ABSTRACT NUMBER: ESOC2026A801 FEASIBILITY, SAFETY, AND USEABILITY ASSESSMENT OF THE WELLUMIO ‘AXANA’ 0.1T PORTABLE MAGNETIC RESONANCE IMAGING DEVICE

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Abstract Background and aims Ultralow-field portable magnetic-resonance (MR) devices (<0.1T) are emerging as novel tools in acute stroke. Axana® (Wellumio Ltd), an ultra-lightweight 0.1T MR device (~100kg), uses Pulsed-Gradient-Free-Mapping technology to acquire spatially localised MR biomarkers for point-of-care stroke detection. This study assesses its feasibility and safety in acute stroke patients. Methods This single-centre, prospective feasibility study will recruit 20 healthy and 40 stroke participants within 24-hours of symptom onset. Participants have conventional 1.5–3T MRI (T1, T2, FLAIR, DWI) and two consecutive Axana scans (DWI, T2) within 72-hours of admission. Safety, a post-scan tolerability survey, data quality and agreement with conventional MRI were evaluated. The primary outcome is the proportion of scans where interpretable signals were obtained. Results Interim analysis includes 14 controls and 28 stroke patients (24-ischaemic, 4-intracerebral haemorrhage). For stroke participants, median age was 69.5, NIHSS of 4, and 92.9% were modified Rankin of 0. No safety concerns reported and most scans were well tolerated. The median time from last-known-well to Axana scan was 24.7-hours (IQR 20.1-29.5), and time from MRI-to-Axana was 54.7-minutes (IQR 49.4-70.9). Of 28 stroke participants, 23/28 (82.1%) demonstrated signal-to-noise-ratios above the target threshold. High-signal quality Axana images (n=2, one ischaemic, one haemorrhagic) showed correct brain sector localisation on diffusion-weighted and T2-weighted imaging, with Initial results to be presented, including localisation and diagnosis of stroke subtype. Conclusions Initial results support the safety, tolerability, and feasibility of the Axana 0.1T portable magnetic-resonance device for acute stroke. Ongoing refinements are underway to optimise performance. Conflict of interest James Barker - collaboration with Wellumio, Ltd for completion of this feasibility study, with in-kind financial support via the Australian Stroke Alliance. Amy McDonald - nothing to disclose. Dion Thomas - employee of Wellumio Ltd. Ziad Rouag - employee of Wellumio Ltd. Sergei Obruchkov - co-founder and co-CEA of Wellumio. Yu-Chieh Tzeng - co-founder and co-CEA of Wellumio. Mark Parsons: nothing to disclose. Bruce Campbell: Nothing to disclosure. Geoffrey Donnan: provision of in-kind financial support through Australian Stroke Alliance. Stephen Davis: provision of in-kind financial support through Australian Stroke Alliance.

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