eyes-8k_20190411.htm

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported):  April 11, 2019

SECOND SIGHT MEDICAL PRODUCTS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

California

(State or Other Jurisdiction of Incorporation)

 

 

001-36747

 

 

02-0692322

 

(Commission File Number)

(IRS Employer Identification No.)

 

 

 

 

12744 San Fernando Road, Suite 400
Sylmar, California 91342

 

(Address of Principal Executive Offices)

 

(818) 833-5000

(Registrant's Telephone Number, Including Area Code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

-1-

 

 

 

 

 

 


 

ITEM 8.01 Other Events

 

On April 11, 2019, Second Sight Medical Products, Inc. (the “Company”) issued a press release announcing that Dr. Jessy D. Dorn, Ph.D., Sr. Director of Scientific Research, will present an update on the Early Feasibility Study of the Orion® Visual Cortical Prosthesis System at the Fifth Annual BRAIN Initiative® Investigators Meeting to be held at the Marriott Wardman Park Hotel in Washington, D.C. on April 11, 2019.

A copy of the Company’s press release entitled “Second Sight Medical Products, Inc. Presents Positive Interim Results at the Fifth Annual BRAIN Initiative Investigators Meeting” is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

 

ITEM 7.01REGULATION FD DISCLOSURE

 

Second Sight Medical Products, Inc. (the “Company”) intends to present a poster entitled “Early Feasibility Study of a Visual Cortical Prosthesis for the Blind: The Orion Visual Prosthesis System” (the “Poster”) at the Fifth Annual BRAIN Initiative® Investigators Meeting being held at the Marriott Wardman Park Hotel in Washington, D.C. on April 11, 2019, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.2 and incorporated herein by reference.  

 

A copy of a slide presentation that the Company intends to use in a presentation by Dr. Jessy D. Dorn, Ph.D., Sr. Director of Scientific Research, also to be made at the Fifth Annual BRAIN Initiative® Investigators Meeting (the "Presentation Materials"), is attached to this Current Report on Form 8-K as Exhibit 99.3, and is incorporated herein by reference.  

 

The Poster and the Presentation Materials provide an update on the Early Feasibility Study of the Orion® Visual Cortical Prosthesis System.  The Poster and the Presentation Materials contain information as of the date of this Current Report on Form 8-K, or otherwise noted in the materials.  While Second Sight may elect to update the Poster or the Presentation Materials in the future or reflect events and circumstances occurring or existing after the date of this Current Report on Form 8-K, Second Sight specifically disclaims any obligation to do so. 

 

The information contained in this Item 7.01, Exhibit 99.2, and Exhibit 99.3 hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by reference in such a filing.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release entitled “Second Sight Medical Products, Inc. Presents Positive Interim Results at the Fifth Annual BRAIN Initiative Investigators Meeting” issued April 11, 2019.

99.2

 

Poster entitled Early Feasibility Study of a Visual Cortical Prosthesis for the Blind: The Orion Visual Prosthesis System

99.3

 

Second Sight Medical Products, Inc. Presentation: An update on the Early Feasibility Study of the Orion® Visual Cortical Prosthesis System, dated April 11, 2019.

 

 

 

 

 

 

 

-2-

 

 

 

 

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.  

Date: April 11, 2019

SECOND SIGHT MEDICAL PRODUCTS, INC.

 

___/s/ John T. Blake___________________

By: John T. Blake

Chief Financial Officer

 

-3-

 

 

 

 

 

 

eyes-ex991_82.htm

Exhibit 99.1

FOR IMMEDIATE RELEASE

 

Second Sight Medical Products, Inc. Presents Positive Interim Results at the

Fifth Annual BRAIN Initiative® Investigators Meeting

 

-- Presentation to Provide Update of Early Feasibility Study of the Orion® Visual Prosthesis System --

 

Los Angeles, CA — April 11, 2019 — Second Sight Medical Products, Inc. (NASDAQ: EYES) (“Second Sight” or the “Company”), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals, today announced that the Company will present an update on its Early Feasibility Study of the Orion® Visual Cortical Prosthesis System (“Orion”) at the Fifth Annual BRAIN Initiative® Investigators Meeting being held at the Marriott Wardman Park Hotel in Washington, D.C. on April 11, 2019.

