Celution® One System, the next-generation device of the Cytori’s Celution® platform, has been granted CE Mark approval.
Celution® One is tailored specifically for the hospital as a platform device with potential life-critical applications across multiple specialties.
The Celution® platform is a GMP compliant technology that extracts and concentrates a patient’s own stem and progenitor cells from adipose at the point of care.
The Celution® One is intended for hospital-based use with key improvements including greater cell yield, greater range of processing volumes and faster processing times, increasing the versatility and efficiencies of potential treatments.
Additionally, it contains new features for improved operator ease-of-use.
“Approval of Celution® One in Europe is an important achievement that lays the foundation for further growth in the European hospital market,” said Christopher J. Calhoun, Chief Executive Officer of Cytori.
“In addition to offering the device to hospitals in Europe, we are using the Celution® One in our pivotal heart attack trial, ADVANCE, with the goal of seeking expanded market access through broader indications-for-use and subsequent reimbursement applications.”