Arsenal Medical’s NeoCast Liquid Embolic Material Evaluated in EMBO-01 FIH Trial

July 24, 2024—Arsenal Medical announced that the open-label, multicenter, prospective EMBO-01 clinical trial of NeoCast met its primary feasibility and safety endpoints. The study demonstrated predictable and well-controlled vascular occlusion with NeoCast, which is the company’s shear-responsive liquid embolic material designed for deep distal penetration into the microvasculature.

The findings were presented at the Society of NeuroInterventional Surgery’s 21st annual meeting held July 22-26 in Colorado Springs, Colorado.

According to the company, EMBO-01 enrolled five patients with extra-axial tumors, from 5.0 ±1.2 cm in size and supplied by one or more branches of the middle meningeal artery.

As summarized in the company’s press release, key results from EMBO-01 include the following:

• The study met the primary safety endpoint of freedom from device-related disabling stroke or neurological death within 30 days of the embolization.
• The study met the primary feasibility endpoint of successful injection of NeoCast into the targeted vessel(s) supplying the tumor before surgical resection resulting in complete occlusion of the targeted vessel(s) at or distal to the point of embolysate injection.
• Treatment with NeoCast resulted in tumor devascularization of 88% (standard deviation, ±7%).
• Complete tumor resection was achieved in all five patients, as graded by the surgeon.

The principal investigator for the EMBO-01 trial is Lee-Anne Slater, MBBS, MMed, an interventional neuroradiologist at Monash Health in Melbourne, Australia.

“NeoCast has the potential to be a game changer for liquid embolics,” commented Dr. Slater in the company’s press release. “The product was easy to handle and performed consistently and reproducibly during injection while providing excellent visibility during and post procedure, unlike currently available options.”

Dr. Slater continued, “Early results show that NeoCast has the potential to fill a treatment gap with a tool that’s straightforward for clinicians to use and will ultimately benefit patients. I am encouraged by its possibilities in other middle meningeal artery indications.”

Arsenal Medical noted that in addition to the findings from the late-breaking EMBO-01 data, results presented from a preclinical study showed that NeoCast occluded approximately five times more vessel branches with improved radiopacity compared to the market-leading liquid embolic in swine kidneys.

David Fiorella, MD, who is an interventional neuroradiologist and EMBO-01 medical monitor from Stony Brook University Medical Center in Stony Brook, New York, discussed the latest findings in the company’s press release.

“These emerging preclinical and clinical data are exciting as they clearly demonstrate the potential for NeoCast to be an optimal liquid embolic agent for the treatment of neurovascular conditions that require distal penetration of the targeted vasculature,” stated Dr. Fiorella. “Middle meningeal artery embolization for the treatment of chronic subdural hematoma is the application that immediately comes to mind.”

Dr. Fiorella continued, “The existing clinical data have suggested that distal penetration into the meningeal circulation is associated with faster and more complete chronic subdural hematoma resolution. Moreover, this agent has the additional advantage of not incorporating an inflammatory solvent or inducing a thermal reaction upon polymerization. This characteristic should allow NeoCast embolization procedures to be carried out under conscious sedation rather than general anesthesia in many or most patients as we would expect that the agent would not create any pain or discomfort during the infusion.”