WALTHAM, Mass. — Arsenal Medical has received Investigational Device Exemption approval from the U.S. Food and Drug Administration for RADIANT, a pivotal clinical trial evaluating its NeoCast liquid embolic device in chronic subdural hematoma.
The Waltham-based clinical-stage company said RADIANT will study NeoCast as an adjunct to surgery for symptomatic subacute and chronic subdural hematoma. NeoCast is designed to provide predictable distal penetration of the middle meningeal artery without causing pain.
The prospective, randomized, multicenter trial will compare NeoCast with Onyx LES, an FDA-approved embolic agent. Arsenal Medical said it will be the first FDA-approved head-to-head study of two liquid embolic agents for chronic subdural hematoma. The company expects to enroll about 360 patients in a 2:1 randomization across as many as 35 sites in the U.S. and Australia.
“Chronic subdural hematoma is becoming one of the most common conditions we manage in neurointervention,” said Charles Matouk, MD, Neurosurgeon at Yale New Haven Hospital and co-principal investigator of the RADIANT trial. “RADIANT will evaluate NeoCast as a potentially differentiated liquid embolic designed to provide predictable distal penetration while minimizing patient discomfort.”
“FDA approval of our IDE is a major step in our effort to demonstrate that NeoCast can offer an innovative embolic to neurointerventionalists,” said Upma Sharma, PhD, CEO of Arsenal Medical. “As MMA embolization gains momentum, many physicians still rely upon legacy materials that can be difficult to use and that contain adhesives or harsh solvents. NeoCast is designed to be simple to use and well tolerated by patients. We are excited to get the RADIANT Trial underway.”
NeoCast is a solvent-free, non-adhesive liquid embolic biomaterial designed to reach distal microvasculature and block blood flow to tumors and diseased tissue. Arsenal Medical said the device’s shear-thinning properties allow it to reach small vessels while supporting controlled delivery without the harsh solvents or adhesives used in some embolic materials.
The company said NeoCast has shown feasibility in two first-in-human studies: EMBO-01, which evaluated preoperative embolization of hypervascular brain tumors, and EMBO-02, which evaluated middle meningeal artery embolization for chronic subdural hematoma. Full EMBO-02 results are expected later this year.
