Gastric clip

1. JUMPSTART-ECD PROGRAM 3-MTH PRESENTATIONA collaborative NUS/NTU Joint University Medtech Commercialization Program Gastric Clip- Innovative Surgical Device for Obesity & Metabolic disorders PI: Shahrzad Rayatpisheh Scientist, NTU, SysteMED Co-PI(s): Davide Lomanto Asim Shabbir Bariatric Surgeons, COMS, NUH CC: Vijay Kumar NUS, Enterprise #T7 v1 – Review Presentation (ECD Stage 1)

2. Problem: Diabesity TheTwinEpidemy Obesity • Quality of Life reduced • Co-morbidities • Mortality 2.8 M/y (WHO) • Healthcare cost $147-210 B/yr in US ProjectNo. https://www.hsph.harvard.edu/news/press-releases/diabetes-cost-825-billion-a-year/ Has reached levels that can bankrupt some countries’ health systems! Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4·4 million participants,” NCD Risk Factor Collaboration, The Lancet, April 6, 2016, dx.doi.org/10.1016/ S0140-6736(16)00618-8. Diabetes • Morbidity (hypertension, heart/ kidney failure, amputation) • Mortality: 2.2M (2012), 7th leading cause of death in 2030 (WHO) • Cost $825 B/yr (2016) and growing at astronomical pace • Exponential growth in the disease calls for immediate attention • 600M obese adults worldwide (2014, WHO) • Obesity kills more than famine! • Annual global economic impact of $2 trillion (2014, WHO global GDP, McKinsey)

3. Current Treatments RiskvsEffectiveness ProjectNo. Non-Surgical Endoscopy Surgical Laparoscopy Overall Risk Balloon Excess weight loss 15% 5% 70% 60% Diet & Exercise Medication By-pass Sleeve Endobarrier 50% Lap Band Looked Promising a decade ago Adjustable Complications led to 50-60% removal rate Which one to choose?

4. ProjectNo. 5% 15% 70% 60% Risk 50% Gastric Clip fits in the GAP for a sustainable, effective & reversible approach with fewer complications GAPEffectiveness Year Sleeve Lap Band 2008 7% 43% 2012 35% 15% http://www.weightlosssurgery.ca/why-is-adjustable-gastric-band-surgery-no-longer-offered/

5. Need Based Approach ProjectNo. Gastric Clip replicates the Sleeve Gastrectomy Surgery for reducing the stomach size. Innovative Elements: • Positioning • Fixation points • Designed to allow for adequate blood flow (anti- erosion) • Acknowledging anatomy & physiology (peristaltic movement) of the stomach

6. Comparison Method Gastric By-Pass Sleeve gastrectomy LapBand Endoscopic approaches Gastric Clip Weight Loss Efficiency (First 2 years) 60-70% 60-70% 40-50% 10-15% 50% Sustainability Yes Yes No No Yes Staple line Leak Yes Yes No No No Reversibility Difficult No Yes Yes Yes Ease of procedure Hardest Difficult Easy Easy Easy Recovery 2d hospital 3 weeks soft diet 2d hospital 2 weeks soft diet Day Surgery 2-3 days soft Dry food afterwards Day Surgery 1 week liquid 6 month complex diet Day Surgery 2-3 days soft diet

7. Value Proposition ProjectNo. 3Year- Cost Effectiveness Medical Rx Balloon Band Sleeve By-pass 70% 60% 50% 15% 10% 5% excess wt loss 5K 25K 15K Clip

8. Project Potential Potential Market 21 B 1% penetration Available Market 300M Target Market 21M ProjectNo. Year No of Gastric Clip Total No of Bariatric Surgeries No of Sleeve Gastrectomies No of Gastric Bypass surgeries No of Lap Bands 2013 _ 470,000 173,900 211,500 47,000 2019 6,000 880,000 605,000 176,000 0 http://www.bariatricnews.net/?q=node/1246 https://www.ncbi.nlm.nih.gov/pubmed/25835983 Institute for Health Metrics and Evaluation. http://www.healthdata.org/infographic/obesity-and-overweight-increasing- worldwide Compound annual growth rate (CAGR) of 9.6% between 2013 and 2018 40% 49% 11% 2013 No of Sleeve gastrectomie s No of Gastric Bypass surgeries

9. Regulatory Pathway ProjectNo. QMS Implementation CE HSA Regulatory Documentation FDA

10. Business Model Canvas 10 Key Partners Key Activities Value Propositions Customer Relationships Customer Segments Key Resources Channels Cost Structure Revenue Streams Bariatric Surgeons Morbid Obese patients Aesthetic Surgeries Technically Simple Procedure Long term sustainable Reversible Fewer complications Faster Recovery Manufacturers No resection Advanced Surgery Training Centre (Feasibility Tests) NUH SGH • Technology development and validation • Feasibility test in pig model Intellectual Property Conferences • International Federation for the Surgery Publications International distributors Sales to hospitals • Certifications and Regulatory Approvals • Intellectual Property – application, licensing, renewal • R&D, Clinical Trials

11. Project Status Technology Development Status Lab model verified Regulatory Pathway  Class of device: FDA III (Lap-band PMA number: P000008)  Preliminary Regulatory Pathway : a) Animal study (Second quarter 2018) b) Clinical trial ProjectNo. 2nd Q -2017 3rd Q -2017 1st Q -2018 2nd Q -2018 Simulation & validation Prototype feasibility test Small scale manufacturing Animal study

12. Additional Help & Resources Feasibility test in pig model (Seed fund 90K SGD) Computational study (Finite Elements): Food transport and gastric clip contact pressure ProjectNo. Item Budget SGD Computational simulation study (Basic performance) 20,000 Computational simulation study (Verification) 20,000 Manpower cost 160,000 Small Scale manufacturing 200,000 Animal test 250,000 Clinical trial 750,000 Regulatory approval (FDA, CE, HSA) 100,000 Total 1,500,000

13. Thank You Project No.