Full Press Release Details
Receives FDA Premarket Notification Clearance for Premvia
ALAMEDA, Calif.--(BUSINESS WIRE)--August 12, 2014--BioTime, Inc. (NYSE
MKT: BTX) today announced that it has received notice from the FDA's
Center for Devices and Radiologic Health that Premvia has been
cleared for marketing as a Class II medical device. Premvia
is the first FDA-cleared member of BioTime's HyStem
family of hydrogels, which are designed to mimic the natural structures
of the human body's extracellular matrix. According to the FDA
clearance, the product is indicated for the management of wounds
including: partial thickness, full-thickness, tunneling wounds, pressure
ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor
skin graft sites, post-Moh's surgery, post-laser surgery, podiatric
wounds, wound dehiscence, abrasions, lacerations, second degree burns,
skin tears and draining wounds.
The global market for aesthetic and reconstructive surgery was estimated
to exceed $6 billion annually and is composed of many distinct market
segments. Premvia is expected to serve a
subset of these segments. "We plan to rapidly complete the review and
implementation of the requisite quality and manufacturing documentation
in advance of introducing the product to the market. Additionally the
Company will undertake selected clinical studies to further refine the
target market niches, and following that, will lay our final plans for
associated marketing initiatives and strategies," said William Tew,
Ph.D., BioTime's Chief Commercial Officer. "HyStem -based
products such as Premvia and Renevia
(the latter anticipated to begin its pivotal clinical trial in Europe
later this year) are anticipated to provide the company with
opportunities for significant near-term revenue, while balancing the
long-term opportunities created by the Company's pluripotent stem cell
technology platform, which provides the potential for the
industrial-scale manufacture of all of the cellular components of the
human body. Together, these matrices and cellular building blocks
provide a combination of technology platforms that we believe can lead
the industry in the revolution underway commonly called regenerative
"Premvia utilizes unique patented technology
that allows the crosslinking of collagen and hyaluronic acid and is
compatible with cells and tissues," remarked Dr. Gregory Keller, MD,
FACS, Clinical Professor at UCLA and co-director of the UCLA/AAFPRS
facial plastic surgery fellowship. "I am excited by the prospects of
using Premvia in treating wounds resulting from a number of the
approved indications in general aesthetic and reconstructive surgery."
The clearance of Premvia in the United States will provide
BioTime with a foundation for the development of even more advanced
bioactive and cell-matrix combination products. The pivotal trial of Renevia
(another HyStem -based product) is expected to
begin later this year in Europe, where BioTime is seeking a CE Mark for
the use of Renevia in combination with cells for the purpose of
lipotransfer in the treatment of HIV-related lipoatrophy. BioTime also
is in the process of developing HyStem
technology for use in formulating a number of products manufactured from
pluripotent stem cells using the Company's proprietary PureStem
technology. Combination products of HyStem -based
hydrogels with PureStem cell lines will require
future human clinical trials.
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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 , an injectable HyStem
hydrogel, is presently undergoing clinical evaluation in Europe as a
delivery matrix for autologous adipose cells to treat the facial
lipoatrophy associated with HIV. 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 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 stock is traded under the symbol
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