Allied Healthcare Group (ASX: AHZ) has released positive 36-month post Phase II human clinical trial follow-up results of paediatric patients who were implanted with the CardioCel® cardiovascular patches during various corrective cardiac surgical procedures.
Lee Rodne, managing director, said the follow up data further supports the data for subsidiary Celxcel’s technology, in particular the prevention of calcium build up in tissue post implantation.
“This is a major market differentiator for products using the technology and provides major benefit for patients longer term,” he said.
Calcification of tissue heart valves shortens the lifespan of implanted tissue. This often results in clinicians choosing to use mechanical valves, which requires patients to undergo lifelong and complicated anticoagulant therapy.
Rodne previously told Proactive Investors currently the build-up of calcification means that implanted heart valve tissue has a shorter lifespan of around 10 years when compared to mechanical valves which is over 20 years.
CardioCel® is a collagenous-based bioprosthetic device, made of tissue derived from bovine pericardium and treated with Celxcel’s ADAPT® Tissue Engineering Process.
In May 2008, 30 patients aged 3 months to 14 years were implanted with the CardioCel® patches.
The study included paediatric patients diagnosed with congenital heart disease that required a tissue patch for corrective surgical repairs during major open-heart surgery.
The follow up program followed selected patients to evaluate over a three year period. To date 14 patients have been followed up after two years and five patients have reached three year follow up points.
Importantly, all patients were free of patch-related complications or adverse events.
Echocardiographic (heart ultrasound) results showed intact haemodynamics (blood flow) with no evidence of significant calcification of the CardioCel® patch at the 24 and 36-month evaluation.
Celxcel will now review all patients in the Phase II study to gain additional long-term data.
Following earlier positive trial results Allied Healthcare Group began discussions on partnering and commercial distribution opportunities for CardioCel®.
CardioCel®is set for Therapeutic Goods Administration audit, approval and launch in 2012. The product is now going through the regulatory approval process in Australia, and this may lead to near-term revenues in the local market as early as 2012-13.