Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has completed a successful share placement, issuing one million new shares at A$23 each and raising A$23 million in gross proceeds.
This funding will support a pivotal Federal Drug Administration study for the DurAVR™ transcatheter heart valve (THV), opening the door to regulatory clearance on the US market.
The funds will also be used for strategic initiatives, valve-in-valve trials and general working capital.
DurAVR transcatheter heart valve
The company’s DurAVR™ heart valve has been implanted in 50 patients (44 with severe aortic stenosis and six valve-in-valve cases to rectify prosthetic valve failure).
Clinical results to date demonstrate that this new class of biomimetic valve outperforms the market leader, returning patients to a near-normal haemodynamic (blood flow) state.
DurAVR™ THV was designed in partnership with leading interventional cardiologists and cardiac surgeons.
It is the first transcatheter aortic valve replacement (TAVR) to use a single piece of bioengineered tissue. This biomimetic valve is shaped to mimic the performance of a healthy human aortic valve.
DurAVR™ THV is made using ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue has been used clinically for at least 10 years and distributed for use in more than 55,000 patients worldwide.
Finally, the company’s ComASUR™ Delivery System was designed to provide controlled deployment and accurate placement of the DurAVR™ THV with balloon-expandable delivery, allowing precise alignment with the heart’s native commissures to achieve optimal valve positioning.
Anteris believes it set to “revolutionise the structural heart market by delivering clinically superior solutions for significant unmet clinical needs”.