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DiabetesMine University 2019: Bigfoot Biomedical Closed Loop Tech Preview

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* Part of the first-ever DIABETESMINE CLOSED LOOP SYSTEMS SHOWCASE *

Jeffrey Brewer of Bigfoot Biomedical previews the company's closed loop automated insulin delivery technology -- including connected insulin pens -- at the Fall 2019 DiabetesMine D-Data ExChange.

Published in: Healthcare
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DiabetesMine University 2019: Bigfoot Biomedical Closed Loop Tech Preview

  1. 1. © 2017-19 Bigfoot Biomedical | Confidential | 2 Bigfoot Biomedical Growing from the seed of the world’s first DIY artificial pancreas system, Bigfoot is developing a portfolio of diabetes management systems - powered by data driven algorithms and delivered holistically as a service. Bigfoot’s first commercial offering is aimed at the largest and most underserved market- that require dose assistance with their multiple daily injection (MDI) therapies. Conceptual Rendering. Product under development and not for sale in the United
  2. 2. © 2017-18 Bigfoot Biomedical | Confidential | 3 Population Requiring Insulin Therapy Is Large & Growing PWD = persons with diabetes.Seagrove Partners, LLC Diabetes Bluebook 2018 and Market Research 30.2M with diabetes 6.6M with insulin-requiring diabetes (InMillions) US Insulin Requiring Population 1.7 1.7 1.8 1.9 1.9 2.0 2.0 4.2 4.5 4.8 5.1 5.5 5.9 6.3 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 2017 2018 2019 2020 2021 2022 2023 T1D Population T2D IR Population 7% CAGR 3% CAGR
  3. 3. © 2017-19 Bigfoot Biomedical | Confidential | 4 Clinical Outcomes Are Poor and Expenses High 4.4M Type 2 1.7M Type 1 Hypo3 - $4.9- $14.7 b DKA4 - $ 5.1 b 6M $20B Population is Large Costs are High Insulin Users in the United States1 Severe Hypo/DKA 70% Outcomes not Met Insulin taking population does not meeting goal of A1C <7.0%2 1. Seagrove Partners Syndicated Services, “CGM Market Primer – 2019 Edition” 2. Stark Casagrande S., Fradkin JE, Saydah SH, Rust KF, Cowie CC (2013) The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013 Aug;36(8):2271-9. doi: 10.2337/dc12-2258. Epub 2013 Feb 15 3. Robert A. Vigersky, MD. The Benefits, Limitations, and Cost Effectiveness of Advanced Technologies in the Management of Patients With Diabetes Mellitus. Journal of Diabetes Science and Technology 2015, Vol. 9(2) 320–330. https://journals.sagepub.com/doi/pdf/10.1177/1932296814565661 4. Dimpi Desai, Dhruv Mehta, Priyanka Mathias, Gopal Menon and Ulrich K. Schubart. Health Care Utilization and Burden of Diabetic Ketoacidosis in the U.S. Over the Past Decade: A Nationwide Analysis.. Diabetes Care 2018 Aug; 41(8): 1631-1638. https://www.ncbi.nlm.nih.gov/pubmed/29773640
  4. 4. © 2017-19 Bigfoot Biomedical | Confidential | 5 Supply of Diabetes Specialist Clinicians Insufficient to Support Insulin Therapy For every one diabetologist there are 4,117 people diagnosed with diabetes in the US 34% 66% Endocrinologist PCP Therefore Primary Care is where most insulin therapy must be supported
  5. 5. © 2017-19 Bigfoot Biomedical | Confidential | 6 T1D Pump 0.5M T2D MDI 1.4M T2D Long Acting Only 2.8M T1D MDI 1.2M5.7M Couldbenefit from insulin Creating a Platform of Solutions for Insulin- Requiring Diabetes 2.6M PWDs Opportunity in USA Alone BigfootUnityBasal BigfootAutonomyBigfootUnity Conceptual Rendering. Product under development and not for sale in the United States.
  6. 6. Blue Ocean Strategy: Tap Vast, Unmet Demand Existing diabetes tech suits engaged users Supported by high prescribing Diabetologists Lack of tools usable by the vast majority of people with insulin requiring diabetes Supported by Primary Care Providers • Integrated, Intuitive, and Easy-to-Use Solution • Improved Clinical Outcomes • Broader Clinician Appeal (primary care not just endocrinologists) • Compelling Payer Economics What gets you to the blue ocean?
  7. 7. Bigfoot Unity Addressing a large, underserved market of people with insulin requiring diabetes
