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Second Sight gains FDA nod for retinal system that may never be produced

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Second SightSecond Sight Medical  (NSDQ: EYES) today announced that the FDA has approved its Argus 2s retinal prosthesis system, but questions remain about whether it will ever be manufactured.

The past year has been tough for Second Sight. The company announced in March 2020 that it would wind down its operations amid the financial shock of the coronavirus pandemic. In April, the company said it took steps to reduce overhead and conserve liquidity ahead of potential partnering, acquiring, or combining with businesses, just days before pricing a $6.8 million offering of its common stock, which closed in May. An auction of its assets was set for June, and Second Sight in January 2021 announced plans to merge with Pixium Vision.

If the merger closes, Pixium — which makes neuromodulation tech to treat blindness — would become the controlling shareholder, owning 60% of the total equity before a capital raise. The combined company would focus on Pixium’s Prima retinal stimulation system and create a new subsidiary to focus on cortical stimulation through Second Sight’s Orion implant. The new combined company would own 40% of the new subsidiary and have the first option to exclusive global marketing rights for Orion, which was designed to provide useful artificial vision to individuals who are blind due to a range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury.

The new company’s management team would also have to decide whether to begin production of the newly approved Argus 2s, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). And it would also have to decide what to do with other Second Sight products in development.

For now, company officials expect that the Argus 2s will be adapted to be the external system for the next-generation Orion system currently under development. In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing, according to Los Angeles-based Second Sight.

“We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhances comfort and aesthetics compared with the legacy Argus II system,” said Matthew Pfeffer, acting CEO of Second Sight, in a news release.

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