clinical trials for the device. The device was created by Focus Surgery Inc. of Indianapolis and is manufactured by Misonix Inc. of Farmingdale, NY. Misonix holds a minority ownership equity position in Focus Surgery and distribution rights in Europe. Takai Hospital Supply Ltd. (THS) of Tokyo also holds a minority equity ownership position in Focus Surgery and is the exclusive distributor in Asia. For more information on U.S. HIFU visit U.S.HIFU online at http://www.ushifu.com/ or http://www.internationalhifu.com/ .
U.S. HIFUCONTACT: Amanda Chinery of U.S. HIFU, +1-704-332-4308, oramandachinery@ushifu.com
