Allied Healthcare (ASX:AHZ) has increased the number of Australian surgeons actively using or having received pre market authorisation from Therapeutic Goods Administration to use its cardiovascular patch CardioCel to five from one.
A number of additional surgeons are also engaged in the application process to use CardioCel via the Authorised Prescriber Scheme.
CardioCel is a cardiovascular patch used to repair paediatric heart deformities. The program has successfully completed a number of animal studies and a Phase II human clinical trial.
Dr Nelson Alphonso, director of paediatric cardiac surgery at the Mater Hospital in Brisbane joins fellow surgeon Dr Tom Karl to become the second surgeon at the hospital to receive TGA authorisation to use CardioCel from treating and repairing congenital heart defects under the APS.
Professor Christian Brizard of Melbourne University and his colleagues have gained early access to the use of the cardiovascular patch under a trial at a Melbourne based hospital.
The purpose of this new investigator-led clinical study is to expand the access to CardioCel in Australia. The early access clinical trial scheme will enroll up to 40 patients with congenital heart disease.
Allied anticipates CardioCel CE mark approval in mid-2013.
It had a cash balance of $1.98 million at the end of 31 December 2013 and raised $2.89 million this January via a share purchase plan at an issue price of $0.02 per share.
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