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Channel Medsystems® Receives U.S. FDA Approval of the Cerene® Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding

Emeryville, California, April 2, 2019. Channel Medsystems®, a company dedicated to bringing innovation to the delivery of women’s healthcare, today announced that the U.S. Food and Drug Administration (FDA) has approved the Cerene® Cryotherapy Device as a new approach to treating heavy menstrual bleeding.

The Cerene Device delivers cryotherapy to freeze the lining of the uterus in order to significantly reduce future menstrual bleeding. The unique design of the Cerene Device and use of extreme cold results in a procedure that does not require general anesthesia and can be performed in the gynecologist’s office. In contrast, heat-based endometrial ablation devices currently on the market are more often performed with general anesthesia in hospitals or surgery centers.

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Channel Medsystems® Secures $14.1mm Financing for Office-Based Treatment of Heavy Menstrual Bleeding

Emeryville, California, August 23, 2017. Channel Medsystems, developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced today that it has secured a $14.1mm Series C-1 financing. The insider-led round included participation by Third Point Ventures, InCube Ventures, Aperture Venture Partners, Scientific Health Development, Longwood Fund, and Boston Scientific.

Channel Medsystems has developed the Cerene® Cryotherapy Device to treat heavy menstrual bleeding. Cerene allows women who are finished with childbearing to receive treatment in their gynecologist’s office, a more comfortable and less-expensive setting of care than a hospital or surgery center. The Company plans to use this funding to support initiatives leading up to anticipated FDA approval as well as initial preparation for commercial launch.

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Channel Medsystems® Earns CE Mark Approval for the Cerene® Cryotherapy Device

Emeryville, California, June 26, 2017. Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced today that it has earned CE Mark approval, allowing the Company to initiate marketing efforts and commercialization 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.

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Channel Medsystems® Completes Treatments in Largest Single-Arm Pivotal Study of Endometrial Ablation; Demonstrates Feasibility of Comfortable, Office-Based Procedure

Emeryville, California, March 20, 2017. Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The goal of the CLARITY study is to evaluate the safety and effectiveness of the Cerene® Cryotherapy Device (Cerene device) in 242 women with heavy menstrual bleeding who are finished with childbearing.

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Channel Medsystems Secures IDE Approval and Treats First Women in the CLARITY Pivotal Study

Emeryville, California, November 14, 2016. Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced the treatment of the first subjects in the US phase of its CLARITY Pivotal Study. CLARITY is a multicenter study to evaluate the safety and effectiveness of the Cerene™ Cryotherapy Device for endometrial ablation in women with heavy menstrual bleeding who are finished with childbearing.

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Channel Medsystems Secures $22 Million Series C Financing Led by Third Point Ventures Company Prepares to Initiate a Pivotal Study for its Novel, Office-Based Therapy for Women with Heavy Menstrual Bleeding

San Francisco, California, August 31, 2015. Channel Medsystems today announced a $22 million Series C financing led by Third Point Ventures. Additional participants in the round included new investor Longwood Fund, joined by insiders Scientific Health Development, Aperture Venture Partners, InCube Ventures and Boston Scientific. Per the terms of this financing, Jason Hong, Ph.D., of Third Point Ventures will join the Company’s Board of Directors.

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