Kallisio expands patient access to 3D-printed intraoral devices for head and neck cancer radiation therapy patients

Kallisio has announced an expanded program to help patients preparing for head and neck cancer radiation therapy gain access to its custom-fit, 3D-printed intraoral device.

Stentra has been cleared by the U.S. Food and Drug Administration (FDA 510(k) K232293) and is in clinical use at leading U.S. cancer centres, including a recently announced collaboration with Stanford Health Care.

Made from a digital dental scan of each patient’s mouth, Stentra is worn during every radiation session to hold the tongue, lips, and other oral structures in the same position each day. Consistent positioning helps the radiation team deliver treatment as planned while keeping healthy tissue out of the high-dose area.

Patients scheduled to begin radiation, along with their caregivers, can contact Kallisio directly from the website to gain access to the device. The team will coordinate with the patient’s radiation oncologist to confirm clinical eligibility, arrange the required intraoral digital scan with a local dental professional, and then work with the care team to enable use.

If the treatment centre is not yet a Stentra provider, Kallisio will sponsor the device for the patient when appropriate.

Q&A: Kallisio CEO Rajan Patel discusses the use of 3D printing for patient-specific immobilisation devices

Kallisio’s patient-specific medtech solutions are designed to help oncologists reduce treatment-related toxicity and protect healthy tissue in cancer care, while enhancing therapy precision and patient outcomes.

TCT MagazineSam Davies

“Patients preparing for head and neck radiation deserve every option that may make treatment more tolerable,” said Rajan Patel, CEO of Kallisio. “We want to help ensure eligible patients have access to Stentra even if their care team has not yet adopted the solution. So we are working directly with patients, oncology teams, and dental partners to bridge that gap.”

Stentra is already in clinical use at several cancer facilities in the US, with an observational case series said to have demonstrated that patients tolerated the device throughout their full course of radiation, and day-to-day positioning remained consistent. Per Kallisio, reported experience to date includes no treatment days missed due to the device and no device-related treatment interruptions. Detailed clinical findings are being prepared for peer-reviewed publication.