We are developing electrical neurostimulation systems to provide artificial vision – perceptions of light and shapes. The U.S. Food and Drug Administration (FDA) approved Argus II, our first commercial system, in March 2013 under a Humanitarian Device Exemption. We have completed an early feasibility trial of Orion, a more advanced system for artificial vision. (Incorporated in Delaware) 

Cortigent, through its predecessor Second Sight Medical Products, Inc., is a pioneer in developing targeted neurostimulation systems to help patients recover critical body functions. Our technology combines advanced neuroscience with proprietary microelectronics, software, and data processing capabilities to provide artificial vision and potentially restore muscle movement. Our first commercial system, “Argus II,” was approved by the U.S. Food & Drug Administration (“FDA”) under a Humanitarian Device Exemption (“HDE”) and has provided artificial vision to hundreds of profoundly blind people who were implanted with this device. Building on this neurostimulation platform we have substantially completed an early feasibility clinical trial to evaluate a more advanced system for artificial vision that we call “Orion.” We are further exploring the application of our Orion^® neurostimulation technology for accelerating the recovery of arm and hand function in patients who are partially paralyzed due to stroke. In February 2023, we held a meeting with the FDA to commence discussions of an early feasibility clinical study in stroke victims. We believe that additional future applications of our platform technology may have the potential to generate substantial business growth over time.

Both the Argus II and Orion devices create artificial vision by using electrical stimulation. Artificial vision does not restore normal stereoscopic vision or vision with color but rather perceptions of light and shapes requiring people with the implants (referred to as implantees) to interpret their environment through specialized training. This artificial vision can aid in supporting basic tasks such as finding a doorway, detecting another person’s presence, following a cross walk or locating an object. For the Argus II device, the stimulation is delivered to the surviving cells of the retina which convey the activity to the brain via the optic nerve. For the Orion device, the electrical stimulation is delivered directly to the visual cortex, the region of the brain responsible for vision. The pattern of electrical stimulation corresponds to the images captured by a small video camera mounted in the center of the glasses that the patient wears and is connected to the video processing unit (“VPU”). The VPU is a battery-powered device worn by the user, typically on a belt or a strap, that sends power and stimulation commands to the implant and receives diagnostic information from the implant via the external antenna of the glasses.

Argus II users undergo surgery to implant an electrode array inside the eye on the surface of the retina and affix a small electronics case (like a metal button) and an antenna to the outer surface of the eye. A small cable traverses the eye wall, connecting the electronics case to the array. Orion users undergo cranial surgery to implant an electrode array placed on the surface of the brain on the visual cortex and have a small electronics case and an antenna implanted on the outside of the skull, but completely covered by the scalp. A small cable passes through the skull to connect the array to the electronics case. No part of the device penetrates or cuts into the brain tissue itself.

The quality of the artificial vision created by both the Argus II and Orion systems varies from patient to patient. The perception typically appears as a collection of up to 60 small points lights that correspond to the brightness of the different regions of the visual image detected by a camera. With scanning and repetition, the users can use their perception of the lights to construct a better understanding of their environment.

 **Note: Cortigent has no revenue. Its net loss was $6.58 million is for the 12-month period that ended June 30, 2023.

(Cortigent, Inc. filed an S-1/A dated June 7, 2023, in which it disclosed its IPO terms: 1.5 million shares at $10.00 each to raise $15.0 million. The company also said a 1-for-4 reverse stock split went into effect on June 5, 2023. In that June 7, 2023, filing with the SEC, Cortigent also updated its financial statements through March 31, 2023. Background: Cortigent filed its S-1 on March 20, 2023, without disclosing terms for its IPO. Cortigent submitted its confidential IPO documents to the SEC on Jan. 13, 2023.)