Study Investigators from
The study’s principal investigators,
The first human subject was implanted with Orion in
The primary outcome measure of the Orion Early Feasibility Study is safety. Secondary outcome measures include the ability to produce phosphenes, assess the long-term functionality of the device and evaluate the benefit to patients in terms of visual function, functional vision and quality of life.
“We are pleased with the continued favorable progress being made in the Orion Early Feasibility Study among the six study participants. The first four subjects have now reached 12 months post-implant, and participants appear to be making steady improvements in their ability to perform everyday tasks and successfully meet the study’s functional vision endpoint goals. It is also encouraging to see that when compared with similar Argus II feasibility study results at the 12-month mark, the Orion study participants are doing as well as or better than Argus II participants in most measurements, such as the Functional Low-Vision Observer Rated Assessment (FLORA).We look forward to continued collaboration with our study investigators and to advancing our Orion technology platform,” said
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
- 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
About Second Sight
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
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the “safe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements.” These statements may be identified by words such as “estimates,” “anticipates,” “appears,” “projects,” “plans,” “goal,” “planned,” “seeks,” “may,” “will,” “expects,” “intends,” “believes,” “should,” and similar expressions, or the negative versions thereof, and which also may be identified by their context. All statements that address operating performance or events or developments that Second Sight expects or anticipates will occur in the future, such as stated objectives or goals, or that are not otherwise historical facts, are forward-looking statements. While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements as a result of various factors, including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report, on Form 10-K, filed on
In-Site Communications, Inc.
Lisa Wilson, President
MZ North America
Greg Falesnik, Managing Director