Highlights from Today's 2nd qtr PR
As of June 30, 2019, Second Sight had $25.2 million in cash and cash equivalents. The Company continues to expect its cash to fund operations into the second quarter of 2020.
Recent Financial and Corporate Highlights:
• Continued progress on development of the Orion® Visual Cortical Prosthesis System (“Orion”); ?Met with the U.S. Food and Drug Administration (“FDA”) in July to provide an update on the Orion Early Feasibility Study, and to discuss pivotal study design and post-market requirements;
? Hired 15 full-time employees year-to-date to support R&D and clinical research priorities;
• Reduced commercial expenses by 41% in the second quarter of 2019 compared to the prior year quarter;
• Notified Argus implanting centers of the Company’s intent to suspend Argus II production by the end of 2019;
• Presented positive topline 12-month results on the Company’s Early Feasibility Study of the Orion Visual Cortical Prosthesis System at the World Society for Stereotactic and Functional Neurosurgery Annual Meeting on June 25, 2019;
•Centers for Medicare and Medicaid Services (“CMS”) released its FY 2020 Inpatient Prospective Payment System (IPPS) Final Rule. In this rule, CMS finalized its proposal to create an alternative payment pathway for innovative technologies with an FDA Breakthrough Devices Designation such as Orion;
• Implanted 11 Argus II systems worldwide; and
• Reported net sales of $1.3 million in the second quarter of 2019.
“We continue to make excellent progress with the development of the Orion platform and are working closely with the FDA to define pivotal study and post-market requirements. We commend CMS for creating a streamlined reimbursement pathway for innovative devices such as Orion with an FDA Breakthrough Devices Designation. In preparation for Orion’s potential commercial launch, we are beginning to engage CMS and private payors in order to define the appropriate reimbursement pathways,” stated Will McGuire, President and Chief Executive Officer of Second Sight.
“Second Sight continues to pioneer the development of neuromodulation technology for artificial vision. The interim data from our Orion Visual Cortical Prosthesis Early Feasibility Study compare favorably to Argus and further support our belief in Orion’s potential to treat nearly all forms of blindness,” concluded McGuire.
Second Half 2019 Key Objectives
• Execute Orion R&D implant and externals projects;
• Finalize agreement with the FDA regarding Orion’s clinical and regulatory path;
• Engage and expand discussions with CMS and private payors while developing a comprehensive reimbursement strategy for Orion in the U.S.;
• Submit Argus 2s, our next-gen externals, to the FDA for U.S. regulatory approval; and
• Add key talent to support our Orion programs and develop a plan for high-volume manufacturing.
About Second Sight
Second Sight Medical Products, Inc. (NASDAQ: EYES) develops, manufactures and markets implantable visual prosthetics that are intended to deliver useful artificial vision to blind individuals. A recognized global leader in neuromodulation devices for blindness, the Company is committed to developing new technologies to treat the broadest population of sight-impaired individuals. The Company’s U.S. headquarters are in Los Angeles, California, and European headquarters are in Lausanne, Switzerland. More information is available at www.secondsight.com.
About the Orion Visual Cortical Prosthesis System
Leveraging Second Sight’s 20 years of experience in neuromodulation for vision, the Orion® Visual Cortical Prosthesis System (Orion) is an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. A six-subject early feasibility study of the Orion is currently underway at the Ronald Reagan UCLA Medical Center in Los Angeles and the Baylor College of Medicine in Houston. No peer-reviewed data is available yet for the Orion system. The Company anticipates enrolling additional feasibility subjects in 2019 while simultaneously negotiating the clinical and regulatory pathway to commercialization with the FDA as part of the Breakthrough Devices Program.
