Arsenal Medical has announced promising late-breaking results from the EMBO-02 clinical trial evaluating NeoCast, a next-generation shear-responsive liquid embolic treatment for chronic subdural hematoma (cSDH). The study, presented at the Society of Neurointerventional Surgery annual meeting in Nashville, demonstrated that all 15 enrolled patients met primary safety and feasibility endpoints while achieving painless administration and rapid hematoma resorption.
Clinical Trial Results
The EMBO-02 study enrolled 15 patients with chronic subdural hematoma across three sites in Australia, evaluating NeoCast for middle meningeal artery embolization (MMAe). The trial was conducted in two cohorts: an initial group of 10 patients allowing either general anesthesia or conscious sedation, and a second cohort of 5 patients specifically using conscious sedation.
Key efficacy outcomes showed that 87% of patients underwent embolization without requiring adjunctive surgery. The treatment achieved 100% target vessel occlusion with no instances of non-target embolization, indicating precise delivery and control of the embolic agent.
Safety and Tolerability Profile
The safety profile of NeoCast proved favorable, with no treatment-related adverse events reported across all study participants. In the first cohort of 10 patients, more than 80% demonstrated clinical outcome measures that were improved or unchanged from baseline across multiple assessment scales including modified Rankin Scale (mRS), Visual Analog Scale (VAS), and Markwalder scores.
The second cohort specifically evaluated pain management, with all 5 patients completing MMAe under conscious sedation. Notably, no patients reported pain during the injection procedure or experienced increased headache 24 hours post-embolization, representing a significant advancement in patient comfort compared to existing liquid embolic agents.
Hematoma Resolution Outcomes
The study demonstrated impressive hematoma resolution rates, with 60% of patients in the first cohort achieving complete hematoma resolution at 3 months, increasing to 90% at 6 months. This rapid resolution timeline suggests potential benefits for patients suffering from chronic subdural hematoma, a condition involving blood collection on the brain's surface.
Clinical Significance
"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," said Lee-Anne Slater, MBBS MMed FRANZCR, Interventional Neuroradiologist at Monash Health and EMBO-02 principal investigator. "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."
Dr. Tim Phillips, MBBS GDSA FRANZCR, Interventional Neuroradiologist at the Neuro-Intervention and Imaging Service of Western Australia, emphasized the clinical advantages: "NeoCast is truly a next-generation liquid embolic agent. 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."
Technology Platform
NeoCast represents Arsenal Medical's biomaterials-based approach to addressing underserved medical conditions. The shear-responsive liquid embolic technology has demonstrated versatility across multiple clinical applications, from hypervascular brain tumors in the EMBO-01 study to chronic subdural hematoma treatment in the current EMBO-02 trial.
