BioTime's Subsidiary Cell Cure Neurosciences Ltd. Receives FDA Fast-Track Designation for OpRegen for the Treatment of the Dry Form of Age-Related Macular Degeneration ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)

Subsidiary Cell Cure Neurosciences Ltd. Receives FDA Fast-Track

Designation for OpRegen for

the Treatment of the Dry Form of Age-Related Macular Degeneration

ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)--September 28,

2015--BioTime, Inc. (NYSE MKT and TASE: BTX) and its subsidiary Cell

Cure Neurosciences Ltd. ("Cell Cure") today announced that the U.S. Food

and Drug Administration ("FDA") has granted Fast Track designation for OpRegen ,

a cell-based therapeutic product consisting of retinal pigment

epithelial (RPE) cells designed to block the progression of the severe

dry-form of age-related macular degeneration (AMD), a leading cause of

blindness in an aging population.

Under an Investigational New Drug Application (IND) for "Retinal Pigment

Epithelium (RPE) Cells derived from Allogenic Human Embryonic Stem

Cells; Transplanted Subretinally" and after receiving approval from the

Israel Ministry of Health, Cell Cure is now enrolling patients

at Hadassah University Medical Center in Jerusalem, Israel, in a

clinical Phase I/IIa dose-escalation study evaluating the safety and

efficacy of OpRegen for geographic atrophy (GA), the severe

stage of the dry form of age-related macular degeneration (dry-AMD). The

first patient was treated earlier this year and Cell Cure expects to

provide interim data in early 2016.

The FDA grants Fast Track designation if it determines that a drug fills

an unmet medical need in a serious condition. According to the FDA, a

drug that receives Fast Track designation is eligible for some or

all of the following:

More frequent meetings with FDA to discuss the drug's development plan

and ensure collection of appropriate data needed to support drug

More frequent written communication from FDA about such things as the

design of the proposed clinical trials and use of biomarkers;

Eligibility for Accelerated Approval and Priority Review, if relevant

criteria are met; and

Rolling Review, which means that a drug company can submit completed

sections of its Biologic License Application (BLA) or New Drug

Application (NDA) for review by FDA, rather than waiting until every

section of the NDA is completed before the entire application can be

reviewed. BLA or NDA review usually does not begin until the drug

company has submitted the entire application to the FDA.

Additional information about the FDA Fast Track Designation can be found

on the FDA's website at www.fda.gov.

About Dry Age-Related Macular Degeneration (Dry-AMD)

Dry AMD is the most common type of macular degeneration and affects

approximately 90% of people with the disorder. In the dry form, there is

a loss or dysfunction of the layer of retinal pigment epithelial (RPE)

cells, generally in the region of the eye called the macula. These RPE

cells support the light detecting photoreceptor cells that are so

critical to vision. When we look at something, the photoreceptors (rods

and cones) detect the light and send the information to the brain

allowing us to perceive our surroundings. The age-dependent loss of the

RPE cells therefore leads to degeneration of nearby photoreceptors and

this can lead to severe vision loss or even blindness. Generally, the

damage caused by the "dry" form is not as severe or rapid as that of the

"wet" form. However, over time, it can cause profound vision loss. The

more advanced stage of dry macular degeneration is called geographic

atrophy. While there are therapeutics available to treat the wet form of

AMD, there are currently no FDA-approved therapies for dry-AMD.

About Cell Cure Neurosciences Ltd.

Cell Cure Neurosciences Ltd. was established in 2005 as a subsidiary

of ES Cell International Pte. Ltd. (ESI), now a subsidiary of BioTime,

Inc. Cell Cure is located in Jerusalem, Israel on the campus of Hadassah

University Hospital. Cell Cure's mission is to become a leading supplier

of human embryonic stem cell-based therapies for the treatment of

retinal and neural degenerative diseases. Its technology platform is

based on the manufacture of diverse cell products sourced from

clinical-grade (GMP) human embryonic stem cells. Its current focus is

the development of retinal pigment epithelial (RPE) cells for the

treatment of age-related macular degeneration. Cell Cure's major

shareholders include BioTime, Inc., Hadasit BioHoldings Ltd. (Tel Aviv

Stock Exchange: HDST), and Teva Pharmaceuticals Industries Ltd. (NYSE:

TEVA). Additional information about Cell Cure can be found on the web at www.cellcureneurosciences.com.

BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage

biotechnology company. BioTime and its subsidiaries are leveraging their

industry-leading experience in pluripotent stem cell technology and a

broad intellectual property portfolio to facilitate the development and

use of cell-based therapies and gene marker-based molecular diagnostics

for major diseases and degenerative conditions for which there presently

are no cures. The lead clinical programs of BioTime and its subsidiaries

include OpRegen , currently in a Phase I/IIa

trial for the treatment of the dry form of age-related macular

degeneration; AST-OPC1, currently in a Phase I/IIa trial for

spinal cord injuries; Renevia , currently in a pivotal trial

in Europe as an injectable matrix for the engraftment of transplanted

cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing

the completion of initial clinical studies for the detection of lung,

bladder, and breast cancers. AST-VAC2, a cancer vaccine, is

in the pre-clinical trial stage.

BioTime's subsidiaries include the publicly traded Asterias

Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem

cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell

Cure Neurosciences Ltd., developing stem cell-based therapies for

retinal and neurological disorders, including OpRegen ; OncoCyte

Corporation, developing cancer diagnostics; LifeMap Sciences, Inc.,

developing and marketing an integrated online database resource for

biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary

of LifeMap Sciences, developing mobile health (mHealth) products; ES

Cell International Pte Ltd, which has developed cGMP-compliant human

embryonic stem cell lines that are being marketed by BioTime for

research purposes under the ESI BIO branding program; OrthoCyte

Corporation, developing therapies to treat orthopedic disorders,

diseases, and injuries; and ReCyte Therapeutics, Inc., developing

therapies to treat a variety of cardiovascular and related ischemic