FDA Clears SynGen Inc.'s Blood Processing Platform
7/15/2013 7:30:49 AM
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SynGen Inc. Receives FDA 510K Clearance to Market SynGenX-1000 Cord Blood Processing Platform
SACRAMENTO, Calif., July 15, 2013 /PRNewswire/ -- SynGen Inc., a company focused on the development and commercialization of medical systems that harvest stem and progenitor cells from umbilical cord blood, bone marrow, peripheral blood, and other tissues, announced today that it has been granted FDA 510(k) clearance to market its three related products to process cord blood:
- SynGenXTM-1000 System: A programmable Control Module, Docking Station and Disposable 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 such as leukemia and lymphoma and more than 70 genetic diseases.
- CryoPRO-2TM Cryopreservation/Storage Bag Set: A disposable processing set with a chamber into which the harvested stem and progenitor cells from the SynGenXTM-1000 are transferred, mixed with cryoprotectant and transferred under sterile conditions 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-1000 Control Module and stores it in a database on the host PC computer.
Earlier, the Company was awarded an ISO 13485:2003 Certificate of Registration and a Full Quality Assurance certificate by the British Standards Institution (BSI), which allows it to CE mark its own Class 1 products and commercialize them in the European Union (EU).
Philip Coelho, SynGen's CEO noted: "We thank the FDA for guiding us through the 510(k) clearance process. SynGen is dedicated to developing products 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."
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.
SynGen Inc. enables regenerative cures through innovative engineering. The company invents and commercializes products that utilize single-use sterile plastic cartridge disposables mated to dedicated, highly automated electromechanical medical devices to isolate and capture stem and progenitor cells from peripheral and umbilical cord blood, bone marrow, and adipose tissue. Our products provide an important enabling platform for use in diagnostic, research, and clinical processes. Our inventions are based upon interdisciplinary fields that apply principles of engineering and life sciences to develop solutions required for regenerative medicine. For more information about SynGen, visit the company's website at www.syngeninc.com.
SOURCE SynGen Inc.
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