Renevia® Data From the Successful Pivotal Trial to Be Presented at the IMCAS Conference
By Business Wire, January 29, 2018, 07:00:00 AM EDT
ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE American:BTX), a late-stage, clinical biotechnology company developing and commercializing products addressing degenerative diseases, today announced that detailed data from the successful pivotal trial of Renevia® in Europe will be presented at the International Master Course on Aging Science (IMCAS) conference on February 3, 2018. The Renevia® data will be presented by primary investigator Ramon Llull, MD, PhD, Director of Stem Europe Mallorca Center, Mallorca, Spain, at the "Contributed Talks - Lipofilling, PRP, Regenerative Medicine and Stem Cells."
The IMCAS conference is one of the premier events dedicated to aesthetic science where therapies related to fat grafting, clinical dermatology and other medical aesthetics procedures are further explored and discussed. The conference is in its 20th year and is expected to have over 8,000 delegates from dermatology, plastic surgery, and related professions from around the world.
Renevia® successfully met the primary endpoint in a European pivotal study for the treatment of HIV-Associated Facial Lipoatrophy. Treated patients retained approximately 100% of transplanted volume at 6 months and there were no device related serious adverse events noted during the trial.
BioTime plans to submit the Renevia® application for CE Marking later this quarter with an expected approval in the second half of 2018. As the company has previously reported, BioTime views the European trial as a gateway into a larger multibillion-dollar market opportunity, like cosmetic facial aesthetics. Currently, the U.S. facial fat transfer and dermal facial filler market is estimated to be over 4 billion dollars and growing at or near double digits.
Renevia® is an investigational medical device that is being developed as an alternative for whole adipose tissue transfer (fat grafting) procedures. Renevia's® hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia® is part of the Hystem® hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells.
About BioTime, Inc.
BioTime is a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company's current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell and drug delivery. Its clinical programs are based on two platform technologies: pluripotent cells, which can become any type of cell in the human body, and cell/drug delivery. Renevia®, a cell delivery product, met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. Submission for approval of Renevia® in the EU is expected to be early 2018, with possible approval in 2018. There were no device related serious adverse events reported to date. OpRegen®, a retinal pigment epithelium transplant therapy, is in a Phase I/IIa multicenter trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no related serious adverse events reported to date. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American:AST) and OncoCyte Corporation (NYSE American:OCX), and a private company, AgeX Therapeutics, Inc.
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