Anteris Technologies hits key milestone on path to FDA submission for ComASUR™ Transfemoral Delivery System

Anteris Technologies Ltd (ASX:AVR) (OTCMKTS:AMEUF) (FRA:DDF) has 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.

Recognising the importance of this development, investors have sent shares more than 5.5% higher intra-day at A$9.00 while the company’s market cap is approximately A$56.5 million.

“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. 

Anteris chief executive officer Wayne Paterson said: “This milestone is highly significant as we continue to innovate our product offerings. 

“The commissural alignment component will give physicians the ability to deliver DurAVR™ accurately and consistently leading to better outcomes for patients. 

“This further strengthens our three key technology pillars (ADAPT®, DurAVR™ and ComASUR™). 

“As we advance towards our FDA EFS submission, these milestones are critical to ensure study approval. 

“Our team continues to run studies and tests as aligned with the FDA requirements for EFS approval.” 

Animal studies demonstrate feasibility 

The animal studies were specifically designed to show the ComASUR™ delivery system’s ability to access the arterial vasculature using minimally invasive techniques and track through the aortic arch to the aortic valve where a DurAVR™ THV was implanted. 

In addition, post-implant echocardiography and CT scan confirmed the functionality of the DurAVR™ THV with stable positioning and good hemodynamic function.

Story by ProactiveInvestors