Full Press Release Details
Provides Financing and Product Development Update
Since October 1, 2013 in At-the-Market Stock Sales
is Awarded New NIH SBIR Grant
510(k) Premarket Notification Submitted to FDA for Review
ALAMEDA, Calif.--(BUSINESS WIRE)--March 3, 2014--BioTime, Inc. (NYSE
MKT: BTX) today announced the results of its capital raising activities
since October 1, 2013 through its $25 million Controlled Equity Offering
facility, and through sales of BioTime common shares by certain of its
subsidiaries, in "at-the-market" transactions through Cantor Fitzgerald
& Co., as sales agent. BioTime and its majority owned subsidiaries,
LifeMap Sciences, Inc., Cell Cure Neurosciences, Inc. and OncoCyte Corp.
raised gross proceeds of approximately $12.6 million, in the aggregate,
from the sale of approximately 3.31 million common shares at a weighted
average price of $3.81 per share in the open market, including
approximately $8.5 million since January 1, 2014.
BioTime also announced today that it has been awarded a SBIR Phase 1
Small Business Grant from the National Institute of General Medical
Sciences (NIGMS) at the National Institutes of Health (NIH). The project
entitled "Reagents for Targeted Ablation of Residual Contaminating
Pluripotent Stem Cells" is aimed at developing a product designed as a
simple cell culture additive that will reduce the risk of contamination
of therapeutic stem cell formulations by residual pluripotent stem
cells. Unlike BioTime's PureStem
technology, first generation protocols used in many laboratories to
manufacture cell types from pluripotent stem cells can be contaminated
with undesired cell types. Under the grant, BioTime will work to develop
reagents that selectively identify and kill residual pluripotent cells
while leaving the intended therapeutic stem cells unharmed. Any products
that may be developed may be marketed to the stem cell research
community and to cell therapy companies that are developing pluripotent
stem cell derived products without BioTime's PureStem
technology, for the treatment of degenerative diseases and injury.
In another product development update, BioTime announced that it has
submitted to the United States Food and Drug Administration (FDA) a
510(k) premarket notification for Premvia as a Class II
wound management medical device, and the FDA has informed BioTime that
the 510(k) notification has been accepted for review. Premvia
is a member of BioTime's HyStem family of
hydrogels. The product is indicated for the management of wounds,
including partial and full-thickness wounds, tunneling wounds, pressure
ulcers, diabetic ulcers, second degree burns, skin tears and draining
wounds where a hydrating tissue matrix is needed. A 510(k) notification
is required in order to market a Class II device intended for human use
and must be followed by an order, in the form of a letter, from the FDA
finding the device to be substantially equivalent to a legally marketed
device. We may be required to provide human clinical data demonstrating
safety and efficacy of Premvia for approval as a medical
device if the FDA determines that marketing approval should not be
granted on the basis of a 510(k) application.
The global market for all wound care products is estimated at $16
billion and is composed of many distinct market segments. Premvia
addresses needs within the advanced wound care segment that is forecast
to reach $8.7 billion in 2015. According to market surveys, greater
efficacy in wound healing and reduced hospital stays is driving an
increasing preference for advanced products over traditional wound
dressings. The increasing aged population, rise in chronic disease, and
technological advancements is expect to further drive demand for
innovative wound care solutions and market growth. In the long term,
advances in tissue-engineered products are expected to dominate the
Approval of the notification will provide BioTime with a foundation for
the use of Premvia to develop more advanced bioactive
dermatological products before marketing Premvia , which would
likely require clinical testing to demonstrate safety and efficacy of
the new products, and additional FDA review and approval.
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:
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 medicine.
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
Cell Cure Neurosciences Ltd. ("Cell Cure Neurosciences") 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.
LifeMap Sciences, Inc. ("LifeMap Sciences") 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