Second Sight Medical Products has successfully implanted and activated a wireless visual cortical stimulator in a human subject during an ongoing University of California, Los Angeles (UCLA) study.
The study provided the initial human proof of concept for the development of the company’s Orion I Visual Cortical Prosthesis (Orion I).
The study is intended to demonstrate the initial safety and feasibility of Orion I as the human visual cortex stimulation.
During the study, a 30-year-old patient was implanted with a wireless multichannel neurostimulation system on the visual cortex and was able to perceive and localise individual phosphenes or spots of light, recording no adverse side effects.
Second Sight chairman of the board Dr Robert Greenberg said: "It is rare that technological development offers such stirring possibilities.
“This first human test confirms that we are on the right track with our Orion I programme to treat blind patients who cannot benefit from the Argus II Retinal Prosthesis (Argus II).
“This initial success in a patient is an exciting and important milestone even though it does not yet include a camera.
“By bypassing the optic nerve and directly stimulating the visual cortex, the Orion I has the potential to restore useful vision to patients completely blinded due to virtually any reason, including glaucoma, cancer, diabetic retinopathy, or trauma.”
The initial success of this study, along with the significant additional pre-clinical work prepares Second Sight to submit an application to the FDA in early 2017 to gain approval for conducting an initial clinical trial of the complete Orion I system, including the camera and glasses.
Following positive initial results in patients and discussions with regulators, an expanded pivotal clinical trial for global market approvals is subsequently planned.