HeMemics Type C Meeting with FDA Blood Applications Division
HeMemics to meet with the FDA to discuss which of the available paths that HeMemics Platelet Additive Solution (HemSol™) may take in pursuit of FDA approval and commercialization
Rockville, MD, February 15, 2014 --(PR.com)-- HeMemics Biotechnologies, Inc. (http://www.hememics.com), a development and manufacturing company, today announced that it will meet with the FDA's blood applications division on February14, 2014. The purpose of the meeting was to determine which of the available paths that HeMemics Platelet Additive Solution (HemSol™) may take in pursuit of FDA approval and commercialization.
Chief Executive Officer David Ho, Ph.D., said, “This meeting with the FDA is a significant step forward in establishing a pathway to initial U.S. approval of HemSol™ as platelet additive solution.”
About HeMemics Biotechnologies, Inc.
HeMemics is a development and manufacturing company that is privately held. Our core competence is applying HeMeDri™, the HeMemics proprietary desiccation technology platform to solve preservation, storage and shipping problems that involve dehydrating and rehydrating proteins, cells and tissues. This platform can be applied to preserving blood and blood components, a wide variety of other cells, and selected tissues with or without desiccation. HeMemics has used this platform to preserve and dehydrate/rehydrate perishable biologics (proteins, cells, tissues, etc.) and has developed processes to extend the shelf life while transporting cells for medical and non-medical applications. The company has demonstrated capabilities to deliver commercial reagents for use in blood banks, hospitals and clinics and for transporting mammalian cells at ambient temperature for use in pharmaceutical or academic research labs. HeMemics has recently demonstrated in vitro, the efficacy of using its buffer for preserving red blood cells for transfusion and in vivo for extending the shelf life and improving the safety of platelets for transfusion. Our technologies and processes can fulfill a number of market requirements for stabilized biologic products for use in research, diagnostic and therapeutic applications.
Contact:
Bruce Campbell--President
bcampbell@hememics.com
Chief Executive Officer David Ho, Ph.D., said, “This meeting with the FDA is a significant step forward in establishing a pathway to initial U.S. approval of HemSol™ as platelet additive solution.”
About HeMemics Biotechnologies, Inc.
HeMemics is a development and manufacturing company that is privately held. Our core competence is applying HeMeDri™, the HeMemics proprietary desiccation technology platform to solve preservation, storage and shipping problems that involve dehydrating and rehydrating proteins, cells and tissues. This platform can be applied to preserving blood and blood components, a wide variety of other cells, and selected tissues with or without desiccation. HeMemics has used this platform to preserve and dehydrate/rehydrate perishable biologics (proteins, cells, tissues, etc.) and has developed processes to extend the shelf life while transporting cells for medical and non-medical applications. The company has demonstrated capabilities to deliver commercial reagents for use in blood banks, hospitals and clinics and for transporting mammalian cells at ambient temperature for use in pharmaceutical or academic research labs. HeMemics has recently demonstrated in vitro, the efficacy of using its buffer for preserving red blood cells for transfusion and in vivo for extending the shelf life and improving the safety of platelets for transfusion. Our technologies and processes can fulfill a number of market requirements for stabilized biologic products for use in research, diagnostic and therapeutic applications.
Contact:
Bruce Campbell--President
bcampbell@hememics.com
Contact
HeMemics Biotech
David Ho
301-560-0415
www.hememics.com
David Ho
301-560-0415
www.hememics.com
Contact
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