Anteris Technologies Secures $23M For FDA Pivotal Heart Study

Anteris Technologies Ltd (ASX: AVR) has placed one million new ordinary shares at A$23 each, raising A$23 million before costs.

The funds will primarily be used for preparing the company’s transcatheter heart valve product for the Food and Drug Administration (FDA) pivotal study.

Its lead product is a transcatheter heart valve for treating aortic stenosis.

The FDA approval is a key step to gaining regulatory clearance for the U.S. market.

Funds will also be used for strategic initiatives, valve-in-valve trials, and general working capital.

Results to date

DurAVR™ has been implanted in 50 patients, including 44 with severe aortic stenosis and six valve-in-valve cases to rectify prosthetic valve failure.

Clinical results demonstrate this new class of biomimetic valves outperforms the market leader, returning patients to a near-normal haemodynamic (blood flow) state.

Biomimetic valve

DurAVR™ THV is a novel first-in-class biomimetic valve made from a single piece of native-shaped tissue.

The valve is designed to mimic the performance of a pre-disease human aortic valve.

Early data from the company’s First-in-Human clinical study show excellent haemodynamic performance at 12 months.

DurAVRTM THV is made using ADAPT® tissue, the company’s patented anti-calcification tissue technology.

ADAPT® tissue has been used clinically for over 10 years and distributed in over 55,000 patients worldwide.

 

 

 

 

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