UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (date of earliest event reported): August
12, 2014
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California
|
1-12830
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94-3127919
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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1301
Harbor Bay Parkway
Alameda,
California 94502
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area
code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Forward-Looking Statements
Any statements that are not historical fact (including, but not
limited to statements that contain words such as “may, “will,”
“believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”)
should also be considered to be forward-looking statements. Additional
factors that could cause actual results to differ materially from the
results anticipated in these forward-looking statements are contained in
BioTime’s periodic reports filed with the SEC under the heading “Risk
Factors” and other filings that BioTime may make with the Securities and
Exchange Commission. Undue reliance should not be placed on these
forward-looking statements which speak only as of the date they are
made, and the facts and assumptions underlying these statements may
change. Except as required by law, BioTime disclaims any intent or
obligation to update these forward-looking statements.
This Report and any accompanying exhibits shall be deemed “furnished”
and not “filed” under the Securities Exchange Act of 1934, as amended.
Section 7 - Regulation FD
Item 7.01 - Regulation FD Disclosure
On August 12, 2014, BioTime, Inc. issued the press release furnished as
Exhibit 99.1, which is incorporated by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01 - Financial Statements and Exhibits.
Exhibit Number
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Description
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99.1
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Press Release Dated August 12, 2014.
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SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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BIOTIME, INC.
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Date:
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August
12, 2014
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By:
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/s/ Michael D. West
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Chief Executive Officer
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Exhibit Number
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Description
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99.1
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Press Release Dated August 12, 2014.
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3
Exhibit 99.1
BioTime
Receives FDA Premarket Notification Clearance for Premvia™
510(k)
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
medicine.’”
“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.
Share this news via Twitter:
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Click to Tweet: BioTime Receives FDA Premarket Notification
Clearance for Premvia 510(k) $BTX http://ctt.ec/fTEG3+
About HyStem®
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.
About BioTime
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:
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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
ASTYV.
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BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
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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.
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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.
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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
database.
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LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences
focused on developing mobile health (mHealth) products.
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OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer, including PanC-Dx™, with three
clinical trials currently underway.
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OrthoCyte Corporation is developing therapies to treat
orthopedic disorders, diseases and injuries.
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ReCyte Therapeutics, Inc. is developing therapies to treat a
variety of cardiovascular and related ischemic disorders, as well as
products for research using cell reprogramming technology.
BioTime stock is traded on the NYSE Market exchange, ticker BTX. For
more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube, and
Google+.
Forward-Looking Statements
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
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390 ext. 301
jsegall@biotimemail.com
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