Allied's CardioCel stands the test of time
Long-term follow-up data from a phase II trial of Allied Healthcare’s (ASX:AHZ) heart patch CardioCel shows no sign of calcification after five years.
Paediatric patients with congenital heart disease and cardiovascular defects implanted with the CardioCel regenerative tissue patch during surgery have no sign of calcification at the site of repair.
The data covers five patients who have been monitored over a five-year period post-surgery, six who have been monitored for over four years and eight for over three years.
These subjects have been participating in an extension study to the original phase II trial, which met its primary endpoint of 30-day survival post surgery. Patients were all aged between 2 months and 14 years.
“This data will be used to support ongoing launch activities in Europe by highlighting the long-term benefits of the product,” Allied Healthcare CEO Lee Rodne said.
The company last month secured a CE Mark for CardioCel and plans to launch in Europe during the next few months.
CardioCel is already available in Australia through the TGA’s Authorised Prescriber Scheme, and Brisbane surgeon Professor Tom Karl last year became the first cardiothoracic surgeon to use the patch in a non-trial procedure. Allied Healthcare is aiming for US approval in 2014.
Allied Healthcare (ASX:AHZ) shares were trading 7.59% higher at $0.084 as of around 1 pm on Wednesday.
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