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SynGen Hires Former Pall Medical Executive as President of Cord Blood Business Unit
Date:7/22/2013

eloped a custom collection set for Cord Blood Registry.  Recently focused on orthopedic applications, Frank concluded agreements with two partners for Pall's cell harvest systems." 

About SynGen's FDA 510K cleared cord blood processing products:

  • SynGenX™-1000 System: A programmable Control Module, Docking Station and companion disposable processing Cartridge for harvesting stem and progenitor cells from units of collected cord blood.  These cells are used to reconstitute the hematopoietic system of patients afflicted with hematologic malignancies, like leukemia and lymphoma, and more than 70 genetic diseases.
  • CryoPRO-2™ Cryopreservation/Storage Set: A disposable processing set that receives the transferred stem and progenitor cells from the SynGenX™-1000 in a chamber that allows the sterile mixing with cryoprotectant and transfer into a multiple compartment bag for freezing and storage at liquid nitrogen temperatures (-196o C).
  • SynGen™ DataTrak software:  The application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer.  It downloads processing and system information from the SynGenX™ Control Module and stores it in a database on the host PC computer. 

About ISO certification
ISO 13485:2003 is an internationally recognized standardization system for the design, development, manufacturing and distribution of medical devices. The certification confirms that SynGen has successfully implemented a quality system that conforms to the exacting standards of the International Organization for Standardization (ISO) standards for medical devices.

About CE Mark
SynGen also received CE Mark from BSI that allows SynGen to begin marketing its SynGenX™-1000 Platform devices for the processing of cord blood in the European Union (EU
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SOURCE SynGen Inc.
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