Anteris Technologies Says Patient Enrollment in Global Pivotal Registration Trial Expected to Begin in Q4

MT Newswires Live

Sep 30, 2025

Anteris Technologies (ASX:AVR) said the patient enrollment in the its global pivotal registration trial is expected to begin in the fourth quarter, according to a Tuesday Australian bourse filing.

Enrollment was initially expected to begin in the third quarter.

It submitted a formal response to the US Federal Drug Administration's (FDA) request for additional information regarding the investigational device exemption. The submission includes the clinical study protocol and demonstrates the DurAVR transcatheter heart valve system was developed and tested for use "appropriately" in the global pivotal trial, per the filing.

A special meeting of the firm's stockholders, held on Monday, approved the grant of a waiver by ASX from certain listing rules, allowing Anteris to issue new securities without obtaining the approval of its stockholders.

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