IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology and the world’s leading provider of proton therapy solutions for the treatment of cancer, announced that the first patient has been treated in the C-FLASH-01 clinical trial (NCT07644585), the first human feasibility study investigating ConformalFLASH^®1 proton therapy, at Penn Medicine under an Investigational Device Exemption (IDE) authorized by the U.S. Food and Drug Administration (FDA).

The study evaluates the feasibility of delivering fractionated ConformalFLASH^® proton therapy using Bragg peak proton beams in patients requiring re-irradiation for head and neck cancer.

The first treatment marks an important milestone for FLASH radiotherapy and for IBA, as sponsor of this clinical trial. It reflects the company’s expanding role in generating clinical evidence for proton therapy innovation and bringing ConformalFLASH^® closer from bench to bedside.

ConformalFLASH^® is designed to combine the physical precision of proton therapy with ultra-high dose rate delivery capabilities to support clinical investigation of FLASH radiotherapy. By leveraging the Bragg peak and proprietary ConformalFLASH^® technologies, the approach aims to deliver highly conformal treatments at ultra-high dose rates associated with FLASH delivery. The potential clinical benefits of this approach remain under investigation.

Olivier Legrain, Chief Executive Officer of IBA, commented: "For nearly forty years, IBA has helped pioneer particle accelerator technologies that have transformed cancer care. Today, we are reaching another important milestone. With C-FLASH-01, IBA is not only providing the technology enabling innovation, but also actively supporting its clinical evaluation through this sponsored clinical trial. This reflects our commitment to helping shape the future of proton therapy, working alongside leading clinical partners to bring promising innovations from the laboratory to clinical practice."

This first treatment is supported by a strong ecosystem of specialized collaborators, each contributing key capabilities: RaySearch Laboratories provides a research version of its FLASH treatment planning system; 3D Systems supports the 3D printing of patient-specific devices, including the ConformalFLASH^® Energy Modulator (CEM); .decimal supplies precision-milled patient-specific apertures; and IBA Dosimetry develops FLASH-enabled dosimetry solutions, including FLASH Lynx and MatriXX Air. The milestone demonstrates how complementary clinical, technological and treatment-planning expertise can help translate innovation from research into clinical evaluation.
For IBA, the evidence generated through C-FLASH-01 may help inform the future development of ConformalFLASH^® technology and its potential integration into clinical proton therapy workflows.