Wellumio is expanding its global footprint by launching a new subsidiary in California, USA—a strategic move that, according to the company, lays the groundwork for planned USA-based clinical trials to validate its innovative Axana device and accelerate its mission to bring this portable, life-saving technology to frontline stroke teams nationwide.
“We’ve designed a novel device that is highly portable and significantly faster than traditional MRIs [magnetic resonance imaging], making it ideal for quick assessments in emergency situations,” said Shieak Tzeng, chief executive officer (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.”
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). The company says that 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, Wellumio claims, also noting that—by delivering this information quickly—Axana supports the prioritisation of advanced imaging and guides urgent treatment decisions.
Wellumio has already completed several successful pre-submission meetings with the US Food and Drug Administration (FDA), marking “significant progress” towards US regulatory filings in preparation for its eventual commercial rollout.
To support these efforts and lay the foundation for a successful launch, Wellumio has bolstered its leadership team with several key appointments:
- Sia Moussavi—a distinguished executive with a background at GE Healthcare who joins the board to provide strategic guidance for navigating the complexities of the US healthcare market
- Ziad Rouag—the new US general manager who brings more than 20 years of experience in the medical device industry, including leadership roles in clinical operations and regulatory affairs
- Daniel Weyers—a former global product manager at GE Healthcare who joins the team as vice president of product development to support product development and launch in the USA
Additionally, Wellumio has several USA-based medical advisory board members, including Anne Alexandrov (University of Tennessee Health Science Center, Memphis, USA), Andrei Alexandrov (University of Arizona College of Medicine, Phoenix, USA), David Liebeskind (University of California Los Angeles Health, Los Angeles, USA) and Osama Zaidat (Mercy Hospital, Toledo, USA).
