Emeryville, California, June 26, 2017
Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced today that it has earned CE Mark approval, allowing the Company to initiate marketing efforts and commercialization of its Cerene Cryotherapy Device (Cerene device) in Europe. The Cerene device is intended for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes in whom childbearing is complete.
Current endometrial ablation procedures can be painful and often necessitate the use of general anesthesia in the hospital outpatient setting. In contrast, the Cerene procedure was designed to address women’s desire for an effective, comfortable, office-based treatment with minimal to no downtime after the procedure. “From inception, our team has worked to understand what women and gynecologists are seeking in a new treatment for heavy menstrual bleeding,” said Ric Cote, President and CEO of Channel Medsystems. “We’ve integrated that feedback into our development process and are excited that women in Europe will now have access to a treatment that is intended to meet their unique needs.”
Although several treatments for heavy menstrual bleeding exist, ranging from hormonal therapy to hysterectomy, many women remain untreated. “Finding the right treatment can be a challenge for women,” said Dr. Mark Hans Emanuel, a gynecology specialist at the University Medical Center in Utrecht, Netherlands. “The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia.”
In March 2017, Channel Medsystems completed the treatment phase of a 242-woman pivotal study in the US and is currently collecting follow-up data as required by the FDA.
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