Shares in Imricor Medical Systems Inc (ASX: IMR) surged to a new 12-month high after the company announced it had secured a key approval in the US.
Imricor shares traded as high as $1.99 on the news, up more than 25%, before settling back to be 16.5% higher at $1.84.
The biotechnology company said in its statement to the ASX that the US Food and Drug Administration (FDA) had granted clearance for its Vision-MR Diagnostic Catheter, which would allow it to be marketed in the US.
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ASX biotech medical innovation
The catheter, the company said, 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''.
The company went on to say:
FDA clearance enables Imricor to commercially market the Vision-MR Diagnostic Catheter in the United States, the world's largest electrophysiology market. This clearance is the first of what the Company expects will be multiple regulatory clearances and approvals this calendar year, as Imricor's full MRI guided EP platform is progressively introduced to the market.
Imricor Chief Executive Officer Steve Wedan said it was a "tremendous milestone for the company" and added:
Most of us have worked at companies that have existing medical devices on the US market, and getting a new device on the market is always a big deal. But getting a company's first device on the US market is an extraordinarily big deal. It's an exciting achievement and a date to be noted and remembered.
ASX biotech product suite growing
The company, in its most recent quarterly report, said it had also submitted its NorthStar Mapping System – another real-time MRI product – for FDA approval, with that product already commercially launched in Europe following CE Mark approval.
Mr Wedan said at the time the company was entering the most exciting chapter in its 20-year history.
This was a milestone quarter for Imricor as we achieved parallel regulatory submissions in the US and launched NorthStar comedically in Europe. In Europe we are already seeing strong momentum following CE Mark approval of NorthStar … with growing demand from hospitals eager to perform cardia ablations in a radiation-free environment.
Imricor's cash outflows during the September quarter were US$4.8 million, while the company's total cash and short-term investments were worth US$45.7 million.
Total receipts for the quarter came in at US$124,000.
Imricor was valued at $503.9 million at the close of trade on Friday.
