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CoAxia On Last Legs Following Contested FDA Panel Meeting

CoAxia is out of money in the wake of an unfavorable neurological devices panel meeting about its de novo application for expanded use of its NeuroFlo catheter. The firm says FDA mishandled the meeting, the first public panel meeting for a de novo submission.

After spending two years trying to attain clearance for an expanded use of the NeuroFlo catheter system to treat patients with acute ischemic stroke within 14 hours of symptom onset, CoAxia Inc. is out of money, and has one remaining employee.

CoAxia CEO Andrew M. Weiss says he remains hopeful that the agency will ultimately grant de novo classification for NeuroFlo despite the outcome of FDA’s Neurological Devices panel last month,...

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