Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has secured the go-ahead from the US Food and Drug Administration (FDA) to manufacture DurAVR™ Transcatheter Heart Valves (THV) at the company’s newly expanded production facility in Minnesota.
AVR is a structural heart company focused on delivering clinically superior and durable solutions through better science and better design.
The FDA’s determination will allow the company to leverage its expanded in-house production capabilities, leading to ‘significant’ cost savings and improvements in efficiency as Anteris prepares to build DurAVR THVs for upcoming clinical trials.
Expanding into largest cardio market
“The commencement of valve production for clinical use at our US Maple Grove facility introduces great efficiencies and reduces manufacturing costs and is within easy reach of the world’s largest TAVR centres and cardiovascular market,” Anteris Technology CEO Wayne Paterson said.
The expanded Maple Grove facility adds to AVR’s existing tissue engineering capabilities in Malaga, Perth, where the company’s patented ADAPT® anti-calcification technology is manufactured, while also expanding overall production capacity.
Anteris believes the proven benefits of its patented ADAPT® tissue technology, paired with the unique design of its DurAVR 3D single-piece aortic heart valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors today.
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