Second Sight Medical, an ocular product manufacturer based in Sylmar, California, announced that it had registered with the United States Securities and Exchange Commission (SEC) for a $25 million funding round. In the round, Second Sight Medical will offer investors options, equity, warrants and debt. The company also stated that it is awaiting approval with the United States Food and Drug Administration (FDA) for its new retinal implant system.
According to a press release by the company, Second Sight Medical has not yet sold any of its $1000 shares available in the offering. However, the company has received positive regulatory news in the past few months.
In September of 2012, the FDA’s Ophthalmic Devices Panel recommended regulatory approval for the company’s Argus II. The Argus II is a “bionic eye” that uses a video signal from an eyeglass-mounted camera to send information directly to the retina. The Argus II has been available in the European Union since March of 2011.
The FDA approval of the Argus II comes with some caveats. The FDA device panel recommended that the Argus II be closely tracked once it enters the United States market. However, this is contingent on the device winning a humanitarian device exemption with the FDA.
Panelists felt that the Argus II showed reasonable potential for patient safety. Since some technical changes were made to the device after a positive clinical trial, regulators at the FDA are worried that new changes could impact device efficacy and safety.