BioTime Submits Protocol for Initiation of Human Clinical Trials of Renevia™ in Europe

  BioTime Submits Protocol for Initiation of Human Clinical Trials of Renevia™
  in Europe

Business Wire

ALAMEDA, Calif. -- January 10, 2013

BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and
markets products in the field of regenerative medicine, today announced it has
submitted a Clinical Investigation Protocol (CIP) to European regulatory
authorities for approval to initiate studies for its Renevia™  stem cell
delivery platform. The Principal Investigator for the studies will be Ramon
Llull, MD, and the planned trials will be conducted at the Stem Center, Palma
de Mallorca, Spain ( The Stem Center is operated by the
GID Group, Inc., of Louisville, Colorado. BioTime is currently completing the
production of clinical materials according to current Good Manufacturing
Practice regulations. The initiation of human clinical studies is expected in
Q2 of this year upon approval of the CIP.

Renevia™,  a member of the Company’s HyStem^® family of hydrogels,  is a
proprietary formulation that mimics the human extracellular matrix, a web of
molecules surrounding cells that is essential to cellular function. Renevia™
is designed to be a liquid injectable matrix capable of safely polymerizing in
the body into a three-dimensional tissue-like scaffold in combination with
transplanted cells. Anchoring the transplanted cells in such a biocompatible
matrix generally increases the percentage of viable cell engraftment. HyStem^®
hydrogels are currently being used by researchers at a number of leading
medical schools in laboratory studies to investigate a broad array of stem
cell therapies, including wound healing, treatment of ischemic stroke, brain
cancer, vocal fold scarring, and cardiac infarct. Videos describing the
technology by the inventor Glenn Prestwich, PhD, are available for viewing
online at

“This is an important step forward in our commercialization efforts and brings
us closer to delivering this much-needed matrix technology for the emerging
field of regenerative medicine,” stated William P. Tew, PhD, Chief
Commercialization Officer of BioTime, Inc. “The technology forms a foundation
for the delivery of cell-based therapeutic products in both the adult and
embryonic stem cell marketplace. Current preclinical studies at leading
medical institutions have shown that HyStem^® hydrogels are compatible with a
wide variety of tissue types including brain, bone, skin, nerve, cartilage,
and heart.”

In the clinical application described in this CIP, Renevia™  will be used as a
delivery matrix for autologous adipose cells in order to restore subcutaneous
tissue lost as a result of injury, oncologic resection, or congenital defects.
Restoration of the normal skin contour is an important quality-of-life issue,
not only in elective cosmetic procedures, but also in reconstructive surgeries
needed to repair deformities and traumatic injuries to the face and upper
extremities. BioTime’s plan is to bring Renevia™  to the medical market first
in the European Union, where the regulatory pathway will allow for faster
approval. Once the use of Renevia™  is established in Europe, BioTime plans to
address an even larger potential market in the United States.

Evaluation of Renevia™  in ISO 10993 biocompatibility studies has been
successfully completed as prescribed by the International Organization for
Standardization for permanent implantable medical devices. This testing is
required by the United States Food and Drug Administration and European Union
regulatory authorities prior to the initiation of clinical studies in humans.
The results of these preclinical studies successfully demonstrated the safety
and biocompatibility of Renevia™.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company
focused on regenerative medicine and blood plasma volume expanders. Its broad
platform of stem cell technologies is enhanced through subsidiaries focused on
specific fields of application. BioTime develops and markets research products
in the fields of stem cells and regenerative medicine, including a wide array
of proprietary PureStem™ cell lines, HyStem^® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (formerly known as
HyStem^®-Rx), a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications. BioTime's therapeutic
product development strategy is pursued through subsidiaries that focus on
specific organ systems and related diseases for which there is a high unmet
medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd.
is developing therapeutic products derived from stem cells for the treatment
of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte
Corporation is developing therapeutic applications of stem cells to treat
orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation,
focuses on the diagnostic and therapeutic applications of stem cell technology
in cancer, including the diagnostic product PanC-Dx™ currently being developed
for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is
developing applications of BioTime's proprietary induced pluripotent stem cell
technology to reverse the developmental aging of human cells to treat
cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences,
Inc. markets GeneCards^®, the leading human gene database, and is developing
an integrated database suite to complement GeneCards^® that will also include
the LifeMap Discovery™ database of embryonic development, stem cell research
and regenerative medicine, and MalaCards, the human disease database. LifeMap
will also market BioTime research products. BioTime Acquisition Corporation
(“BAC”) is a subsidiary being used to acquire the stem cell assets of Geron
Corporation, including patents and other intellectual property, biological
materials, reagents and equipment. BioTime's lead product, Hextend^®, is a
blood plasma volume expander manufactured and distributed in the U.S. by
Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive
licensing agreements. Additional information about BioTime can be found on the
web at

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future
growth in research, technology, clinical development, and potential
opportunities for BioTime 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 to be 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 and its subsidiaries, particularly those
mentioned in the cautionary statements found in BioTime's Securities and
Exchange Commission filings. BioTime disclaims any intent or obligation to
update these forward-looking statements.

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BioTime, Inc.
Peter Garcia, 510-521-3390, ext 367
Chief Financial Officer
Judith Segall, 510-521-3390, ext 301
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