BERKELEY, Calif. — (BUSINESS WIRE) — Channel Medsystems, Inc., a medical device company whose mission is to empower every woman to take control of her health journey, today announced that the first procedures in Europe were performed with the Cerene® Cryotherapy Device for the treatment of heavy menstrual bleeding (HMB). The procedures were performed by Fleur Bergwerff, M.D. at Bergman Clinics in Amsterdam, the largest network of clinics in The Netherlands providing outpatient care and procedures to focused medical specialists and their patients.
Professor Jan-Paul Roovers, Gynecologist and Director of Science and Innovation at Bergman Clinics, commented, “We are very pleased to have the opportunity to evaluate the Cerene Cryotherapy Device for the control of heavy menstrual bleeding. This important innovation provides an in-office, minimal anesthesia treatment that is much more accessible for patients and physicians, which will help more women gain relief from bothersome menstruation symptoms.”
Cerene Cryotherapy provides an endometrial ablation treatment using cooling technology (cryoablation) that can significantly reduce menstrual bleeding and dysmenorrhea. The use of cryotherapy also results in a unique healing profile that can preserve access to the uterine cavity for future diagnostic evaluations. The Cerene Cryotherapy Device received a CE Mark for endometrial ablations in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete.
“The evaluation of our Cerene Cryotherapy Device at the Bergman Clinics represents the first phase of our assessment of the clinical and commercial opportunity in Europe for this innovative technology,” said Ric Cote, Chief Executive Officer of Channel Medsystems. “We are pleased that our first procedures demonstrated the potential of the Cerene Cryotherapy Device to safely treat patients with heavy menstrual bleeding in an office environment with minimal anesthesia.”
About Cerene Cryotherapy
Cerene is an in-office endometrial cryoablation treatment that safely and effectively reduces heavy menstrual bleeding while naturally minimizing pain without requiring general anesthesia. The Cerene FDA pivotal clinical study (“CLARITY”), published in The Journal of Minimally Invasive Gynecology, concluded that 90% of all patients experienced normal, light or no bleeding and were satisfied with the procedure at 12 months following treatment. Additionally, results published in The Journal of Minimally Invasive Gynecology in November 2021 demonstrated that the use of cryoablation to treat the endometrium preserved access to the uterine cavity, with visualization in 91% of evaluated patients, and the ability to evaluate for pathologic change in 96% of patients whose uterine cavities could be fully visualized. The 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.
About Channel Medsystems
Channel Medsystems® is a privately-held company dedicated to empowering every woman to take control of her health journey and live her best life. With a commitment to deliver innovative technologies that exceed the expectations of women and their gynecologists, Channel strives to develop easy-to-use, safe, and cost-effective medical devices, resulting in exceptional outcomes and superior patient comfort that are accessible to all women. Channel Medsystems, Inc. is headquartered in Berkeley, CA.
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