Business Context and Reporting Period
This Form 8-K was filed by Second Sight Medical Products, Inc. on November 6, 2017, reporting events occurring on November 2, 2017. The filing addresses the receipt of full U.S. Food and Drug Administration (FDA) approval to commence the feasibility clinical study for the Orion Cortical Visual Prosthesis System.
Key Financial Metrics
This filing is a Current Report on Form 8-K regarding a regulatory milestone and does not contain financial statements. Consequently, data regarding revenue, profit, cash flow, margins, debt, and liquidity are not provided in this document.
Material Changes
The material change reported is the transition from conditional FDA approval (granted August 28, 2017) to full FDA approval for the Orion clinical study. The Company successfully completed the additional tests and answered the additional questions required by the FDA following the conditional approval.
Outlook, Management Commentary, and Risks
- Clinical Study Scope: The approval permits enrollment of up to five total patients across two designated U.S. sites: the University of California at Los Angeles (UCLA) and Baylor College of Medicine in Houston.
- Technology Overview: The Orion system converts images from a miniature camera into electrical pulses transmitted to electrodes implanted on the visual cortex, bypassing the retina and optic nerve to potentially restore vision in patients blinded by conditions such as glaucoma or diabetic retinopathy.
- Prior Validation: The Company previously conducted a proof-of-concept trial in Q3 2016 at UCLA using a commercially available device from a different manufacturer.
Investor Verification Checklist
- Verify the full text of the press release attached as Exhibit 99.1 for specific study protocols.
- Confirm the enrollment status and timeline for the five-patient limit at UCLA and Baylor College of Medicine.
- Review subsequent filings for financial impact related to the clinical trial costs and potential future revenue timelines.
- Note that the registrant name in the filing header is Second Sight Medical Products, Inc., despite the request metadata referencing Vivani Medical, Inc.