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NCI Funded Clinical Trial to Study Treatment of Breast Cancer Using Cryoablation
Date:10/28/2008

Sanarus' Visica 2(TM) Treatment System Selected as Exclusive Cryoablation

Treatment Technology

PLEASANTON, Calif., Oct. 28 /PRNewswire/ -- The American College of Surgeons Oncology Group (ACOSOG) which just initiated a National Cancer Institute (NCI) funded clinical trial entitled, "A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma," has selected the Visica 2(TM) Treatment System from Sanarus Medical as the exclusive technology to be utilized in the cryoablation portion of this study.

The ACOSOG study protocol (designated as Z1072) will evaluate not only cryoablation but also the ability of Magnetic Resonance Imaging (MRI) to evaluate post-cryoablation efficacy in approximately 100 patients and 20 clinical sites. Patient enrollment into the study is currently anticipated for early 2009. The Phase II Trial is similar to a pilot study conducted by Gary Levine, MD, Medical Director at Hoag Breast Care Center in Newport Beach, Calif., and Steven Poplack, MD, Co-Director of Breast Imaging at Dartmouth Hitchcock Medical Center. Results of the pilot study will be presented for the first time at this year's Radiological Society of North America (RSNA) 94th Scientific Assembly and Annual Meeting in Chicago. Both the pilot study and pending ACOSOG clinical trial share the common clinical protocol elements of cryoablation followed by MRI, surgical resection of the tumor and subsequent pathological evaluation.

"Cryoablation has been used effectively for years to treat a number of medical conditions, including benign breast tumors, so it is a natural progression to study its use in the treatment of breast cancer," said Dr Levine. "We are very encouraged about the promising initial results in our pilot study and believe further research is warranted in order to develop and refine this potential breakthrough breast cancer treatment."

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SOURCE Sanarus Medical
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