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News Breaks
May 28, 2014
08:58 EDTBTXBioTime receives ISO 13485 certification for medical devices
BioTime announced that it has received ISO 13485:2003 certification from British Standards Institution for design, development, manufacture, and distribution of BioTime HyStem hydrogels for cell delivery applications. If Renevia is approved for the treatment of HIV-related facial lipoatrophy, BioTime plans to seek to expand its uses into other cell-based applications in reconstructive surgeries, traumatic injuries, and age-related lipoatrophy. BioTime’s plan is to bring Renevia to the medical market first in the E.U., where the regulatory pathway will allow for faster approval than in the U.S. Once the use of Renevia is established in Europe, BioTime will address an even larger potential market in Asia and the U.S.
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September 19, 2014
09:04 EDTBTXBioTime unit presents PanC-Dx data
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September 17, 2014
09:04 EDTBTXBioTime unit receives OpRegen preclinical safety and efficacy study results
BioTime, HBL Hadasit Bio-Holdings and Cell Cure Neurosciences announced that Cell Cure has received the final results of a series of extensive preclinical safety and efficacy studies of its development-stage product designated OpRegen, which is intended for use in the treatment of dry form age-related macular degeneration. These studies were conducted by Cell Cure and contract research organizations in preparation for an IND filing with the Food and Drug Administration for a Phase 1/2a study in patients with geographic atrophy, the severe stage of dry-AMD. OpRegen is intended to be administered into the subretinal space of patients as a suspension of cells to treat this leading cause of blindness. The company said, "The protection of the animal’s vision from decay was dose dependent. As an additional indicator of therapeutic potential, the number of cone photoreceptors, which are responsible for fine vision in humans and are degenerating in the macula of dry-AMD patients, was found to remain constant over an extended period in the animal model.”
September 15, 2014
09:01 EDTBTXBioTime's OncoCyte unit announces collaboration with Abcodia
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September 11, 2014
16:18 EDTBTXBioTime division partners with Cancer Research UK for lung cancer vaccine trial
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