Emeryville, California, July 21, 2020
Next-generation technology enhances ease-of-use for physicians and streamlines manufacturability
The Company is targeting limited market introduction in Q42020 and commercial launch of the Cerene® Device in the first half of 2021
Channel Medsystems® (“Channel”), a company dedicated to bringing innovation to the delivery of women’s healthcare, today announced that the U.S. Food and Drug Administration (FDA) recently approved the newest Cerene® Cryotherapy Device, a next-generation technology for the treatment of heavy menstrual bleeding in the office setting.
Originally approved by the FDA in March 2019, Channel’s Cerene® Device uses proprietary, hand-held technology to deliver cryotherapy to the lining of the uterus, freezing the tissue and significantly reducing future menstrual bleeding.
In most patients, the procedure preserves the ability to access and evaluate the uterine cavity in order to diagnose and care for intrauterine conditions post-treatment. The Cerene® Device’s innovative and disposable design does not require gynecologists to invest in capital equipment, and does not require use of general anesthesia, together enabling procedures to be performed conveniently and comfortably in a gynecologist’s office. In contrast, heat-based global endometrial ablation devices currently on the market require investment in capital equipment and are typically performed with general anesthesia in hospitals or surgery centers.
Channel’s newest Cerene® device delivers the same 2.5-minute cryotherapy treatment and clinically-validated effectiveness as its previously FDA-approved predecessor, further enhanced with improvements to rapidly scale-up manufacturing to meet the anticipated demand for office-based therapy. The approval comes following a comprehensive FDA review of all design and manufacturing process changes.
“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.” said Ric Cote, Chief Executive Officer of Channel Medsystems®. “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.”
For more information about the Cerene® Cryotherapy Device, please visit www.cerene.com.
About the Cerene® Cryotherapy Device
Developed with feedback from leading clinicians, the Cerene® Cryotherapy Device is Channel’s next-generation technology 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 while preserving the possibility to adequately evaluate the endometrial cavity in most patients to diagnose and treat future intrauterine conditions. 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.
About Heavy Menstrual Bleeding
It is estimated approximately 10 million women of reproductive age experience abnormal uterine bleeding in the US annually. 24 percent of the US women rated their periods as heavy or very heavy and some two million women seek treatment each year. Heavy Menstrual Bleeding (HMB) is associated with diminished quality of life, loss of productivity and increased healthcare expenses.
About Channel Medsystems®
Channel Medsystems® is a privately-held company founded to bring innovation to the delivery of women’s healthcare. Channel strives to develop treatments to meet the unique needs of female patients and the high standards of their healthcare providers. Channel Medsystems® is committed to ensuring that women have access to high quality outcomes that can be delivered in the convenience and comfort of their healthcare provider’s office. For more information, please visit www.cerene.com.
Megan Bouchier / Leah Polito
Sard Verbinnen & Co.
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