ALAMEDA, Calif.--(BUSINESS WIRE)--Oct. 4, 2013--
BioTime, Inc. (NYSE MKT: BTX), today announced that it has initiated the
development of two new products based on its HyStem®
hydrogel technology platform.
The first of these new products is ReGlydeTM, a
cross-linked thiol-modified hyaluronan hydrogel for the management and
protection of tendon injuries following surgical repair of the digital
flexor or extensor tendons of the hand. The product is intended to be
applied in the vicinity of the repaired tendon via a syringe or similar
device immediately prior to closing of the surgical area. Separation of
the tendon from surrounding tissue has been shown to significantly
reduce post-surgical adhesions that can lead to complications such as
restricted finger mobility and flexibility. BioTime believes that the
flowable and in-situ gelling capability of ReGlydeTM
could provide an advantage over the existing technology which is in the
form of a sheet causing difficulty in application in what is often a
small compartment after surgery.
The second new product, PremviaTM, is a HyStem®
hydrogel formulation of cross-linked thiol-modified hyaluronan and
thiol-modified gelatin for the management of wounds including partial
and full-thickness wounds, ulcers, tunneled/undermined wounds, surgical
wounds, and burns. Due to its high water content, PremviaTM
is able to donate water molecules to the wound surface and to
maintain a moist environment at the wound bed, which is critical for
wound healing. Additionally, the biodegradable matrix provides a
scaffold for the cellular infiltration and proliferation as well as
capillary growth needed to promote healing. There is significant
competition in the wound healing dressing space, however, one advantage
that PremviaTM appears to have over most other
technologies is the ability to flow into the wound and cross-link, or
change from a flowing liquid to a semi-solid gel consistency, in-situ,
thereby providing a moist environment to every part of a wound which a
traditional covering cannot.
Both ReGlydeTM and PremviaTM are
expected to be regulated as medical devices in the United States.
BioTime has initiated for these development-stage products the requisite
studies for marketing approval, including ISO 10993 biocompatibility
studies and animal studies to demonstrate safety and efficacy for a
510(k) application to the Food and Drug Administration. BioTime may be
required to provide human clinical data demonstrating safety and
efficacy for approval as a medical device if the FDA determines that
marketing approval should not be granted on the basis of a 510(k)
PremviaTM is also intended to serve as a
foundation for the further development of bioactive wound healing
products that could deliver biological factors or cells to accelerate
wound healing. PremviaTM may face a different
level of regulatory approval for those uses.
Significant quantities of the components common to ReGlydeTM
and PremviaTM have been manufactured under cGMP
conditions, therefore, BioTime will have cGMP
quantities of both products available for its pre-clinical
investigations and the initiation of human clinical use if FDA approval
for marketing is obtained.
About BioTime, Inc.
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem™
progenitors, HyStem® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications. In addition,
BioTime has developed Hextend®, a blood
plasma volume expander for use in surgery, emergency trauma treatment
and other applications. Hextend® is manufactured and
distributed in the U.S. by Hospira, Inc. and in South Korea by CJ
CheilJedang Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
ES Cell International Pte Ltd., a Singapore private limited company,
develops hES products for research use.
OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
ReCyte Therapeutics, Inc. is developing therapies to treat a variety
of blood and lymphatic vascular disorders, as well as products for
research using iPS and other cell reprogramming technology.
Cell Cure Neurosciences Ltd. is an Israel-based biotechnology company
focused on developing stem cell-based therapies for retinal and
neurological degenerative diseases. Its lead product is OpRegen®
for the treatment of macular degeneration.
LifeMap Sciences, Inc. markets, sells and distributes GeneCards®,
the leading human gene database, the leading human gene database, as
part of an integrated database suite that also includes the LifeMap
Discovery™ database of embryonic development, stem cell research
and regenerative medicine, and MalaCards, the human disease
database. LifeMap Sciences also markets BioTime research products and PanDaTox,
an innovative, recently developed, searchable database that can aid in
the discovery of new antibiotics and biotechnologically beneficial
Asterias Biotherapeutics, Inc. is a newly formed subsidiary whose
first acquisition was the stem cell assets of Geron Corporation,
including patents and other intellectual property, biological
materials, reagents and equipment for the development of new
therapeutic products for regenerative medicine.
Additional information about BioTime can be found on the web at www.biotimeinc.com.
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.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.biotimeinc.com
Source: BioTime, Inc.
Lesley Stolz, Ph.D., 510-521-3390, ext. 367
Vice President, Corporate Development
Segall, 510-521-3390, ext. 301