Anteris Technologies (ASX:AVR) has been granted expanded approval by the United States Food and Drug Administration for its DurAVR™ THV System in Subjects with Severe Aortic Stenosis, allowing the company to accelerate certain activities related to study execution.
The DurAVR™ THV System is a single-piece transcatheter heart valve designed to help treat aortic stenosis patients.
Anteris' patented ADAPT® anti-calcification process and innovative tissue-shaping technology promise to deliver a game-changing treatment to aortic stenosis patients worldwide.
Anteris Technologies has also raised $35M in a capital raising by offering 1.458 million new ordinary shares to various sophisticated and professional investors at an issue price of $24.00 per share.
The investment is subject to shareholder approval and will be considered at the Annual General Meeting.