BioTime Reports Isolation of Seven Diverse Cartilage and Bone Cell Types From Human Embryonic Stem Cells

  BioTime Reports Isolation of Seven Diverse Cartilage and Bone Cell Types
  From Human Embryonic Stem Cells

Business Wire

ALAMEDA, Calif. -- December 18, 2012

BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and
markets products in the field of regenerative medicine, and its subsidiaries
OrthoCyte Corporation and LifeMap Sciences reported today a means of
manufacturing seven distinct types of cartilage, bone, and tendon cells from
human embryonic stem cells. The paper, scheduled to be published online (ahead
of print) at 1600 GMT today in the peer-reviewed journal Regenerative
Medicine, characterizes the seven cell types generated using BioTime’s
proprietary PureStem^TM technology. The study compared the novel cells with
adult stem cells, known as mesenchymal stem cells (MSCs), and revealed
properties of the new cell lines that are suggestive of a wide array of future
applications in the practice of orthopedic medicine.

In the study published today, it was demonstrated that BioTime’s cells, which
can be manufactured on an industrial scale, are progenitors to diverse
skeletal tissues of the human body. These cell lines bear diverse molecular
markers that distinguish them from each other and from MSCs. The molecular
markers of BioTime’s cell lines suggest the lines may therefore be applicable
to the repair of different types of bone, cartilage, and tendon for the
treatment of degenerative diseases afflicting these tissue types such as
non-healing bone fractures, osteoarthritis and degeneration of intervertebral
discs, and tendon tears (tendinosis).

Chronic orthopedic disorders such as osteoarthritis, degeneration of the discs
in the spine, osteoporosis, and tendon tears are among the leading complaints
and causes of disability in an aging society. The recent isolation of new
pluripotent stem cells such as human embryonic stem (hES) cells and induced
pluripotent stem (iPS) cells opens the door to the manufacture of all of the
cell types in the human body on an industrial scale. These achievements in the
emerging field of regenerative medicine have made it feasible to introduce new
modalities of repairing these and other tissues in the body.

As promising as these new stem cells may be for eventual human tissue repair,
there has been little progress to date in identifying new ways to generate
pure populations of the diverse cellular components of the human body using
methods that are also compatible with industrial-scale manufacture. To address
this need, BioTime scientists developed a novel and proprietary manufacturing
process. These isolated PureStem^TM  (previously ACTCellerate^TM) cell lines
allow for the scale-up of more than 200 highly purified and identified cell

In today's publication, BioTime scientists reported on seven PureStem^TM cell
lines representing diverse cells of the developing human skeleton. One of
these cell lines, 4D20.8, was previously shown by BioTime scientists to
exhibit site-specific markers of craniofacial mesenchyme, and in particular,
markers of proximal mandibular mesenchyme. This tissue type is of significance
in that it naturally produces one of the strongest joint cartilages of the
body. In today’s report, this line was compared to the BioTime’s lines
7PEND24, 7SMOO32, E15, MEL2, SK11, SM30, and to other commonly studied MSCs.
BioTime’s cell lines displayed markers that indicated the cells were
progenitors of diverse cartilage, bone, and tendon cell types in the body.

There remains the need for safe methods of manufacturing cells at a high
degree of purity and site-specific identity, in addition to an FDA-approvable
combination with a matrix to facilitate the stable transplantation of those
cells into the body. BioTime’s HyStem^® technology is designed to be an
effective means of transplanting cells in an injectable liquid that can
polymerize safely in the body into a tissue construct. BioTime anticipates
that during the first quarter of 2013, a submission of a Phase I safety trial
in humans will be made to the appropriate European Committee for review and
approval of HyStem^®  formulated for the delivery of autologous fat-derived
cells for skin applications, a product called Renevia™. In today’s
publication, the seven novel osteochondral cell lines were demonstrated to be
successfully differentiated in HyStem^®  in laboratory experiments, supporting
the potential use of the product together with these and other PureStem^TM
cell lines in combination products.

The study’s demonstration of the manufacture of diverse site-specific tissue
progenitors from pluripotent stem cells serves to highlight the utility of
LifeMap Discovery™, a powerful new database that provides a roadmap to the
complex fabric of cells constituting the human body. In today’s publication,
BioTime and LifeMap scientists collaborated to map the molecular markers of
the published PureStem^TM cell lines within the database, thus making the
lines available for the research community in the context of the human
developmental tree.

“We are gratified to finally report in a scientific publication the power of
monoclonal human embryonic progenitor cell lines to scale diverse cell types
of the human body,” said Michael D. West, Ph.D., BioTime's Chief Executive
Officer. “Our confidence that many other cell types of the human body can be
manufactured in this manner is the reason for our focus on this platform and
for participating in building LifeMap Discovery^TM to help the medical
research community navigate this fascinating yet complex network of product

Arnold Caplan, Ph.D., OrthoCyte's Chief Scientific Officer and Director of the
Skeletal Research Center at Case Western Reserve University, commented that
the paper by Sternberg and colleagues “emphasizes the scalability of clonal
human embryonic stem cell-derived cell lines for musculoskeletal tissue
engineering.The analysis at the molecular level of the biological markers
gives us confidence that these groups of cells can be used for cartilage
repair and regeneration. The amount of cells that can be generated is really
practical for human musculoskeletaltissue regeneration.”

A discussion of OrthoCyte's product development strategy delivered by Dr.
Caplan and comments on the implications of BioTime's scientific advances are
available online at and

Authors of today’s publication include Hal Sternberg, Jennifer Kidd, James T.
Murai, Jianjie Jiang, Isaac E. Erickson, Walter D. Funk, Karen B. Chapman, and
Michael D. West of BioTime and OrthoCyte Corporation; Ariel Rinon of LifeMap
Sciences; and C. Thomas Vangsness, Jr., of the Keck School of Medicine at the
University of Southern California.

About BioTime, Inc.

BioTime, headquartered in Alameda, Calif., 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 has developed
an integrated database suite to complement GeneCards^® that includes the
LifeMap Discovery™ database of embryonic development, stem cell research and
regenerative medicine, and MalaCards, the human disease database. LifeMap is
also marketing BioTime research products. 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

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Forward-looking statements involve risks and uncertainties, including, without
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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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