 

The BRAIN Initiative Investigators Meeting convenes BRAIN Initiative awardees, staff, and leadership from the contributing federal agencies (NIH, NSF, DARPA, IARPA, and FDA), plus representatives and investigators from participating non-federal organizations.

 

Dr. Jessy D. Dorn, Ph.D., Sr. Director of Scientific Research, today will discuss interim findings from the ongoing feasibility study of Orion, a breakthrough technology 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 converts images captured by a miniature video camera mounted on glasses into a series of small electrical pulses transmitted wirelessly to electrodes implanted directly on the visual cortex of the individual subject’s brain.  

 

The first human subject was implanted with Orion in January of 2018. A total of six subjects have been implanted in the Orion Early Feasibility Study, including two subjects at the Baylor College of Medicine in Houston, Texas, and four subjects at the Ronald Reagan UCLA Medical Center (UCLA).

 

Highlights of the presentation will include (the presentation is available on the Company’s website under “Investors”/“Events and Presentations” and on Form 8-K as filed with the U.S Securities and Exchange Commission):

 

 

Study design and subject overview

 

o

One female and five male subjects, ranging in age from 29 to 57

 

Preliminary performance assessment of ability to locate objects and detect motion

 

o

Ability to locate a high-contrast target with the System ON was significantly better (t-test, p<0.05) than with the System OFF for three of five subjects at 6 months as measured by Square Localization

 

o

Ability to determine the direction of motion of a high-contrast target with the System ON was significantly better (t-test, p<0.05) than with the System OFF for two of five subjects at six months (four out of five in subsequent measurements) as determined  by Direction of Motion

 

Overview of real-world use of Orion

 

o

Five out of five subjects 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

 


Exhibit 99.1

 

o

Observations from rehabilitation sessions include that subjects are able to use Orion to visually detect parked cars, identify the direction of motion of a person walking by, and visually order small objects by size

 

Adverse events

 

o

One serious adverse event (seizure), four non-serious adverse events, no unanticipated adverse device effects through the last adjudication date of February 8, 2019

 

“We are delighted to share preliminary Orion feasibility study findings with this esteemed group of investigators. This conference provides a forum for discussing exciting advancements and to continue to engage with other scientists who are conducting cutting-edge research in the field,” said Will McGuire, President and Chief Executive Officer of Second Sight.

 

“We are encouraged by the progress Orion subjects are making on visual function endpoints like square localization and direction of motion. With the help of our highly-trained low-vision specialists, our subjects are using Orion at home to perform everyday visual tasks that they cannot do without the system. We look forward to completing the analysis of 12-month data from the Orion Early Feasibility Study and to future refinements that enhance Orion’s ability to provide useful artificial vision to blind individuals,” McGuire continued.

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.

Safe Harbor

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,” “projects,” “plans,” “goal,” or “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 March 19, 2019, and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in events, conditions, or circumstances on which any such statement is based.

Investor Relations Contacts:

Institutional Investors

In-Site Communications, Inc.
Lisa Wilson, President
T: 212-452-2793
E: lwilson@insitecony.com
or

Individual Investors
MZ North America
Greg Falesnik, Managing Director
T: 949-385-6449
E: greg.falesnik@mzgroup.us

 

Media Contacts:
Nobles Global Communications
Laura Nobles or Helen Shik
T: 617-510-4373
E:
Laura@noblesgc.com
E:
Helen@noblesgc.com

