This authorization marks a significant milestone in the Company's clinical and regulatory strategy and enables patient recruitment to commence at leading centers in France.

"Securing French regulatory clearance is an important step in the execution of the PARADIGM Trial," said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. "France represents a strategically important market with highly experienced centers and investigators, reinforcing the quality and conduct of the study."

The Company continues to advance its global clinical strategy, with ongoing site activations and patient enrollment across the United States and Europe.