Wellumio has today revealed the establishment of a new branch in California, marking an expansion of its presence in the United States. Originating from New Zealand, the company specializes in cutting-edge stroke detection technologies, particularly with its Axana device. This move is part of their strategy to lay the groundwork for conducting clinical trials in the U.S., aimed at validating the efficacy of the Axana device.
Axana stands out as a portable and potentially life-saving tool, employing pulsed gradient-free mapping (PGFM) rather than traditional magnetic gradients used in standard MRIs. This method removes the requirement for cumbersome components, allowing the device to analyze the magnetic resonance properties of brain tissue. According to a recent press statement, this compact and easy-to-transport design can identify established stroke biomarkers like molecular diffusion.
According to Wellumio, the device’s ease of use and portability make it suitable for bedside application. It enables rapid identification of stroke-related damage while delivering vital information about its severity and extent. The company has already completed multiple pre-submission discussions with the FDA as it moves forward with regulatory approval and commercialization.
“We’ve developed an innovative device that is both highly portable and much quicker than conventional MRIs, making it perfect for rapid assessments in crisis situations,” stated Shieak Tzeng, CEO of Wellumio. “Axana provides radial brain maps, empowering emergency physicians, neurologists, radiologists, and stroke care professionals to quickly identify strokes and facilitate critical treatment decisions during the crucial initial moments of medical intervention.”
Leadership Enhancements Amid U.S. Growth
To bolster its U.S. expansion efforts, Wellumio has announced several significant additions to its leadership team. Joining the board is Sia Moussavi, with the appointment of Ziad Rouag as the U.S. General Manager and Daniel Weyers as VP of Product Development.
Moussavi, armed with expertise from GE HealthCare, will offer strategic insights tailored to the U.S. healthcare landscape. Rouag, boasting over two decades of medical device industry experience, has held key roles in clinical operations and regulatory affairs. Meanwhile, Weyers, who formerly served as a global product manager at GE HealthCare, will drive product development and launch efforts in the U.S.
In addition, Wellumio benefits from the advice of several U.S.-based medical advisors, including Dr. Anne Alexandrov, Dr. Andrei Alexandrov, Dr. David Liebeskind, and Dr. Osama Zaidat.