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SynGen Inc. Receives FDA 510K Clearance to Market SynGenX-1000 Cord Blood Processing Platform
Date:7/15/2013

that consistently exceed our customers' expectations. This "next generation" SynGenXTM-1000 System improves the recovery of stem and progenitor cells from cord blood units, which should increase the number of clinical grade units available for transplantation. The CryoPRO-2TM simplifies the cryopreservation workflow for cord blood bank personnel and provides a medical record of the process. The SynGen™ DataTrak software captures the data associated with processing each cord blood unit for the blood bank's records. 

"SynGen recently received additional financing from Bay City Capital to support our commercialization efforts. We look forward to providing U.S. cord blood banks with the competitive advantage they will enjoy by using our products."

(Photo: http://photos.prnewswire.com/prnh/20130715/SF46899-a)

(Photo: http://photos.prnewswire.com/prnh/20130715/SF46899-b)

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) for medical devices.

About CE marking
SynGen also received a Full Quality Assurance Certificate from BSI that allows SynGen to CE mark its SynGenX™-1000 Platform devices for the processing of cord blood in the European Union (EU). The CE mark indicates that a product meets the requirements of all relevant European Directives, and permits the manufacturer to sell the product within the EU.  

About SynGen
SynGen Inc. enables regenerative cures through innovative engineering. The company invents and commercialize
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