by
Gus Iversen, Editor in Chief | June 10, 2026
IBA has received an Investigational Device Exemption (IDE) from the FDA, clearing the way for what the company says will be the first human feasibility study of its ConformalFLASH proton therapy platform in the United States.
The Louvain-la-Neuve, Belgium-based proton therapy and particle accelerator company will sponsor the study and provide the ConformalFLASH technology. The trial, known as C-FLASH-01, is expected to begin in summer 2026 at the Abramson Cancer Center of the University of Pennsylvania.
According to IBA, the prospective pilot study will enroll 10 patients who require re-irradiation in the head and neck region. Participants will receive ultra-high-dose-rate conformal proton therapy. Researchers will evaluate the clinical feasibility of the approach and monitor for potential acute toxicity.
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The study protocol was co-developed by IBA and Penn Medicine. Dr. Alexander Lin, executive vice chair of the department of Radiation Oncology at Penn, will serve as principal investigator.
Several technology partners are also participating in the project. RaySearch Laboratories is providing a research version of its FLASH treatment planning system, while 3D Systems will support production of patient-specific devices, including the ConformalFLASH Energy Modulator. .decimal will supply patient-specific apertures, and IBA Dosimetry will provide FLASH-capable dosimetry tools, including FLASH Lynx and MatriXX AiR.
Olivier Legrain, CEO of IBA, said: “Receiving FDA IDE approval for our first Phase 1 ConformalFLASH clinical trial in the United States is a major milestone for IBA and a strong validation of our technological leadership.”
Penn officials said the study represents an early step in evaluating proton FLASH therapy in patients.
“This milestone marks an important step in advancing proton flash therapy toward clinical evaluation,” said James M. Metz, MD, chair and Henry K. Pancoast Professor of Radiation Oncology at Penn. “Together, we aim to establish the medical framework needed to study this promising approach and better understand how it may benefit patients in the future.”
