Channel Medsystems announced today that it received FDA approval for its next-generation Cerene cryotherapy device for treating menstrual bleeding.
Cerene initially received FDA premarket approval in March 2019 as a device with proprietary, hand-held technology for delivering cryotherapy to the lining of the uterus, freezing the tissue and significantly reducing future menstrual bleeding.
The device does not require gynecologists to invest in capital equipment and does not require the use of general anesthesia, enabling convenient and comfortable procedures to be performed in a gynecologist’s office.
Emeryville, Calif.-based Channel Medsystems’ newest version of the device delivers the 2.5-minute cryotherapy treatment with improvements to the manufacturing process ahead of scale-ups intended to meet the anticipated demand for office-based therapy, according to a news release.
“We are extremely pleased to announce the latest milestone in the evolution of our Cerene technology and feel the FDA’s approval of the newest Cerene device could not be more timely,” Channel Medsystems CEO Ric Cote said in the release. “With the COVID-19 pandemic, comfortable and efficient in-office treatment options are more critical to patients and gynecologists than ever. This approval will allow Channel, through our contract manufacturing partner SMC Ltd., to more quickly scale up and meet the demands of the marketplace.
“More importantly, it will put an innovative, safe and effective product for treating heavy menstrual bleeding in the hands of even more physicians, and will provide patients with the opportunity to receive effective treatment in a safe, familiar environment – their physician’s office.”