Arsenal Medical has announced that NeoCast—a first-of-its-kind, shear-responsive liquid embolic material designed for deep distal penetration—met its primary feasibility and safety endpoints in the open-label, multicentre, prospective EMBO-01 clinical trial. These data were presented earlier today at the 2024 Society of NeuroInterventional Surgery (SNIS) annual meeting (22–26 July, Colorado Springs, USA).
“NeoCast has the potential to be a gamechanger for liquid embolics,” said Lee-Anne Slater (Monash Health, Melbourne, Australia), the principal investigator for the EMBO-01 trial who presented findings at SNIS 2024. “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. 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.”
An Arsenal press release states that NeoCast “stands alone” in clinically demonstrating predictable and well-controlled vascular occlusion. The late-breaking data presented today, according to Arsenal, are further bolstered by an additional presentation highlighting preclinical study results showing that it occluded approximately five times more vessel branches with improved radiopacity, compared to the market-leading liquid embolic, in swine kidneys. The company describes NeoCast as a next-generation, solvent-free, non-adhesive liquid embolic that can enable the significant distal penetration of hypervascular brain tumours.
“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,” said EMBO-01 medical monitor Dave Fiorella (Stony Brook University Medical Center, Stony Brook, USA). “Middle meningeal artery embolisation for the treatment of chronic subdural haematoma [cSDH] is the application that immediately comes to mind. The existing clinical data have suggested that distal penetration into the meningeal circulation is associated with faster and more complete cSDH resolution. Moreover, this agent has the additional advantage of not incorporating an inflammatory solvent or inducing a thermal reaction upon polymerisation. This characteristic should allow NeoCast embolisation procedures to be carried out under conscious sedation rather than general anaesthesia in many or most patients, as we would expect that the agent would not create any pain or discomfort during the infusion.”
“This is an important milestone in the clinical development of NeoCast as a differentiated solution for middle meningeal artery embolisation and other conditions where deep distal penetration is beneficial,” added Upma Sharma, chief executive officer and president of Arsenal. “NeoCast is making the leap from legacy products that utilise technology developed decades ago. We appreciate Dr Slater and our other clinical investigators; their commitment and hard work have been crucial to this first experience.”
