Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has been granted expanded approval for the DurAVR™ 'THV System in Subjects with Severe Aortic Stenosis: Early Feasibility Study (EFS)'.
DurAVR™ is a new class of ‘biomimetic’ aortic heart valve replacement device. It is the world’s first single-piece transcatheter heart valve, made with AVR’s patented ADAPT® anti-calcification process and innovative tissue-shaping technology.
Chance to accelerate activities
The United States Food and Drug Administration (FDA) grant takes away previous conditions placed on the study and gives Anteris the opportunity to accelerate activities related to study execution.
Notably, Anteris will be able to finalise the reimbursement level under the Category B designation previously granted by the FDA after approval from the Centers for Medicare & Medicaid Services.
The EFS will evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
“The DurAVR™ THV clinical program continues to gather significant momentum with the removal of conditions by the FDA further paving the way for our ground-breaking technology,” Anteris CEO Wayne Paterson said.
“We are excited to continue building our remarkable real-world evidence base amongst patients receiving DurAVR™ in the United States as we progress on our path to regulatory approval.”
Anteris raises A$35 million
A A$35 million capital raise will also help Anteris on its regulatory approval journey.
The company placed 1.458 million new ordinary shares to various sophisticated and professional investors at an issue price of $$24.00 per new share to raise the funds.
Its two largest holders Perceptive Advisors and L1 Capital cornerstoned the placement, subscribing beyond their existing pro-rata shareholding.
Anteris will use the money primarily for the clinical development of DurAVR™ and for general working capital.
Participants in the placement will also receive one attaching unlisted option to acquire an ordinary share in Anteris for each new share, expiring two years from the date of issue with an exercise price of $29.00.
In a strong show of support, Paterson, himself, has entered into a binding agreement, subject to shareholder approval, to invest in the capital raise on the same terms amounting to A$100,008.
Settlement is expected to occur on February 14, 2023, with new shares to start trading a day later.