What You Should Know:
– Wellumio, a New Zealand-based medical device innovator announced the launch of a new subsidiary in California, a strategic move aimed at facilitating US-based clinical trials for its groundbreaking Axana device and accelerating its commercial rollout in the United States.
– Wellumio’s expansion to the United States marks a significant milestone in its journey to revolutionize stroke care.
Axana: Transforming Stroke Detection
Axana is a portable, bedside stroke detection device that utilizes a novel technology called Pulsed Gradient Free Mapping (PGFM). Unlike traditional MRI machines that require large superconducting magnets and coils, Axana eliminates the need for bulky components, enabling a compact and portable design. This innovation allows for rapid stroke assessment at the patient’s bedside, providing crucial information about the severity and extent of stroke-related damage.
Axana offers several advantages for stroke care:
- Portability: Enables bedside assessment, eliminating the need to transport critically ill patients.
- Speed: Provides rapid detection of stroke-related damage, facilitating timely treatment decisions.
- Accuracy: Identifies clinically proven stroke biomarkers, offering valuable insights into the severity and extent of the stroke.
Strategic Expansion and Leadership
Wellumio’s expansion to California is a key step in its US market entry strategy. The company has already engaged in pre-submission meetings with the FDA, signaling its progress towards regulatory approval and commercialization.
To support these efforts, Wellumio has strengthened its leadership team with key appointments:
- Sia Moussavi: A seasoned executive with experience at GE Healthcare joins the board to provide strategic guidance for navigating the US healthcare landscape.
- Ziad Rouag: Takes on the role of US general manager, bringing over 20 years of experience in the medical device industry, including expertise in clinical operations and regulatory affairs.
- Daniel Weyers: Joins as VP of Product Development, leveraging his experience as a former Global Product Manager at GE Healthcare to support Axana’s US launch.
Furthermore, Wellumio has assembled a distinguished US-based medical advisory board, comprising leading experts in stroke care and neurology.
“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.”
