The Belgian biotechnology company, Cardio3--BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces that it has received CE Marking (Conformité Européenne) for its intra-myocardial C-Cath® Injection Catheter. The CE Mark certifies that C-Cath complies with applicable European health, safety and environmental protection legislation. C-Cath is now available for commercial use in the EU and many other countries where the CE mark allows commercialization.
The C-Cath Injection Catheter is the most advanced device of its kind and was designed to address three key requirements: ease of use, safety and efficacy. During its development Cardio3 BioSciences combined its extensive experience in stem cell therapies and specific knowledge of the properties of heart tissue with key insights from leading cardiologists in the field. C-Cath's performance is based on its unique needle design as well as unique catheter properties. Previously announced pre-clinical data from a head to head comparison with the 'best' injection catheter available until now showed a close to threefold increase in retention of stem cells within the heart muscle in favour of the C‐Cath Injection Catheter. Within a clinical setting, an increased retention rate could allow an increase in efficacy while reducing side effects.-
Dr Christian Homsy, CEO of Cardio3-BioSciences comments on today's announcement: "Today marks an important milestone for Cardio3 BioSciences and our innovative C-Cath technology. With C-Cath, we developed an advanced injection catheter that meets the requirements of physicians and has the potential to deliver better outcomes for patients. C-Cath demonstrates our commitment to continued innovation in regenerative heart therapy. This is a major step forward in addressing the patient needs for regenerative therapies for the heart and provides physicians with new treatment options."