Renevia® Data From the Successful Pivotal Trial to Be Presented at the IMCAS Conference
January 29 2018 - 7:00AM
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.
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 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,
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.
Forward-Looking Statements
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20180129005315/en/
Investor Contact:BioTimeDavid Nakasone,
510-871-4188Dnakasone@biotime.comorMedia Contact:JQA
Partners, Inc.Jules Abraham,
917-885-7378jabraham@jqapartners.com
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