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Investors Seeing Green as FDA Approves Second Sight Medical's Argus 2s Retinal Prosthesis System

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Second Sight Medical Products shares trade more than 400% higher after the company reported that the FDA granted approval for its Argus 2s Retinal Prosthesis System designed to deliver useful artificial vision to blind individuals diagnosed with retinitis pigmentosa.

Developer of implantable visual prosthetics Second Sight Medical Products Inc. (EYES:NASDAQ), which is striving to create an artificial form of useful vision for blind individuals, today announced that "the U.S. Food and Drug Administration (FDA) has approved the Argus 2s Retinal Prosthesis System, 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)."

The firm indicated that it anticipates that the Argus 2s system will be incorporated into the external system for the next generation Orion Visual Cortical Prosthesis System, which the company stated is presently undergoing development.

Second Sight Medical Products pointed out that the Argus 2s system now comes with significantly greater processing power that offers the potential for enhanced video processing capabilities. The firm noted that the system has also been designed to provide additional ergonomic improvements.

Matthew Pfeffer, acting CEO of Second Sight Medical, commented, "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."

The company advised that it plans to continue working together with Pixium Vision on production of the newly FDA approved hardware. The two firms are currently in discussions as to how best to structure the joint production efforts and to establish a timeline for when production will commence. Second Sight indicated that if the business management combination details are worked out then the firms will proceed with evaluating the best path forward with the Argus 2s Retinal Prosthesis System and other products in development.

Second Sight Medical Products is a developer and marketer of implantable visual prosthetics based in Los Angeles, Calif. The company's products are designed to deliver functional artificial vision to blind people. The firm specializes in the area of creating neuromodulation devices and developing new neurostimulation technologies to treat the broadest population of sight-impaired individuals. The firm is focused initially on individuals who have lost vision due to retinitis pigmentosa (RP), but there are also potential applications for other eye diseases and injuries including glaucoma, diabetic retinopathy, optic nerve injury or disease, cancer and trauma.

The company noted that its Argus II system is the first artificial retina to have received widespread commercial approval. The firm explained that "the Argus II Retinal Prosthesis System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound RP and works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina."

Second Sight indicated that "the Orion Visual Cortical Prosthesis System is an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury." Orion works by converting video captured images into a series of small electrical pulses. The wearable device is a miniature camera embedded into eyeglasses that bypasses the injured or diseased eye and wirelessly transmits electrical impulses to electrodes implanted on the brain's visual cortex surface where patterns of light are detected and perceived.

The firm stated that an early feasibility study of Orion is now being conducted in six individual subjects at the Ronald Reagan UCLA Medical Center and the Baylor College of Medicine.

Second Sight Medical Products started off the day with a relatively small market capitalization of around $33.2 million with approximately 23.21 million shares outstanding and a short interest of about 1.3%. EYES shares opened 60% higher today at $2.29 (+$0.86, +60.14%) over yesterday's $1.43 closing price and then soared to a new 52-week high price this morning of $9.89 on greater than 400 times average 200-day trading volume. The stock has traded today between $2.07 to $9.89 per share and is currently trading at $7.44 (+$6.01, +420.28%).


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