Australia-based Allied Healthcare Group has received CE mark approval for its lead regenerative product called CardioCel, which is used in treating congenital heart disease and repairing heart valves.
The approval will help the company to market CardioCel in the European markets. It will provide surgeons in Europe with an important addition to their treatment in the repair of cardiac defects.
CardioCel benefits patients and surgeons as it requires no external stem cells for displaying strong levels of regeneration of self-tissue.
Additionally, it does not cause cytotoxicity at the site of repair and is also ready to use, off the shelf, saving time during surgery.
Allied Healthcare Group CEO Lee Rodne said that CardioCel offers children and adults suffering from cardiac defects and disease a promising new technology that displays strong levels of regeneration and long term benefits.
"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," added Rodne.
The approval of CardioCel technology is expected to help Allied Healthcare to launch additional cardiovascular products and regenerative tissue products in Europe.
Allied Healthcare Group intends to begin marketing of CardioCel in Europe in the fourth quarter of 2013.
The group which is currently seeking US approval for CardioCel hopes to obtain it in 2014.