 

eyes-ex992_86.pptx.htm

Slide 1

Early Feasibility Study of a Visual Cortical Prosthesis for the Blind: The Orion Visual Prosthesis System Jessy D. Dorn, Ph.D. 1, Nader Pouratian, M.D., Ph.D.2, Robert J. Greenberg, M.D., Ph.D.3 INTRODUCTION METHODS Six-subject clinical trial: first-in-human use of Orion I System Objectives are to: evaluate the safety, functionality, and benefit of the System; research the quality and extent of visual perception and iterate device design if warranted Two centers: UCLA and Baylor College of Medicine Subjects are completely bilaterally blind due to any cause other than damage to the visual cortex May include trauma to eyes or optic nerve, diabetic retinopathy, glaucoma, or other etiology Medial View Top View Lateral View Video Processing Unit Glasses & Antenna SAFETY There have been 5 adverse device or procedure-related events (ADEs) 1 serious adverse device or procedure-related event (SADE) 4 non-serious adverse device or procedure-related events (ADEs) Four subjects have not experienced any device- or procedure-related AEs RESULTS FIRST THRESHOLD MEASUREMENT -Thresholds: amount of current required for subject to see phosphene 50% of the time -Thresholds have been stable over time Data are reported as of Feb 2019 The Orion System is a visual cortical prosthesis intended to restore some artificial vision to subjects who are completely blind due to any non-cortical etiology. The implant leverages the commercialized Argus II Retinal Prosthesis System technology, including: -Fully hermetic metal/ceramic package -High density hermetic feed-through scalable to 500+ channels -Long-lasting electrode array and integrated cable -Interconnect technology scalable to 500+ channels -Robust electrode-tissue interface due to fractal electrode surface Site Subject Implant Date Age at time of implant Gender Reason for Vision Loss Implant Duration as of 4/1/19 (months) UCLA S1 01/30/2018 56 Male Optic neuropathy secondary to severe burn/trauma 14 UCLA S2 03/29/2018 29 Male Eye trauma 12 UCLA S3 04/26/2018 56 Female Endophthalmitis 11 Baylor S4 04/27/2018 34 Male Pediatric glaucoma 11 UCLA S5 05/31/2018 52 Male Congenital glaucoma 10 Baylor S6 01/17/2019 57 Male Eye/optic nerve trauma 2.4 Mean ± Std Dev 47.3 ± 12.5 Ratio F:M 1 : 5 Mean ± Std Dev 10.7 ± 4.0 Patient ID Implant Duration as of 4/1/19 (months) # Serious Adverse Events # Non-serious AEs S1 14 0 1 S2 12 1 (seizure) 3 S3 11 0 0 S4 11 0 0 S5 10 0 0 S6 2.4 0 0 Subject Average Threshold (µA) Standard Deviation (µA) No. of Thresholds S1 2893 1322 56/60 S2 1645 828 60/60 S3 2194 789 59/59 S4* 3765 1603 54/58 S5 2693 1248 59/59 S6 3730 1170 55/59 Subject S2 at 6 months * Mean error significantly different ON vs. OFF, t-test, p<0.05 SQUARE LOCALIZATION -ON mean error was significantly lower than OFF for 3 subjects at 6 months. -Subject S1’s performance was better ON than OFF at 12 months. DIRECTION OF MOTION -ON mean error was significantly lower than OFF for 2 subjects at 6 months. -Subjects S1 and S5 had better ON than OFF performance at other time points * Mean error significantly different ON vs. OFF, t-test, p<0.05 GRATING VISUAL ACUITY -Grating Visual Acuity is measured between 2.9 – 1.6 logMAR. -Gratings are presented for only 5 seconds -No subjects (0 of 5) have scored on the scale with the System ON or OFF as of March 2019 -Training on this task has improved performance considerably FLORA Trained observers rate the impact of the Orion implant on patients’ well-being and functional vision periodically at specific time points (e.g. M6, M12, M24) Interview Observer-rated functional vision tasks (System ON and OFF) Final rating of benefit of Orion System on subject’s life Positive Mild Positive Neutral Mild Negative Negative 40% (2/5) 60% (3/5) 0 0 0 Real-time video is captured by a glasses-mounted camera. The image is downsampled and processed by a body-worn video processing unit and translated into stimulation patterns according to the brightness in the scene. A 60-channel subdural electrode array creates phosphenes by stimulating neurons in the primary visual cortex. Funding: NIH BRAIN Initiative grant UH3NS103442 1 Second Sight Medical Products, Inc. (Employee and financial interest in SSMP) 2 UCLA (Consultant to SSMP) 3 Alfred E. Mann Foundation (Consultant to and financial interest in SSMP) Exhibit 99.2

