Kallisio Receives CE Mark for Stentra™ Precision Oral Immobilization System

Availability in Europe Drives Highly-targeted Radiation Therapy for Head and Neck Cancer Patients through Personalized Solutions

BALTIMORE--(BUSINESS WIRE)--Kallisio, a company focused on advancing precision oncology through patient-specific, technology-enabled solutions, today announced CE certification under the European Union Medical Device Regulation (EU MDR 2017/745) for its Stentra intraoral positioning system. This certification enables commercialization within the European Economic Area, with initial deployment planned in Germany through selected clinical pilot sites.

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

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.

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, 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,” said Rajan Patel, CEO of Kallisio. “Our focus remains on enabling clinicians with tools that integrate seamlessly into existing workflows while supporting precision and consistency in treatment delivery.”

Clinics interested in bringing Stentra into their practice are invited to inquire about Kallisio’s limited Proof-of-Value pilot program.

Forward-looking Statements

This release contains forward-looking statements regarding future product applications and clinical use. Actual results and adoption may vary based on clinical, regulatory, and market factors.