Arsenal Medical Receives FDA IDE Approval for the RADIANT Pivotal Trial of NeoCast™ in Chronic Subdural Hematoma
A randomized, controlled study of a novel liquid embolic, NeoCast, adjunctive to surgery
WALTHAM, Mass. – May 21, 2026 Arsenal Medical, a clinical-stage company developing innovative biomaterial-based devices, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for RADIANT, a pivotal trial evaluating NeoCast™. NeoCast is a novel liquid embolic under development that is designed to achieve pain-free, predictable distal penetration of the middle meningeal artery (MMA).
RADIANT is a prospective, randomized, multicenter study for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) adjunctively with surgery. The trial will compare NeoCast to Onyx LES, an FDA-approved embolic agent. This will be the first FDAapproved head-to-head study of two liquid embolic agents for cSDH. Approximately 360 subjects will be enrolled in a 2:1 randomization across up to 35 sites in the United States and Australia.
