Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Second Sight Medical Products — Technical Presentation (April 2019)
20 slides from Vivani Medical's technical presentation, Apr 11, 2019
Slide 1: Early Feasibility Study of a Visual Cortical Prosthesis for the Blind: The Orion Visual Prosthesis System
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
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
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 sec
Slide 4: Implant: Concept
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: Implant
Orion I Implant Medial View Top View Lateral View Electrode array (60 channels) Cable Electronics package Implant coil (receiving antenna) Cover
Slide 6: System: User-Worn Externals
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: Early Feasibility Study
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
Slide 8: Study Subjects Status Overview
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/
Slide 9: Orion Early Feasibility - Safety
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
Slide 10: Research Focus: First Months
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 su
Slide 11: First Threshold Measurement
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
Slide 12: Early Feasibility Study Focus on Spatial Mapping
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 pre
Slide 13: Study – Performance Measures
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
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: Square Localization at 6 months post-implant
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
Slide 16: Direction of Motion at 6 months post-implant
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
Slide 17: Grating Visual Acuity
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
Slide 18: Functional Low-Vision Observer-Rated Assessment (FLORA)
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 - Per
Slide 19: “Real World Use”: observations from rehabilitation sessions
“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 c
Slide 20: Questions?
~ Questions? Thank you! SEC@NDSIGHT
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