San Francisco, California, November 18, 2013.
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.
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,” said Dr. Coad. “The precision in the depth of ablation is a key factor in achieving an effective outcome without compromising the function of the underlying uterine tissue.”
“These results are promising and indicate that our cryothermic therapy is ready for the next stage of evaluation,” said Ric Cote, President and CEO of Channel Medsystems. “We are looking forward to beginning enrollment in our Cryoablation Feasibility Trial (CRYSTAL), where we will focus on assessing outcomes in women with heavy menstrual bleeding up to six months after the procedure.” The CRYSTAL study is designed to further evaluate the effectiveness and tolerability of Channel Medsystems’ in-office cryothermic procedure at leading centers in Canada and will begin enrollment this month.
About the Cryothermic Technology Platform: Channel Medsystems’ novel cryothermic technology and streamlined delivery system were developed with feedback from leading clinicians and biomedical engineers at the healthcare incubator, Theranova. The technology integrates cryothermic energy and the user controls into a self-contained, handheld device, eliminating the need for a separate control unit or capital equipment.
About Channel Medsystems: Channel Medsystems is a venture-backed company that was founded to bring innovation to the delivery of women’s healthcare. The Company strives to develop treatments to meet the unique needs of female patients and the high standards of their healthcare providers. Channel Medsystems is committed to ensuring that patients have access to high quality outcomes that can be delivered in the convenience and comfort of their healthcare provider’s office. For more information, please visit www.cerene.com.
CAUTION: This device is available for investigational use in Canada. It is not available for sale or
investigational use in the United States.
Christine Greenspan, Operations Manager
Ric Cote, President & CEO
Important Safety Information
Cerene® Cryotherapy Device is indicated to ablate the endometrial lining of the uterus in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete. Pregnancy following the Cerene procedure can be dangerous; therefore, contraception must be used until menopause. The Cerene procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Cerene Cryotherapy Device. Temporary side effects may include cramping, nausea, vomiting, vaginal discharge and spotting. For detailed benefit and risk information, consult the Cerene Instructions for use (IFU) or your healthcare professional. Learn More