ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 29, 2018--
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.
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 Twitter, LinkedIn, Facebook, YouTube,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotime.com.
Certain statements contained in this release are “forward-looking
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
management constitute forward-looking statements. Any statements that
are not historical fact including, but not limited to statements that
contain words such as “will,” “believes,” “plans,” “anticipates,”
“expects,” “estimates” should also be considered forward-looking
statements. Forward-looking statements involve risks and uncertainties,
including, without limitation, risks inherent in the development and/or
commercialization of potential products, uncertainty in the results of
clinical trials or regulatory approvals, need and ability to obtain
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 SEC
(copies of which may be obtained at www.sec.gov).
Subsequent events and developments may cause these forward-looking
statements to change. BioTime specifically disclaims any obligation or
intention to update or revise these forward-looking statements as a
result of changed events or circumstances that occur after the date of
this release, except as required by applicable law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180129005315/en/
Source: BioTime, Inc.
David Nakasone, 510-871-4188
JQA Partners, Inc.
Jules Abraham, 917-885-7378