Emeryville, California, March 20, 2017
Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The goal of the CLARITY study is to evaluate the safety and effectiveness of the Cerene® Cryotherapy Device (Cerene device) in 242 women with heavy menstrual bleeding who are finished with childbearing.
Investigators in the CLARITY study enrolled women at eight US and limited international study sites. The first US subject was treated in October 2016, with the completion of treatments just five months later in early March 2017. Study Investigators were able to rapidly enroll women in the study due to the strong appeal of the Cerene device, which was designed to address women’s need for an effective, comfortable, office-based treatment with minimal to no downtime after the procedure. “The Cerene cryoablation is a convenient, simple, and well-tolerated office procedure,” said Dr. Ted Anderson, Director of the Division of Gynecology at Vanderbilt University Medical Center and Investigator in the CLARITY study. “A patient can have this treatment the same way she has an IUD placed – in her gynecologist’s office with minimal pain management and very little discomfort. This has the potential to be a real game-changer for ablation.”
In contrast to studies of heat-based ablation devices, almost all the women in the CLARITY study were awake and aware during the Cerene procedure. This allowed Investigators to collect pain scores at seven unique time points before, during, and after the procedure, resulting in nearly 1,700 data points. “A true, office-based endometrial ablation device has eluded gynecologists because the patient pain associated with heat-based ablation devices often requires the use of conscious sedation or hospitalization for general anesthesia,” said Dr. Andrew Brill, former President of AAGL and Medical Advisor to Channel Medsystems. “However, the treatment phase of the CLARITY study demonstrated that it is possible – and even preferable – to comfortably perform ablations with this device using local anesthesia along with an over-the-counter pain reliever.”
Providing endometrial ablation in the office setting also creates value for key healthcare stakeholders: women, gynecologists, and payers. In addition to being a more efficient setting of care for gynecologists, the office is associated with lower out-of-pocket costs for women and lower total procedural costs for payers.
About the Cryothermic Technology: The Cerene Cryotherapy Device was developed with feedback from leading clinicians. Cryoablation, the use of extreme cold to destroy tissue, is a well-characterized, durable therapy routinely used to ablate malignant and benign cardiac, liver, breast, and prostate tissue, among others. In the uterus, the use of cryothermic energy has been shown to reduce the likelihood of scarring and intrauterine adhesions that are often associated with heat-based treatments. Intrauterine scarring and adhesions may contribute to the development of long-term complications including re-operation and, ultimately, the failure of endometrial ablation. The team at Channel Medsystems has integrated the cryothermic energy delivery system and the user controls into a disposable, self-contained, ergonomic device, eliminating the need for capital equipment.
About Channel Medsystems: Channel Medsystems is a privately-held company that was spun out of the incubator TheraNova. The Company 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 women 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 limited to investigational use in the US, Canada, and Mexico.
Ric Cote, President & CEO
Rhonda Bracey, VP Finance
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