SECOND SIGHT MEDICAL PRODUCTS, INC. (NASDAQ:EYES) Files An 8-K Other Events

SECOND SIGHT MEDICAL PRODUCTS, INC. (NASDAQ:EYES) Files An 8-K Other Events
Item 8.01

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By letter dated February 26, 2021, the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) approved the Argus 2s Retinal Prosthesis System developed by Second Sight Medical Products, Inc. (the “Company”).  Argus 2s is a redesigned set of external hardware (glasses and video processing unit) to be used in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company issued a press release on March 5, entitled Second Sight Medical Products, Inc. Receives FDA Approval for the Argus 2s Retinal Prosthesis System, which is attached hereto as Exhibit 99.1.  Argus II, and now Argus 2s, are approved under a humanitarian device exemption (HDE).  The approval is contingent upon the Company filing periodic reports with CDRH, use only under prescription, under the supervision of an institutional review board (IRB), and taking all other required actions under FDA rules.  The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development.  

A decision on when or if to begin production of the newly approved hardware is pending completion of the Company’s planned business combination with Pixium Vision, which currently is in progress. Should the business combination be completed, the new management team will then evaluate how best to proceed with the Argus 2s Retinal Prosthesis System, as well as all other products in development.

The company announced the approval in a press lease date March 5, 2021.  A copy of the release is attached as Exhibit 99.1 and is incorporated herein by reference.  

SECOND SIGHT MEDICAL PRODUCTS INC Exhibit
EX-99.1 2 eyes-ex991_6.htm EX-99.1 eyes-ex991_6.htm Exhibit 99.1   FOR IMMEDIATE RELEASE Second Sight Medical Products,…
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About SECOND SIGHT MEDICAL PRODUCTS, INC. (NASDAQ:EYES)

Second Sight Medical Products, Inc. is engaged in developing, manufacturing and marketing prosthetic devices that restore vision to blind individuals. The Company’s product, the Argus II System, treats outer retinal degenerations, such as retinitis pigmentosa (RP). The Argus II System provides an artificial form of vision that differs from the vision of people with normal sight. It does not restore normal vision and it does not slow or reverse the progression of the disease. The Company’s Argus II System employs electrical stimulation to bypass degenerated photoreceptor cells and to stimulate remaining viable retinal cells thereby inducing visual perception in blind individuals. The Argus II System works by converting video images captured by a miniature camera housed in a patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes that are implanted on the surface of the retina.

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