Anteris Technologies Ltd (ASX:AVR) (OTCMKTS:AMEUF) (FRA:DDF) has received results from an anti-calcification study that indicate its ADAPT® treated tissue has superior anti-calcification attributes compared with tissues used in competitor valves.
Results showed the ADAPT® treated tissue, used in the DurAVR™ 3D single-piece aortic valve, had around 38% less calcium concentration compared with the Medtronic AOA™ porcine arm – the tissue used in commercially available TAVR Valves – and 26% less calcium in the bovine arm.
Bovine tissue is used in some of the Medtronic SAVR (surgical aortic valve replacement) valves.
Using a well-established rat model to determine if different anti-calcification methods are likely to have clinical relevance, four tissue samples (ADAPT®, AOA™ Porcine, AOA™ Bovine and control= GA treated bovine pericardium) were implanted subcutaneously in each rat (n=48).
The animals were sacrificed at four and eight months after implantation and tissue samples were analysed histologically as well as for calcium per tissue weight.
“Supports previous human studies”
Chief executive officer Wayne Paterson said: “These findings clearly demonstrated the superior performance of the ADAPT® tissue-engineered process as an anti-calcification technology against some of the top competitors in the marketplace.
“It further supports previous human studies and clinical experience demonstrating ADAPT® has a clinically relevant profile in terms of resisting calcification.
Dr Phillip McCloud, of McCloud Consulting Group, a renowned biostatistician who performed an independent review of the data said: “The geometric mean ratios demonstrated clear separation between the 95% CI and 1.0, thus confirming the highly significant reduction of calcium for the ADAPT® arm compared to the AOA™ Bovine arm (P = 0.007), and AOA™ Porcine arm (P < 0.001).”
Looking ahead
Results correlated with existing clinical data and those of the prior head-to-head study with a similar protocol which produced significant differentials between ADAPT® tissue and Edwards Life Sciences’ Thermafix™ tissue at the eight to 12-month mark.
Based on these encouraging results, Anteris plans to undertake a further study comparing the ADAPT® anti-calcification treatment in a head-to-head study with both Medtronic’s AOA™ and the next generation TAVR tissue treatment, Resilia® from Edwards Lifesciences.