Stroke Detection Innovator Wellumio Expands into the U.S. Market

Revolutionary portable device leverages advanced magnetic resonance technology to rapidly detect acute stroke biomarkers, enabling frontline care teams to make faster, life-saving decisions within the critical 'golden hour.'

SAN FRANCISCO, Jan. 6, 2025 /PRNewswire/ -- Wellumio, a New Zealand-based medical device company pioneering advancements in stroke detection, is expanding its global footprint by launching a new subsidiary in California. This strategic move lays the groundwork for planned U.S.-based clinical trials to validate the company's innovative Axana device and accelerate its mission to bring the 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, 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."

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). 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. By delivering this information quickly, Axana supports the prioritization of advanced imaging and guides urgent treatment decisions. Wellumio has already completed several successful pre-submission meetings with the FDA, marking significant progress toward U.S. regulatory filings and preparing 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, Sia joins the board to provide strategic guidance for navigating the complexities of the U.S. healthcare market.
  
  
• Ziad Rouag: As the new U.S. general manager, Ziad brings over 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, Daniel joins the team as VP of Product Development to support product development and launch in the US.

Additionally, Wellumio has several US-based medical advisory board members, including Anne Alexandrov, PhD, RN, CCRN, FAAN, Andrei Alexandrov, MD, David Liebeskind, MD, and Osama Zaidat, MD.

Executives will present at RESI JPM 2025 on Tuesday, January 14, at 10:00 a.m. PST and meet with investors throughout the week at the JP Morgan Healthcare conference. For more information or to schedule an appointment, please contact Ruth Consuelo at [email protected].

About Wellumio
Wellumio is a New Zealand-based medical device company transforming acute stroke care with its innovative Axana® device. The portable, lightweight technology utilizes a groundbreaking Pulsed Gradient Free Mapping (PGFM) method to rapidly identify areas of brain tissue affected by stroke. Designed to address the limitations of traditional MRI systems, Axana enables frontline healthcare workers in diverse settings, including emergency departments and ICUs, to make timely, life-saving interventions within the critical golden hour, leading to better patient outcomes. To learn more, visit www.wellumio.com

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SOURCE Wellumio