San Francisco, California, November 11, 2013.
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.
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 well tolerated under minimal anesthesia. We believe our innovative delivery of cyrothermic energy provides an excellent platform to treat heavy menstrual bleeding and we are excited to validate this application in our CRYSTAL clinical trial. Ultimately, we believe our technology will accelerate the transition of GEA procedures into the office setting, which in turn should translate into significant cost reductions for the healthcare system,” said Ric Cote, President and CEO of Channel Medsystems.
Channel Medsystems also announced it has hired Mary Edwards, one of the top clinical and regulatory experts in the field of women’s health, to run its North American trial and to serve as the Company’s Senior Vice President of Clinical and Regulatory Affairs. “Throughout my career, I have been a passionate advocate for technologies and procedures that benefit women,” said Ms. Edwards. “Our technology couples the gentle and safe profile of cryothermic energy with an intelligent system that supports precision and ease of use. I am excited to be in a position where I can help bring a much-needed innovation to women suffering with heavy menstrual bleeding.”
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, hand held 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