Channel Medsystems has announced that it has earned CE Mark approval, allowing the Company to initiate marketing efforts and commercialisation 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.