Establishment Labs Holdings Inc. · NASDAQ:ESTA

Establishment Labs — Investor Day (June 2019)

61 slides from Establishment Labs's investor day presentation, Jun 19, 2019

  1. Slide 1: Investor Day - Costa Rica, June 18th: RDI

    Roberto de Mezerville Chief Technology Officer INVESTOR DAY - COSTA RICA | JUNE 18TH | RDI

  2. Slide 2: Since 2004 - Motiva Evolution

    Since 2004 - Motiva Evolution Company confidential. Proprietary information. Do not distribute.

  3. Slide 3: Motiva Implants focus on customer needs – the Patient

    Motiva Implants® focus on customer needs – the Patient Aesthetics issues - reoperation Clinical issues - reoperation EXCESSIVE LACK OF MALPOSITION & RUPTURE CAPSULAR FIRMNESS DYNAMICS ROTATION CONTRACTION Safety through Innovation Company confidential. Proprietary information. Do not distribute.

  4. Slide 4: Capsular Contracture factors

    Capsular Contracture Implant Placement Immune Response Bacteria Colonization Surface & & Biofilm Particles Filling material Surgical Techniques (diffusion) Company confidential. Proprietary information. Do not distribute.

  5. Slide 5: Design Thinking Ergonomy Concept

    Design Thinking Ergonomy Concept Company confidential. Proprietary information. Do not distribute.

  6. Slide 6: 2010 – First product launched

    2010 – First product launched 100% filled Company confidential. Proprietary information. Do not distribute. MIT – Robert Langer Lab images from rabbit model pilot testing

  7. Slide 7: Company confidential. Proprietary information. Do not distribute.

    Company confidential. Proprietary information. Do not distribute.

  8. Slide 8: TrueMonobloc Uniform Shell Thickness

    TrueMonobloc® UNIFORM SHELL THICKNESS Company confidential. Proprietary information. Do not distribute.

  9. Slide 9: Focus on the Patient: Capsular Contraction

    Motiva Implants® focus on customer needs – the Patient CAPSULAR CONTRACTION Company confidential. Proprietary information. Do not distribute.

  10. Slide 10: Traditional smooth surface is not really smooth

    Traditional “Smooth” surface is not really smooth Difficult to control, Silicone flow and air drying creates waves and irregularities Source: Barr, S. Hill, E., and Bayat, A. Current Implant Surface Technology: An Examination of Their Nanosurface and their influence on Fibroblast Alignment and Bioco

  11. Slide 11: Traditional Breast Implant Surfaces Manufacturing

    Traditional Breast Implants Surfaces Manufacturing Secondary processes to add texturing Company confidential. Proprietary information. Do not distribute. Illustrative image by Establishment Labs

  12. Slide 12: Micro & Macro Surfaces of commercially available implants

    Micro & Macro - Surfaces commercially available breast implants Internal Study - Establishment Labs property, Salt-loss process Company confidential. Proprietary information. Do not distribute.

  13. Slide 13: 2010 - SmoothSilk/SilkSurface

    2010 - SmoothSilk®/SilkSurface® Company confidential. Proprietary information. Do not distribute.

  14. Slide 14: Learning from other areas: immune cascade response

    Learning from other areas the immune cascade response Surface optimization had improved the biocompatibility and longevity of medical implants BONE-ANCHORED IMPLANTS VASCULAR GRAFTS Company confidential. Proprietary information. Do not distribute.

  15. Slide 15: Science based - SmoothSilk/SilkSurface

    Science based - SmoothSilk®/SilkSurface® Company confidential. Proprietary information. Do not distribute.

