Healthcare Industry News: blood filter
News Release - July 22, 2013
SynGen Hires Former Pall Medical Executive as President of Cord Blood Business UnitFrank Pascale to lead Commercialization of FDA 510K Cleared SynGenX™-1000 Cord Blood Processing Systems
SACRAMENTO, Calif., July 22, 2013 -- (Healthcare Sales & Marketing Network) -- SynGen Inc., a company focused on the clinical implementation of medical systems that harvest stem and progenitor cells, from cord blood, bone marrow, peripheral blood, and other tissues, announced today that it has appointed Frank Pascale, formerly Senior Vice President of Business Development for Pall Medical, to lead its Cord Blood Processing business unit.
This appointment follows the 510K clearance of three integrated cord blood processing products provided by the FDA on July 10, 2013.
Philip Coelho, SynGen's CEO, hailed the hiring as a major step forward for the company. "Frank is one of the truly accomplished veterans in the field of cell therapy and regenerative medicine. His customer focus, experience, reputation and skill sets are exactly what we need at this time as we begin the commercialization of our advanced products.
"As Senior Vice President, Business Development, for Pall Medical, Frank successfully negotiated Haemonetic Corp's choice of Pall's leukodepletion blood filters for their automated blood collection equipment and orchestrated, along with Pall's sales, technical, and legal counsel groups, the successful closing of numerous agreements for the sale of Pall's leukodepletion blood products into the marketplace in US, Europe and Asia. He then acted as a key member of the Pall team that concluded the sale of Pall Medical's blood businesses to Haemonetics.
"Most recently Frank focused on Pall's Cell Therapy applications. His efforts concluded in important agreements with industry leaders including ViaCord, Smith & Nephew, and Cord Blood Registry (the largest private cord collection bank in the USA). Frank's 'hands-on' and varied background involved such activities as a special projects manager, which developed 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.
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). A CE Marking is a European marking of conformity that indicates a product complies with the essential 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 browse http://www.syngeninc.com/
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