Chemomouthpiece, a medical device company focused on supportive oncology care, has formed a partnership with Zeal Specialty Pharmacy to expand access to its Chemo Mouthpiece oral cooling device in the US.
The two companies are working together to provide access and coordination services for oncology practices and patients receiving the device.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Zeal Specialty Pharmacy will offer support for prescribing coordination, benefits investigation, prior authorisation, patient onboarding and assistance programmes related to the Chemo Mouthpiece.
Receiving 510(k) clearance from the US Food and Drug Administration (FDA) in January 2024, the device is designed to cool the oral mucosa and reduce the incidence and severity of chemotherapy-induced oral mucositis in adults.
The FDA also granted the Chemo Mouthpiece a breakthrough device designation in December 2021.
Chemomouthpiece stated that oral mucositis is a frequent and serious side effect of chemotherapy that can interfere with a patient’s ability to eat, speak, maintain nutrition, or continue treatment.
In some cases, oral mucositis limits the dosage or continuation of cancer therapies and can lead to increased healthcare use, including hospitalisation and additional medication needs.
A multi-institutional randomised controlled trial of the Chemo Mouthpiece, published in Supportive Care in Cancer, reported that patients using the device experienced a 46% reduction in self-reported oral pain and a 68% drop in opioid or analgesic use during chemotherapy.
Chemomouthpiece chief commercial officer Frank Jacobucci said: “Our mission has always been to help patients better manage one of the most painful and clinically disruptive side effects of chemotherapy treatment.
“Through our partnership with Zeal, we aim to help more patients access the Chemo Mouthpiece early in their treatment journey, ideally before chemotherapy begins, while providing oncology practices with the coordination and support needed throughout the prescribing and onboarding process.”
The Chemo Mouthpiece is available by prescription as a reusable, self-contained device suitable for use in clinical and home settings.
Its function is to cool the entire oral cavity, causing vasoconstriction and thereby limiting exposure of the mouth’s tissues to chemotherapy drugs.
