Texas Cancer Institute Adopts Kallisio 3D-Printed Oral Stent for Head and Neck Radiation

A patient-specific stent graduates from pilot to standard care

Texas Cancer Institute (TCI) has moved Kallisio's Stentra system from pilot evaluation into routine clinical use for head and neck cancer radiation therapy. The decision follows an observational case series in which every evaluated patient completed treatment without missing a single session.

Stentra is a 3D-printed patient-specific oral stent. It immobilizes and repositions sensitive anatomy during intensity-modulated radiation therapy, with the goal of improving dose targeting while sparing healthy tissue. Each device is built from a patient's own intraoral scan data, processed through automated design software, and printed on demand.

What the pilot data showed

TCI's observational pilot tracked head and neck cancer patients over multi-week treatment courses. The institution reported zero missed treatment days, no device-related interruptions, and mild-to-moderate oral toxicities across the group. Notably, clinicians saw no Grade 4 or Grade 5 mucositis events in the evaluated cohort.

Dr. Paiman Ghafoori, radiation oncologist at TCI, said the system lets the center enhance treatment precision while actively protecting healthy tissue: an outcome that matters both clinically and for patient experience.

How Stentra differs from conventional immobilization

Standard head and neck radiotherapy relies on thermoplastic masks, generic bite blocks, or handcrafted dental appliances. None of those were designed for the sub-millimeter positioning demands of modern IMRT. Stentra replaces one-size-fits-all hardware with a custom-fit device produced through a digital scan-to-stent workflow.

Kallisio says the system integrates into existing radiation oncology workflows without adding significant complexity. The turnaround from scan to delivered stent runs roughly five days, which the company says does not delay treatment initiation.

A broader trend in patient-specific 3D printing

Stentra received FDA 510(k) clearance in January 2024. Stanford Health Care implemented it later that year, making it one of the first major academic centers to use a digitally fabricated, patient-matched intraoral device in routine head and neck radiotherapy. TCI's adoption reinforces the signal that 3D-printed medical devices are moving from experimental to everyday clinical practice.

Kallisio also earned CE certification under EU MDR in March 2026, with initial European deployment planned in Germany. The company partners with Ricoh 3D for Healthcare to manufacture devices through a network of certified production facilities.

The road ahead still has obstacles. Reimbursement codes for patient-specific immobilization remain inconsistent across payers. Broader adoption will depend on published multi-institutional data showing consistent improvements in setup reproducibility and toxicity rates. But if TCI's experience holds at scale, patient-specific 3D-printed stents could become the default standard for head and neck radiotherapy within a few years.