Wellumio has announced enrolment of the first patient in a feasibility, safety and usability assessment of the company’s Axana 0.1T portable magnetic resonance imaging (MRI) device, which will study the ability of the Axana device to detect acute stroke in emergency department (ED) patients. A Wellumio press release notes that, through its compact, portable design, the device 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.
A hospital in Melbourne, Australia recently assessed the first case using Axana, with the care team there performing the scan on a 77-year-old female suspected of acute stroke with Wellumio’s device.
According to the company, this portable MRI study is a two-part, dual-centre, feasibility/ observational study of the Axana 0.1T brain-scanning device in subacute stroke patients—the primary objective of which is to assess the safety (adverse events) and feasibility (ability to acquire a scan in a timely manner without technical fault) of the Axana device, in a hospital setting, with healthy controls versus stroke patients. Secondary objectives include assessing usability of the Axana device; acquiring physiological data from healthy controls and hospital patients with the device to investigate agreement with hospital MRI; and investigating the repeatability and reproducibility of scans acquired with the device within and between participants.
The clinical study is being supported by the Australian Stroke Alliance as principal study partner, and managed by clinical research organisation Titan Prehospital Innovation in partnership with the Australian Stroke Alliance.
“This innovative imaging approach to stroke detection has the potential to accelerate treatment and improve patient outcomes,” said co-principal investigator Stephen Davis (Royal Melbourne Hospital, Parkville, Australia). “MRI techniques have the potential to sensitively diagnose stroke.”
“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,” added co-principal investigator Geoffrey Donnan (University of Melbourne, Melbourne, Australia). “That makes this an exciting innovation milestone as we enrol the first patient in this important first clinical trial.”
“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,” commented Shieak Tzeng, chief executive officer (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.”
Wellumio claims that—unlike conventional MRIs, which rely on superconducting magnets and large coils to generate magnetic gradients for imaging—Axana’s innovative technology is powered by the “groundbreaking approach” of pulsed gradient free mapping (PGFM).
