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Anteris Secures FDA Nod, Kicks Off PARADIGM Trial Across US and Europe
9:35am on Thursday 13th of November, 2025 AEDT
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Healthcare
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Anteris Secures FDA Nod, Kicks Off PARADIGM Trial Across US and Europe
9:35am on Thursday 13th of November, 2025 AEDT
Key Points
FDA approval granted to commence US patient recruitment for PARADIGM Trial
First patients treated in Denmark after European regulatory clearance
Manufacturing scale-up and ISO 13485 certification underway
Q3 R&D expenses total $16.8 million, reflecting trial preparation
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