Spectral Medical Inc · TSX:EDT
Spectral Medical — Investor Presentation (September 2021)
27 slides from Spectral Medical's investor presentation, September 2021
Slide 1: Precision Treatment for Significant Critical Care Needs
PRECISION TREATMENT FOR SIGNIFICANT CRITICAL CARE NEEDS Addressing Septic Shock and Renal Disease September 2021 EDT:TSX
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include statements regarding our future fi
Slide 3: Spectral Overview
Spectral Overview Spectral Medical is a clinical stage medical device company creating next generation products for the treatment of significant critical care needs – specifically in the areas of septic shock and renal disease • Addressing Unmet Need in Treatment of Endotoxemic Septic Shock – Precis
Slide 4: Spectral's Targeted Therapy for Septic Shock
Spectral’s Targeted Therapy for Septic Shock
Slide 5: Addressable US Market Size ~ US$1.5B
Addressable US Market Size ~ US$1.5B >40% Mortality & Limited Therapeutic Options • 20% mortality SEPSIS1 • 1.7M patients with sepsis • > 40% mortality SEPTIC SHOCK2 • 330K patients in septic shock • > 40 % mortality SPECTRAL • Spectral estimates US$1.5B+ market ▪ 100-120K patients with multiple org
Slide 6: Measuring & Treating Endotoxemic Septic Shock
Measuring & Treating Endotoxemic Septic Shock 5 A Clear Registration Pathway for PMX The Tigris trial, designed to build on the Euphrates generated body of evidence has been reviewed and approved by the FDA. 4 The EUPHRATES Trial Post-Hoc analysis demonstrated reduced mortality at 28 days in key sub
Slide 7: PMX 'Competitive' Landscape
PMX ‘Competitive’ Landscape • Differentiation: PMX is a targeted therapy vs. ‘competitor’ therapies which are non-specific PMX Cytosorb Oxiris Aethlon Boa Garnet Exthera Target Endotoxin Small molecules <70kd Small molecules <70kd Viruses, Viral Live organisms and Live organisms RNA/DNA PAMPs Techno
Slide 8: PMX Endotoxin Removal Cartridge: Real World Clinical Evidence
PMX Endotoxin Removal Cartridge: Real World Clinical Evidence • Regulatory acceptance in Japan, Europe, Canada and many other countries • >300 published papers1 • Approx. 10,0001 patients entered into trials • 200,000+ patients treated worldwide • 20+ years of proven safety profile worldwide • Resul
Slide 9: Lessons Learned From the EUPHRATES Trial
Lessons Learned From the EUPHRATES Trial • While the top line data did not demonstrate a mortality benefit, it did show a trend for cardiovascular improvements in the PMX group • The post-hoc analysis identified a subset of patients who benefitted from the PMX treatments1,2 • When strict patient sel
Slide 10: Regulatory Status: Confirmatory TIGRIS Trial
Regulatory Status: Confirmatory TIGRIS Trial 1) Trial Design agreed upon with the FDA: US sites only, randomized (2:1), Open Label trial 2) Prior population consists of 179 patients from US sites in EUPHRATES (target weight* 75%) 3) 150 new patients to be added from the TIGRIS trial (23 patients hav
Slide 11: PMX/EAA Milestones: Path to FDA Approval
PMX/EAA Milestones: Path to FDA Approval Q1 2019 Q2 2019 Q4 2019 Q1 2020 Q1 2020 – Q3 2020 Q4 2020 Q3 2021 Q4 2021 Q2 2022 FDA Q3 2020 Approval Beginning of Begin site 3 sites 9 sites COVID Tigris Currently Project all 15 Anticipated Anticipated Q4 2022 TIGRIS – selection actively actively pandemic
Slide 12: PMX Opportunity – Illustrative Financial Benefits to Spectral
PMX Opportunity – Illustrative Financial Benefits to Spectral • There are 1.7 Million patients each year in the US diagnosed with sepsis Illustrative Potential US Net Economics to Spectral – PMX + EAA (per annum) • There are 330K patients who are expected to develop sepsis shock (in USD) Illustrativ
Slide 13: Dialco Medical Inc.