  16. Slide 16: Motiva way - controlled surfaces

    Motiva® way - controlled surfaces – SmoothSilk®/SilkSurface® Company confidential. Proprietary information. Do not distribute. Illustrative image by Establishment Labs

  17. Slide 17: Motiva Controlled Surface Process

    Motiva® Controlled Surface Process Company confidential. Proprietary information. Do not distribute. Illustrative image by Establishment Labs

  18. Slide 18: Biocompatibility Risk Assessment – Shell & Filling Gel

    Biocompatibility Risk Assessment – Shell & Filling Gel Patient Benefits Biocompatibility Testing: Regulatory Requirements - Leachable characterization - Cytotoxicity - ISO 10993 - Sensitization - ISO 14971 - Irritation or intracutaneous reactivity - EU Directive 93/42/EEC - Acute systemic toxicity -

  19. Slide 19: 2010 - SmoothSilk/SilkSurface

    2010 - SmoothSilk®/SilkSurface® SmoothSilk® Barr, S., Hill, E., & Bayat, A. (2010). Patterning of novel breast implant surfaces by enhancing silicone biocompatibility, using biomimetic topographies. Eplasty, 10, e31. Company confidential. Proprietary information. Do not distribute.

  20. Slide 20: 2012 – BluSeal

    2012 – BluSeal® Company confidential. Proprietary information. Do not distribute.

  21. Slide 21: 2012 – ProgressiveGel PLUS

    2012 – ProgressiveGel® PLUS Company confidential. Proprietary information. Do not distribute.

  22. Slide 22: ProgressiveGel PLUS - Rheology: Visco-Elasticity

    2012 – ProgressiveGel® PLUS - Rheology: Visco-Elasticity ProgressiveGel® ProgressiveGelPLUS® Maintains upper-pole fullness A more natural look and feel Company confidential. Proprietary information. Do not distribute.

  23. Slide 23: Since 2014 – Ergonomix

    Since 2014 – Ergonomix® Company confidential. Proprietary information. Do not distribute.

  24. Slide 24: Company confidential. Proprietary information. Do not distribute.

    Company confidential. Proprietary information. Do not distribute.

  25. Slide 25: Company confidential. Proprietary information. Do not distribute.

    Company confidential. Proprietary information. Do not distribute.

  26. Slide 26: 2014 – ProgressiveGel ULTIMA Rheology

    2014 – ProgressiveGel ULTIMA® Rheology: Visco-Elasticity Gravity sensitive ProgressiveGel® ProgressiveGel PLUS® Ergonomix® ProgressiveGel ULTIMA® Maintains upper-pole fullness A more natural look and feel The most natural look and feel Company confidential. Proprietary information. Do not distribute

  27. Slide 27: Motiva Implants Rheology & Morphology

    Motiva Implants® Rheology & Morphology Shell & Filling gel interaction Company confidential. Proprietary information. Do not distribute.

  28. Slide 28: Biomechanical Tissue Characterization (BTC-2000)

    Biomechanical Tissue Characterization (BTC-2000™) Rheological map in breast implant filling gel Company confidential. Proprietary information. Do not distribute.

  29. Slide 29: Breast Implants Rheology Map

    Breast Implants Rheology Map Company confidential. Proprietary information. Do not distribute.

  30. Slide 30: 2014 – Qid Safety Technology

    2014 – Qid® Safety Technology UNIQUE SERIAL TEMPERATURE OTHER IDENTIFICATION NUMBER BIOSENSING PARAMETERS Company confidential. Proprietary information. Do not distribute.

  31. Slide 31: Motiva Evolution continues…

    Motiva® Evolution continues… - 2016 MotivaImagine® South Korea MFDS and Australia TGA approval - 2017 MotivaHybrid® MDSAP Quality Certification Brazil ANVISA/INMETRO approval US FDA IDE submission -2018 USA FDA Clinical Trial Started Aesthetics cohorts completed March 2019 Company confidential. Prop

  32. Slide 32: Company confidential. Proprietary information. Do not distribute.

    Company confidential. Proprietary information. Do not distribute.

  33. Slide 33: The Science of the Breast Management: The Scientific Evidence

    THE SCIENCE OF THE BREAST MANAGEMENT The Scientific Evidence Company confidential. Proprietary information. Do not distribute.

