Second Sight eyes $25M funding round | Wall Street Beat

January 29, 2013 by MassDevice staff

Second Sight Medical registers for a $25 million funding round as it awaits the FDA's decision on its Argus II "bionic eye" retinal implant. Wall Street Beat

Second Sight Medical registered with the SEC for a $25 million offering of equity, debt, options and warrants as it waits for the FDA to decide whether to give the green light to its "bionic eye" retinal implant.

The Sylmar, Calif.-based medical device company filed with the securities watchdog agency yesterday, saying it has yet to sell any of the $1,000 shares in the offering.

Second Sight won a nod from an FDA advisory committee last September. The agency's Ophthalmic Devices Panel  recommended approval for the Argus II, with caveats. The device, implanted in the eye in front of the retina, uses the video signal from an eyeglass-mounted camera to send input to the retina.

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The panel said the Argus II, which has been on the market in Europe since March 2011, should be closely tracked once it's on the U.S. market, should the FDA decide to grant a humanitarian device exemption.

A majority of panelists agreed that Argus II demonstrated a reasonable assurance of safety even though different versions of 2 device configurations were implanted in 30 subjects in the clinical trial; no subjects were implanted with the version of the device proposed for marketing because modifications were made to the implant's application-specific circuit chip, suture tab and carrier frequency; the testing was non-randomized; evaluators were unmasked; numerous modifications were made to the study protocol during the course of study; and there were a number of protocol deviations.