Arsenal’s EMBO-02 Study of NeoCast for cSDH Treatment Enrolls Initial Cohort

February 6, 2025—Arsenal Medical announced the completion of the initial cohort enrollment in the EMBO-02 clinical study of the company’s NeoCast to treat chronic subdural hematomas (cSDHs). The cohort is composed of 10 patients enrolled at three sites in Australia.

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 patient’s middle meningeal artery (MMA) to treat cSDH.

Arsenal stated that NeoCast is a next-generation, nonadhesive, solvent-free, liquid embolic material designed for deep distal penetration. The company noted that NeoCast demonstrated safety and feasibility in the first-in-human EMBO-01 study evaluating its use in the preoperative embolization of hypervascular brain tumors.

Findings from the initial cohort were discussed by Laetitia de Villiers, MD, in a late-breaking presentation at the American Stroke Association’s International Stroke Conference 2025 held February 5-7 in Los Angeles, California. Dr. Villiers is a specialist interventional and diagnostic neuroradiologist at Gold Coast University Hospital in Southport, Australia.

Arsenal reported that all MMA embolization procedures in the trial were successfully completed with NeoCast, and all patients passed the 30-day safety endpoint with no device-related serious adverse events. The company noted that on average, investigators were “very satisfied” with NeoCast’s acute performance and usability, highlighting the material’s ease of use.

Tim Phillips, MD, Lead Interventional Neuroradiologist at the Neuro-Intervention and Imaging Service of Western Australia in Nedlands, Australia, commented on the product in the company’s press release.

“NeoCast is a promising new material for treating cSDH,” stated Dr. Phillips. “NeoCast has differentiated performance characteristics. It is a uniquely responsive liquid embolic agent, and its physical properties allow continuous control and visualization throughout the injection. The ability to penetrate the microvasculature with the material is very impressive, as are our early clinical and imaging results. I’m excited about the potential of NeoCast to address the limitations of currently available liquid embolics.”