Anteris Technologies Ltd (ASX:ARV) has been granted a trading halt by the ASX with an announcement pending in regard to a proposed capital raising.
The halt will remain in place until the beginning of regular trade on Tuesday, May 25, or when an announcement is released to the market, whichever occurs earliest.
Key milestone achieved
Anteris recently hit a key milestone by reaching concept lock on critical components of its ComASUR™ Transfemoral Delivery System.
Importantly, the novel commissural alignment component that gives a physician the ability to align the commissures of the replacement valve to the native valve is now fully functional.
This is a key step for the company, as this aspect of Transcatheter Aortic Valve Replacement (TAVR) delivery is not available with currently marketed products but is highly desired by physicians.’
Advancing towards FDA submission
A series of animal studies have been completed to demonstrate the feasibility of the DurAVR™ THV (prosthetic aortic valve) and its bespoke ComASUR™ delivery system.
These studies are a critical part of the test plans agreed with the FDA as part of its approval process for the company’s early feasibility study planned later in the year.