EYES Second Sight Medical Products Inc

ITEM 8.01 Other Events

On November 17, 2016, the Agency for Healthcare Research and Quality (AHRQ), which is an agency of the Department of Health and Human Services, published a technology assessment entitled “Retinal Prosthesis in the Medicare Population.” The technology assessment provides an overview of multiple types of retinal prosthetic devices including the Argus II, and examined the available clinical evidence for each. The technology assessment concluded that some patients clearly benefit from retinal prostheses and future studies of retinal prosthesis should make an effort to report valid and reliable measures of day-to-day function and quality of life.  Further, the assessment concluded that for these patients, no other intervention exists to address their vision problems, so even small gains may be considered important for clinical and policy decision making. No assurance can be given as to what impact, if any, this report may have on Second Sight Medical Products, Inc. The report, which is dated September 30, 2016, can be accessed at the following web site: (https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id103TA.pdf). The foregoing summary is qualified in its entirety by reference to that report. To date our Argus II Retinal Prosthesis System remains the only FDA approved and commercially available Retinal Prosthesis for the treatment of retinitis pigmentosa.