eyes-ex993_85.pptx.htm

Slide 1

Early Feasibility Study of a Visual Cortical Prosthesis for the Blind: The Orion Visual Prosthesis System Jessy D. Dorn, Ph.D. Nader Pouratian, M.D., Ph.D. Robert J. Greenberg, M.D., Ph.D. UH3NS103442 Exhibit 99.3

Slide 2

Disclosures Jessy D. Dorn, Ph.D. – Employee of & financial interest in Second Sight Nader Pouratian, M.D., Ph.D. – Consultant to Second Sight Robert J. Greenberg, M.D., Ph.D. – Consultant to & financial interest in Second Sight Study partly funded by NIH BRAIN Initiative grant: UH3NS103442

Slide 3

Forward-Looking Statements This presentation 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,” “projects,” “plans,” “goal,” or “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 presentation 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 March 19, 2019, and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in events, conditions, or circumstances on which any such statement is based

Slide 4

Orion I Implant: Concept Leverages existing Argus II technology Bypasses the eyes and optic nerve and directly stimulates the visual cortex Early Feasibility Study IDE approval received Pre-clinical testing completed Designated a Breakthrough Device

Slide 5

Orion I Implant Medial View Top View Lateral View Electrode array (60 channels) Cable Electronics package Implant coil (receiving antenna) Cover

Slide 6

Orion System: User-Worn Externals Video Processing Unit Glasses & Antenna Real-time video captured by the camera is downsampled and processed by the VPU and converted into stimulation patterns based on the brightness in the scene. Data are power are send wirelessly through RF link to the implant.

Slide 7

Orion Early Feasibility Study Six subjects to be followed for five years Two centers: UCLA and Baylor College of Medicine Primary outcome measure: safety (adverse events) Secondary outcome measures: ability to produce phosphenes, long-term functionality of the device, and benefit in terms of visual function, functional vision, quality of life Subjects are completely bilaterally blind due to any cause other than damage to the visual cortex May include trauma to eyes or optic nerve, diabetic retinopathy, glaucoma, or other etiology

Slide 8

Site Subject Implant Date Age at time of implant Gender Reason for Vision Loss* Implant Duration as of 4/1/19 (months) UCLA S1 01/30/2018 56 Male Optic neuropathy following severe burn/trauma 14 UCLA S2 03/29/2018 29 Male Eye trauma 12 UCLA S3 04/26/2018 56 Female Endophthalmitis 11 Baylor S4 04/27/2018 34 Male Pediatric glaucoma 11 UCLA S5 05/31/2018 52 Male Congenital glaucoma 10 Baylor S6 01/17/2019 57 Male Eye/optic nerve trauma 2.4 Mean ± Std Dev 47.3 ± 12.5 Ratio F:M 1 : 5 Mean ± Std Dev 10.7 ± 4.0 Orion Early Feasibility Study - Status Overview *As reported by clinical sites

Slide 9

There have been 5 adverse device or procedure-related adverse events (ADEs) in 2 (out of 6) subjects 1 serious ADE 4 non-serious ADEs Four out of 6 subjects have not experienced any device- or procedure-related AEs Orion Early Feasibility - Safety Data are reported as of the last independent medical safety monitor meeting, Feb 8, 2019 Patient ID Implant Duration as of 4/1/19 (months) # Serious Adverse Events # Non-serious AEs S1 14 0 1 S2 12 1 (seizure) 3 S3 11 0 0 S4 11 0 0 S5 10 0 0 S6 2.4 0 0

