In short
We’ve covered on a few occasions the clinical evidence that direct injection of stem cells into the myocardium of heart attack patients is showing startling results, for example here. Now Belgian biotech company, Cardio3–BioSciences (C3BS), has announced that it has received CE Marking for its intra-myocardial C-Cath® Injection Catheter. C-Cath is now available for commercial use in the EU and many other countries where the CE mark allows commercialization.
Background
C3BS describes itself as a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.
Its lead C3BS-CQR-1 product is a pharmaceutical consisting of autologous cardiac progenitor stem cells and is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis. Cardiopoiesis is a process in which adult stem cells mimic the natural signals triggered in the early stages of life during the cardiac tissue development.
C-Cath, the next-generation injection catheter is designed to facilitate what the company calls super-efficient delivery of bio therapeutic agents into the myocardium.
C3BS claims its 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.
Company comments
Dr Christian Homsy, CEO of Cardio3-BioSciences comments: “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.”
Source: PR Newswire, Cardio3–BioSciences
