Imricor Medical Systems Inc (ASX: IMR) shares are having a strong session on Thursday.
At the time of writing, the ASX stock is up 11% to $1.56.
This means the medical device company's shares are now up over 200% since this time last year.
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Why is this ASX stock jumping?
Investors have been buying the company's shares after it released an update on a study and the US Food and Drug Administration (FDA).
Imricor notes that it is aiming to make interventional medical procedures better, safer, and more cost effective by making it possible for these procedures to be performed under real-time magnetic resonance imaging (MRI) guidance, rather than under x-ray fluoroscopy guidance.
According to the release, the ASX stock has successfully completed its Human Factors (HF) study covering all devices that are currently under review by the U.S. FDA.
Management notes that the HF study is a critical step in the FDA approval process, as it ensures that each device can be used safely and effectively by clinicians in real-world settings. It believes that completion of this extensive study across the company's full product portfolio represents a major milestone in advancing toward FDA market approval.
It also feels that it highlights both the scale and complexity of the project, which required comprehensive testing across multiple devices, workflows, and clinical scenarios. In addition, it emphasises the strong momentum the ASX stock is building as it continues to progress through the U.S. regulatory pathway.
What's next?
With the HF study now complete, the ASX stock advised that it is one step closer to unlocking access to the world's largest electrophysiology market. Management believes this represents a significant growth opportunity for the company and a major inflection point in its global strategy.
Imricor's chair and CEO, Steve Wedan, commented:
The scale of this study cannot be overstated, having taken our team over a year from planning through execution. Completing human factors testing across our entire product portfolio is an extraordinary achievement and a clear demonstration of the strength and dedication of the Imricor team. It also marks a major milestone on our path to FDA approval and positions us strongly as we prepare to bring MRI-guided ablation to the United States.
I am grateful to the physicians and medical staff that took the time to travel to the Imricor's iCMR Design Centre in Minneapolis to complete this study. They have played an important and vital role in shaping the future of Imricor and of interventional medicine.
