Cytori’s Celution One system, intended for hospitals as a platform device with life-critical applications across multiple specialties, has been granted the CE Mark.
Celution One is the next-generation device of the company’s Celution platform, which is a GMP-compliant technology that extracts and concentrates a patient’s own stem and progenitor cells from adipose at the point of care.
Celution One is designed to improve cell yield, processing volumes and processing times, and the versatility and efficiency of potential treatments.
Cytori CEO Christopher Calhoun said it is using the Celution One in pivotal heart attack trial ADVANCE, and aim of expand market access through broader indications for use and subsequent reimbursement applications.