Wellumio, a New Zealand-based medical device company pioneering advancements in stroke detection, today announced enrollment of the first patient in the Feasibility, safety, and usability assessment of the Wellumio 'Axana' 0.1T portable magnetic resonance imaging device (Portable MRI study) which will study the ability of the Axana device to detect acute stroke in ED patients. The Axana device, through its compact, portable design, enables the user to rapidly track the magnetic resonance properties of brain tissue and identify clinically proven stroke biomarkers, such as molecular diffusion identified by Diffusion Weighted Imaging (DWI) at the patient's bedside. 

The Melbourne hospital recently assessed the first case using the Wellumio Axana device. The care team there performed the scan on a 77-year-old female suspected of acute stroke with the Wellumio Axana device.

The Portable MRI study is a two-part, dual-center, feasibility/ observational study of the Wellumio 'Axana' 0.1T brain scanning device in subacute stroke patients. The primary objective of this first clinical study is to assess the safety (adverse events) and feasibility (ability to acquire a scan in a timely manner without technical fault) of the Wellumio 'Axana' device in the hospital setting with healthy controls and stroke patients. Secondary objectives include 1) assessing usability of the Axana device, 2) acquiring physiological data from healthy controls and hospital patients with the Axana device to investigate the agreement with hospital MRI, and 3) investigating the repeatedly and reproducibility of scans acquired with the Axana device within and between participants.

The clinical study is supported by the Australian Stroke Alliance, principal study partner, and managed by Titan Prehospital Innovation, a Clinical Research Organisation in partnership with the Australian Stroke Alliance.

"This innovative imaging approach to stroke detection has the potential to accelerate treatment and improve patient outcomes. MRI techniques have the potential to sensitively diagnose stroke," said Professor Stephen Davis, co-principal investigator.

"Integrating this type of technology in the pre-existing workflow by bringing MRI imaging to the patient has the potential, if successful, to improve acute stroke assessment and treatment. That makes this an exciting innovation milestone as we enroll the first patient in this important first clinical trial," added Professor Geoffrey Donnan, co-principal investigator.

"We've designed a novel device that is highly portable and significantly faster than traditional MRIs, making it ideal for quick assessments in emergency situations," said Dr. Shieak Tzeng, CEO of Wellumio. "By delivering radial maps of the brain, Axana will potentially empower emergency physicians, neurologists, radiologists, and stroke care team members to rapidly detect strokes and guide critical treatment decisions during the crucial golden hour of care."

Unlike conventional MRIs, which rely on superconducting magnets and large coils to generate magnetic gradients for imaging, Axana's innovative technology is powered by Pulsed Gradient Free Mapping (PGFM). This groundbreaking approach eliminates the need for bulky components, enabling the device to track the magnetic resonance properties of brain tissue and identify clinically proven stroke biomarkers, such as molecular diffusion, in a compact, portable design.

Axana's portability and simplicity make it ideal for bedside use, where it enables fast detection of stroke-related damage and provides critical insights into its severity and extent. By delivering this information quickly, Axana supports the prioritization of advanced imaging and guides urgent treatment decisions.