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Channel Medsystems Receives Health Canada Approval to Begin Clinical Evaluation of its Innovative Procedure for Heavy Menstrual Bleeding; Hires Mary Edwards as Senior Vice President, Clinical and Regulatory Affairs.
Date:11/11/2013

SAN FRANCISCO, Nov. 11, 2013 /PRNewswire/ -- Channel Medsystems has received investigational testing authorization from Health Canada to begin enrolling patients in the Cryoablation Feasibility Trial (CRYSTAL), a multi-site clinical trial designed to evaluate its innovative cryothermic treatment for heavy menstrual bleeding due to benign causes.  The CRYSTAL study is designed to evaluate the efficacy and tolerability of Channel Medsystems' in-office cryothermic procedure. The Company expects to enroll its first patient in November.

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One in five women suffers from heavy menstrual bleeding, impacting both their health and quality of life. In the US, global endometrial ablation (GEA) is the most common procedure for treating heavy menstrual bleeding.   Existing GEA procedures are typically performed in a hospital or outpatient surgical center and often require general anesthesia or conscious sedation to reduce discomfort during treatment.   Recovery times and outcomes are often highly dependent on the technology used, the skill of the physician and the anesthesia regimen elected.

Channel Medsystems' cryothermic device was developed to provide patients suffering from heavy menstrual bleeding -- and the physicians who treat them -- the option of an effective, safe and well-tolerated treatment that can be easily incorporated into the physician's office practice.  The technology uses cryothermic energy that gynecologists have relied on for years to perform delicate procedures. The two-and-a-half minute treatment takes advantage of the analgesic effect of cold energy and early clinical results suggest that Channel's cryothermic procedure can be comfortably done with minimal anesthesia.

"Our mission is to develop procedures that are effective, safe and
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