Allied Healthcare Group (ASX: AHZ) has taken another strategic step towards bringing its regenerative medicine products to market with the submission of a CE Mark application for the cardiovascular patch, CardioCel®.
The CE Mark submission is a key value driver for Allied Healthcare, with 2013 set to mark the launch of the company's first product from the ADAPT® TEP platform technology into major cardiovascular marketplaces.
The importance of this application is that Europe is one of the major markets for regenerative medicine products. If successful, this provides the potential for substantial revenue for the company.
The regenerative medicine market is currently around $3 billion and growing. Allied Healthcare has the upper hand, because at present there is no similar product available to surgeons on the market.
The initial application for the CardioCel® patch will be in cardiac surgical repair, such as congenital heart disease.
About eight in 1,000 children are born with the disease and around half of them have surgery. This presents an extensive global market potential for the technology.
As CardioCel® is manufactured using animal derived material, the CE Mark submission will be evaluated by Allied Healthcare's Notified Body, as well as the Medicines and Healthcare Regulatory Agency in the United Kingdom.
Over the past 10 years the ADAPT® technology and its use to prepare tissue for surgical repair has been tested in a large number of animal studies as well as a Phase II study.
Subsidiary Celxcel has previously demonstrated the potential for the CardioCel® patch, having delivered positive results from a tissue heart valve study of its ADAPT® Tissue Engineering technology that show a reduction in visible calcification of implanted tissue heart valves.
The results open up the possibility of extending the lifespan of implanted tissue valves dramatically.
Reducing calcium formation on implanted tissue valves with ADAPT® could allow cardiologists and surgeons to treat many more patients and to intervene earlier.
Lee Rodne, managing director, commented on the important advancement:
"This is another step towards the commercialisation of the CardioCel® and ADAPT® technology and part of the company strategy to bringing products to market in the regenerative medicine multi-billion dollar markets.
"The next 12 to 18 months will be exciting for our regenerative medicine franchise as it seeks approval in numerous jurisdictions."
Allied Healthcare is expecting to file for U.S. marketing approval for the CardioCel® product later this year.
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