Emeryville, California, November 14, 2016
Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced the treatment of the first subjects in the US phase of its CLARITY Pivotal Study. CLARITY is a multicenter study to evaluate the safety and effectiveness of the Cerene™ Cryotherapy Device for endometrial ablation in women with heavy menstrual bleeding who are finished with childbearing.
In addition to demonstrating safety and effectiveness in reducing monthly bleeding, the CLARITY Study is designed to demonstrate outcomes across several key parameters including patient comfort, recovery time, and uterine healing. “We expect that the CLARITY study will confirm that the Cerene device can support a comfortable procedure without the need for IV sedation or narcotic pain medication,” said Ric Cote, President and CEO of Channel Medsystems. “This is the first endometrial ablation technology that was designed to deliver reproducible, successful outcomes in the comfort of the physician’s office — a lower-cost setting of care that both women and gynecologists prefer.”
In contrast to the heat-based endometrial ablation technologies available today, the Cerene device was designed and engineered from inception with patient comfort in mind. In addition to providing an analgesic effect, treatment with cryothermic energy has been shown to reduce the likelihood of scarring and intrauterine adhesions that are often associated with heat-based endometrial ablation. Intrauterine scarring and adhesions may contribute to the development of long-term complications and, ultimately, the failure of endometrial ablation.
“Cerene is different from other endometrial ablation technologies I routinely use,” said Dr. Jose Garza Leal, a leading Investigator at the Universidad Autónoma de Nuevo León in Monterrey, Mexico. “Unlike current heat-based ablation devices, my patients actually relaxed once the two-and-a-half-minute treatment was initiated. This was a completely different treatment experience for me, my patients, and my staff.”
The CLARITY Study includes clinical sites in the US, Mexico, and Canada.
About the Cryothermic Technology: The Cerene Cryotherapy Device was developed with feedback from leading clinicians and biomedical engineers. 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. The team at Channel Medsystems has integrated the cryothermic energy delivery system and the user controls into a disposable, self-contained, handheld 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