--Total Grant Amount Up to $6.3 Million Over
Five Years--
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 individuals, today
announced that the Company has received a $1.6 million grant (with
the intent to fund $6.3 million over five years subject to annual
review and approval) from the National Institutes of Health (NIH)
to fund the “Early Feasibility Clinical Trial of a Visual Cortical
Prosthesis” that commenced in January 2018.
The NIH grant funds ongoing and planned clinical activities and
will be used to:
- Conduct and support clinical testing of
five subjects implanted with the Orion™ Cortical Visual Prosthesis
(Orion);
- Submit and obtain Investigational
Device Exemption approval from the U.S Food and Drug Administration
(FDA), and Institutional Review Board approval for a larger and
final clinical study as approved by FDA;
- Evaluate Orion reliability;
- Create and test spatial maps with
multiple spatial mapping methods in up to five patients;
- Establish and validate a fitting
process for Orion; and
- Demonstrate improvements in the
Functional Low-Vision Observer Rated Assessment (FLORA).
“We are delighted to be working with the researchers at the NIH
and are deeply appreciative of this grant as we aim to advance
Orion and work toward commencing a final clinical study to gain FDA
approval. With this grant, we are one step closer to bringing Orion
to a broader market that potentially treats a segment of the
millions of blind individuals worldwide who have no other option,”
stated Will McGuire, President and CEO of Second Sight.
About Second Sight
Second Sight Medical Products, Inc. (NASDAQ: EYES) develops,
manufactures and markets implantable visual prosthetics that are
intended to deliver useful artificial vision to blind individuals.
A recognized global leader in neuromodulation devices for
blindness, the company is committed to developing new technologies
to treat the broadest population of sight-impaired individuals.
Second Sight’s Argus® II Retinal Prosthesis System is the only
FDA and CE Mark approved device for treating retinitis pigmentosa,
with proven implant durability of multiple years. In 2016, the
company published five year results. Today, several Argus II
devices have been implanted and operational in humans for more than
10 years. The company is developing the Orion™ I Visual Cortical
Prosthesis which is intended to provide useful artificial vision to
individuals who are blind due to various causes. The company’s U.S.
headquarters are in Los Angeles, and European headquarters are in
Lausanne, Switzerland. More information is available at
www.secondsight.com.
About Retinitis Pigmentosa
Affecting one in 4,000 individuals worldwide, retinitis
pigmentosa (RP) is a rare, inherited genetic disorder that damages
retinal cells called photoreceptors. Photoreceptors absorb and
convert light into electrical signals sent to other retinal cells,
then through the optic nerve to the brain which processes them into
images. Common early symptoms of RP, often experienced in
childhood, include difficulty seeing at night and lost peripheral
vision. Later, the disease may lead to blurring of vision, tunnel
vision, loss of central vision or loss of the ability to see
colors. In many cases, severe vision problems occur in early
adulthood. RP may impact an individual’s ability to perform
essential tasks of daily living such as reading, driving, walking
without assistance, or recognizing faces and objects.
About the Argus II Retinal Prosthesis System
The Argus® II Retinal Prosthesis System is an established, FDA
and CE mark approved retinal implant that delivers a useful form of
artificial vision to individuals who are blind due to severe to
profound retinitis pigmentosa (RP). The Argus II works in place of
lost photoreceptor cells and sends electrical pulses to remaining
viable retinal cells to induce visual perception. The system works
by converting images captured by a miniature video camera mounted
on 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, enabling perception of patterns of light in the
brain. The user learns to interpret these visual patterns in order
to regain some visual function. The Argus platform, which leverages
the unique, patented design of its 60-contact array, is supported
by more than 10 years of clinical experience and has been evaluated
in multiple peer reviewed publications. Argus II was also the first
retinal neuromodulation prosthesis to receive widespread commercial
approval and is presently available at more than 50 leading medical
centers in North America, Europe, the Middle East and Asia. 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
Leveraging Second Sight’s 20 years of experience in
neuromodulation for vision, the Orion™ Visual Cortical Prosthesis
System is an implanted cortical stimulation device intended to
provide useful artificial vision to individuals who are blind due
to a wide range of causes, including glaucoma, diabetic
retinopathy, optic nerve injury or disease, or forms of cancer and
trauma. The Orion System is intended to convert images captured by
a miniature video camera mounted on glasses into a series of small
electrical pulses. The device is designed to bypass diseased or
injured eye anatomy and to transmit these electrical pulses
wirelessly to an array of electrodes implanted on the surface of
the brain’s visual cortex, where it is intended to provide the
perception of patterns of light. A feasibility study of the Orion I
device is currently underway at the Ronald Reagan UCLA Medical
Center in Los Angeles and Baylor College of Medicine in Houston. No
published in-human data is available yet for the Orion system.
Based on the results of this first in-human testing of the Orion I
cortical stimulation device, the company anticipates initiation of
the next study in 2019.
Forward looking statement
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,” “goal,” 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, filed on March 20, 2018, our most recent 10-Q, filed
on August 7, 2018, 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.
About the National Institutes of Health (NIH)
NIH, the nation's medical research agency, includes 27
Institutes and Centers and is a component of the U.S. Department of
Health and Human Services. NIH is the primary federal agency
conducting and supporting basic, clinical, and translational
medical research, and is investigating the causes, treatments, and
cures for both common and rare diseases. For more information about
NIH and its programs, visit www.nih.gov.
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Investor Relations:Institutional
InvestorsIn-Site Communications, Inc.Lisa Wilson,
PresidentT: 212-452-2793E: lwilson@insitecony.comorIndividual InvestorsMZ North AmericaGreg Falesnik,
Managing DirectorT: 949-385-6449E:
greg.falesnik@mzgroup.usorMedia:Nobles Global CommunicationsLaura
Nobles or Helen ShikT: 617-510-4373E: Laura@noblesgc.comE:
Helen@noblesgc.com
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