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2014

High Intensity Focused Ultrasound (HIFU) Treatment for Prostate Cancer Now Available in Bermuda

US HIFU Selects Bermuda for Easy Access to Treatment for Patients and Physicians in the Northeast

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CHARLOTTE, N.C., May 17 /PRNewswire/ -- US HIFU, a worldwide leader in the development, distribution and use of minimally invasive high intensity focused ultrasound ("HIFU") technologies, is pleased to announce that its HIFU treatment for prostate cancer is now available in Bermuda. King Edward VII Memorial Hospital in Bermuda joins more than 100 centers in 30-plus countries to offer the innovative treatment with the Sonablate® 500 medical device.

Bermuda is the newest location to become part of US HIFU's international treatment program, which provides patients from the U.S. access to the Sonablate technology ("Sonablate HIFU") in international facilities where it is approved or authorized, since Sonablate HIFU is in the final phase of the FDA clinical trials and not approved for use in the U.S. As part of the US HIFU international treatment program, which began in 2004, patients and physicians travel to the Bahamas, Mexico, Canada and other jurisdictions outside the U.S. for the procedure.

"We were strategic in our selection of Bermuda so we could open up access to Sonablate HIFU for interested patients and physicians in the northeast," said US HIFU's CEO Steve Puckett, Jr. regarding the company's decision to introduce Sonablate HIFU in Bermuda at this time. "For ease of transportation, we expect to see a good number of patients and doctors from that area and eastern seaboard in general, but Bermuda's King Edward VII Memorial Hospital is just one more high-caliber choice open to any patients and doctors throughout the country."

Dr. Donald Thomas, the hospital's chief of staff, said, "We are very pleased to be able to offer this treatment. As we are only about a two-hour flight from the eastern U.S., we can offer this high-tech procedure very close to home for some U.S. patients in a stunningly beautiful island setting."

The first two patients were treated at the beginning of May by Dr. Stephen Scionti, NYU clinical associate professor of urology, who has been involved with Sonablate HIFU since 2006.

"The hospital is a modern, first-rate organization staffed by world-class physicians. As with the other US HIFU facilities, I believe patients can feel as confident in traveling offshore for the treatment as they can in going to their local hospital for an already approved procedure," said Scionti. "As a physician working away from my regular office, I am able to focus on my patients and their treatment when everything in the venue is in perfect order; King Edward VII Memorial Hospital was no exception."

Sonablate HIFU is designed as a minimally invasive prostate cancer treatment. International, 10-year data shows that men who choose Sonablate HIFU may be able to treat their disease while also minimizing risk for significant side effects common with prostate cancer therapies such as surgery or radiation. The technology allows physicians to ablate prostatic tissue with extreme heat generated from focused ultrasound waves. The ultrasound energy is delivered in rapid-fire succession to targeted tissue throughout the gland. The tissue at each target is destroyed while surrounding tissue remains unharmed.

Atlanta-resident Robert Jenkins, who received his HIFU treatment on Saturday, May 1, said, "From my perspective—and my physician's—everything ran like clockwork, from the procedure to the logistics involved with traveling to a different location. The staff was focused, friendly, caring and made sure I felt right before I left."

Regarding the future of Sonablate HIFU in Bermuda, Puckett said, "The current therapy involves whole gland ablation but we are looking ahead to the focal treatment of prostate cancer, beginning with the upcoming UK clinical trials. Bermuda is slated to be the international specialty site for our focal HIFU procedure."

About US HIFU US HIFU (USHIFU, LLC), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU manufactures the Sonablate® 500 medical device and is focused currently on treating primary and recurrent prostate cancer using Sonablate® HIFU. The company is engaged in ongoing research for technological advancements for the Sonablate® system or other ultrasound applications.

About the Sonablate® 500 The Sonablate® 500 is a minimally invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by Focus Surgery, Inc. and is manufactured in part by Misonix, Inc. (Nasdaq: MSON), which also holds distribution rights in Europe. Takai Hospital Supply Ltd. distributes the Sonablate® 500 in Southeast Asia. The Sonablate® 500 is not approved for use in the U.S. The Sonablate® 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer.

SOURCE US HIFU



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