Shares in Anteris Technologies Ltd (ASX: AVR) have jumped more than 10% after the company said it had secured a key US approval for a clinical trial.
The company said in a statement to the ASX on Monday that it had received US Food and Drug Administration (FDA) approval to start its "Paradigm" trial, which is designed to evaluate the DurAVR Transcatheter Heart Valve (THV) in patients with "severe calcific aortic stenosis''.
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Trial to collect key data
The trial will be a randomised controlled trial, evaluating the safety and effectiveness of the device compared to currently available options on the market.
As the company explained in its statement to the ASX:
This head-to-head study will enrol approximately 1000 patients across the Unites States, Europe and Canada … with 1:1 randomisation of patients who will receive either the DurAVR THV or transcatheter aortic valve replacements using commercially available and approved THVs. The Paradigm Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.
The trial is designed to provide "robust clinical evidence", which would then be used by the company to apply for premarket approval in the US.
Anteris chief executive Wayne Paterson said it was a key milestone for the company.
We are extremely pleased to receive FDA approval for the Paradigm trial, which allows us to commence patient recruitment in the United States. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition.
The company said its device is the "first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow''.
Anteris Technologies was valued at $271.6 million at the close of trade on Friday.
The company's shares hit a high of $8.08 on the news on Monday morning before settling back to be changing hands for $7.90, up 11.7%.
Anteris shares have traded in a wide range over the past 12 months, from as low as $4.26 to as high as $13.36 in February.
The company's major shareholders include global investment fund L1 Capital, which holds an 18.7% stake. SIO Partners owns 9.6% of the company while Preceptive Life Sciences Master Fund owns 6.8%.
