Business Context and Reporting Period
This Form 8-K was filed by Second Sight Medical Products, Inc. (not Vivani Medical, Inc.) on December 8, 2017, reporting events occurring on December 5, 2017. The filing announces the company's market entry into Iran.
Key Financial Metrics
This filing is a Current Report regarding a specific corporate event and does not contain financial statements, revenue, profit, cash flow, margin, debt, or liquidity data.
Material Changes
- Market Expansion: The Company successfully implanted its Argus II Retinal Prosthesis System in two patients in Iran.
- Partnership: The procedure was facilitated by Arshia Gostar Darman Co. Ltd., the exclusive distribution partner for Iran.
- Procedure Details: Implants were performed in November 2017 in Shiraz, Iran, by Professor Mohsen Farvardin at Shiraz Pars Hospital and Khalili Hospital.
- Patient Profile: The recipients were a 44-year-old and a 33-year-old patient diagnosed with Retinitis Pigmentosa.
Guidance, Outlook, and Risks
The filing does not provide financial guidance, outlook, or specific risk factors beyond the operational context of the new market entry. The event is presented as a milestone in the commercialization of the Argus II system.
Investor Verification Checklist
- Verify the regulatory approval status of the Argus II system in Iran.
- Confirm the terms and scope of the distribution agreement with Arshia Gostar Darman Co. Ltd.
- Review the attached press release (Exhibit 99.1) for additional details on the implantation outcomes.
- Check subsequent filings for any financial impact or revenue recognition related to the Iranian market entry.