Wellumio, a New Zealand-based medical device company, is expanding its global presence by launching a U.S. subsidiary in California to support clinical trials and commercialization of its Axana device, a portable MRI system for rapid stroke detection. The company's expansion aims to bring its innovative technology to frontline stroke teams across the nation, addressing the critical need for faster diagnosis and treatment during the 'golden hour' of stroke care.
Axana: A Novel Approach to Stroke Detection
The Axana device employs Pulsed Gradient Free Mapping (PGFM) technology, a departure from traditional MRI systems that rely on superconducting magnets and large coils. This allows Axana to be highly portable and significantly faster than conventional MRIs. According to Shieak Tzeng, CEO of Wellumio, Axana delivers radial maps of the brain, empowering healthcare professionals to rapidly detect strokes and guide critical treatment decisions.
Unlike conventional MRIs, Axana's PGFM technology tracks the magnetic resonance properties of brain tissue and identifies clinically proven stroke biomarkers, such as molecular diffusion, in a compact, portable design. This enables quick assessments in emergency situations, providing critical insights into the severity and extent of stroke-related damage.
Clinical Validation and Regulatory Pathway
Wellumio has already made significant progress toward U.S. regulatory filings, having completed several pre-submission meetings with the FDA. To support these efforts, the company has strengthened its leadership team with key appointments, including Sia Moussavi, Ziad Rouag, and Daniel Weyers, each bringing extensive experience in the medical device industry.
In addition to its U.S. expansion, Wellumio has initiated clinical trials in Australia. The first subject, a 77-year-old female suspected of having an acute stroke, was enrolled in a study to evaluate the device's feasibility, usability, and safety in subacute stroke patients. The trial, supported by the Australian Stroke Alliance, aims to assess the device's ability to acquire prompt scans without technical issues and to compare the data with hospital MRI results.
Addressing the Critical Need for Rapid Stroke Diagnosis
Stroke is a leading cause of disability and death worldwide, with timely intervention being crucial for improving patient outcomes. The Axana device offers a potential solution to the challenges of rapid stroke diagnosis, enabling frontline healthcare workers in diverse settings, including emergency departments and ICUs, to make timely, life-saving interventions within the critical golden hour.
"This innovative imaging approach to stroke detection has the potential to accelerate treatment and improve patient outcomes," said Stephen Davis (Royal Melbourne Hospital, Parkville, Australia). Geoffrey Donnan (University of Melbourne, Melbourne, Australia) added, "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."
