Channel Medsystems announced today that long-term clinical outcomes support its Cerene cryotherapy for treating heavy menstrual bleeding (HMB).
Long-term outcomes from the Clarity clinical study evaluating the safety and effectiveness of Cerene cryotherapy were published in the International Journal of Women’s Health.
Emeryville, California-based Channel Medsystems designed Cerene as a proprietary, hand-held technology for delivering cryotherapy to the lining of the uterus, freezing the tissue and significantly reducing future menstrual bleeding. The company received FDA approval for the platform in 2020.
The in-office endometrial cryoablation treatment safely and effectively reduces heavy menstrual bleeding while naturally minimizing pain without requiring general anesthesia, the company said in a news release.
In the study, Cerene is presented as a well-tolerated endometrial ablation that provides a significant reduction in HMB symptoms and an improvement in quality of life with high satisfaction through three years after treatment.
The prospective, multi-center, single-arm, open-label study evaluated 242 premenopausal women who underwent cryoablation with Cerene, with follow-up assessments at 12, 24 and 36 months. In total, 201 patients completed long-term follow-up at 36 months.
Channel Medsystems said that results demonstrated reduced menstrual bleeding patterns reported by patients remaining stable from month 12 to month 36, with 90.9% of patients describing their menstrual period as none, lighter than normal, or normal at 12 months, followed by 88.6% at 36 months.
The company also reported high patient satisfaction (85% “satisfied or “very satisfied”) while 91% said they would “definitely” or “maybe” recommend Cerene. Patients maintained quality of life improvements, with 91% of patients reporting zero or slight limitations in life activities at 36 months.
Additionally, 85% of patients reported being free of premenstrual symptoms “often,” “most often,” “very often,” or “all of the time” at 36 months. No serious adverse device-related effects were reported in the study and the cumulative incidence of medical and surgical interventions was statistically low at 8.7%.
Lead author, Dr. Howard L. Curlin of the Vanderbilt University Medical Center, said in the release that the findings “should give physicians confidence in the long-term benefits of Cerene endometrial cryoablation.”
“The 36-month results adds to the growing body of evidence that support the clinical utility, durability and safety profile of Cerene. The data confirm that this novel treatment is an important advancement for patients suffering with HMB,” said Ric Cote, president and CEO of Channel Medsystems. “We look forward to building on our commercialization efforts to bring Cerene to more physicians and their patients across the country.”