Full Press Release Details
Receives ISO 13485 Certification for Medical Devices
ALAMEDA, Calif.--(BUSINESS WIRE)--May 28, 2014--BioTime, Inc. (NYSE MKT:
BTX) today announced that it has received ISO 13485:2003 certification
from BSI (British Standards Institution) for design, development,
manufacture, and distribution of BioTime HyStem
hydrogels for cell delivery applications.
BSI is currently one of the world's largest independent certification
bodies for quality management systems and ISO 13485:2003 is the world's
most recognized standard for quality management systems for medical
devices, and is the most commonly chosen path for companies to meet the
quality system requirements in Europe, Canada, Japan, Australia, and
ISO certification is a prerequisite for CE marking of medical devices
within the European Union and this certification is an important
milestone in BioTime's development program for Renevia ,
a cell delivery matrix scheduled to begin pivotal human clinical trials
in 2014 at the Stem Center in Palma de Mallorca, Spain. In this first
clinical application, Renevia will be used as a
delivery matrix for autologous adipose cells to treat the facial
lipoatrophy associated with HIV. Restoration of normal skin contour is
an important quality-of-life issue with this chronic condition and
BioTime believes that this cell-based therapy will offer fewer
complications and a more natural like appearance compared to products
currently available. It has been estimated that worldwide over 40% of
individuals receiving long-term antiretroviral therapies suffer from
this disfiguring condition. According to www.avert.org in 2011
there were approximately 800,000 persons living with HIV/AIDS in Western
Europe. Globally the number exceeds 30 million.
If Renevia is approved for the treatment of HIV-related
facial lipoatrophy, BioTime plans to seek to expand its uses into other
cell-based applications in reconstructive surgeries, traumatic injuries,
and age-related lipoatrophy. 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 than in the United
States. Once the use of Renevia is established in
Europe, BioTime will address an even larger potential market in Asia and
William P. Tew, Ph.D., BioTime's Chief Commercial Officer stated, "We
are very pleased with our ISO Certification and BSI's acknowledgement of
our on-going commitment to quality. Our quality management systems will
provide a solid foundation for our clinical, regulatory, manufacturing,
and future commercial activities. While this present certification
focuses on HyStem hydrogels for cell delivery
applications, should BioTime decide to pursue CE marks for other
applications of its hydrogel technology we will expand the scope of our
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. 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. 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 a new subsidiary which has acquired
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
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, and
treatments for multiple sclerosis.
ESI BIO is the research and product marketing division of BioTime,
providing stem cell researchers with products and technologies to
enable them to translate their work into the clinic, including PureStem
progenitors and HyStem hydrogels.
LifeMap Sciences, Inc. markets, sells, and distributes GeneCards ,
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
LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on
developing mobile health (mHealth) products.
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer, including PanC-Dx , with three
clinical trials currently underway.