Today before the bell, Cardium Therapeutics announced that it has received ISO 13485:2003 certification for its Excellagen® advanced wound care product by BSI, one of the world’s leading certification bodies. This certification is a stand-alone standard developed by the International Organization for Standardization that provides harmonized quality management systems requirements for manufacturers of medical devices. Cardium’s 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,” stated Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics.
Cardium also reported today that it has completed its submission of required documentation including the technical file and design dossier of its CE mark filing for review by BSI. Additionally, Angel Biomedical’s operations has been acquired by a United Kingdom-based private equity company. Angel Biomedical is responsible for a segment of Excellagen’s collagen manufacturing process. It is expected that the new entity, Collbio Ltd., will continue manufacturing of new batches required for their ISO re-certification, which is necessary for final certification of Cardium’s CE mark application, in the second quarter 2013. Cardium previously established a supply of manufactured bulk collagen in the United States and does not anticipate any disruption in the Excellagen supply chain.
For more information on Cardium Therapeutics, visit www.cardiumthx.com
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