Allied Healthcare Group has obtained Conformité Européenne (CE) marking for its lead regenerative product CardioCel, used for congenital heart disease treatment and cardiovascular repair.
CardioCel benefits patients and surgeons as it does not cause cytotoxicity at the site of repair and requires no external stem cells for displaying strong levels of regeneration of self-tissue. It cuts down surgery time, reduces chances of repeated surgeries and can be used off the shelf.
The CE mark allows the company to market and sell the product across Europe.
Allied Healthcare Group CEO Lee Rodne said that CardioCel’s European approval provides surgeons with an important addition to treatment in the repair of cardiac defects.
"The CE mark approval for our lead regenerative product CardioCel is a key milestone for Allied," he said.
"As we continue to roll-out CardioCel in different markets, we can look forward to increased revenue streams and we expect to see a significant lift in company revenue over the coming years."
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The approval of CardioCel technology in Europe allows Allied Healthcare to launch other cardiovascular and regenerative tissue products for treating, repairing and reconstructing cardiac diseases and defects, and other medical conditions such as vascular reconstructions, hernia repairs and pelvic floor reconstructions.
Sales of CardioCel are expected to begin in the fourth quarter of 2013 in Europe, while the group anticipates US approval of the product in 2014.