Results Promising From U.K. Clinical Trial Investigating Sonablate HIFU as a Focal Treatment for Prostate Cancer

CHARLOTTE, N.C., April 28, 2011 /PRNewswire/ -- USHIFU LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate® 500 (Sonablate) medical device, announces results from the first-ever prospective clinical investigation of HIFU with the Sonablate (Sonablate HIFU) to focally treat prostate cancer, a modality in which only the confirmed cancerous regions within the gland are treated as opposed to the entire prostate. Results from the study appear in this month's Journal of Urology.

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Researchers at UCL (University College London) and clinicians at University College London Hospitals NHS Foundation Trust (UCLH), backed by US HIFU and eight U.K. partner organizations* conducted the ethics-approved, independently audited study to determine the effectiveness of focal Sonablate HIFU at reducing side effects such as impotence and incontinence—comorbidities that can accompany more traditional modes of treatment and diminish a patient's quality of life—while also treating the cancer.

Trial investigators treated 20 patients with low- and medium-risk disease by delivering HIFU energy to the side of the prostate affected by cancer, a procedure known as a hemi-ablation. Patients returned regularly for follow-up testing for one year following treatment. Study results showed reduced harmful side effects and positive cancer control results.

"Based on percentages, our early trial results have shown that more men were unaffected by the long-term problems of leaking urine or poor sexual function than has been possible with any other standard treatments," said Professor Mark Emberton, M.D., chief study investigator and clinical director for cancer services at UCLH. "Early cancer control was also very encouraging, but more work needs to be done to look at this," said Emberton.

"Nearly 90 percent of study participants achieved the perfect result, or trifecta status, meaning that they achieved pad-free, leak-free continence, erections sufficient for intercourse and cancer control at 12 months. In addition, 95 percent of participants achieved good erections, 90 percent had no cancer on tissue samples taken following treatment and 100 percent had no significant cancer.

"Prostate cancer has a long natural history, meaning that the cancer grows slowly. Focal therapy appears to offer the balance between treating the cancer and minimizing the collateral tissue damage, which marks a paradigm shift in how we treat prostate cancer," said Hashim Uddin Ahmed, lead author and clinical lecturer in urology at UCL.

Sonablate HIFU is a minimally invasive, 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 targeted tissue is ablated while untargeted tissue remains unharmed.

Study authors concluded that the results were sufficiently promising to support the further evaluation of focal therapy. A larger, multi-center study involving more than 120 patients across the U.K. will determine whether the findings are reproducible. "Currently the decision pathways for how to manage prostate cancer are very polarized. On one end of the spectrum you can do nothing and monitor the disease and, on the other end, there is radical intervention which is associated with major quality-of-life implications," said US HIFU CEO Steve Puckett, Jr. "We believe focal HIFU will strike the right balancing act between these polarized extremes."

Sonablate HIFU is under FDA investigation in the U.S., but commercially available in more than 30 countries. 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.

*A complete list of U.K. partner organizations may be found at www.pelicancancer.org.

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.

SOURCE USHIFU LLC

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