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Cytori’s (CYTX) Celution(R) One receives EU CE Mark Approval

 CYTX’s Celution(NYSE:R) One System  has been granted CE Mark approval.

 

Celution(R) one, the next-generation device of the Celution(R) platform, is tailored specifically for the hospital as a platform device with potential life-critical applications across multiple specialties. The Celution(R) platform is a GMP-compliant technology that extracts and concentrates a patient’s own stem and progenitor cells from adipose (fat) at the point-of-care.

  • The Celution(R) 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.

The Bottom Line: Approval of Celution(R) One in the EU is an important achievement that lays the foundation for further growth in the European hospital market. CYTX is  using the Celution(R) One in their pivotal heart attack trial, ADVANCE, with the goal of seeking expanded market access through broader indications-for-use and subsequent reimbursement applications.

Pre-market trading, CYTX is UP $0.30 <+11.54%> to $2.90.