Channel Medsystems, a medtech company based in California, created the Cerene cryotherapy device for the treatment of heavy menstrual bleeding. Heavy menstrual bleeding can affect quality of life for many women, and the condition can be associated with abdominal pain, cramping, and tiredness.
The Cerene technology aims to provide an effective treatment for heavy menstrual bleeding, a procedure which can be performed in a doctor’s surgery in just a few minutes, and which does not require general anesthesia. The procedure involves the insertion of the device into the uterus, where cryoablation of the endometrial lining occurs. It is intended for premenopausal women who do not plan to have any further children.
The Cerene device has been FDA approved for endometrial ablation to treat heavy menstrual bleeding.
Check out a video animation about the procedure:
Medgadget had the opportunity to speak with Ric Cote, CEO of Channel Medsystems, about the technology.
Conn Hastings, Medgadget: Please give us an overview of heavy menstrual bleeding, the women who experience it, and its consequences.
Ric Cote, Channel Medsystems: Heavy menstrual bleeding is a common condition that unfortunately affects one in five women, or more than 10 million women in the U.S. Symptoms can include bleeding lasting more than seven days, soaking more than one pad/tampon an hour, or experiencing constant pain in the lower part of one’s stomach during menstruation.
Heavy periods can have a negative impact on a woman’s quality of life and self-esteem. It often causes feelings of tiredness and weakness and may prevent women with the condition from enjoying and participating in everyday activities.
Medgadget: How is the condition treated at present?
Ric Cote: Heavy menstrual bleeding is typically treated with medication, hormone therapy, hysterectomy, or endometrial ablation using either cooling or heating technologies.
Medgadget: Please give us an overview of the Cerene device and how it works.
Ric Cote: The Cerene Cryotherapy Device is FDA-approved for in-office endometrial ablations to treat women suffering with heavy menstrual bleeding. The treatment is well-tolerated and provides period relief by significantly reducing both heavy bleeding and cramping, thus improving quality of life. Importantly, Cerene preserves the ability to access and evaluate the uterine cavity in order to diagnose and care for intrauterine conditions post-treatment.
The Cerene treatment uses cryotherapy, or cooling technology, to remove the lining of the uterus, known as the endometrium, which is often the cause of heavy bleeding and discomfort. As monthly shedding of the endometrium causes menstrual blood flow, removing the lining of the uterine cavity can result in reduced or no menstrual bleeding, nor cramps. Cerene is for premenopausal women with heavy menstrual bleeding due to benign causes who are done having children.
Medgadget: Is there any previous use of cryotherapy to treat this condition? How did the idea for this technology come about?
Ric Cote: Advances in cryotherapy have continued since the introduction of cryoprobes in 1961. Yet, despite the advantages of cryotherapy over heating tissue with regard to analgesia and anesthesia requirements, it has been underutilized. Data has also shown that cryoablation provides a more favorable tissue healing response resulting in preserved access to the endometrial cavity by minimizing the development of significant intrauterine adhesions. Previous cryotherapy options have historically required more physician skill and patience to complete the treatment.
Medgadget: What can women expect when undergoing the treatment in terms of the procedure itself, side-effects, and follow-up?
Ric Cote: Cerene Cryotherapy is a 2.5 minute treatment, as part of a 7 minute procedure, that can be performed in the comfort and familiarity of a woman’s doctor’s office without the need for general anesthesia. Unlike heat-based ablation technologies, Cerene uses cryotherapy that provides a natural pain-relieving or numbing effect during treatment.
In fact, participants in the CLARITY clinical study had a median pain score of 2/10 during the treatment. After the treatment, patients come in for a 2-4 week checkup. It may take a few months to see the full results of the treatment. At 12 months post treatment, 90% of patients had normal, light or no periods, and were satisfied with their treatment with durable results 36 months after treatment.*
*Curlin HL, Cintron LC, Anderson TL. A prospective, Multicenter, clinical trial evaluating the safety and effectiveness of the CERENE device to treat heavy menstrual bleeding. Journal of Minimally Invasive Gynecology. 2021;28(4):899-908. doi:10.1016/j.jmig.2020.08.013
Medgadget: Do you have any plans for additional technologies to help improve reproductive health for women? Where is the Cerene treatment currently available?
Ric Cote: At this point in time, we are focused on physician training and adoption of Cerene, however, we are always interested in exploring technologies that can be performed in the office setting. Cerene is currently available in the United States.