Researchers Present Latest Positive Results of Second Sight’s Orion Visual Cortical Prosthesis Feasibility Study - Seite 2

Study Results

Safety outcomes as of the last independent medical safety monitor review:

• Only two out of six study participants have experienced an adverse device event (ADE), which, as of May 3, 2019, included one serious adverse event (seizure), five non-serious adverse events such as headache, and no unanticipated adverse device events.

Ability to see phosphenes demonstrated for all patients:

• The perception threshold measurements, which is the energy required to produce a spot of light, for all participants have remained generally consistent over time.

Preliminary performance assessment of ability to locate objects and detect motion at 12 months post-implant (four subjects measured as of June 25, 2019):

• Three out of four Orion subjects at 12 months demonstrated the ability to locate a high-contrast target significantly better with the System ON than with the System OFF (t-test, p<0.05) as measured by Square Localization.
• Three out of four Orion subjects at 12 months demonstrated the ability to determine the direction of motion of a high-contrast target significantly better with the System ON than with the System OFF (t-test, p<0.05).

Overview of real-world use of Orion:

• Four out of four Orion subjects at 12 months were rated by certified Orientation and Mobility specialists as having received positive or mild positive benefit from Orion in terms of functional vision and well-being on the FLORA.

The presentation is available on Form 8-K as filed with the U.S. Securities and Exchange Commission.

About Second Sight

Second Sight Medical Products, Inc. (NASDAQ: EYES) develops, manufactures and markets implantable visual prosthetics that are intended to deliver useful artificial vision to blind individuals. A recognized global leader in neuromodulation devices for blindness, the Company is committed to developing new technologies to treat the broadest population of sight-impaired individuals. The Company’s U.S. headquarters are in Los Angeles, California, and European headquarters are in Lausanne, Switzerland. More information is available at www.secondsight.com.

About the Orion Visual Cortical Prosthesis System

Leveraging Second Sight’s 20 years of experience in neuromodulation for vision, the Orion Visual Cortical Prosthesis System (Orion) 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 is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. A six-subject early feasibility study of the Orion is currently underway at the Ronald Reagan UCLA Medical Center in Los Angeles and the Baylor College of Medicine in Houston. No peer-reviewed data is available yet for the Orion system. The Company anticipates enrolling additional feasibility subjects in 2019 while simultaneously negotiating the clinical and regulatory pathway to commercialization with the FDA as part of the Breakthrough Devices Program.