#United States #California #Wellumio #Axana #Stroke Detection

Wellumio's Expansion into the U.S. Market

Wellumio, a groundbreaking medical device firm hailing from New Zealand, has officially made its entry into the U.S. market with the launch of a new subsidiary in California. The company is known for its innovative Axana device, designed specifically for rapid stroke detection—a critical advancement in emergency healthcare.

As reported, the Axana device employs an advanced form of magnetic resonance technology to swiftly identify key stroke biomarkers, enabling frontline healthcare professionals to make life-saving decisions during the crucial 'golden hour' after a stroke event. Wellumio aims to validate Axana through U.S.-based clinical trials, which are essential for the device's acceptance in the market.

CEO Shieak Tzeng emphasized the need for speed in emergency medicine, stating, "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." This attribute allows for the delivery of essential information concerning stroke-related brain damage, aiding in urgent treatment decisions.

Unlike conventional MRI technology, the Axana device utilizes a unique Pulsed Gradient Free Mapping (PGFM) platform. This innovative system does away with the bulky machinery typically required for magnetic imaging. Instead, Axana can detect molecular diffusion in brain tissue through its compact form, making it readily deployable in emergency and intensive care environments.

The device’s design means it can be effectively used at a patient’s bedside, offering rapid insights into the severity of a stroke. This prompt data delivery boosts the ability to prioritize further imaging modalities and makes informed treatment easier for doctors and medical teams.

Progressing toward regulatory approval, Wellumio has successfully conducted several pre-submission meetings with the FDA, signaling readiness for the next steps in its commercial rollout. As part of this growth strategy, the company has introduced significant new hires to strengthen their leadership, including:

• - Sia Moussavi, who brings experience from GE Healthcare and will help navigate the complexities of the U.S. healthcare landscape.
• - Ziad Rouag, the new U.S. general manager with over two decades of experience in clinical operations and regulatory affairs.
• - Daniel Weyers, a former Global Product Manager at GE Healthcare, who will lead product development efforts.

In addition to these appointments, Wellumio has also formed a medical advisory board consisting of key figures in the healthcare industry to guide its operations and strategies effectively. Experts such as Dr. Anne Alexandrov and Dr. David Liebeskind will bring invaluable insights as the firm prepares for the commercial release of Axana.

Looking ahead, executives from Wellumio are set to present at the upcoming RESI JPM 2025 conference, scheduled for January 14, at 10:00 a.m. PST. This platform will allow them to engage with investors while discussing their ambitious plans for the U.S. market.

About Wellumio: Wellumio is dedicated to transforming acute stroke care through its portable Axana® device, which can identify brain tissue affected by strokes quickly. Its cutting-edge technology aims to enable healthcare staff to deliver timely interventions within the golden hour of treatment to improve patient outcomes. To learn more, visit www.wellumio.com.