The New Zealand-based company develops advancements in stroke detection, including its Axana device. It aims to expand to the U.S. to lay the groundwork for planned U.S.-based clinical trials to validate the Axana device.
Axana, a portable, potentially life-saving device, utilizes pulsed gradient-free mapping (PGFM), rather than the magnetic gradients used for conventional MRIs. This approach eliminates the need for bulky components, enabling the device to track the magnetic resonance properties of brain tissue. This compact, portable design can identify clinically proven stroke biomarkers, such as molecular diffusion, according to a news release.
Wellumio says the device’s portability and simplicity make it ideal for bedside use. There, it enables the fast detection of stroke-related damage and provides critical insights into its severity and extent. The company says it’s already completed multiple pre-submission meetings with the FDA as it moves toward regulatory approval and commercialization.
“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 Shieak Tzeng, CEO of Wellumio. “By delivering radial maps of the brain, Axana empowers 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 adds industry veterans to aid expansion
To support its expansion to the U.S., Wellumio made a series of key appointments to its leadership team. The company added Sia Moussavi to its board and named Ziad Rouag U.S. GM and Daniel Weyers VP of product development.
Moussavi brings a background at GE HealthCare to the company and intends to deliver strategic guidance for the U.S. healthcare market. Rouag has more than 20 years of experience in the medical device industry, including leadership roles in clinical operations and regulatory affairs. Weyers, a former global product manager at GE HealthCare, joins to support product development and launch in the U.S.
Additionally, Wellumio already has several U.S.-based medical advisory board members. That includes Dr. Anne Alexandrov, Dr. Andrei Alexandrov, Dr. David Liebeskind and Dr. Osama Zaidat.
