Anyone listen to 3rd quarter conference call?
Earnings at this point are irrelevant IMHO
Recent Corporate Highlights:
• Reached agreement with the U.S. Food and Drug Administration (“FDA”) regarding the primary efficacy endpoint to be used in the Orion® Visual Cortical Prosthesis System (“Orion”) pivotal trial;
• Presented additional positive data from the Company’s Early Feasibility Study of Orion at three scientific conferences in October: the American Academy of Ophthalmology (AAO), the Congress of Neurological Surgeons (CNS), and the Society for Neuroscience (SfN);
• Met with Centers for Medicare and Medicaid Services (“CMS”) to discuss future reimbursement for artificial vision to include the critically important post-surgical training and rehabilitation; and
• Received a $2.4 million, four-year grant from the National Institutes of Health (NIH) to develop spatial localization and mapping technology (SLAM) in collaboration with the Johns Hopkins University Applied Physics Laboratory (APL).
“Our ongoing discussions with the FDA are proceeding well, and we are pleased to have reached agreement on the primary efficacy endpoint for the Orion pivotal trial. This endpoint is a new version of the FLORA assessment tool used in the Argus II trial and is designed to measure the technology’s impact to orientation, mobility and activities of daily living. Our efforts are currently focused on finalizing agreement with the FDA on the primary safety endpoint by year end. We are also engaged in productive dialogue with CMS about reimbursement for the critically important post-surgical training for Orion users, in an effort to ensure that patients are able to achieve the greatest benefit from the device,” stated Will McGuire, President and Chief Executive Officer of Second Sight.
“Orion has received excellent coverage in the media recently, as awareness and excitement builds for this innovative, life-changing device. R&D efforts continue to focus on enhancements to Orion that are required for a pivotal trial and ultimately for commercialization. Most importantly, the Orion subjects in our feasibility study are doing well, and we look forward to advancing this important technology and making it available to the large population of blind individuals who can benefit,” concluded McGuire
