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BioTime to Collaborate With the University of Wisconsin and Louvain University in Test of HyStem -Based Hydrogel for Vocal Fold Scarring Investigator-initiated clinical trial may follow preclinical studies ALAMEDA, Calif

Key Takeaway: to Collaborate With the University of Wisconsin and Louvain University in Test of HyStem -Based Hydrogel for Vocal Fold Scarring Investigator-initiated clinical trial may follow preclinical studies ALAMEDA, Calif.--(BUSINESS WIRE)--August 28, 2014--BioTime, Inc. (NYSE MKT:B

Full Press Release Details

to Collaborate With the University of Wisconsin and Louvain University
in Test of HyStem -Based
Hydrogel for Vocal Fold Scarring
Investigator-initiated
clinical trial may follow preclinical studies
ALAMEDA, Calif.--(BUSINESS WIRE)--August 28, 2014--BioTime, Inc. (NYSE
MKT:BTX) today announced that it has entered into a collaboration with
Susan Thibeault, Ph.D., of the University of Wisconsin and Marc Remacle,
M.D. of Louvain University to evaluate BioTime's proprietary HyStem -based
hydrogel for the treatment of vocal fold scarring. Preclinical studies
published by Dr. Thibeault and her colleagues have demonstrated that
localized delivery of HyStem into injured vocal
folds resulted in a significant improvement in function. Under a
sponsored research agreement, Dr. Thibeault's laboratory will evaluate HyStem -based
hydrogels to identify formulations with optimum properties for reducing
scarring. Upon completion of these preclinical studies, an
investigator-initiated clinical trial in patients with vocal fold
scarring due to disease or prior surgical interventions is planned,
under the direction of Dr. Remacle, at the Cliniques Universitaires UCL
Mont-Godinne in Belgium, subject to institutional and regulatory
Scarring of the vocal folds is the most common cause of undesired
changes in the voice (dysphonia) following injury, disease, or surgical
procedures. Current treatments are limited to microsurgical treatments
including scar lysis/excision, medialization laryngoplasty, or
engraftment of tissue flaps/grafts. Since the region of the vocal fold
affected by scarring is rich in hyaluronic acid, nonclinical studies of HyStem -based
hydrogels have been performed which indicate that localized injection of
a HyStem hydrogel during surgical release of the
adhesions provides an environment for improved tissue viscoelasticity
vital for vocal fold function. Because vocal fold scarring remains one
of the most challenging problems for otolaryngologists using the
available technology, continued successful preclinical studies could
lead to investigator-initiated clinical investigations, and efforts for
regulatory approval for this indication.
"If products could be developed that would improve vocal fold healing
with decreased scarring, it could have widespread clinical application
for improved patient outcomes," said Dr. Remacle, at the Cliniques
Universitaires UCL Mont-Godinne in Belgium.
"The expanded application of HyStem hydrogels
in the field of vocal fold disorders, is just one example of the breadth
of potential applications of the technology," said Dr. William Tew,
BioTime's Chief Commercial Officer. "Our numerous academic
collaborations play an important role in advancing these novel
applications in medicine. For example, we are seeing numerous scientific
publications utilizing HyStem technology in stem
cell transplantation in the central nervous system, heart, liver, skin,
orthopedic, and other tissues. We plan additional collaborations to
further expand the breadth of uses of HyStem technology
as part of our strategy to aggressively commercialize this platform."
BioTime's HyStem family of hydrogels are
unique biomaterials that are designed as matrices and scaffolds in
medical device, tissue engineering, and regenerative medicine
applications. HyStem hydrogels are distributed
and sold worldwide by BioTime and its distributors for pre-clinical
research. Renevia is an injectable HyStem
hydrogel, for which clinical studies in Europe are scheduled for the
purpose of evaluating Renevia as a delivery matrix for
autologous adipose cells to treat the facial lipoatrophy associated with
HIV. Premvia is a recently FDA-cleared medical device
indicated for the management of wounds. Clinical grade hydrogels are
also available to support translational research and investigator
initiated clinical studies. BioTime's HyStem
technology is covered by two issued US patents with applications pending
in the EU, Canada, Japan, and Australia.
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, and is planning
to initiate a pivotal clinical trial around Renevia , in 2014.
The HyStem -based product PremviaTM
is cleared the FDA in the US for use in wound management. 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
HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
Asterias Biotherapeutics, Inc. is developing pluripotent
stem-cell based therapies in neurology and oncology, including
AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury,
multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic
cell-based cancer vaccine. Asterias Series A common stock is traded
under the symbol ASTY.
BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime's ESI BIO Division.
Cell Cure Neurosciences Ltd. is an Israel-based biotechnology
company focused on developing stem cell-based therapies for retinal
and neurological disorders, including the development of retinal
pigment epithelial cells for the treatment of macular degeneration,
Last updated: Aug 28, 2014