Sonablate® HIFU for Prostate Cancer in New Locations Outside the U.S.

CHARLOTTE, N.C., Feb. 16, 2011 /PRNewswire/ -- USHIFU LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate® 500 medical device (Sonablate), announces that HIFU with the Sonablate (Sonablate HIFU) is available to prostate cancer patients for the first time in Brazil at Hospital Nossa Senhora das Gracas in Curitiba, capital city of the state of Parana in southern Brazil. In addition, prostate cancer patients may now seek Sonablate HIFU treatments at Russia's Center Zdorovie in Rostov-on-the-Don, the second institution in that country to offer the minimally invasive procedure.

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Sonablate HIFU is a targeted approach to treating prostate cancer with precision-focused ultrasound energy that, when delivered, raises the temperature of the tissue in a matter of seconds, resulting in its destruction. The tissue throughout the prostate is destroyed while structures outside the gland remain unharmed.

US HIFU worked with a seven-physician group headed by urologist Marcelo Bendhack, M.D. to bring Sonablate HIFU to Brazil. Bendhack, president of UROLA (Latin American Uro-Oncology Association) trained in the HIFU technology in 2007 and has since performed multiple procedures and participated in treatments in Germany, Mexico and Argentina. He has treated four patients at Hospital Nossa Senhora das Gracas since mid-January when the technology became available there.

"It is exciting to be able to offer this very important modality to the hospital's prostate cancer patients in Brazil and to be involved with the first four patients, all of whom did very well during and post treatment," said Bendhack. "Ultrasound technologies are highly appreciated because of their cancer control and lower risk for complications as compared to other classic treatment modalities."

Russia's Zdorovie acquired a Sonablate device in late 2010. Professor Igor Aboyan, the center's lead physician, and Dr. Sergey Pavlov, head of the surgical department, and Dr. Konstantin Badyan and Dr. Armen Galstyan, who oversees the new Sonablate HIFU program, trained in the technology in preparation for the first HIFU prostate cancer treatment on January 18. The physicians performed eight additional procedures over the next three days.

"The technology is new and is very exciting to our colleagues. We were happy to have such a good start and hope to help many more men not only from our region but from the nearby regions as well," said Aboyan.

Specialists from the U.K. and doctors from the NII of Urology, Russia's main urological institute located in Moscow, assisted with the initial procedures. Physicians from NII began performing Sonablate HIFU procedures in 2008.

For more information on these organizations, please visit: http://www.hnsg.org.br/ (Hospital Nossa Senhora das Gracas), http://center-zdorovie.ru/ (Zdorovie) and www.ushifu.com (US HIFU).  

Sonablate HIFU is under FDA investigation in the U.S., but commercially available in more than 30 other countries, including Brazil and Russia. There are nearly 400 trained Sonablate users worldwide. More than 9,000 patients have undergone Sonablate HIFU outside the U.S. where the technology is available.

Currently there are 19 active clinical trial sites in North America, including some of the most respected institutions, enrolling men who have experienced a prostate cancer recurrence following external beam radiation therapy (EBRT). Additional information, including enrollment criteria and site details, may be found at www.clinicaltrials.gov (search term fsi003) or www.ushifu.com.

"We are so pleased to extend Sonablate HIFU to patients in Brazil and expand in Russia, particularly via such well-known facilities," said Alex Gonzalez, International HIFU's vice president of international operations. "With prostate cancer being such a prevalent disease and one whose treatment options can carry significant quality-of-life risks, the more minimally invasive treatment choices patients have access to, the better. We look forward to our continued relationship with the hospitals and their physicians and what this means for patient care."

About USHIFU LLC

USHIFU LLC (US HIFU),a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU is committed to treating prostate cancer using HIFU with the Sonablate® 500, a minimally invasive, outpatient procedure pioneered to control cancer and significantly improve patients' quality of life. The company is engaged in ongoing research for technological advancements for the Sonablate® system and/or other ultrasound applications.

US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. Additional information may be found at www.ushifu.com.

About the Sonablate® 500

Focus Surgery, Inc., a US HIFU subsidiary based in Indianapolis, Ind., developed the Sonablate® 500 medical device. Takai Hospital Supply Ltd. distributes the Sonablate® 500 in Southeast Asia.

The Sonablate® 500 is approved for investigational use within the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer. Currently, the device is available for the treatment of prostate cancer outside the U.S. in more than 30 countries.

About Hospital Nossa Senhora das Gracas

Hospital Nossa Senhora das Gracas is a private hospital in Curitiba, renown for its bone marrow and liver transplant programs, neurosurgery and cardiac surgery, to name a few. More than 500 physicians and 1,100 staff members make up the hospital system, which offers treatment for a wide variety of disorders and diseases. Within the uro-oncology department, clinicians perform a high volume of radical prostatectomies, surgeries for adrenal and kidney cancer and cistectomies with orthotopic bladder replacements, among others.

For additional information, please contact the hospital: 55 41 33525911 or 55 41 99637888; Rua Maua, 1111, Curitiba 80030-200, Brazil, http://www.hnsg.org.br/.

About Zdorovie

Clinical diagnostic center Zdorovie, located in Rostov-on-the-Don is a multi-disciplinary medical center that deals with diagnostics, treatment, analysis, ultrasound diagnostics, surgery and more. The center, established in 1993, has become one of the largest medical centers in the southern region of Russia.

SOURCE USHIFU, LLC