ChemoMouthpiece has entered into a partnership with commercialisation services provider EVERSANA to launch and market its cryotherapy device called Chemo Mouthpiece for oncology patients in the US.
The Chemo Mouthpiece device is an intraoral ice pack that is said to provide cryotherapy to the oral cavity of a patient subjected to chemotherapy.
The US-based company has designed the cryotherapy device to proactively manage and treat oral mucositis, which is a side effect of chemotherapy.
As per the terms of the partnership, EVERSANA will offer a variety of commercialisation services to support the launch of the device in the US.
It will provide compliance and regulatory services, market access strategy, patient services, field deployment solutions, data and analytics, strategy for pricing, and 3PL distribution services for the device.
ChemoMouthpiece founder and CEO David Yoskowitz said: “Commercializing medical devices, especially for oncology, is extremely complex, and as we continue to work to bring the Chemo Mouthpiece to market we need a partner that has experience not only in commercialisation but with intricate knowledge of the oncology space.
“EVERSANA fits this bill, but what really sets them apart and made them the right partner for us is their commitment to patient-centred care and unmatched energy to create a healthier world.”
The Chemo Mouthpiece device recently received breakthrough device designation from the US Food and Drug Administration (FDA) to reduce the incidence and severity of oral mucositis.
The cryotherapy device, which is claimed to be simple, effective, and easy-to-use, enables patients to continue their treatment with comfort and less disruption. It cools the entire oral cavity when used during chemotherapy treatments at home or in a hospital.
EVERSANA said that patients can freeze the device in their houses and take it with them for treatment, thus creating a new solution for an unmet patient need.
The Chemo Mouthpiece cryotherapy device is anticipated to launch in the US in late 2023, pending regulatory approvals.
