- Published: 24 February 2015
- Written by Editor
Second Sight Announces First Commercial Implants of the Argus® II Retinal Prosthesis System in France
SYLMAR, Calif.-- Second Sight Medical Products, Inc. (EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics to provide functional vision to blind patients, today announced that all three of the centers approved to implant the Argus II Retinal Prosthesis System (“Argus II”) under the French Government national healthcare reimbursement program entitled ‘Forfait Innovation’ have successfully completed their first implants in patients with retinitis pigmentosa (RP). Current French implant centers are located in Paris, Bordeaux, and Strasbourg.
In 2014, the Argus II became the first-ever medical device to be named as the recipient of Forfait Innovation, allowing select hospitals in France to offer this “early access” and innovative treatment to patients with advanced RP. Forfait Innovation provides dedicated support to patients implanted with Argus II, funding the costs of implantation and patients’ hospital fees. 36 RP patients in France now stand to benefit from this life-changing technology with this first step in national reimbursement.
“We are pleased to see RP patients, who previously had no treatment option, gain access to this revolutionary device through Forfait Innovation,” stated Dr. Robert Greenberg, Chief Executive Officer of Second Sight. “There is great potential for patients in France, as the French government has taken a progressive step in supporting a sometimes overlooked patient population.”
RP, an inherited disease that often results in nearly complete blindness, affects roughly 24,000 French persons and 167,000 persons across Europe in total.
To date, the Argus II has been implanted in more than 100 individuals worldwide, and is the first approved retinal prosthesis in the world. Currently, the treatment is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, United Kingdom and the United States. 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.
About 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, blindness. There are an estimated 1.2 million people worldwide with RP. Second Sight’s Argus II System employs electrical stimulation to bypass the defunct cells and stimulate remaining viable retinal cells inducing visual perception in blind individuals. The Argus II is the first artificial retina to receive approval in the United States and worldwide.
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 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 widespread approval, and is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, United Kingdom and the United States. The system is controlled by software and is upgradeable, which may provide improved performance as new algorithms are developed and tested.
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. The company’s Argus II retinal prosthesis is approved in the U.S., Canada, Europe and Saudi Arabia, and trials are currently underway to test the safety and efficacy of the Argus II in patients with Dry AMD. Clinical trials are planned to test improved software, which is currently under development. Second Sight is also developing the OrionTM cortical prosthesis to restore functional vision to individuals who are blind due to causes other than preventable or treatable conditions. The population of legally blind people potentially eligible for the future Orion cortical prosthesis in France is about 40,000 and 6 million worldwide. The company’s headquarters are in Sylmar, California, and its European Headquarters are in Lausanne, Switzerland. For more information, 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 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 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 contained within our final prospectus filed with the United States Securities and Exchange Commission on November 20, 2014. 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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