Varian announced that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to advance Varian's Flash clinical research program with the FAST-02 (FeAsibility Study of Flash therapy for the Treatment of Symptomatic Bone Metastases) clinical trial. Data from FAST-01, the first-ever human clinical trial of Flash, was used to support the approval of the FAST-02 study and will be reported later this year. The FAST-02 clinical trial builds on the clinical evidence from FAST-01 and will include bone metastases in the chest, providing critical insights into the clinical use of Flash treatment for cancer metastases.

FAST-02 is expected to enroll 10 patients with painful thoracic bone metastases and aims to evaluate treatment-related side effects and efficacy of treatment, which will be assessed using trial participants' reported pain relief. Similar to FAST-01, FAST-02 was designed with input from leading scientific experts from the FlashForward™ Consortium and will be conducted at the Cincinnati Children's/UC Health Proton Therapy Center with John C. Breneman, M.D., FASTRO, as principal investigator. In connection with the FAST-02 clinical trial, the Varian ProBeam® system's proton particle accelerator has been modified to deliver Flash therapy, and Varian's Eclipse™ treatment planning system has also been modified to create plans for the Flash treatments.

Varian is the only industry partner to advance the development of Flash therapy as an integrated, end-to-end solution that includes innovations in treatment planning, quality assurance, and therapy delivery technologies.