AHG files for CE Mark for heart patch

Allied Healthcare Group (ASX:AHZ) has submitted a CE Mark application for subsidiary Celxel's tissue matrix product, CardioCel, to help pave the way for its sale in Europe.

The company has lodged the application with its European Notified Body. The submission will be evaluated by this body, as well as the UK's Medicines and Healthcare Regulatory Agency.

A notified body is an organisation that has been accredited by an EU member state to assess whether a product meets the standards required for CE Mark approval.

CE Mark is required for distribution and sale into the EU, which is a major market for regenerative medicine products.

The company plans to file for US marketing approval for CardioCel later this year.

CardioCel is a cardiovascular patch designed to repair a range of paediatric heart deformities.

The company has conducted phase II trials using the product to correct deformities caused by congenital heart disease, and multiple phase I animal trials including a recent study implanting the patch in animals undergoing heart valve reconstruction.

The patch uses Celxel's ADAPT tissue engineering technology, which is designed to repair tissue for surgical repair. ADAPT has shown promise at reducing calcification in heart valves in preclinical trials.

Celxel is also evaluating how to use the ADAPT platform in pelvic floor reconstructions, hernia repairs, orthopaedics and as a biological scaffold to grow stem cells.

Allied Healthcare (ASX:AHZ) shares were trading 5% higher at $0.021 as of 3:30pm on Tuesday.