08 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Brisbane-based pediatric and adult heart surgeon, Dr Homayoun Jalali, has been granted approval to use Allied Healthcare's CardioCel to treat and repair heart defects. Dr Jalali is the sixth surgeon to obtain access to use CardioCel under early access schemes which allows Australian surgeons to apply to use the product prior to full marketing approval.
"This is a key step for Allied as it represents the first adult surgeon to gain access to use CardioCel under the Authorised Prescriber Scheme, and has the potential to increase market potential and revenue for the Company considerably," said Allied Healthcare Group CEO Mr Lee Rodne.
"CardioCel offers considerable ease of use for surgeons, as it can be used straight out of the box, and we are encouraged to see growing support for the product both locally and internationally. CardioCel is also proven to deliver key benefits to patients compared to current marketed tissue repair products."
CardioCel is a cardiovascular tissue product used to repair heart deformities including repairing and reconstructing heart valves.
Ten years of preclinical and clinical studies have shown CardioCel patches have no evidence of cytotoxicity or calcification at the site of repair for four years post-surgery. CardioCel has also shown superior cell survival and regenerative properties when compared with existing gold standard patches implanted with stem cells.
Allied Healthcare Group has filed for marketing approval for CardioCel with both the European Regulatory Authority (EMA) and the US FDA.