Arsenal Medical has announced promising late-breaking data from the EMBO-02 clinical study evaluating NeoCast™, its next-generation, shear-responsive liquid embolic, in patients with chronic subdural hematoma (cSDH). Conducted across three sites in Australia, the study enrolled 15 patients who underwent middle meningeal artery embolization (MMAe), a minimally invasive procedure used to manage cSDH. The primary objective of the trial was to assess safety and feasibility, and all patients successfully met these endpoints. The study was presented during podium sessions at the Society of Neurointerventional Surgery (SNIS) annual meeting, reinforcing the potential of NeoCast as a safe and effective alternative to current treatment approaches.
The results highlight several key advantages of NeoCast. Notably, 87% of patients were treated without requiring adjunctive surgery, and 100% target vessel occlusion was achieved with no incidents of non-target embolization or NeoCast-related adverse events. Cohort 1 demonstrated a 90% complete hematoma resolution rate at 6 months, and Cohort 2 showed that MMAe could be completed using conscious sedation with no patient-reported pain or post-procedural headaches—a stark contrast to many current embolic agents. These findings underscore the agent’s ease of use, controllability, and comfort for the patient, pointing to NeoCast's potential to raise the standard in embolization procedures.
NeoCast was purposefully engineered as a non-adhesive, pain-free liquid embolic to address longstanding challenges with traditional embolization agents. Its deep distal penetration, lack of procedural discomfort, and positive clinical outcomes validate its design principles and demonstrate its versatility across neurovascular indications. According to Arsenal Medical, these early EMBO-02 results, combined with insights from prior studies such as EMBO-01, support the continued advancement of NeoCast through a robust clinical development program. As research expands into other neurovascular and peripheral applications, NeoCast holds strong promise to significantly enhance patient care by offering minimally invasive, well-tolerated, and effective solutions for complex vascular pathologies.
MedTech Spectrum's Summary
Demonstrated Safety and Efficacy: The EMBO-02 trial showed that NeoCast™ safely achieved 100% target vessel occlusion without adverse events, offering a minimally invasive and pain-free alternative for treating chronic subdural hematoma.
Clinical and Patient-Centric Advantages: With rapid hematoma resolution, no injection-related pain, and successful use under conscious sedation, NeoCast sets a new benchmark for comfort, control, and effectiveness in embolic therapy.
Future Potential Across Indications: These promising results support NeoCast’s broader clinical utility in neurovascular and peripheral conditions, underscoring the ongoing need for next-generation embolics that improve outcomes and enhance procedural experience.
