BioTime Enters Into Exclusive Agreement With Orbit Biomedical Ltd. to Access Innovative Device for the Sub-Retinal Delivery o...
07 Janeiro 2019 - 11:00AM
BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage
biotechnology company focused on degenerative diseases, today
announced that it has entered into a research and option agreement
with Orbit Biomedical Limited (“Orbit Biomedical”). Orbit
Biomedical, based in London, UK and Ambler, PA, was founded in 2018
to develop a surgical device and training platform for the delivery
of cell and gene therapies to the sub-retinal space. Under
the terms of the agreement, BioTime and Orbit Biomedical will
collaborate on the use of Orbit Biomedical’s proprietary injection
technology to deliver OpRegen® for the treatment of dry age-related
macular degeneration (“dry-AMD”).
Traditionally, the sub-retinal space is accessed
via vitrectomy (removal of the vitreous, the gel-like substance
that fills the eye), followed by an injection into the eye and
through the retina. Orbit Biomedical’s injection system is designed
to precisely and consistently deliver therapeutics to the
sub-retinal space via a suprachoroidal route, avoiding the need for
a vitrectomy and perforation of the retina.
“Orbit Biomedical’s specifically-designed device
offers surgeons an innovative solution for the delivery of
therapies to the sub-retinal space, a well-known challenge in
ophthalmology,” stated Brian M. Culley, Chief Executive Officer of
BioTime. “This alliance gives us the opportunity to evaluate the
Orbit Biomedical technology early in the clinical development
process of OpRegen® and also provides BioTime with an option to
negotiate an exclusive license for the commercial use of the device
with OpRegen® for the treatment of dry-AMD. We believe access to
the Orbit device has the potential to meaningfully enhance the
clinical profile of OpRegen® to further benefit dry-AMD patients.”
“We are excited to have entered into this
collaboration with BioTime, one of the most clinically-advanced
companies delivering retinal pigment epithelial cells for the
treatment of dry-AMD,” stated Susan Hill, Ph.D., Chief Executive
Officer of Orbit Biomedical. “Our partnership fully supports
our mission to revolutionize gene and cell therapy treatment by
setting a new standard for precise, targeted surgical delivery.”
Under the terms of the exclusive 12 month
agreement, BioTime and Orbit Biomedical plan to investigate the
safety and utility of Orbit Biomedical’s surgical delivery
technology in the ongoing Phase I/II clinical study of OpRegen® for
the treatment of dry-AMD.
About OpRegen®OpRegen® is a retinal pigment
epithelium transplant therapy in Phase I/IIa development for the
treatment of dry age-related macular degeneration, the leading
cause of adult blindness in the developed world. OpRegen® consists
of a suspension of retinal pigment epithelial (RPE) cells delivered
subretinally as an intraocular injection. RPE cells are essential
components of the back lining of the retina and function to help
nourish the retina including photoreceptors. OpRegen® has been
granted Fast Track designation from the U.S. Food and
Drug Administration. OpRegen® is a registered trademark of Cell
Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime,
Inc.
About BioTime,
Inc.BioTime is a clinical-stage biotechnology company
focused on the development and commercialization of novel therapies
for the treatment of degenerative diseases. BioTime’s pipeline is
based on two platform technologies which encompass cell replacement
and cell/drug delivery. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium transplant
therapy in Phase I/IIa development for the treatment of dry
age-related macular degeneration, the leading cause of blindness in
the developed world. BioTime’s lead cell delivery clinical program
is Renevia®, an investigational medical device being developed as
an alternative for whole adipose tissue transfer procedures.
BioTime common stock is traded on the NYSE American and TASE
under the symbol BTX. For more information, please
visit www.biotime.com or connect with the company on
Twitter, LinkedIn, Facebook, YouTube, and Google+. To
receive ongoing BioTime corporate communications, please
click on the following link to join the Company’s email alert
list: http://news.biotime.com.
About Orbit Biomedical,
Ltd.Orbit Biomedical is a specialist medical device
company, operating at the intersection of biomedical engineering,
surgeon training and curative therapeutics. Orbit Biomedical’s
mission is to revolutionize gene and cell therapy treatment by
setting a new standard for precise, targeted surgical delivery. The
Company’s current focus is delivery to the sub-retinal space for
the treatment of retinal disease. Orbit Biomedical’s 510k approved
microcannula is indicated for microinjection into the subretinal
space. The Orbit Biomedical microcannula accesses the subretinal
space from the front of the eye by approaching it through the
suprachoroidal tissue layer, without the need to remove the
vitreous (the gel-like substance in the centre of the eye) or to
pierce the retina itself. Located in London, UK and Ambler, PA,
Orbit Biomedical was founded in 2018 with Series A funding from
Syncona, a leading life sciences investor. For more
information visit www.orbitbiomedical.com
Forward-Looking
StatementsCertain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. 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 forward-looking
statements. Forward-looking statements involve risks and
uncertainties. 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, Inc. and its subsidiaries,
particularly those mentioned in the cautionary statements found in
more detail in the “Risk Factors” section of BioTime’s Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q (copies of
which may be obtained at www.sec.gov). Subsequent events and
developments may cause these forward-looking statements to change.
BioTime specifically disclaims any obligation or intention to
update or revise these forward-looking statements as a result of
changed events or circumstances that occur after the date of this
release, except as required by applicable law.
BioTime Inc. IRIoana C.
Hone(ir@biotimeinc.com)(510) 871-4188
Solebury Trout IRGitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
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