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Channel Medsystems Announces Publication of Long-term Clinical Outcomes with Cerene® Cryotherapy for the Treatment of Heavy Menstrual Bleeding

Cerene Cryotherapy is clinically proven to significantly reduce menstrual bleeding and premenstrual symptoms safely and effectively with high patient satisfaction through 36 months following treatment

BERKELEY, Calif. — (BUSINESS WIRE) — Channel Medsystems, Inc., a medical device company whose mission is to empower every woman to take control of her health journey, today announced the publication of long-term clinical outcomes from the CLARITY clinical study, evaluating the safety and effectiveness of Cerene® Cryotherapy for the treatment of heavy menstrual bleeding (HMB) in the International Journal of Women’s Health.

“Findings from the CLARITY study should give physicians confidence in the long-term benefits of Cerene endometrial cryoablation”

The CLARITY study was a prospective, multi-center, single-arm, open-label study that evaluated 242 premenopausal women who underwent cryoablation with Cerene. Follow-up assessments were performed at 12, 24 and 36 months. Two hundred and one patients completed a long-term follow-up visit at month 36 post-treatment.

Summary of Key Results:

  • Reduced menstrual bleeding patterns reported by patients remained stable from month 12 to month 36 – 90.9% of patients described their menstrual period as none, lighter than normal, or normal at 12 months, and 88.6% at 36 months.
  • High patient satisfaction and willingness to recommend Cerene to others remained consistent through 36 months. At 36 months, 85% of patients were “satisfied” or “very satisfied” and 91% would “definitely” or “maybe” recommend Cerene.
  • Patient quality of life improvements were also maintained through 36 months post-treatment. At 36 months, 91% of patients reported no or slight limitations in life activities. Eighty-five percent of patients reported being free of premenstrual symptoms “often,” “most often,” “very often,” or “all of the time” at month 36.
  • There were no serious adverse device-related effects reported in the study. Following Cerene treatment, the cumulative incidence of medical and surgical interventions was low (8.7%).

“Findings from the CLARITY study should give physicians confidence in the long-term benefits of Cerene endometrial cryoablation,” said lead author Howard L. Curlin, M.D., Vanderbilt University Medical Center. “Heavy menstrual bleeding significantly diminishes a woman’s health. This study demonstrates that Cerene is a highly tolerable in-office treatment that provides women relief from their heavy menstrual bleeding symptoms through three years, helping to restore them to health.”

“The 36-month results adds to the growing body of evidence that support the clinical utility, durability and safety profile of Cerene. The data confirm that this novel treatment is an important advancement for patients suffering with HMB,” said Ric Cote, President and Chief Executive Officer of Channel Medsystems. “We look forward to building on our commercialization efforts to bring Cerene to more physicians and their patients across the country.”

About Cerene Cryotherapy

Cerene is an in-office endometrial cryoablation treatment that safely and effectively reduces heavy menstrual bleeding while naturally minimizing pain without requiring general anesthesia. The Cerene FDA pivotal clinical study (“CLARITY”), published in The Journal of Minimally Invasive Gynecology, concluded that 90% of all patients experienced an improvement in bleeding symptoms and were satisfied with the procedure at 12 months following treatment. Additionally, results published in The Journal of Minimally Invasive Gynecology in November 2021 demonstrated that the use of cryoablation to treat the endometrium preserved access to the uterine cavity, with visualization in 91% of evaluated patients, and the ability to evaluate for pathologic change in 96% of patients whose uterine cavities could be fully visualized.

About Channel Medsystems

Channel Medsystems® is a privately-held company dedicated to empowering every woman to take control of her health journey and live her best life. With a commitment to deliver innovative technologies that exceed the expectations of women and their gynecologists, Channel strives to develop easy-to-use, safe, and cost-effective medical devices, resulting in exceptional outcomes and superior patient comfort that are accessible to all women. Channel Medsystems, Inc. is headquartered in Berkeley, CA.

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Michaela Hill

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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