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The Chemo Mouthpiece™ has been 510(k) cleared for marketing in the United States. See our press release for exciting news.

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™ has completed its randomized, placebo controlled, prospective, multi-center trial. The purpose of the trial was to assess the efficacy of this cryotherapy device versus best supportive oral care in mitigating and easing the symptoms of chemotherapy related oral mucositis, a painful and debilitating condition. Click here to see trial design and information.

The Chemo Mouthpiece™ is a cryotherapy device for inside the oral cavity. The device is comprised of three components: medical grade silicone, filtered water, and saline solution. Its innovative design has 2 chambers: an inner chamber prefilled with filtered water and an outer chamber prefilled with saline solution. When placed in a standard freezer, the inner filtered water chamber freezes solid while the chamber filled with the saline solution will not freeze solid. The frozen inner chamber allows the circulating saline solution in the outer chamber to stay very cold which cools the patient's entire oral cavity.

Oral cryotherapy, in the form of ice chips, is widely used and recognized by NCCN, MASCC and ONS to prevent oral mucositis. Cryotherapy used during treatment reduces blood flow to the oral cavity by narrowing the blood vessels, a mechanism known as vasoconstriction. This limits the amount of chemotherapy drugs flowing to the oral cavity; therefore, helping to mitigate oral mucositis. The Chemo Mouthpiece™ is a more efficient option than ice as it cools the entire oral cavity uniformly, is more tolerable for patients whose teeth are sensitive, does not melt the way ice does in the patient's mouth which potentially causes the patient to feel nauseous.

ChemoMouthpiece, LLC has filed for numerous patents both in the US and globally. A number of patents have already been granted. The status of those not yet granted is either published or pending.

1. Data on file
The Chemo Mouthpiece™ reduced patients' oral temperature by an average of 31.2 degrees F, while ice chips only reduce it by an average of 23.2 degrees F. It also cooled the oral cavity more uniformly.1