|Renevia® Data From the Successful Pivotal Trial to Be Presented at the IMCAS Conference|
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.
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.
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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statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Statements pertaining to product technology,
clinical development, regulatory approval timelines, the success of
potential cosmetic applications and potential opportunities for BioTime,
Inc. and its subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
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future capital, and maintenance of intellectual property rights. Actual
results may differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together with
the many uncertainties that affect the business of BioTime, Inc. and its
subsidiaries, particularly those mentioned in the cautionary statements
found in more detail in the “Risk Factors” section of its Annual Reports
on Form 10-K and Quarterly Reports on Form 10-Q filed with the