The British Standards Institution (BSI) has granted ISO 13485:2003 certification to Cardium Therapeutics' Excellagen advanced wound care gel product.
Excellagen, which is designed for application at only one-week intervals, is a fibrillar Type I bovine collagen gel that is topically applied using pre-filled, sterile, single-use syringes.
The product functions as an acellular biological modulator to activate the wound healing process and accelerate the growth of granulation tissue.
Cardium Therapeutics chairman and CEO Christopher Reinhard said compliance with ISO 13485 represents an important next step forward to compliance with European regulatory requirements.
"This ISO certification represents a major achievement and milestone for Cardium and moves us forward in our CE Mark Certification application for authorization to market and sell Excellagen in the European Union, which currently consists of 27 member countries," Reinhard added.
In addition, Angel Biomedical operations, a segment of Excellagen's collagen manufacturing process, has been acquired by a UK-based private equity company Collbio.
Collbio will continue to manufacture new batches required for the ISO re-certification, which is necessary for final certification of its CE mark application, in the second quarter 2013.
