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., BioTimes 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. About the Renevia Clinical Trial The Spanish Agency of Medicines and Medical Devices (AEMPS) authorized BioTime to conduct a randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia as a resorbable matrix for the delivery of autologous adipose-derived cells to treat subcutaneous facial lipoatrophy defects arising from HIV infection. The study will include a minimum of 56 and up to 92 HIV positive males … Continue reading
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