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.
The new round of funding follows significant achievements by the Company in 2017, including completion of the treatment phase of a 242-patient, multi-center pivotal study in March and receipt of the CE mark approval in July. “I am proud of the achievements the team at Channel has made this year,” said Ric Cote, President and CEO of Channel Medsystems. “We remain focused on delivering an exceptional device and treatment experience to women and their physicians, and we appreciate the continued support of our investors in this process.”
About the Cerene Cryotherapy Device: The Cerene Cryotherapy Device was developed with feedback from leading clinicians. Cryoablation, the use of extreme cold to destroy tissue, 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 heat-based treatments. Intrauterine scarring and adhesions may contribute to the development of long-term complications including re-operation and, ultimately, the failure of endometrial ablation. The team at Channel Medsystems has integrated the cryothermic energy delivery system and the user controls into a disposable, self-contained, ergonomic device, eliminating the need for capital equipment.
About Channel Medsystems: Channel Medsystems is a privately-held company that was spun out of the incubator TheraNova. The Company was founded to bring innovation to the delivery of women’s healthcare. The Company 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.channelmedsystems.com.
CAUTION: This device is limited to investigational use in the US, Canada, and Mexico.
Ric Cote, President & CEO
Rhonda Bracey, VP Finance & Treasurer
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.
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.”
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.
Investigators in the CLARITY study enrolled women at eight US and limited international study sites. The first US subject was treated in October 2016, with the completion of treatments just five months later in early March 2017. Study Investigators were able to rapidly enroll women in the study due to the strong appeal of the Cerene device, which was designed to address women’s need for an effective, comfortable, office-based treatment with minimal to no downtime after the procedure. “The Cerene cryoablation is a convenient, simple, and well-tolerated office procedure,” said Dr. Ted Anderson, Director of the Division of Gynecology at Vanderbilt University Medical Center and Investigator in the CLARITY study. “A patient can have this treatment the same way she has an IUD placed – in her gynecologist’s office with minimal pain management and very little discomfort. This has the potential to be a real game-changer for ablation.”
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.
In addition to demonstrating safety and effectiveness in reducing monthly bleeding, the CLARITY Study is designed to demonstrate outcomes across several key parameters including patient comfort, recovery time, and uterine healing. “We expect that the CLARITY study will confirm that the Cerene device can support a comfortable procedure without the need for IV sedation or narcotic pain medication,” said Ric Cote, President and CEO of Channel Medsystems. “This is the first endometrial ablation technology that was designed to deliver reproducible, successful outcomes in the comfort of the physician’s office — a lower-cost setting of care that both women and gynecologists prefer.”
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.
Channel Medsystems’ unique solution for heavy menstrual bleeding allows women to receive treatment in the comfort of their gynecologist’s office rather than in a hospital or surgery center. “Today, it is estimated that 85% of endometrial ablation procedures are performed in a hospital or surgery center,” said Ric Cote, President and CEO of Channel Medsystems. “Our technology has the potential to shift this procedure exclusively to the office setting and make the current, heat-based ablation technologies obsolete.”
San Francisco, California, November 18, 2013. Results from histopathology and initial tolerability studies of Channel Medsystems’ novel technology for endometrial ablation were presented at last week’s AAGL Global Congress in Washington, D.C. The findings represent a first indication of the safety and effectiveness of this device, which is intended for use in the treatment of heavy menstrual bleeding, a condition that affects one in five women in the United States. The published data demonstrate that the Company’s cryothermic therapy had preliminary safety, created a favorable ablation profile, and was well-tolerated by subjects. Evidence from these initial studies forms the foundation of a data set designed to prove that Channel Medsystem’s device is an appropriate technology for the physician office setting.