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.
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.
Bausch & Lomb looks to possible IPO
Bausch & Lomb is exploring the idea of becoming a public concern again after 4 years under private equity ownership, according to the Wall Street Journal. The optical and ophthalmic device maker hasn’t been able to generate enough interest in a $10 billion buyout, the newspaper reported, citing "people familiar with the matter."
Europe’s healthcare VC investment hits new low
Venture capital investment in healthcare companies hit an all-time low during the 4th quarter last year, with backers putting
€983 million (about $1.33 billion) into 186 deals, for declines of 29% and 30%, respectively, compared with the same period last year.
Baxter backs Zytoprotec’s dialysis tech
The venture investing arm of Baxter (NYSE:BAX) put € (about $2.7 million) into Zytoprotec and its novel peritoneal dialysis device that uses active cytoprotection, part of a €4 million ($5.4 million) Series A round.
GE Capital shepherds $9M credit line for Tyrx
GE (NYSE:GE) Capital’s Healthcare Financial Services said it served as agent for an $8.5 million senior secured credit facility for medical device company Tyrx, including a $7 million term loan and a $1.5 million revolver.