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The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.

The Chemo Mouthpiece is a device that reduces the temperature in the oral cavity to reduce the incidence and severity of oral mucositis (OM) associated with chemotherapy. The device is completely passive (e.g. there are no electrical components) and is designed to manually circulate saline solution and purified water inside a mouthpiece worn by the patient. The Chemo Mouthpiece (CMP) is designed with an inner chamber, an outer chamber, and breathing tubes. Prior to use the device is placed inside a standard freezer for a minimum of 6 hours, which freezes the water solid in the inner chamber, while the saline solution chamber in the outer chamber becomes cold but remains in liquid form. The device is then retrieved from the freezer and placed by the user in the oral cavity per the instructions for use. Cryotherapy is maintained continuously as the user squeezes the device to circulate the cold saline solution around the in the device. Breathing tubes that run throughout the length of the device facilitate breathing during device use.