Allied Healthcare gets CE Mark for CardioCel
Shares in Allied Healthcare (ASX:AHZ) grew 12% after the company revealed it has won CE mark approval for cardiovascular patch CardioCel.
The company’s regenerative medicine division now expects to start selling CardioCel in Europe in the fourth calendar quarter.
The CE mark will allow Allied Healthcare to market and sell CardioCel for the repair and reconstruction of heart defects, including procedures to treat congenital heard disease and repair heart valves.
“The CE mark approval for our lead regenerative product CardioCel is a key milestone for Allied,” Group CEO Lee Rodne said.
He said the company will be able to use the approval as a platform to build a portfolio of regenerative tissue products for both cardiovascular and other indications in Europe.
Allied Healthcare applied for CE Mark approval for CardioCel in June 2012 and cleared the key hurdle of receiving ISO certification in February.
The company has also applied for FDA approval in the US and hopes to receive approval next year.
In Australia, Professor Tom Karl of Brisbane’s Mater Hospital was the first surgeon to receive authorisation to use CardioCel in a procedure under the Therapeutic Goods Administration’s Authorised Prescriber Scheme.
Allied Healthcare (ASX:AHZ) shares were trading at $0.084 as of around 2 pm on Monday.
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