The Anteris Technologies Ltd (ASX: AVR) share price is edging higher today after releasing the results from its anti-clarification study.
During early morning trade, shares in the structural heart company pushed as high as $3.84 but have since retreated. At the time of writing, the Anteris share price is swapping hands for $3.75, up 2.46%.
Let's take a look at what Anteris does and what were the clinical results.
What does Anteris do?
Anteris, formerly known as Admedus Ltd, is a medical company that focuses on designing and manufacturing heart valves. Its next-generation technology re-engineers xenograft tissue into pure collagen scaffold, helping surgeons replace valves for patients during surgery.
Positive interim results
Anteris advised that it received positive results in its anti-clarification study using its Adapt technology.
The four-month interim report showed superior attributes for anti-clarification compared to other tissues used in competitor valves. The treated tissue used in the DurAVR 3D single-piece aortic value exhibited a 40% less calcium concentration. This was measured against the Medtronic AOA arm, tissue used in commercially available surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) valves.
In the study, 48 juvenile rats were implanted with four different samples underneath the skin for evaluation. The company stated that the concluded results correlated with existing clinical data. Head-to-head trials displayed significant differences between Adapt tissue and Edwards Life Sciences' Thermafix tissue at the eight to 12-month mark.
Anteris noted that clarification (hardening) is a major contributor to the failure of heart valve replacements made from animal tissue.
The final results at the end of the 8-month study will be submitted to the United States Food and Drug Administration (FDA). The company hopes to demonstrate that its DuARV product is better than the currently available valves in the market.
What did management say?
Anteris CEO Wayne Paterson commented on the findings and pathway for commercialisation. He said:
The results were highly positive for ADAPT, indicating our ADAPT anti-calcification treatment is statistically superior to both of the major competitors.
Whilst we have long understood the clinical superiority of ADAPT, it's critical for the regulatory submission to prove this against market incumbents specifically in the TAVR space.
About the Anteris share price
The company went through a name change earlier this year as a part of its restructuring program. Since completion of the shuffle, the Anteris share has not been a strong performer, falling more than 50% from May.
Shares in the med tech business have been mostly stagnant the past couple of months hovering around the $4 mark.
