ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE Amex:BTX) announced today that it has elected to seek regulatory approval of HyStem®-Rx as an implantable cell delivery vehicle that can be used to significantly improve outcomes in reconstructive surgery and potentially a wide array of other cell-based therapies. Such applications may include numerous cell transplant procedures currently being developed in which a patient’s own adult stem cells are utilized. Similarly, once newer cell replacement products derived from human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells become available for medical use, HyStem®-Rx may provide the best means of implanting those cells in patients. Filing for regulatory approval of HyStem®-Rx as a medical device in Europe may begin within approximately 14 months, which is the estimated time for completing non-clinical studies and performing manufacturing and assay validations. Regulatory approval may take as few as two years, after which the product may be sold for use in existing cell transplant therapies.
