Second Sight Announces Record Number of Argus II Retinal Prosthesis Systems Implants & Completes First-in-Human Orion Cortica...
February 05 2018 - 8:00AM
Business Wire
Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second
Sight" or "the Company"), a developer, manufacturer and marketer of
implantable visual prosthetics that are intended to create an
artificial form of useful vision to blind patients, today provided
an update on several key performance metrics, demonstrating the
Company’s continued progress in executing its near- and long-term
goals.
Business Highlights as of January 31, 2018:
- Implanted 30 Argus® II Retinal
Prosthesis Systems worldwide during the fourth quarter of 2017 for
a total of 75 implants in 2017. This compares to seven implants in
the fourth quarter of 2016 and a total of 42 implants in 2016,
representing implant volume growth of 329% and 79%,
respectively;
- The first human patient was implanted
with the Orion™ Cortical Visual Prosthesis System (Orion) by Nader
Pouratian, MD, PhD, Vice Chairman of the Department of Neurosurgery
at the Ronald Reagan UCLA Medical Center (UCLA) in late January as
part of Second Sight’s feasibility clinical study;
- Enrollment of the first patient(s) is
expected during Q1 2018 in a clinical study of better-sighted
patients with Retinitis Pigmentosa (RP) in Germany. Two sites are
actively screening subjects with a third site to begin screening
shortly;
- Added a new Center of Excellence in
Houston, TX in early January, further validating the success of the
Company’s business model that emphasizes close partnering with
implanting sites; and,
- Reimbursement for the Argus II in
Germany was renewed for the 2018 calendar year, marking the eighth
year that Argus II implants have been reimbursed through the NUB
program.
“We are excited about our milestones and achievements in 2017,
which speak to the strength of our business and the momentum we
expect for continued success in 2018,” said Will McGuire, President
and CEO of Second Sight.
“The first-in-human implant of the Orion is a significant
milestone for Second Sight, and a critical step forward in meeting
our Company’s mission to develop devices that could potentially
treat nearly all forms of blindness. We expect that an additional
four patients will be included in this feasibility study at UCLA
and the Baylor College of Medicine in Houston,” stated Dr. Robert
Greenberg, Chairman of the Board.
“We continue to advance our Argus II R&D efforts and have
initiated screening for a clinical trial in better-sighted RP
patients. Second Sight is committed to executing on our strategy to
expand the availability of the Argus II to a larger patient
population and explore the potential of our technology to treat
those suffering from other forms of blindness. We look forward to
updating investors on our continued progress,” concluded
McGuire.
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 Retinitis Pigmentosa. 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 stimulate the retina's
remaining cells, intending to result in the perception of patterns
of light in the brain. The patient must learn to interpret these
visual patterns, having the potential to regain some visual
function. The Argus II was the first artificial retina to receive
widespread commercial approval, and is offered at approved centers
in Canada, France, Germany, Italy, Russia, Saudi Arabia, South
Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United
States. Further information on the long-term benefits and risks can
be found in the peer reviewed paper at:
http://www.sciencedirect.com/science/article/pii/S0161642016305796
About the Orion Visual Cortical Prosthesis System
Like the Argus II, the Orion converts images captured by a
miniature video camera mounted on the patient's glasses into a
series of small electrical pulses. The Orion is designed to
transmit these electrical pulses wirelessly to an array of
electrodes implanted on the surface of the visual cortex, intended
to result in the perception of patterns of light. By bypassing the
retina and optic nerve and directly stimulating the visual cortex,
a cortical prosthesis system has the potential to restore useful
vision to patients completely blinded due to many reasons,
including glaucoma, diabetic retinopathy, or forms of cancer and
trauma – which has the potential to treat many fold more patients
than for the current Argus II indications. No clinical data is yet
available for the Orion.
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. New hardware and
software to improve the quality of the vision produced is underway.
A clinical trial to study the Argus II in better-sighted subjects
earlier in the disease was recently approved in Germany. Second
Sight is also developing the Orion™ Visual Cortical Prosthesis to
restore some vision to individuals who are blind due to causes
other than preventable or treatable conditions. Second Sight’s U.S.
Headquarters are in Sylmar, California, and European Headquarters
are in Lausanne, Switzerland. For more information, please visit
www.secondsight.com
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,"
and similar expressions, or the negative versions thereof, and
which also may be identified by their context. All statements that
address operating performance or events or developments that Second
Sight expects or anticipates will occur in the future, such as
stated objectives or goals, or that are not otherwise historical
facts, are forward-looking statements. 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 our Annual Report, on Form 10-K, as filed on March 16,
2017, and our other reports filed from time to time with
the Securities and Exchange Commission. We urge you to
consider those risks and uncertainties in evaluating our
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
our 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,
PresidentT: 212-452-2793E: lwilson@insitecony.comorIndividual InvestorsMZ North AmericaGreg Falesnik,
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greg.falesnik@mzgroup.usorMedia:Nobles
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Laura@noblesgc.comE: Helen@noblesgc.com
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