Dialco Medical Inc. Wholly owned subsidiary of Spectral Medical
Slide 14: Dialco Strategic Priorities 2021 – 2023
Dialco Strategic Priorities 2021 – 2023 Strategic Priorities Dialco Commercialization Roll-out Developing Footprint • Strengthen pipeline of • Execute IDE usability trial • 10 new clinical evaluation sites 2021 • 60 new machines installed tender and RFPs • Achieve positive conversion • Increase clin
Slide 15: Acute Dialysis Market – SAMI Positioning
Acute Dialysis Market – SAMI Positioning PrisMax NxStage System One Intensive Care Units Step Down Units Hospital Wards CRRT PIRRT/SLED IHD Tablo 15 9/12/2021
Slide 16: Virtual Training, Deployment & Clinical Support
Virtual Training, Deployment & Clinical Support SAMI Virtual Training Program SAMI CRRT System in Action Dialco team providing virtual training The SAMI System deployed shortly after virtual training to University of Michigan team 24/7 Virtual Clinical Support Dialco clinical staff available 24/7 to
Slide 17: User Experience
User Experience Users Prefer SAMI over Traditional CRRT Machines Surveyed 10 nurses trained remotely 1 “The disposable cassette is very easy to assemble, you just plug and play.” 2 Training and Learning 4.4 “Nurses were successfully trained through only one-time virtual training provided by Dialco,
Slide 18: Chronic Dialysis Market – DIMI Positioning
Chronic Dialysis Market – DIMI Positioning Traditional HD Devices NxStage System One Traditional PD Devices HD HD PD In-Center Home/SNF Home/SNF Tablo 18 9/12/2021
Slide 19: Addresses Barriers to Home Adoption
Addresses Barriers to Home Adoption Complexity of current technology and required skillset Lack of confidence with training and 30% 1 patients usability (both patient and doctor) are eligible for HHD Water is hard or low-quality in many areas in North America 2% 1 patients are currently on HHD RO sy
Slide 20: Patient Experience
Patient Experience 1 “DIMI is extremely instinctive and playful” 10 novice and experienced users (5/5) from various social categories “The pictogram clearly helps to understand and use” 53 years old on average (34 ~ 83 years) “The information, alarm signals and 60% vs 40% female and male messages do
Slide 21: Dialysate – Online Generation or Pre-Mixed?
Dialysate – Online Generation or Pre-Mixed? External ✓ Smaller footprint More portable RO System Online ✓ No risks or challenges associated with water quality Generation vs ✓ No extra water preparation time Pre-mixed Water Bags ✓ Inherited PD habits using pre-filled dialysate bags Build-in ✓ No extr
Slide 22: Dialysate – Online Generation or Pre-Mixed?
Dialysate – Online Generation or Pre-Mixed? Water hardness effects over 85% of the water supply in US 1… VERY HARD HARD MODERATE SLIGHT 1. Dialco Management estimates based on a study from the National Water-Quality Assessment Project 22 9/12/2021
Slide 23: Consumables Storage – Online Generation or Pre-Mixed?
Consumables Storage – Online Generation or Pre-Mixed? Dialysate Choice Consumables Requirements Storage Requirements 5L Pre-Mixed Dialysate x 4/session • 80 5L Pre-mixed Dialysate Bags (40 Packs) • 20 DIMI Cassette (Smaller and lighter) Reverse Osmosis 5L Concentrate Disinfectant • 40 5L Concentrate
Slide 24: Usability Trial at a Glance
Usability Trial at a Glance Phase 3: Phase 1: Phase 2: Phase 4: Phase In-Center to In-Home Run-in In-Center Therapy In-Home Therapy Transition Control Phase Cross-over Phase Test Phase Duration 2 Weeks 6 Weeks 4 Weeks 6 Weeks In-Center hemodialysis In-Center hemodialysis Dialysis therapies performed
Slide 25: Spectral Medical Inc. Corporate Highlights
Spectral Medical Inc. Corporate Highlights
Slide 26: Upcoming Catalysts
Upcoming Catalysts • Tigris Interim patient enrollment / Baxter milestone payment • Tigris Last patient enrollment • PMX FDA approval • Initial patient enrollment in DIMI usability study • Reporting topline data for DIMI usability study • DIMI PD FDA clearance and Health Canada approval • FDA cleara
Slide 27: Capitalization
Capitalization Ticker Symbol June 30, 2021 Pro Forma1 As at June 30, 2021 No. Outstanding No. Outstanding Common Shares 244,213,075 267,743,075 Options 9,866,013 9,866,013 RSUs 790,588 790,586 Warrants 4,760,000 6,459,581 Fully Diluted Shares Outstanding 3 259,629,676 274,202,656 As at March 31, 202
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