  34. Slide 34: Research Fields on Breast Implant Surfaces Topographies

    Research Fields on Breast Implant Surfaces Topographies Breast Implants Surface Characterization and Biocompatibility • In vivo testing • In vitro testing • Immune response • Immunocytochemistry Inmune response Surface Characterization Biofilm Tribology • Bacteria attachment • Friction coefficient •

  35. Slide 35: Research Developed in Collaboration with ESTA

    Research Developed in Collaboration with ESTA Company confidential. Proprietary information. Do not distribute.

  36. Slide 36: Activator: Surface Characteristics from Manufacturing Process

    Activator: Surface Characteristics Resulting of Manufacturing Process Traditional Smooth “Foam imprint” surface Salt-loss surface SmoothSilk®/SilkSurface® VelvetSurface® SEM images of different textures available in the market, at a scale of 500 µm and 100X magnification. Images Property of Establis

  37. Slide 37: Activator: Surface Characteristics from Manufacturing Process

    Activator: Surface Characteristics Resulting of Manufacturing Process Traditional Smooth SmoothSilk®/SilkSurface® VelvetSurface® “PU foam imprint” “Salt-loss” texture Company confidential. Proprietary information. Do not distribute.

  38. Slide 38: SmoothSilk/SilkSurface has more peaks than valleys

    SmoothSilk®/SilkSurface® has more peaks than valleys Peaks that function as contact points for cells attachment during the immune response Negative Skewness: Means more valleys than peaks Positive Skewness: Means more peaks than valleys Company confidential. Proprietary information. Do not distribut

  39. Slide 39: Size comparison of a fibroblast on the surface

    Size comparison of a fibroblast on the surface Representation of how a fibroblast may look on a breast implant surface at the same magnification, considering the standardized fibroblast size of 25 µm used by Dalby et al. (2004). Company confidential. Proprietary information. Do not distribute. Dalby

  40. Slide 40: Optimization of Surfaces biocompatibility: Fibroblasts & Macrophages

    Optimization of Surfaces biocompatibility Fibroblasts & Macrophages Attachment - Experimental Results Company confidential. Proprietary information. Do not distribute. SEM images of fibroblasts (obtained from breast tissue) and macrophages (from THP-1 monocytes cell line, ATCC) growing on different

  41. Slide 41: Cytokines expression for SmoothSilk/SilkSurface

    Cytokines expression for SmoothSilk®/SilkSurface® at 12 hours & 24 hours Company confidential. Proprietary information. Do not distribute.

  42. Slide 42: Immunophenotypic characterization – BI surfaces

    Cappellano G. et al; Immunophenotypic characterization – 7 BI surfaces Company confidential. Proprietary information. Do not distribute.

  43. Slide 43: Evaluation of miniature implant surfaces on fibrosis animal model

    Evaluation of miniature breast implants surfaces on fibrosis animal model (C57BL/6 pro-fibrotic rodent strain) Research performed at the Robert Langer Laboratory at MIT, Boston , USA Veiseh, O. Next Generation Biomaterials Design for Chronic Implants. 5 Oct 2018. 4th World Symposium on Ergonomic Imp

  44. Slide 44: Explanted miniature implants with tissue overgrowth

    6 Months Explanted miniature implants with tissue overgrowth Control: Traditional Smooth Breast Implant Surface SmoothSilk®/SilkSurface® Breast Implant Surface Company confidential. Proprietary information. Do not distribute. Veiseh, O. Next Generation Biomaterials Design for Chronic Implants. 5 Oct

  45. Slide 45: Low inflammation response at different timepoints

    Low inflammation response at different timepoints Control SmoothSilk®/SilkSurface® Less macrophages presence with SilkSurface® SmoothSilk® / SilkSurface® decreases fibrosis-dependent innate immune macrophages Veiseh, O. Next Generation Biomaterials Design for Chronic Implants. 5 Oct 2018. 4th World

  46. Slide 46: Full-size Human-scale Implants testing in Rabbit Model

    Full-size Human-scale Implants testing in Higher Order Rabbit Model 3-week retrievals Veiseh, O. Next Generation Biomaterials Design for Chronic Implants. 5 Oct 2018. 4th World Symposium on Ergonomic Implants, Lago di Garda.Company confidential. Proprietary information. Do not distribute. Research p

  47. Slide 47: Tribology: the study of surfaces moving relative to one another

    Tribology: the study of surfaces moving relative to one another Wear particles Wear rate Friction coefficient Company confidential. Proprietary information. Do not distribute.

