CE Mark Granted to Kallisio for its Precision Oral Immobilization System

Kallisio has earned CE Mark certification under the European Union Medical Device Regulation for the Stentra intraoral positioning system.

Stentra is a patient-specific intraoral device used by trained healthcare professionals to support positioning and stabilization during head and neck radiation therapy planning and delivery. The system integrates into existing clinical workflows without requiring changes to treatment planning systems, IT infrastructure, or data integration, according to the company.

Kallisio combines advanced design automation, rapid 3D manufacturing, and seamless clinical integration to deliver precision treatment solutions tailored to each patient. Stentra enables high-dose delivery accuracy in head and neck cancer radiation therapy for improved patient outcomes, executives claim.

By delivering intraoral devices customized for the patient’s unique anatomy and clinical intent, Stentra ensures millimeter-accurate immobilization, optimized patient comfort and displacement of organs at risk (OARs). The result is greater therapeutic accuracy, reduced radiation-induced toxicity, and improved treatment tolerance.

“Kallisio’s Stentra represents a significant advancement in the treatment and precision for repeat positioning of patients undergoing radiation therapy against head and neck cancer,” said Univ.-Prof. Dr. Stefan Rieken, director of the Department of Radiation Therapy and Radiation Oncology at Universitätsmedizin Göttingen in Germany. “I am keenly interested in its potential to reduce the incidence of oral mucositis.”

The Stentra system is supported by a digital-first workflow, beginning with scan acquisition and culminating in a patient-specific device delivered for clinical use. Multiple configurations are available to support physician-directed positioning strategies, including tongue depression, elevation, and lateralization.

“CE certification marks an important step in expanding access to patient-specific solutions in radiation oncology,” Kallisio CEO Rajan Patel stated. “Our focus remains on enabling clinicians with tools that integrate seamlessly into existing workflows while supporting precision and consistency in treatment delivery.”

Kallisio has built a new category of patient-specific, digitally manufactured medical devices that reportedly deliver both clinical excellence and economic value to healthcare systems. The company is based in Baltimore.