SYLMAR, 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 restore some functional vision to blind patients, today announced that Health Canada has approved the Argus® II Retinal Prosthesis System to treat individuals with severe to profound outer retinal degeneration.
The Argus II, implanted in more than 100 individuals worldwide, is the only retinal prosthesis approved by Health Canada and the U.S. Food and Drug Administration (FDA), and the first approved retinal prosthesis in the world. The system induces visual perception in blind individuals by providing electrical pulses to stimulate the retina’s remaining cells, resulting in a perception of light patterns in the brain. The Argus II has the potential to offer life changing visual capabilities to those with little or no remaining functional vision. The Argus II implant can positively impact a blind person’s ability to conduct routine daily activities, such as recognizing shapes or large objects, locating people, identifying the location of doorways, and following lines or edges. Ultimately, this is meant to allow Argus II users to live their daily lives with more confidence.
“This is one of the most exciting medical developments I have witnessed in my career,” said Robert Devenyi, MD, FACS, Ophthalmologist-in-Chief, Donald K. Johnson Eye Centre and Director, Retinal Services, at the University Health Network. “The Argus II offers so much hope and possibility for patients with degenerative eye disease. I am delighted to be part of the first team in Canada that can provide this technology to patients.” Dr. Devenyi implanted the Argus II in the first Canadian patient on June 5, 2014, at Toronto Western Hospital in Toronto, Ontario, as part of an investigator-sponsored study.
“This regulatory approval and the first implants of the Argus II in Canada are tremendous milestones, not only for Second Sight, but also for those affected by outer retinal degenerations in Canada,” stated Robert Greenberg, MD, PhD, president and CEO of Second Sight. “Leveraging more than 20 years of research and development, supported by strong intellectual property, and coming on the heels of our approval in the U.S., today’s approval enables us to expand our international network of Centers of Excellence, which offer the Argus II retinal implant, into additional Canadian provinces beyond Ontario.” Second Sight is currently recruiting additional centers in major metropolitan areas and plans to apply for reimbursement in the provinces where they are established.
About Outer Retinal Degeneration
Outer retinal degeneration is the deterioration of the outer layer of the retina (e.g. the photoreceptors), caused by the progressive death of the cells in this region of the retina. An important type of outer retinal degeneration is Retinitis Pigmentosa (RP). RP is a rare, hereditary disease that causes a progressive degeneration of the light-sensitive cells of the retina, leading to significant visual impairment and ultimately can lead to blindness. There are an estimated 13,000 people in Canada and 1.2 million people worldwide with RP.
About the Argus® II Retinal Prosthesis System
Second Sight's Argus II System provides electrical stimulation to bypass the defunct cells and stimulate remaining viable retinal cells inducing visual perception in individuals with severe to profound outer retinal degeneration. 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 visual function. The Argus II is the first artificial retina to receive approval in Europe (CE Mark), and the first and only retinal prosthesis approved in the U.S. and now in Canada.
About Second Sight
Second Sight Medical Products, Inc. was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer-retinal degenerations such as RP. Second Sight's mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight is also developing the Orion™ cortical prosthesis to restore vision to individuals who are blind due to causes other than preventable or treatable conditions. The population of people potentially eligible for the future Orion cortical prosthesis in Canada is about 70,000. U.S. Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com.
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, that 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”. 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 statement 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 recently filed registration statement on Form S-1. 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.