TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 2, 2017
|SECOND SIGHT MEDICAL PRODUCTS, INC.|
|(Exact Name of Registrant as Specified in Its Charter)|
|(State or Other Jurisdiction of Incorporation)|
|(Commission File Number)||(IRS Employer Identification No.)|
San Fernando Road, Suite 400
|(Address of Principal Executive Offices)|
|(Registrant’s Telephone Number, Including Area Code)|
|(Former Name or Former Address, if Changed Since Last Report)|
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
On November 2, 2017, Second Sight Medical Products, Inc. (the “Company” “or “we”) issued a press release announcing the receipt of the U.S. Food and Drug Administration (FDA) full approval to begin the Orion™ Cortical Visual Prosthesis System (Orion) feasibility clinical study. On August 28, 2017, the Company announced that the FDA had granted conditional approval, requesting the Company answer additional questions and perform additional tests. We now have completed those additional tests, answered those additional questions, and received a full approval from the FDA.
The Orion converts images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes implanted on the surface of the visual cortex of the brain, intended to result in the perception of patterns of light. Orion, by bypassing the retina and optic nerve and directly stimulating the visual cortex, 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.
The Company conducted 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 in Q3 2016 at the University of California at Los Angeles (UCLA).
The approval allows two U.S. sites to enroll up to five total patients. The Company has designated UCLA and Baylor College of Medicine in Houston as the U.S. clinical trial sites.
A copy of our press release entitled “Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study” is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
|99.1||Press Release issued November 2, 2017|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 6, 2017
SECOND SIGHT MEDICAL PRODUCTS, INC.
|/s/ Thomas B. Miller|
|By: Thomas B. Miller|
|Chief Financial Officer|
Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study
--Second Sight has completed additional device testing and addressed outstanding questions previously requested by the FDA--
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 that are intended to create an artificial form of useful vision to blind patients, today announced that the Company has received full approval from the U.S. Food and Drug Administration (FDA) to begin the Orion™ Cortical Visual Prosthesis System (Orion) feasibility clinical study. The approval allows two U.S. sites, the University of California at Los Angeles (UCLA) and Baylor College of Medicine (Baylor) in Houston, to enroll up to five total patients. Second Sight has also completed the additional device testing and addressed the remaining outstanding questions requested by the FDA in their prior conditional approval announced by the Company on August 28, 2017.
“We are grateful for the rapid and thorough review by the FDA and are pleased to be able to commence the Orion feasibility study. We look forward to working with the teams at UCLA and Baylor to complete the final steps to begin patient recruitment,” said Robert Greenberg, Chairman of Second Sight. “We remain on track toward achieving our stated goal of implanting our first Orion patient before year end, and the potential opportunity to provide useful vision to millions of blind individuals worldwide who have no other option today, stated Will McGuire, President and Chief Executive Officer of Second Sight.
Blind patients interested in the Orion clinical trial can contact Second Sight customer service at 1-855-756-3703 for further information or referral to one of our clinical trial sites.
About the Orion Visual Cortical Prosthesis System
Second 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 at UCLA demonstrating the viability of stimulation of the human visual cortex with a commercially available device from a different manufacturer was announced in Q4 2016. First-in-human clinical studies with the Orion are planned to begin 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 and trauma - many fold more patients than for the current Argus II indications. No clinical data is yet available for the Orion.
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 benefits and risks can be found in the peer reviewed paper at: http://www.sciencedirect.com/science/article/pii/S0161642016305796
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. U.S. Headquarters are in Sylmar, California, 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, 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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