Full Press Release Details
Sight Receives Conditional FDA Approval to Begin First Orion Human Clinical Study
Calif.--(BUSINESS WIRE)-- Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"),
a developer, manufacturer and marketer of implantable visual prosthetics to provide useful vision to blind patients, today announced
that the Company has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin the Orion
Cortical Visual Prosthesis System (Orion) feasibility clinical study. The conditional approval allows two U.S. sites to enroll
up to five total patients. The FDA has also requested that the Company conduct additional device testing and address outstanding
questions. Second Sight has 45 days to respond to FDA's requests.
is an exciting milestone for the Company given the potential of Orion to provide useful vision to millions of blind individuals
worldwide who have no other option today. We are delighted to have received conditional approval from the FDA to move forward
and can now focus on finalizing the various approvals and agreements required at each clinical trial site. Once we complete those
steps, our designated U.S. clinical trial sites, the University of California at Los Angeles (UCLA) and Baylor College of Medicine
(Baylor) in Houston, can begin patient recruitment efforts. The Orion team has met all major internal milestones this year and
we remain on-track to achieve the Company's stated goal of implanting our first Orion patient before year end," stated Will
McGuire, President and Chief Executive Officer of Second Sight.
ability to implant the first Orion system, which has the potential to treat nearly all forms of profound blindness, has been a
stated goal of the Company since our IPO. We are grateful for the rapid review and approval by the FDA. This milestone is a testament
to the careful, high-quality work completed by the Second Sight and UCLA teams to date. We look forward to continuing our work
with UCLA as this exciting clinical trial begins and also welcome Baylor to this important effort," stated Dr. Robert Greenberg,
Chairman of the Board.
patients interested in the Orion clinical trial can contact Second Sight customer service at 1-855-756-3703.
the Orion Visual Cortical Prosthesis System
Sight, the manufacturer of the Argus II Retinal Prosthesis System (Argus II), has developed a new device, the Orion. A proof-of-concept
clinical trial demonstrating the viability of stimulation of the human visual cortex with a commercially available device from
a different manufacturer began in Q4 2016 at UCLA. First-in-human clinical studies with the Orion are planned in 2017. Like the
Argus II, the idea behind Second Sight's Orion is to convert 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
the Argus II Retinal Prosthesis System
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, United Kingdom, and the U.S.
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 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.
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.
Institutional Investors
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