Kallisio receives EU Certification for head and neck cancer positioning system

Kallisio announced Tuesday it has received CE certification under the European Union Medical Device Regulation for its Stentra intraoral positioning system, clearing the device for commercial sale in the European Economic Area.

The company plans initial deployment in Germany through selected clinical pilot sites.

Stentra is a patient-specific intraoral device designed to support positioning and stabilization during head and neck radiation therapy planning and delivery. The system is intended for use by trained health care professionals and integrates into existing clinical workflows without requiring changes to treatment planning systems or IT infrastructure.

The device provides millimeter-accurate immobilization customized to each patient's anatomy while displacing organs at risk during radiation delivery. Multiple configurations support physician-directed positioning strategies, including tongue depression, elevation and lateralization.

"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 Stefan Rieken, director of the Department of Radiation Therapy and Radiation Oncology at Universitätsmedizin Göttingen, Germany. "I am keenly interested in its potential to reduce the incidence of oral mucositis."

The system uses a digital workflow beginning with scan acquisition and ending with delivery of a patient-specific device for clinical use. The company manufactures devices using rapid 3D printing technology and design automation.

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

The company is offering a limited proof-of-value pilot program for interested clinics.

Recent advances in radiation therapy positioning and immobilization

Precision positioning and immobilization technologies have emerged as a critical component of modern radiation oncology, particularly as treatment techniques become increasingly sophisticated and dose escalation strategies more common. Recent years have seen substantial progress in patient-specific devices, imaging-guided systems and adaptive treatment approaches that collectively aim to improve therapeutic accuracy while reducing toxicity.

Head and neck cancer radiation therapy presents unique technical challenges due to complex anatomy, proximity of critical structures and significant inter-fraction motion. Traditional immobilization methods using thermoplastic masks have been the standard for decades, but newer approaches focus on addressing limitations in internal anatomy control and patient comfort that can affect treatment consistency.

Advances in intraoral stenting and positioning devices have gained attention for their ability to displace radiation-sensitive tissues such as the tongue, oral mucosa and salivary glands away from high-dose regions. These systems can reduce radiation exposure to organs at risk by several millimeters, which translates to clinically meaningful reductions in acute and late toxicity. Research has demonstrated that improved positioning consistency can lower rates of severe oral mucositis, dysphagia and xerostomia—complications that significantly impact quality of life during and after treatment.

The integration of 3D scanning, digital design workflows and additive manufacturing has enabled more anatomically precise, patient-specific solutions that can be produced rapidly and at scale. This technological convergence supports adaptive radiation therapy strategies where devices can be iteratively refined as patient anatomy changes during treatment courses.

Imaging technologies including cone-beam computed tomography and surface-guided radiation therapy have also advanced positioning verification capabilities, allowing real-time monitoring and correction of patient setup errors. Together, these innovations support the broader shift toward ultra-hypofractionated regimens and stereotactic approaches that demand submillimeter accuracy for safe delivery of ablative doses.