Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Second Sight Medical Products — Technical Presentation (February 2016)
18 slides from Vivani Medical's technical presentation, Feb 26, 2016
Slide 1: Safety and Performance Results of the Argus II Retinal Prosthesis System
Safety and Performance Results of the Argus® II Retinal Prosthesis System Five Years Post-Implant James T. Handa, MD Handa, JT?, daCruz L?, Dagnelie G.*, Stanga P., Olmos L.5, Greenberg R.§, Birch D.’, Duncan J. Sahel J.®, Thumann G..®, Argus Il Study Grou
Slide 2: Second Sight Argus II Retinal Prosthesis
Second Sight Argus II Retinal Prosthesis * Equivalent to visual field of ~20° * Each electrode individually programmable * Epiretinal placement using standard vitreoretinal surgical techniques
Slide 3: Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind
Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind Beck Rd Se MB day Brun AD, ls Hide, MO” Cod eg, MD? “ise, TD Dane Racha, PAD: Roe) Crab MD, TAD, Today’s presentation of 5 year data confirms that performance is maintained, with no additional SAE’s
Slide 4: Argus II Clinical Trial Sites
Argus II Clinical Trial Sites Europe and Mexico United States CHNO des Quinze-Vingts (Paris, France) Columbia University (New York, NY) H6pitaux Universitaires de Genéve (Geneva, Doheny Eye Institute/University of Southern Switzerland) California (Los Angeles, CA) Manchester Royal Eye Hospital (Manc
Slide 5: Study Design
Study Design « Prospective single-arm, non-randomized trial * 3 years minimum follow-up — extended follow-up to 10 years * Key inclusion Criteria — Severe to profound outer retinal degeneration — Remaining visual acuity worse than 2.3 logMAR in both eyes — US Label: Retinitis Pigmentosa with remaini
Slide 6: Study Demographics
Study Demographics Subjects (n) 30 Age at Time of Implant (years) 58 + 10 (range 28 — 77) Females : Males 9:21 Diagnosis Retinitis pigmentosa Choroideremia 97% (n=29) 3% (n=1) Baseline Vision Bare light perception* No light perception 97% (n=29) 3% (n=1) Median Surgery Time (hours) 4:04 (range 1:53
Slide 7: Implant Duration & Long-Term Reliability
Implant Duration & Long-Term Reliability As of January 1, 2016 Subjects (n) 30 # Years Implanted (Ave.) 6.9 (range 1.2— 8.6) Cumulative Implant Time 207 subject-years Range of implant functionality | 3.9 — 8.6 years (not including explants) # Subjects with device 3 explant # Subjects with device fai
Slide 8: Total Serious Adverse Events
Total Serious Adverse Events Five Years Post-Implant INsubjects — % subjects with \Serious Adverse Event Type _|withSAE [SAE {95% Confidence Interval |Conjunctival erosion al 13.3% 3.1 - 30.7% lHypotony al 13.3% 3.1 - 30.7% Conjunctival dehiscence 3] 10.0% 2.1 - 26.5% lPresumed endophthalmitis 3] 10
Slide 9: Safety Profile Improving in the Commercial Setting
Safety Profile Improving in the Commercial Setting SAEs in Year 1: Clinical Trial vs. Commercial* Clinical Trial All Commercial In patients [Conjunctival dehiscence 10.0% 1.3% |Conjunctival erosion 10.0% 5.1% |corneal opacity 3.3% 0.0% itis - infective 10.0% 0.0% lEpiretinal membrane 3.3% 0.0% Kscle
Slide 10: Probable Benefit Year Results
Probable Benefit 5 Year Results Visual Function * Object Localization * Motion Discrimination ¢ Visual Acuity Testing Functional Vision and Quality of Life * Orientation and Mobility * Functional Low-Vision Observer Rated Assessment (FLORA)
Slide 11: Visual Function
Visual Function Square Localization TESystem ON _ASystem OFF
Slide 12: Visual Function
Visual Function Direction of Motion aaa aoe a so | »| a qo 4 tly i” | rial zs | } T $y 3 % g° | Eo is | » of Tae Nee Wen ee et a ie Wie Soe’ i
Slide 13: Visual Function
Visual Function Grating Visual Acuity | 60% 5 50% g 4 Faox z 30% Ff 5 B20% 3 3 E10% é % Casene aYew 2Yanrs BYeurs Years Stans Ne Ne Ne Best acuity in the clinical trial to date is 20/1260 (1.8 logMAR)
Slide 14: Functional Vision
Functional Vision Orientation & Mobility Finding a Door
Slide 15: Functional Vision
Functional Vision Orientation & Mobility Following a Line
Slide 16: Benefits of Argus II
Benefits of Argus II ¢ Patient reported advantages * Participation in bowling, archery, —" skiing 2 * Locate doors and windows *¢ Sort light and dark clothes * Stay within a crosswalk * Detect and track other people * Feel more socially connected * Enjoy being “visual” again * Tracking players on a
Slide 17: Benefits of the Argus II System Through FLORA
Benefits of the Argus II System Through FLORA (Functional Low Vision Observer Rated Assessment) OPTOMETRY Self-report section Functional visual tasks Tasks rated at impossible, difficult, moderate, easy 75% judged “vision only” during tasks with system “ON” 29% judged “vision only” with system “OFF”
Slide 18: Conclusions
Conclusions Argus Il has an acceptable safety profile in this blind population. — Safety has possibly improved since commercial approval. Visual function performance gains and reliability are maintained through 5 years Subjects report using Argus Il in their daily lives and the System has a positive
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