Arsenal Medical’s EMBO-02 Study of NeoCast Liquid Embolic for cSDH Begins in Australia

November 14, 2024—Arsenal Medical announced the initiation of the EMBO-02 clinical study of its NeoCast liquid embolic to treat chronic subdural hematomas (cSDH) via middle meningeal artery (MMA) embolization.

According to the company, EMBO-02 is an open-label, multicenter, prospective clinical trial to evaluate the early safety and feasibility of NeoCast to embolize target vessels of the patients’ MMA to treat cSDH and potentially reduce hematoma recurrence. The study is enrolling up to 10 patients at three sites in Australia. The first patient was enrolled at Monash Health in Melbourne, Australia.

In EMBO-02, the primary endpoints are safety (defined as freedom from device-related disabling stroke or neurological death within 30 days of the embolization procedure) and feasibility (defined as the successful injection of NeoCast into the MMA, resulting in complete occlusion at or distal to the point of embolysate injection).

The company stated that NeoCast is a shear-responsive, nonadhesive, solvent-free, liquid embolic material designed for deep distal penetration.

Arsenal Medical noted that EMBO-02 is the second study for NeoCast after the EMBO-01 trial demonstrated safety and feasibility in hypervascular brain tumors. In July 2024, the company announced the presentation of findings from EMBO-01 at the Society of NeuroInterventional Surgery’s 21st annual meeting in Colorado Springs, Colorado.

Lee-Anne Slater, MBBS, an interventional neuroradiologist at Monash Health, is the Principal Investigator of the EMBO-02 and EMBO-01 trials.

“We are encouraged by our experience with NeoCast in cSDH,” commented Dr. Slater in Arsenal’s press release. “The initial case was an excellent translation of middle meningeal embolization from EMBO-01, which studied hypervascular brain tumors. NeoCast performed predictably throughout injection and provided robust distal occlusion, further demonstrating its unique properties, which sets it apart from current embolic products.”

Dr. Slater continued, “Better performing, innovative solutions are needed to manage this significant neurovascular condition. We look forward to continuing enrollment in EMBO-02 and uncovering the potential for NeoCast for this population.”