Kallisio Expands Patient Access to Stentra™, an FDA-cleared Custom Mouthpiece for Head and Neck Cancer Radiation Therapy

BALTIMORE--(BUSINESS WIRE)--Kallisio today announced an expanded program to help patients preparing for head and neck cancer radiation therapy gain access to Stentra, a custom-fit, 3D-printed intraoral device cleared by the U.S. Food and Drug Administration (FDA 510(k) K232293).

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 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.”

How Patients Access Stentra

Patients scheduled to begin radiation, along with their caregivers, can contact Kallisio directly from the website. 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.
• work with the care team to enable use.

If the treatment center is not yet a Stentra provider, Kallisio will sponsor the device for the patient when appropriate. Patients, caregivers, and families can learn more on Kallisio’s patient resource page or read one patient’s experience in a recent case study.

Clinical Experience to Date

Stentra is in clinical use at leading U.S. cancer centers, including a recently announced collaboration with Stanford Health Care. In an observational case series, patients tolerated the device throughout their full course of radiation, and day-to-day positioning remained consistent. 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.

About Kallisio

Kallisio develops patient-specific devices and supportive-care technologies for cancer treatment, combining digital design and 3D printing with established clinical workflows. Stentra is FDA 510(k) cleared (K232293) using technology licensed from The University of Texas MD Anderson Cancer Center. Learn more at kallisio.com.