StemCor Systems Receives FDA Clearance for Bone Marrow Harvesting System
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StemCor Systems, Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its MarrowMiner™ for the harvest of bone marrow.
"Regulatory clearance of StemCor's MarrowMiner is a major accomplishment for the Company as we develop the necessary tools to extract, process and deliver bone marrow-derived adult stem and progenitor cells," said Vartan Ghazarossian, PhD, President and CEO of StemCor Systems.
"The MarrowMiner is the first minimally-invasive system for the collection of bone marrow, making marrow extraction faster, safer and more comfortable. Physicians will now be able to use this system to collect marrow from healthy donors for bone marrow transplantation, as well as from patients who are to be treated with their own marrow-derived cells, for an expanding array of current and emerging regenerative medicine applications."
"We believe this novel and innovative system addresses a large unmet clinical need to gain access to sufficient adult-bone marrow derived cells in a safe, convenient and reliable manner," said Paul Yock, MD, Weiland Professor of Medicine and Bioengineering and Director, Program in Biodesign, Stanford University.
"This technology meets a key need to access a patient's own cells for use in treating a variety of diseases and conditions."
