Second Sight Announces Successful Implantation and Activation of Wireless Visual Cortical Stimulator in First Human Subject
October 25 2016 - 8:00AM
Business Wire
Provides Proof of Concept for the Ongoing
Development of the Orion™ I Visual Cortical Prosthesis
Second Sight Medical Products, Inc. (NASDAQ:EYES) (Second Sight
or the Company), a developer, manufacturer and marketer of
implantable visual prosthetics to restore functional vision to
blind patients, today announced the first successful implantation
and activation of a wireless visual cortical stimulator in a human
subject, providing the initial human proof of concept for the
ongoing development of the Company’s Orion™ I Visual Cortical
Prosthesis (Orion I). In the UCLA study supported by Second Sight,
a 30 year old patient was implanted with a wireless multichannel
neurostimulation system on the visual cortex and was able to
perceive and localize individual phosphenes or spots of light with
no significant adverse side effects.
Dr. Robert Greenberg, Chairman of the Board of Second Sight,
said, “It is rare that technological development offers such
stirring possibilities. This first human test confirms that we are
on the right track with our Orion I program to treat blind patients
who cannot benefit from the Argus® II Retinal Prosthesis (Argus
II). This initial success in a patient is an exciting and important
milestone even though it does not yet include a camera. By
bypassing the optic nerve and directly stimulating the visual
cortex, the Orion I has the potential to restore useful vision to
patients completely blinded due to virtually any reason, including
glaucoma, cancer, diabetic retinopathy, or trauma. Today these
individuals have no available therapy and the Orion I offers hope,
increasing independence and improving their quality of life.”
“While we still have much work ahead, this successful human
proof of concept study gives us renewed energy to move our Orion I
development efforts forward,” said Will McGuire, President and CEO
at Second Sight. “We believe this technology will ultimately
provide a useful form of vision for the nearly six million people
worldwide who are blind but not a candidate for an Argus II retinal
prosthesis. We also remain focused on further developing our Argus
II technology for patients with Retinitis Pigmentosa, making it
more widely available, and exploring its potential to improve the
vision of nearly two million patients blinded by Age-Related
Macular Degeneration worldwide.”
Dr. Nader Pouratian, the UCLA neurosurgeon who performed the
surgery, added, “Based on these results, stimulation of the visual
cortex has the potential to restore useful vision to the blind,
which is important for independence and improving quality of
life.”
This implant was performed as part of a proof of concept
clinical trial whose purpose is to demonstrate initial safety and
feasibility of human visual cortex stimulation. The initial success
of this study, coupled with the significant additional pre-clinical
work gathered to-date readies Second Sight to submit an application
to the FDA in early 2017 to gain approval for conducting an initial
clinical trial of the complete Orion I system, including the camera
and glasses. Assuming positive initial results in patients and
discussions with regulators, an expanded pivotal clinical trial for
global market approvals is then planned.
About Second Sight
Second Sight's mission is to develop, manufacture and market
innovative implantable visual prosthetics to enable blind
individuals to achieve greater independence. Second Sight has
developed and now manufactures and markets the Argus® II Retinal
Prosthesis System. Enrollment has been completed in a feasibility
trial to test the safety and utility of the Argus II in individuals
with Dry Age-Related Macular Degeneration. Second Sight is also
developing the Orion™ I Visual Cortical Prosthesis to restore some
vision to individuals who are blind due to causes other than
preventable or treatable conditions. U.S. Headquarters are in
Sylmar, California and European Headquarters are in Lausanne,
Switzerland. For more information, visit www.secondsight.com.
About the Argus® II Retinal Prosthesis System
Second Sight's Argus II System provides
electrical stimulation that bypasses the defunct retinal cells and
stimulates remaining viable cells inducing visual perception in
individuals with severe to profound outer retinal degeneration such
as retinitis pigmentosa (RP). The Argus II works by converting
images captured by a miniature video camera mounted on the
patient's glasses into a series of small electrical pulses, which
are transmitted wirelessly to an array of electrodes implanted on
the surface of the retina. These pulses are intended to stimulate
the retina's remaining cells, resulting in the perception of
patterns of light in the brain. The patient then learns to
interpret these visual patterns, thereby regaining some useful
vision. The system is controlled by software and is upgradeable,
which may provide improved performance as new algorithms are
developed and tested. Therefore current and future Argus II users
may benefit from the continuously improving technology. The Argus
II is the first artificial retina to receive widespread approval,
and is offered at approved centers in Austria, Canada, France,
Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland,
Turkey, United Kingdom and the United States.
Safe Harbor
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange and Exchange
Act of 1934, as amended, which are intended to be covered by the
"safe harbor" created by those sections. All statements in this
release that are not based on historical fact are "forward looking
statements." These statements may be identified by words such as
"estimates," "anticipates," "projects," "plans," or "planned,"
"seeks," "may," "will," "expects," "intends," "believes," "should,"
"potentially," "objectives," and similar expressions or the
negative versions thereof and which also may be identified by their
context. While management has based any forward looking statements
included in this release on its current expectations, the
information on which such expectations were based may change.
Forward-looking statements involve inherent risks and uncertainties
which could cause actual results to differ materially from those in
the forward-looking statements, as a result of various factors
including those risks and uncertainties described in the Risk
Factors and in Management's Discussion and Analysis of Financial
Condition and Results of Operations sections of the Company's
Annual Report on Form 10-K as filed on March 11, 2016 and the
Company's other reports filed from time to time with
the Securities and Exchange Commission. We urge you to
consider those risks and uncertainties in evaluating the Company's
forward-looking statements. We caution readers not to place undue
reliance upon any such forward-looking statements, which speak only
as of the date made. Except as otherwise required by the federal
securities laws, we disclaim any obligation or undertaking to
publicly release any updates or revisions to any forward-looking
statement contained herein (or elsewhere) to reflect any change in
the Company's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is
based.
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Investor Relations:Institutional InvestorsIn-Site
Communications, Inc.Lisa Wilson,
212-452-2793Presidentlwilson@insitecony.comorIndividual InvestorsMZ
North AmericaGreg Falesnik, 949-385-6449Managing
Directorgreg.falensik@mzgroup.usorMedia Relations:Pascale
Communications, LLCAllison Howell, 412-228-1678Senior Account
Directorallison@pascalecommunications.com
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