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Imricor Medical Systems (ASX:IMR) has won its first keystone FDA clearance Monday, with the United States health and drug regulator effectively thumbs-upping Imricor’s diagnostic catheter product, which takes electrophysiological data from the human heart during an MRI scan to effectively map a patient’s heart.
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“The Vision-MR Diagnostic catheter is designed to be used under real-time magnetic resonance imaging (MRI) guidance and represents a key component of Imricor’s comprehensive platform of MRI-compatible electrophysiology (EP) devices,” Imricor wrote on Monday.
The market response clearly underscores enthusiasm; at least one HotCopper user pondered aloud (well, submitted a forum comment) whether Imricor shareholders are looking at the next 4DMedical (ASX:4DX), which is quite spectacularly staging something like an +800% one-year return at this moment.
That remains to be seen; other users noted Imricor has a second product, Northstar, which investors are hopeful will also see FDA clearance in coming months.
For all intents and purposes, Northstar is very similar to the diagnostic catheter in that it’s ultimately leveraging MRI machines to provide high-quality imaging solutions. Still, a second clearance there from the world’s best-known drug regulator would likely be a catalyst for further upside.
“Most of us have worked at companies that have existing medical devices on the U.S. market, and getting a new device on the market is always a big deal,” IMR chief executive Steve Wedan said.
“But getting a company’s first device on the U.S. market is an extraordinarily big deal. It’s an exciting achievement and a date to be noted and remembered.”
IMR last traded at $1.84/sh.
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