FDA approves Cryotherapy device for treatment of heavy menstrual bleeding

The U.S. Food and Drug Administration (FDA) has approved the Cerene® Cryotherapy Device as a new approach to treating heavy menstrual bleeding. The device uses cryotherapy to freeze the endometrial lining of the uterus to reduce future menstrual bleeding in premenopausal women who are not planning to become pregnant.

The new Device delivers cryotherapy to freeze the lining of the uterus to significantly reduce future menstrual bleeding and this procedure does not require general anaesthesia. It can, therefore, be performed in the gynaecologist's office in n contrast, heat-based endometrial ablation devices which are more often performed with general anaesthesia in hospitals or surgery centres.

"The Cerene Device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system,” said Ric Cote, President and Chief Executive Officer of Channel Medsystems. “The shift away from the operating room that the Cerene Device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually.”

CLARITY, the pivotal study supporting the safety and effectiveness of the Cerene Device and its FDA approval, included treatment of 242 subjects. At 12 months, the observed reduction in menstrual bleeding exceeded treatment goals. "We are extremely pleased by the results of the CLARITY study and the positive feedback we have received about the Cerene Device, both from study investigators and numerous gynecologists surveyed," said Ric Cote, President and Chief Executive Officer of Channel Medsystems. "The Cerene Device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system. The shift away from the operating room that the Cerene Device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually."

CLARITY is the first study to provide comprehensive data on both the patient experience of pain and post-ablation cavity access, two clinical findings that are highly relevant to gynecologists when selecting an endometrial ablation device. Subjects' median pain score ranged from 0 to 2 (on a 0-10 numeric scale) across eight different peri-procedural time points, with no subjects requiring general anesthesia. Hysteroscopy performed 12 months following the procedure demonstrated an accessible uterine cavity in 98.7% of 223 available subjects. CLARITY investigator Ted Anderson, M.D., Ph.D., Vice Chair of Clinical Affairs and Director of the Division of Gynecology at Vanderbilt University Medical Center, noted this was a "critical finding that allows for diagnostic evaluation including sampling of the endometrium rather than forcing hysterectomy because of unevaluable post-ablation bleeding and/or pain."

In a Channel Medsystems survey of over 450 gynecologists, the vast majority reported that they would recommend endometrial ablation more often if perioperative pain and clinically-significant intrauterine adhesions were reduced (81% and 79%, respectively). Anderson stressed "women who suffer from heavy menstrual bleeding are seeking safe and effective treatments that are well tolerated with minimal inconvenience. Channel Medsystems has developed a treatment that is easy to use, is reproducible in any setting of care, and is very well tolerated without anesthesia. The development of new technology like the Cerene Device could allow gynecologists to provide a safe, effective, affordable, and convenient treatment to the millions of women who seek care for heavy menstrual bleeding annually in the United States."

The Cerene Device was developed with feedback from leading clinicians and is indicated for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. Cryoablation is a well-characterized, durable therapy routinely used to ablate malignant and benign human tissues. 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 the failure of heat-based ablation treatments. The team at Channel Medsystems has integrated the cryothermic energy delivery system into a disposable, self-contained, ergonomic device, eliminating the need for capital equipment.