SECOND SIGHT MEDICAL PRODUCTS, INC. (NASDAQ:EYES) Files An 8-K Other EventsItem 8.01 Other Events
On July 17, 2017, Second Sight Medical Products, Inc. (the “Company”) submitted an application for an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) for approval to conduct an early feasibility study of its OrionTM Cortical Visual Prosthesis System in a clinical trial of up to five patients. It is typical for an IDE application to involve several rounds of question and answer interactions with the FDA. Timing of the review and FDA approval process is unpredictable and no assurance can be given as to when the Company will receive an IDE for the planned Orion feasibility study.
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.