Cytori (CYTX), IDE Filing for Chronic Myocardial Ischemia
CYTX filed its Investigational Device Exemption (IDE) application to begin a clinical trial of the Celution® System for chronic myocardial ischemia (CMI).
- ATHENA is a device-based safety and feasibility trial (Phase I/II) to investigate the use of autologous, clinical-grade adipose tissue-derived stem and regenerative cells (ADRCs), processed at the point-of-care with Cytori’s proprietary Celution® System. The submission initiates a review process with the FDA before approval is granted to begin the trial.
The Bottom Line: CYTX had reported 6 and 18 month trial data from PRECISE, an EU clinical trial for this same indication showing statistically significant improvement in cardiac functional capacity, which was incorporated into the US IDE filing. CYTX has also applied to expand its Celution® System CE Mark to include no-option CMI claims in Europe based on this data. CYTX is further enrolling an EU pivotal trial using the Celution® System for acute heart attacks. No-option CMI is estimated to affect approximately 6% of all coronary heart disease patients worldwide. In theUS, more than 1M patients are in this class with an annual cost of more than $10B. CMI patients typically have undergone multiple revascularization procedures, may suffer from serious abnormal heart rhythms, and have few therapeutic options. One goal of cell therapy in CMI is to revive hibernating heart muscle, which is living tissue that is not contributing to the pumping action of the heart.