Slide 10

Research Focus: First 6 Months Create video settings and establish stimulation safety Custom-programming: measure thresholds, perform spatial mapping, create video configuration file – direct stimulation through computer control Testing for comfort and safety during camera-based stimulation Clear subjects for home use Allowing subjects to take the system home quickly was a high priority First five took the device home between 4 and 7 months post-implant Initiate rehabilitation sessions and train subjects on hand-camera coordination, eye movement, and visual skills In-home rehabilitation in progress for five subjects

Slide 11

First Threshold Measurement Subject Average Threshold (µA) Standard Deviation (µA) No. of Thresholds S1 2893 1322 56/60 S2 1645 828 60/60 S3 2194 789 59/59 S4* 3765 1603 54/58 S5 2693 1248 59/59 S6 3730 1170 55/59 Thresholds amount of current required for subject to see phosphene 50% of the time on a single electrode Thresholds have been mostly stable over time * Measured with a modified staircase method

Slide 12

Orion Early Feasibility Study Focus on Spatial Mapping In Argus II, we assumed a 1:1 spatial mapping Stimulated pattern Perceived pattern In Orion, 1:1 mapping will not work Performing efficient and accurate spatial mapping is a large focus of our early Orion research Comparing mapping data with predictive maps based on array placement is ongoing

Slide 13

Orion Study – Performance Measures A suite of assessments to measure performance administered at multiple time points Visual function – objective, controlled, artificial Functional vision – subjective, real-world, more meaningful Well-being & quality of life – patient-reported

Slide 14

Measuring Ultra-Low Vision Visual Function 20/20 20/200 Bare LP No LP Count Fingers Hand Motion LP with Projection LP = Light Perception Legally Blind Square Localization Direction of Motion Grating Visual Acuity (1.6 – 2.9 LogMAR) (20/800 – 20/16000)

Slide 15

ON mean error was significantly lower than OFF for 3 of 5 subjects at 6 months. Subject S1’s performance was better ON than OFF at 12 months. Orion Early Feasibility Study - Performance * Mean error significantly different ON vs. OFF, t-test, p<0.05 System OFF System ON Subject S2 at 6 months Square Localization at 6 months post-implant

Slide 16

Orion Early Feasibility Study - Performance ON mean error was significantly lower than OFF for 2 out of 5 subjects at 6 months. Subjects S1 and S5 had better ON than OFF performance at 12 other time points * Mean error significantly different ON vs. OFF, t-test, p<0.05 System OFF System ON Direction of Motion at 6 months post-implant

Slide 17

Grating Visual Acuity Grating Visual Acuity is measured between 2.9 – 1.6 logMAR. Gratings are presented for only 5 seconds No subjects (0 of 5) scored on the scale with the System ON or OFF at 6 months post-implant Training on this task has improved performance considerably Orion Early Feasibility Study - Performance

Slide 18

Trained observers rate the impact of the Orion implant on patients’ well-being and functional vision periodically at specific time points Interview Observer-rated functional vision tasks (System ON and OFF) Final rating of benefit of Orion System on subject’s life Orion Early Feasibility Study - Performance Functional Low-Vision Observer-Rated Assessment (FLORA) at 6 months post-implant * Data are reported as of Mar 2019 Positive Mild Positive Neutral Mild Negative Negative 40% (2/5) 60% (3/5) 0 0 0

Slide 19

“Real World Use”: observations from rehabilitation sessions Subjects are finding success with Orion for everyday visual tasks “…He was able to find the cue ball with no problems on the table. He was able to tell the cue ball from the blue ten, and also from balls with a stripe vs. the cue ball. He could find the racked balls at the other end of the table too.” “…we've found that looking forward is where [the Orion] shines better for the user as they can detect upcoming objects... He was able to see cars parked on the side of the street, openings in the sidewalk up into driveways, etc.” “…He was able to order patterns from small checkers, big checkers, and white cloth. There's a half inch difference in checker size in the patterns.” “When working throughout her apartment building, she was able to tell where I was located when standing in front of a 10’ wide light wall w/out visual clutter. She was also able to correctly determine whether I was traveling from left to right or right to left along this wall, 7/10 times.”

Slide 20

Questions? Thank you!