Anteris Technologies (ASX:AVR) launches $35m capital raise as FDA approves DurAVR study

• Anteris Technologies (AVR) launches a $35 million capital raise for the clinical development of its DurAVR transcatheter heart valve (THV) system
• The company also received expanded FDA approval for an early feasibility study (EFS) assessing the DurAVR THV system in subjects with severe aortic stenosis
• Anteris CEO Wayne Peterson says the removal of prior study conditions by the FDA will pave the way for the company’s “ground-breaking technology”
• The capital raise will go towards funding DurAVR development and also providing general working capital
• AVR shares are down 4.7 per cent, trading at $22.91 at 2:50 pm AEDT

Anteris Technologies (AVR) has launched a $35 million capital raise for the clinical development of its DurAVR transcatheter heart valve (THV) system.

The news comes as the company announces the receipt of expanded approval from the US Food and Drug Administration (FDA) for a DurAVR early feasibility study (EFS).

The expanded approval allows the company to accelerate its EFS, assessing the DurAVR THV system in subjects with severe aortic stenosis. It removes prior conditions attached to the study.

Anteris CEO Wayne Peterson said the removal of conditions by the FDA would accelerate the development of the company’s technology.

“The DurAVR THV clinical program continues to gather significant momentum, with the removal of conditions by the FDA further paving the way for our ground-breaking technology,” Mr Peterson said.

“We are excited to continue building our remarkable real-world evidence base amongst patients receiving DurAVR in the United States as we progress on our path to regulatory approval.”

The DurAVR THV system is a biomimetic aortic heart valve replacement device and the world’s first single-piece transcatheter heart valve, made using the company’s patented ADAPT anti-calcification process and tissue-shaping technology.

The EFS will assess the safety and feasibility of the technology in the treatment of individuals with symptomatic severe native aortic stenosis.

As for the capital raise, the company will issue 1.458 million new shares at $24 per new share to raise the $35 million. The placement is strongly supported by the company’s two largest shareholders, Perceptive Advisors and L1 Capital.

The fresh funds will go towards the development of Anteris’ DurAVR system and providing general working capital.

Mr Paterson has also taken part in the placement, entering a binding agreement to invest $100,008. This remains subject to shareholder approval which will be decided at an upcoming shareholder meeting.

The placement is expected to be settled on February 14, 2023, with the new shares to commence trading on the 15th.

AVR shares were down 4.7 per cent and trading at $22.91 at 2:50 pm AEDT.