Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) is trading higher on news that the US Food and Drug Administration (FDA) has conditionally approved the DurAVR™ transcatheter heart valve (THV) system for investigational device exemption (IDE) application to kick off an early feasibility study (EFS).
The study will evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Shares have been as much as 6.3% higher to A$24.50 while AVR's market cap is approximately A$322.62 million.
US clinical trial imminent
The FDA concluded the company provided adequate data to support the initiation of a clinical study in the United States.
For the EFS, Anteris will enrol 15 subjects at seven heart valve centres of excellence within the United States. It is anticipated the study will begin in early 2023.
The FDA has categorised DurAVR™ in this study as a CMS Category B device, which permits the device to be sold during the study pending CMS approval.
“I am pleased and eager to begin the DurAVR™ THV EFS to further evaluate this promising novel technology,” said Dr Michael Reardon, Allison Family distinguished chair in Cardiovascular Research, Department of Cardiovascular Surgery, Professor of Cardiovascular Surgery, Houston Methodist Hospital, Houston, TX and study chair for the DurAVR™ THV Early Feasibility Study.
“The single-piece, native-shape valve design of the DurAVR™ THV represents an advancement to existing heart valve technologies. I am excited to see the potential of the DurAVRTM THV in treating patients suffering from severe aortic stenosis.”
"Critical milestone"
“The FDA approval to begin the DurAVR™ EFS is a critical milestone for Anteris achieving pre-market approval in the United States,” Anteris Technologies chief medical officer Dr Chris Meduri said.
“It is also another validation of the remarkable work done so far. This study will build upon clinical data from the DurAVR™ First-in-Human Study recently presented at the Transcatheter Cardiovascular Therapeutics conference in Boston USA and London Valves in London, England.
“I am extremely proud of the entire Anteris Team for achieving this pivotal milestone in the clinical development of the DurAVR™ THV System.”
CEO Wayne Paterson added: “This study sets up 2023 to be a significant year of milestones and catalysts as we continue to build our remarkable base of evidence among patients who have had DurAVR™ implanted.
“In the next year, we will significantly expand the patient population implanted with DurAVR™, a new class of valve made with a first-in-class, single-piece, native-like valve design built upon our breakthrough ADAPT® tissue treatment that has years of real-world experience.”