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Initial Studies of Channel Medsystems' Cryothermic Therapy Demonstrate Preliminary Safety and Tolerability; Results Presented at the 42nd AAGL Global Congress
Date:11/21/2013

SAN FRANCISCO, Nov. 21, 2013 /PRNewswire/ -- Results from histopathology and initial tolerability studies of Channel Medsystems' novel technology for endometrial ablation were presented at last week's AAGL Global Congress in Washington, D.C. The findings represent a first indication of the safety and effectiveness of this device, which is intended for use in the treatment of heavy menstrual bleeding, a condition that affects one in five women in the United States.  The published data demonstrate that the Company's cryothermic therapy had preliminary safety, created a favorable ablation profile, and was well-tolerated by subjects.  Evidence from these initial studies forms the foundation of a data set designed to prove that Channel Medsystem's device is an appropriate technology for the physician office setting.

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These initial studies were performed in subjects undergoing a planned hysterectomy. Histopathology data from these studies were analyzed by Dr. James Coad, a pathologist from West Virginia University and co-author of the published data.

The studies demonstrated that Channel Medsystems' cryothermic therapy (1) had an acceptable safety profile, (2) can be performed in a clinically appropriate timeframe, and (3) was well-tolerated by the subject without the need for general anesthesia or conscious sedation.  In addition, evaluation of the removed uteri revealed excellent cavity coverage and an ablation profile that mirrors currently-available hyperthermic therapies.  "This procedure appears to facilitate an appropriate depth of ablation of the endometrium, from a full-thickness ablation of the body of the uterus to a thinner ablation that is desirable in the cornua and lower uterine segment," sa
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