  48. Slide 48: Tribology: Friction and Wear

    Tribology: Friction and Wear Company confidential. Proprietary information. Do not distribute.

  49. Slide 49: Study of the particles and the inflammatory response

    Study of the particles and the inflammatory response Company confidential. Proprietary information. Do not distribute.

  50. Slide 50: Bacteria & Biofilm on Breast Implant Surfaces

    James G. et al. Bacteria & Biofilm on Breast Implant Surfaces Company confidential. Proprietary information. Do not distribute.

  51. Slide 51: Biofilm formation (24 h)

    Biofilm formation (24 h) Smooth Microtexture Macrotexture As per ISO 14607:2018 0 - 10µm 10 - 50µm >50 µm SmoothSilk® / “Traditional Smooth” VelvetSurface® “Foam imprint surface” “Salt-loss” texture SilkSurface® Staph. epidermidis Gram + Pseudomonas aeruginosa Gram - Ralstonia pickettii Gram - 630x

  52. Slide 52: ISO 14607:2018 Non-active surgical implants – Mammary implants

    ISO 14607:2018 Non-active surgical implants – Mammary implants Published in April 2018 Company confidential. Proprietary information. Do not distribute.

  53. Slide 53: Bacteria & Biofilm Research on Breast Implant Surfaces

    Jones et al. Bacteria & Biofilm Research on Breast Implant Surfaces Company confidential. Proprietary information. Do not distribute.

  54. Slide 54: Proposed Breast Implant Surface Classification

    Jones et al. Proposes a Breast Implant Surface Classification Company confidential. Proprietary information. Do not distribute.

  55. Slide 55: Surface & Medical Complications Reported Linkage

    Surface & Medical Complications Reported Linkage Traditional Smooth SmoothSilk® (SilkSurface®) Company confidential. Proprietary information. Do not distribute.

  56. Slide 56: Less inflammation – less fibrosis: Post-Market Surveillance

    Less inflammation – less fibrosis Motiva Implants® Post-Market Surveillance Company confidential. Proprietary information. Do not distribute. Quirós, M.C., Bolaños, M.C., Fassero, J.J. (2018). Six-Year Prospective Outcomes of Primary Breast Augmentation With Nano Surface Implants. Aesthet Surg J., 3

  57. Slide 57: Summary of scientific advantages on Motiva Surface

    Summary of scientific advantages on Motiva® Surface Low Low Friction Roughness Low Surface Low Biofilm Area Development Less medical complication Less s according Inflammation to PMS Company confidential. Proprietary information. Do not distribute.

  58. Slide 58: Clinical Evaluation Process

    Clinical Evaluation Process Design and Development Real Pre- World Clinical Evidence Clinical Data Evaluation Process Published Clinical Data Data COMPANY CONFIDENTIAL. PROPRIETARY. DO NOT DISTRIBUTE.

  59. Slide 59: Motiva Implants US IDE Clinical Trial Overview

    Motiva Implants® US IDE CLINICAL TRIAL Overview CLIN-17-008 “Study of the safety and effectiveness of the Motiva Implants®” Indication Breast implant Surgery Devices Motiva Implants® Round Plus and Ergonomix® with or without Q Inside Safety Technology® Estimated 800 participants Enrollment Primary A

  60. Slide 60: US IDE Clinical Trial: Modular PMA Submission

    Motiva Implants® US IDE CLINICAL TRIAL Overview Submit Modular PMA Module 1 Module 2 Module 3 Non-Clinical Tests Module 4 Non-Clinical Tests Clinical Data • Physico-Chemical • Eng/Bench Manufacturing • Biocomp/Tox • Financial Disclosure • Sterilization/Shelf- Information • Proposed Labeling • Animal

  61. Slide 61: Thank you!

    Thank you! jMuchas gracias! >) Establishment Labs:

Establishment Labs Holdings — Investor Day (June 2019) on 6ix