A first-in-human, prospective feasibility trial of a next-generation, shear-responsive, liquid embolic biomaterial, NeoCast.

BACKGROUND: NeoCastTM is a solvent-free, non-adhesive biomaterial engineered to achieve microvascular occlusion. EMBO-01 is the first-in-human trial of NeoCast for the pre-surgical embolization of hypervascular brain tumors supplied by the middle meningeal artery (MMA). METHODS: EMBO-01 was an open-label, multicenter, prospective, externally monitored, and core lab adjudicated clinical trial. The primary safety endpoint was freedom from device-related disabling stroke or neurological death within 30 days of embolization. The primary effectiveness endpoint was successful injection of NeoCast into targeted vessel(s), resulting in complete occlusion at or distal to the point of embolysate injection. Additional assessments included occurrence of microcatheter adhesion and non-target embolization, percent tumor devascularization, extent of resection, estimated intraoperative blood loss, and surgical time. RESULTS: Five subjects were enrolled with an average tumor size of 5.0±1.2 cm. NeoCast achieved occlusion in all targeted vessels for all subjects. There were no adverse events or device deficiencies during embolization. The average NeoCast injection volume was 0.68±0.28 mL with an average injection time of 7.8±6.4 min. There was no microcatheter entrapment or non-target embolization. The average percent tumor devascularization was 89±7%. Tumor resection was complete in all subjects, with an average estimated blood loss of 240±164 mL and average total surgery time of 167±75 min. All subjects successfully met both the primary feasibility and safety endpoints. CONCLUSION: This first-in-human study provides evidence that NeoCast can be used to reproducibly and safely achieve substantial preoperative devascularization of brain tumors supplied by the MMA.