  8. 8. + + Episodic Insulin Injection Episodic & Continuous Glucose Monitoring CONNECTING ALL THE DEVICES + Conceptual Rendering. Product under development and not for sale in the United States. Single Prescription * Auto Resupply of Bundled Offering* Adaptive Digital Learning AND A COMPLETE BUNDLED SERVICE VISION: TO DELIVER A FULLY COMPREHENSIVE DIGITAL DIABETES MANAGEMENT PLATFORM + Ongoing Data- Driven Clinical Insights Smartphone Alarms & Alerts Automated Insulin Therapy Personalizatio n PROVIDING INTELLIGENCE * Insulin pens prescribed and obtained separately
  9. 9. Delivered under a single prescription* Digital, self-paced learning experience All therapy components auto- fulfilled* as a bundled service offering* Insulin pens prescribed and obtained separately CGM integrated injection system for insulin requiring people using multiple daily injection therapy Conceptual Rendering. Product under development and not for sale in the United States.
  10. 10. How much insulin should I take? A surprisingly difficult question to answer
  11. 11. © 2017-18 Bigfoot Biomedical | Confidential | 12 Diabetes is a Data Disease; Insulin Dosing is a complex Math Problem Variables Measured by Person w/ Diabetes Change across population Change throughout the day Change over time (193 – 140) ÷ 40 + (29 x 2.5 ÷ 12) – 1 Total Number of Units to Inject or Pump Variables Personalized by Clinician …and the variables continuously change: Current Glucose (mg/dl) Target Glucose (mg/dl) Insulin Sensitivity Factor (mg/dl/u) Carbs/serving (g/serving) Servings Carb Ratio (g/u) Insulin onboard (u)
  12. 12. © 2017-19 Bigfoot Biomedical | Confidential | 13 The Broken Therapy Cycle Therapy Rx: Dosing Directions Feedback Loop: Data/ Log Daily Therapy: Dosing Decisions Conceptual Rendering. Product under development and not for sale in the Unite
  13. 13. © 2017-19 Bigfoot Biomedical | Confidential | 14 PWDs want Ease-of-use with their Insulin Therapy Therapy Rx: Digital App Feedback Loop: History & Insights Daily Therapy: Pen Cap Dose Reminder & Hypoglycemia Alerts Provider Insights Digitized Therapy Remote Therap y Update s Conceptual Rendering. Product under development and not for sale in the Unite
  14. 14. Clinicians Don’t Want Data. They Want Insights. Cloud Services Storage and Transport Information Conceptual Rendering. Product under development and not for sale in the United States.
  15. 15. © 2017-19 Bigfoot Biomedical | Confidential | 16 Our Vision for Personalization of Insulin Therapy for the Clinician Therapy Rx: Digital App Feedback Loop: Insulin & Glucose Data Daily Therapy: Pen Cap Dose Guidance Single Input Onboardin g Conceptual Rendering. Product under development and not for sale in the Unite
  16. 16. © 2017-19 Bigfoot Biomedical | Confidential | 17 Bigfoot Unity™ Next Gen Vision - MDI Therapy Personalization Optimum regimen Personalized/ Optimized MDI regimen Personalized MDI Dosing Adjustment Recommendations over Time BestBetterGood Insulin Delivery Insulin Delivery Insulin Delivery
  17. 17. © 2017-19 Bigfoot Biomedical | Confidential | 18 ~3 minutes to simulate a 3 month, 100 person trial 4,000,000x faster and less expensive than real-time Human Clinical Trials • Commercial • Product • Automation DataDriven Disruption Data Driven in Silico Modeling EmpiricalData Real World • Published Trials • Proprietary • Device Validation Modeling Human Physiology • Human Behavior • System Components Simulation Virtual Clinic • Virtual Trial Protocol • Bigfoot Algorithms
  18. 18. © 2017-19 Bigfoot Biomedical | Confidential | 19 in Silico Modeling: Estimated HbA1c – Potential of Optimized & Personalized MDI Therapy UKPDS Group. Lancet, 1998; 352:837-853 Every 1% Decrease in Hemoglobin A1c (HbA1c) results in: • 21% decrease in risk of diabetes related end point • 14% decrease in risk of Myocardial Infarction(MI) • 12% decrease in risk of stroke • 37% decrease in risk of microvascular complications Optimized MDI
  19. 19. © 2017-19 Bigfoot Biomedical | Confidential | 20 Launch Goals of Bigfoot’s Diabetes Management Platform 2021 ~2022 ~2023 1 Prescription* E-Learning Population Health Management Tools DELIVERED asa SERVICE Remote Monitoring Supply Management HCP Tools Data Analytics for Payers Actionable Insights Unity MDI Initial Launch MDI Next Generation Automated Insulin Delivery (AID) AutonomyUnity (NextGen) Conceptual Rendering. Product under development and not for sale in the Unite * Insulin pens prescribed and obtained separately
  20. 20. @facebook/BigfootBiomed @BigfootBiomed

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