Pilot-to-commercial conversion after an observational case series of zero missed treatment days and favorable toxicity and tolerance signals in head and neck radiotherapy

Kallisio, a leader in patient-specific solutions for radiation oncology, today announced Texas Cancer Institute (TCI) has transitioned from a pilot evaluation to clinical use of Stentra™ for precision head and neck cancer radiation therapy. This follows an observational case series in which the use of Kallisio’s Stentra system supported zero missed treatment days across all evaluated patients.

Stentra delivers individualized 3D-printed oral stents that immobilize and displace sensitive anatomy during radiation, including the tongue and other organs at risk. Customized using patient-specific oral data and advanced design automation, the system integrates into clinical practice with a rapid scan-to-stent turnaround and streamlined ordering process—enabling personalized precision care without delaying treatment.

“We are committed to providing the most advanced patient-centered care to our community,” said Dr. Paiman Ghafoori, Radiation Oncologist, TCI. “Implementing Stentra allows us to enhance treatment precision while proactively protecting healthy tissue, an important step forward in improving both clinical outcomes and the patient experience.”

Stentra is designed to address challenges that generic bite blocks and handcrafted dental appliances are not built to solve by efficiently delivering a custom sub-millimeter fit intended to support more precise dose targeting and improved sparing of healthy tissue. During TCI’s observational pilot of head and neck cancer patients, sustained device tolerance over multi-week treatment courses with reliable reproducibility across fractions was achieved. Stentra reliably contributed to:

• zero missed treatment days
• no device-related treatment interruptions
• generally mild-to-moderate oral toxicities
• no Grade 4 or Grade 5 mucositis events

“Leading cancer centers like TCI are driving the shift toward personalized precision care,” said Rajan Patel, CEO, Kallisio. “Their decision to move Stentra from pilot into routine clinical use reinforces our conviction that patient-specific immobilization belongs as the standard-of-care for head and neck radiotherapy.”

About Kallisio: Kallisio develops patient-specific systems that integrate into existing oncology workflows, leveraging digital design, additive manufacturing, and coordinated clinical processes to support precision treatment delivery across radiation, chemotherapy, cryotherapy, and drug delivery.

About TCI: TCI provides advanced, patient-centered radiation oncology care utilizing state-of-the-art TrueBeam and Edge technology to deliver highly precise, efficient treatments designed to improve outcomes, reduce side effects, and enhance the patient experience.

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“Implementing Stentra allows us to enhance treatment precision while proactively protecting healthy tissue, an important step forward in improving both clinical outcomes and the patient experience.”