SYLMAR, California,
October 25, 2016 /PRNewswire/ --
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 http://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.