UPDATE: BioTime Receives Authorization To Begin Pivotal Human Clinical Trial Of Renevia In Europe

BioTime, Inc. (NYSE MKT: BTX) today reported that it has received authorization to begin its pivotal human clinical trial of Renevia™ in Europe. In the trial, Renevia will be used in combination with the patient's own fat-derived cells and injected into portions of the patient's face where there has been a loss of fat from under the skin (lipoatrophy). Lipoatrophy is estimated to occur in 35-50% of the 10 million HIV patients on antiretroviral therapy. This pivotal trial follows the previous successful safety trial of Renevia, the completion of which was announced earlier in 2014. “Renevia has the potential to be the first approved product that allows cells to be easily transplanted through a syringe and then safely polymerized into three-dimensional tissue constructs within the human body,” said William Tew, Ph.D., BioTime's Chief Commercial Officer. “We are excited to enter this last phase of clinical trials for Renevia as well as by the promise of this technology for the transplantation of other types of cells to address unmet medical needs. BioTime considers Renevia a key strategic asset for its future regenerative medicine programs which are focused on the development of human embryonic stem cell-derived brown adipocytes, vascular, and osteochondral cells to treat tissues afflicted with degenerative disease. If the pivotal trial meets its primary end points, then we would expect to submit Renevia for CE Mark approval in 2016.”