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3D-printed stent for the treatment of head and neck cancer (HNC) receives FDA approval

Kallisio, a company specializing in the development of toxicity management solutions for cancer treatment, announces FDA 510(k) clearance for Stentra, a customized 3D-printed oral stent solution designed to protect healthy tissue in head and neck cancer (HNC) patients.

By integrating patient mouth data with advanced 3D printing, Stentra is carefully customized to mitigate targeting inaccuracies associated with radiotherapy methods such as IMRT (intensity modulated radiation therapy). A Stentra device immobilizes the tongue, lips and other OARs (organs at risk) to keep them out of the high-dose radiation target zone.

Key advantages of Stentra:

  • High treatment accuracy: patient-specific solution for precise and targeted radiation therapy.
  • Effective toxicity management: Protects surrounding healthy tissue from high doses of radiation.
  • Fast scan-to-stent delivery: Patient-matched oral stents are produced in less than 5 days.

“Designed to address each patient’s unique treatment and anatomical needs, Stentra delivers an unmatched level of customization and effectiveness in addressing the critical need to safeguard healthy tissue during radiation therapy,” emphasizes Rajan Patel, Kallisio Co-founder and CEO. “FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.”

The underlying technology behind Stentra was licensed by Kallisio from The University of Texas MD Anderson Cancer Center, where it was developed by Eugene Koay, M.D., Ph.D., Associate Professor of Gastrointestinal Radiation Oncology at MD Anderson.

Kallisio is working with cancer centers across the U.S. to implement Stentra. The solution includes state-of-the-art intraoral scanning equipment and a cloud-based clinical portal ordering system with real-time monitoring, best-in-class compliance and seamless integration into the radiation oncology workflow.

Dr. Koay serves in an advisory capacity to Kallisio. MD Anderson has an institutional conflict of interest with Kallisio, and this relationship is managed in accordance with an MD Anderson Conflict of Interest Management and Monitoring Plan.

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