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Press Release

Additional Renevia Data From the Successful Pivotal Trial Was Presented at the IFATS Conference

BioTime,Inc.
Posted on: 04 Dec 17

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 was presented at the International Federation for Adipose Therapeutics and Science (IFATS) conference on November 30, 2017. The Renevia® data was presented by primary investigator Ramon Llull, MD, PhD, Director of Stem Europe Mallorca Center, Mallorca, Spain at the “Plenary Session 2 - Clinical Studies with SVF.”

As we announced earlier this year, Renevia® successfully met its primary endpoint, and treated patients retained approximately 100% of transplanted volume at six months. As well as meeting the primary endpoint, treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. All Renevia® transplants were shown to be well tolerated and there were no device-related serious adverse events noted during this trial.

The Renevia® application for CE Marking will be submitted next quarter with an expected approval in the second half of 2018. “With this submission for CE mark in Europe, we will be one step closer to becoming a commercial company,” said Adi Mohanty, Co-CEO of BioTime.

We view this European trial as an entryway into a larger market opportunity, like cosmetic facial aesthetics. Currently, the cosmetics facial aesthetics market is estimated to be over 5 billion dollars and growing at or near double digits. Execution of our label expansion plans into this broader market have already begun with an investigator-led trial in the U.S. This ongoing facial aesthetics trial is being conducted by Dr. Joel A. Aronowitz, who is a leading Beverly Hills plastic surgeon.

We will build upon this investigator-led trial in conjunction with the EU pivotal trial data to expand the potential label into other indications and geographies, including the U.S. We plan to submit our data package to the FDA later this month and expect to meet with the FDA next quarter to confirm the path for U.S. approval.

About Renevia ®

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 earlier this year. Submission for approval of Renevia® in the EU is expected to be early 2018, with possible approval and commercial launch in 2018. There were no device related serious adverse events reported. 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. 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.

BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on TwitterLinkedInFacebookYouTube, and Google+.

To receive ongoing BioTime corporate communications, please click on the following link to join the Company’s email alert list: http://news.biotime.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171204005326/en/

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Last updated on: 04/12/2017

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