Cytomedix Angel Whole Blood Separation System

Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care.

The Angel® Whole Blood Separation System (Angel®) is used primarily in operating rooms for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma. The Angel® System provides great flexibility to physicians with the option to process variable blood volumes and high concentration platelets according to each clinical situation. It is a state-of-the art, flexible, closed PRP System that can be customized for individual clinician preference.

Service Provided by Sparton:

Sparton supported the technology transfer from Sorin’s manufacturing facility in Italy our Frederick, CO manufacturing facility after Cytomedix purchased Angel in a divestiture.  The detailed services provided by Sparton include:

Full scale production

  • Device History File transfer
  • First article qualifications
  • Supply Chain Redeployment – some of the components were re-sourced with a new, domestic supply chain based on geographic parameters.
  • Production Initialization – Production ramp through a mix of existing and new purchased parts and components

Key Challenges:

  • Technology transfer from Italy to the United States
  • Rebuilding parts of the supply chain from domestic partners
  • Ramp up in Sparton’s Frederick,CO facility while bringing down the Sorin facility in Italy
  • Re-qualifying the product including FDA approval and validation

End Result

Cytomedix has been pleased with the transfer to the Frederick,CO facility and the Angel system continues to perform well in the marketplace.  Today, Cytomedix brings the Angel system to market through a commercial licensing agreement with Arthrex.

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