Mont-Saint-Guibert, Belgium, February 29, 2012 - The Belgian biotechnology company, Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces that it has been certified EN ISO 13485:2003 by the National Standards Authority of Ireland.
The ISO certification acknowledges that Cardio3 BioSciences has been assessed and deemed to comply with the requirements of the ISO standard with respect to the design, development, manufacture and distribution of sterile cardiovascular catheters. The certification guarantees that all processes at Cardio3 BioSciences are fully controlled and documented and compliant with the company's Quality Management System.
Cardio3 Biosciences is developing C-Cath®, a proprietary cardiovascular catheter which is designed to administer a range of bio-therapeutics to the heart. C-Cath is designed to take into account organ tissue structure and properties to maximize patients’ safety, improve performance and increase user confidence during the injection procedure.
Dr Christian Homsy, CEO of Cardio3 BioSciences comments on today’s announcement: “The ISO certification is a significant accomplishment and an important milestone for Cardio3 BioSciences and for our proprietary C-Cath technology. Certification confirms that our Quality System meets the highest standards, and is another step for the Company towards reaching the goal of becoming a leader in regenerative therapies for the treatment of heart diseases. With an ISO 13485-compliant quality system in place, Cardio3 BioSciences is now one major step closer to obtaining allowance to affix the CE Mark necessary for commercialization of our C-Cath Injection Catheter.”