WALTHAM, Mass. — Arsenal Medical has released late-breaking results from its EMBO-02 clinical trial, showing that its next-generation liquid embolic treatment, NeoCast™, is both pain-free to administer and effective in rapidly resolving chronic subdural hematomas (cSDH). The findings were presented at the Society of Neurointerventional Surgery (SNIS) Annual Meeting held in Nashville, Tennessee.
NeoCast is a shear-responsive liquid embolic agent designed to treat cSDH—a condition characterized by blood accumulation on the surface of the brain—through middle meningeal artery embolization (MMAe). In the EMBO-02 study, researchers evaluated NeoCast’s performance across 15 patients in Australia, demonstrating positive results in both safety and efficacy.
The trial was conducted in two cohorts. The first group of 10 patients underwent the procedure under either general anesthesia or conscious sedation, while the second group of five patients received treatment exclusively under conscious sedation. Across both groups, patients reported no pain during injection, and there were no NeoCast-related adverse events.
Dr. Lee-Anne Slater, Interventional Neuroradiologist at Monash Health and the principal investigator of EMBO-02, praised the agent’s potential across different clinical applications. “NeoCast’s unique material characteristics have translated from pre-clinical studies to the EMBO-01 first-in-human study in hypervascular brain tumors, and now to the treatment of chronic subdural hematoma in EMBO-02,” she said. “Results from these studies demonstrate the potential of NeoCast to provide deep distal penetration in multiple clinical scenarios and suggest benefits in speed of hematoma resolution for patients suffering from chronic subdural hematoma.”
Among key results, 87 percent of EMBO-02 participants underwent the embolization procedure without requiring any adjunctive surgery. In all cases, the treatment achieved 100 percent target vessel occlusion with no non-target embolization. By the six-month mark, 90 percent of patients in the first cohort experienced complete hematoma resolution.
Dr. Tim Phillips, Interventional Neuroradiologist at the Neuro-Intervention and Imaging Service of Western Australia (NIISwa), emphasized the comfort and control NeoCast offers compared to other embolic agents. “NeoCast is truly a next-generation liquid embolic agent,” he said. “The ease of use, controllability, and the lack of pain during or after the injection are such differentiating factors for NeoCast over currently available liquid agents.”
Arsenal Medical CEO Upma Sharma said the company developed NeoCast specifically to address shortcomings in existing embolic technologies. “We designed NeoCast to be a pain-free, non-adhesive biomaterial to overcome the limitations of existing liquid embolic technologies,” she said. “These clinical results provide early reinforcement of what we set out to achieve, demonstrating excellent performance with an easy-to-use agent. As NeoCast continues through its robust clinical research program, we’re excited about the potential impact for patients and physicians across a range of neurovascular and peripheral indications.”
NeoCast continues to undergo clinical evaluation as part of Arsenal Medical’s broader research efforts targeting neurological and vascular disorders.
