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Friday, Jan 24, 2025

Second Sight Gets FDA’s Green Light

After U.S. Food and Drug Administration approval of its Argus IIs Retinal Prosthesis System on March 5, Second Sight Medical Products Inc. enjoyed an explosive stock surge, with shares gaining by 1000 percent in the next three days.As of Wednesday, March 10, shares of Second Sight (EYES) were trading at $11.63 on the Nasdaq.It’s quite a turn of fortune for the Sylmar company, which had announced a wind down process and layoffs a little less than a year ago. Second Sight noted an “inability to secure additional financing” at the time, along with the economic shock caused by the pandemic.The 23-year-old company has been developing implantable visual prosthetics since its inception, as one of many companies founded by late serial entrepreneur Alfred Mann.“The company was in a pretty unfortunate circumstance in March, when we lost our primary funding source due to COVID-19 at the worst possible time, which left the company insolvent,” acting Second Sight Chief Executive Matthew Pfeffer said in a Business Journal report in June. “It left us no choice but to take some immediate, very strong actions to reserve the remaining funds for creditors and others.”Since then, Second Sight announced a public offering of 7.5 million shares in May, with proceeds intended for a partnership, business combination, acquisition or investment. And the company agreed to a business combination with French biotech Pixium Vision SA last month.The move combines two biotech companies with similar IP; they have been in opposition with each other in the past over patient disputes, according to a March 1 Business Journal report.A manufacturing plan for the Argus IIs is on hold until the deal with Pixium is completed, Second Sight said.Second Sight’s Argus II system uses an implant and a camera mounted on a pair of sunglasses to stimulate the optic nerve, giving patients limited vision. The company had originally developed the IIs system for use in combination with previously implanted Argus II systems in blind patients. Participants implanted with the system had been diagnosed with retinitis pigmentosa, a genetic disorder..Moving forward, Second Sight expects to use the hardware with its next generation Orion Visual Cortical Prosthesis System, currently under development.“We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system,” Pfeffer said in a statement.

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