Allied Healthcare Group has reported that it will receive a US$1.9 million grant from Commercialisation Australia for the commercialisation and launch of its lead regenerative tissue product, CardioCel. Under the project, which has been supported with assistance from the Australian Government, Allied will receive matching funding of US$1.9 million until August 2014. The grant funding begins immediately.
CardioCel is the company's lead regenerative tissue product for the repair and reconstruction of cardiovascular defects including repairing heart valves. It has demonstrated superior characteristics including anti-calcification properties, beneficial mechanical properties, off the shelf ease of use, and allows tissue regeneration post implantation without needing to use growth factors or external stem cells.
CardioCel has delivered proven benefits for both surgeons and patients under the Authorised Prescriber Scheme in Australia. Allied expects the product to be available in global markets offering improved patient outcomes to this patient group over the next 12 months. The company continues to pursue marketing approval for CardioCel via a CE mark in Europe, and FDA 510(k) clearance in the US, as part of its global launch plan. Currently, the product is being used by Australian surgeons in Brisbane and Melbourne under early access schemes. Allied expects additional Authorised Prescribers in the coming months. This project has been supported with assistance from the Australian Government through Commercialisation Australia and will partially fund additional key resources in Europe and the US and build up global manufacturing capabilities.
Allied's regenerative tissue engineering technology started as a research programme in 2001 focusing on tissue engineering and regenerative medicine based around the proprietary Adapt engineering process as a platform technology. The lead programme CardioCel has successfully completed a number of animal studies and a Phase II study. CardioCel is a cardiovascular patch used to repair paediatric heart deformities. These deformities range from routine "hole in the heart" operations to major vessel outflow tract repairs. The patch may also be used to repair leaking heart valves in paediatric patients. CardioCel has been shown to allow tissue regeneration once implanted.