Business
Second Sight Reports Fourth Quarter and Full Year 2019 Financial Results
-- Received CE Mark Certification and U.S. Food and Drug Administration conditional approval for Argus 2s, next-generation wearables -- LOS
About this update from Vivani Medical, Inc.
[{"type":"text","content":"\n-- Received CE Mark Certification and U.S. Food and Drug Administration conditional approval for Argus 2s, next-generation wearables --\n\n LOS ANGELES--(BUSINESS WIRE)--\nSecond 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 for blind individuals, today reported financial results for the three months and full year ended December 31, 2019.\n\n\nRecent Financial and Corporate Highlights:\n\n\n\nReceived CE Mark Certification and U.S. Food and Drug Administration (“FDA”) conditional approval for Argus 2s, the Company’s next-generation wearables. Enhancements include a more powerful video processing unit, an improved camera and more ergonomic glasses;\n\n\nCompleted the 12-month testing for the sixth subject in the Orion® Visual Cortical Prosthesis System (“Orion”) Early Feasibility Study, with continued positive overall safety and efficacy results across key measures;\n\n\nCommenced validation of a new version of the Functional Low Vision Observer Rated Assessment (“FLORA 20”), which will serve as the primary efficacy endpoint for the Orion pivotal trial. This process has been suspended due to the implementation of COVID-19 social distancing protocols;\n\n\nHeld in-person discussions with Centers for Medicare and Medicaid Services (“CMS”) regarding reimbursement pathways available for Orion; and\n\n\nEffected a 1:8 reverse split of the Company’s common stock.\n\n\n\n“We are pleased that our development work on the Argus 2s has been completed, and that we received both FDA conditional approval and CE Mark Certification for these new wearables. The improved technology will serve as an important base for the next generation Orion system that will be used in the U.S. pivotal study. Our discussions with FDA around the primary safety endpoint for the pivotal trial are ongoing, as we work together to determine the appropriate parameters for a first-in-class technology like Orion,” stated Pat Ryan, Chief Operating Officer of Second Sight.\n\n\n“Now that the last subject enrolled in our Early Feasibility Study has reached the 12-month mark, we are pleased to report that overall safety and efficacy metrics remain positive and support moving forward with a pivotal study. It...