News & Events

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.

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.”

Although several treatments for heavy menstrual bleeding exist, ranging from hormonal therapy to hysterectomy, many women remain untreated. “Finding the right treatment can be a challenge for women,” said Dr. Mark Hans Emanuel, a gynecology specialist at the University Medical Center in Utrecht, Netherlands. “The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia.”

In March 2017, Channel Medsystems completed the treatment phase of a 242-woman pivotal study in the US and is currently collecting follow-up data as required by the FDA.

About the Cryothermic Technology: 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 cardiac, liver, breast, and prostate tissue, among others. 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.

Contact:
Ric Cote, President & CEO
rcote@channelmedsystems.com

Rhonda Bracey, VP Finance
rbracey@channelmedsystems.com

More

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.

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.”

In contrast to studies of heat-based ablation devices, almost all the women in the CLARITY study were awake and aware during the Cerene procedure. This allowed Investigators to collect pain scores at seven unique time points before, during, and after the procedure, resulting in nearly 1,700 data points. “A true, office-based endometrial ablation device has eluded gynecologists because the patient pain associated with heat-based ablation devices often requires the use of conscious sedation or hospitalization for general anesthesia,” said Dr. Andrew Brill, former President of AAGL and Medical Advisor to Channel Medsystems. “However, the treatment phase of the CLARITY study demonstrated that it is possible – and even preferable – to comfortably perform ablations with this device using local anesthesia along with an over-the-counter pain reliever.”

Providing endometrial ablation in the office setting also creates value for key healthcare stakeholders: women, gynecologists, and payers. In addition to being a more efficient setting of care for gynecologists, the office is associated with lower out-of-pocket costs for women and lower total procedural costs for payers.

About the Cryothermic Technology: 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 cardiac, liver, breast, and prostate tissue, among others. 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.

Contact:
Ric Cote, President & CEO
rcote@channelmedsystems.com

Rhonda Bracey, VP Finance
rbracey@channelmedsystems.com

More

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.

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.”

In contrast to the heat-based endometrial ablation technologies available today, the Cerene device was designed and engineered from inception with patient comfort in mind. In addition to providing an analgesic effect, treatment with cryothermic energy has been shown to reduce the likelihood of scarring and intrauterine adhesions that are often associated with heat-based endometrial ablation. Intrauterine scarring and adhesions may contribute to the development of long-term complications and, ultimately, the failure of endometrial ablation.

“Cerene is different from other endometrial ablation technologies I routinely use,” said Dr. Jose Garza Leal, a leading Investigator at the Universidad Autónoma de Nuevo León in Monterrey, Mexico. “Unlike current heat-based ablation devices, my patients actually relaxed once the two-and-a-half-minute treatment was initiated. This was a completely different treatment experience for me, my patients, and my staff.”

The CLARITY Study includes clinical sites in the US, Mexico, and Canada.

About the Cryothermic Technology: The Cerene Cryotherapy Device was developed with feedback from leading clinicians and biomedical engineers. Cryoablation, the use of extreme cold to destroy tissue, is a well-characterized, durable therapy routinely used to ablate malignant and benign cardiac, liver, breast, and prostate tissue, among others. The team at Channel Medsystems has integrated the cryothermic energy delivery system and the user controls into a disposable, self-contained, handheld 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.

Contact:
Ric Cote, President & CEO
rcote@channelmedsystems.com

Rhonda Bracey, VP Finance
rbracey@channelmedsystems.com

More

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.

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.”

The Company has completed extensive clinical evaluations of its cryothermic technology, including a 40-patient feasibility study in Canada, which demonstrated that gynecologists can successfully and comfortably deliver the endometrial ablation procedure in their office without the need for conscious sedation. “We have an opportunity to deliver tremendous value to healthcare’s three key stakeholders: patients, physicians and payers,” said Dr. Daniel Burnett, the Company’s Chairman. “The technology provides an effective treatment for women in the familiar and convenient setting of their gynecologist’s office; it does not require capital equipment, enabling gynecologists to treat women in any exam room; and it is well known that the office is the least-expensive setting of care for patients, physicians and payers.”

Channel Medsystems will use the Series C funds to initiate the pivotal study of its cryothermic technology and move closer towards commercialization of the first true, office-based endometrial ablation procedure.

About the Cryothermic Technology Platform: Channel Medsystems’ novel cryothermic technology and streamlined delivery system were developed with feedback from leading clinicians and biomedical engineers at the healthcare incubator, Theranova. The technology integrates cryothermic energy and the user controls into a self-contained, handheld device, eliminating the need for a separate control unit or capital equipment.

About Channel Medsystems: Channel Medsystems is a venture-backed company that 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 patients 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 available for investigational use in Canada. It is not available for sale or
investigational use in the United States.

Contact:

Christine Greenspan, Operations Manager
cgreenspan@channelmedsystems.com

Ric Cote, President & CEO
rcote@channelmedsystems.com

 

More

Initial Studies of Channel Medsystems’ Cryothermic Therapy Demonstrate Preliminary Safety and Tolerability; Results Presented at the 42nd AAGL Global Congress

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.

More