Cardiogenics Holdings Inc · OTC:CGNH
Cardiogenics — Investor Presentation (2015)
23 slides from Cardiogenics's investor presentation, 2015
Slide 1: CardioGenics Holdings Inc.
CARDIOGENICS HOLDINGS INC. OTCBB:CGNH 2015
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS Certain statements made in this presentation that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and may contain forward-looking statements, with words such as "anticipate, "believe," "expect," "future," "m
Slide 3: The QL Care Analyzer
THE QL CARE™ ANALYZER Chemiluminescence + Whole Blood + solution phase First Point- Of-Care (POC) testing Platform to provide Lab-Like testing results at the POC 3
Slide 4: CardioGenics Holdings Inc.
CARDIOGENICS HOLDINGS INC. • A biotechnology company dedicated to the development of products for the In- Vitro Diagnostics Testing market • Became a public company in 2009 (OTC:BB) • Two operating subsidiaries • CardioGenics Inc. (CGI) founded in 1997 • LuxSpheres Inc., founded in 2007 • Since ince
Slide 5: Team
TEAM MANAGEMENT Yahia A. Gawad, MB.ChB, MD, MSc , Founder, CEO and Director . Dr. Gawad is a Physician/Scientist, primary training in Cardiology, Biochemistry and Immunology. Previously, a co-founder of Syn X and prior to that, Director of Clinical Research at Spectral Diagnostics Inc. For the last
Slide 6: CardioGenics Holdings Inc.
CARDIOGENICS HOLDINGS INC. Ms. Linda J. Sterling, F.Inst.L.C.O., Corporate Secretary/Director. Linda has been managing CardioGenics’ legal affairs since 2003. She is licensed as a Legal Executive (F.Inst.L.C.O.) with the Institute of Law Clerks of Ontario Neil Tabatznik, Acting Chairman. Mr. Tabatzn
Slide 7: Advisory Boards
CARDIOGENICS HOLDINGS INC. Advisory Boards Prof. Robert Roberts, MD, CEO and CSO, Ottawa Heart Institute Prof. William Kostuk, MD, Professor of Medicine, U. Western Ontario 7
Slide 8: Chemiluminescence + Whole Blood + solution phase
THE QL CARE™ ANALYZER Chemiluminescence + Whole Blood + solution phase First Point- Of-Care (POC) testing Platform to provide Lab-Like testing results at the POC 8
Slide 9: The QL Care Analyzer
THE QL CARE™ ANALYZER • A small, portable , Quantitative Immunoassay POC analyzer • Cartridge employs non-metered sample (whole blood/ plasma) • Disposable pre-loaded test cartridge • Quantitative result in 15 minutes • Highly competitive among other POC products 9
Slide 10: The QL Care Analyzer
THE QL CARE™ ANALYZER • Open architecture • New application require no changes to Analyzer/ Cartridge • Device placement in ERs • Consumables business model, disposable cartridge tests • Strong licensing potential • Can be deployed to 200 Human clinical lab immunoassays • Can be deployed for Non-Hum
Slide 11: The QL Care Analyzer
THE QL CARE™ ANALYZER A. High testing SENSITIVITY: B. High testing ACCURACY: • CL-based light emission • walk-away testing- no operator steps • Electronic CL trigger -no moving parts • Self-metering Cartridge (patented) • Photon-counted light emission • No sample processing- Whole blood • Silver-pla
Slide 12: QL Care Analyzer Differentiation
QL CARE™ ANALYZER DIFFERENTIATION High ACCURACY Lab machines for less Low developed regions < 30 min. > 30 min. TIME 12
Slide 13: The QL Care Analyzer Tests
THE QL CARE™ ANALYZER TESTS PRIMARY TEST: • Troponin-I For AMI Detection - $650M US Market OTHER TESTS: • Heart Failure Risk Stratification (HFRS) - $1B US Market • Plasminogen Activator Inhibitor-1 (PAI-1) - $300M US Market • Heart Failure Genomics Risk (HFGS) - $400M US Market 13
Slide 14: Troponin-I
TROPONIN-I • Troponin-I (TnI) testing is the current standard of care (Market size of about $650 million in the US) • Quick/reliable diagnosis of Acute Myocardial Infarction is critical (lives/resources) • Over 95% of market employs central laboratory tests (2.8h) (No POC device delivers results sim
Slide 15: Test Results Required in 30 Minutes
TEST RESULTS REQUIRED IN 30 MINUTES AMERICAN HEART AMERICAN COLLEGE OF ASSOCIATION CARDIOLOGY GUIDELINES Source: Circulation. 1999;100:1016-1030 15
Slide 16: 2.8 Hrs Current Time to Lab Results
CURRENT TIME TO LAB-RESULTS 2.8 HRS AVERAGE TIME FOR HOSPITAL-BASED LAB RESULTS 16
Slide 17: Cost Saving Tool
COST SAVING TOOL 8M patients present with chest pain 1.3M AMI heart attack patients = MILLION PATIENTS =$31B 17
Slide 18: QL Care Troponin-I
QL Care TROPONIN-I • A accurate (lab-quality) POC test for AMI • Treating patients with heart attacks within the “golden hour” • CardioGenics’ data demonstrates sensitivity/accuracy similar to central lab results • Currently in Pilot testing • Rapid Turn-Around-Time to assist in proper patient triag
Slide 19: The QL Care Analyzer Path to Market
THE QL CARE™ ANALYZER PATH TO MARKET PILOT TESTING 510K FDA Trial 200 patients Predicate device (Siemens Centaur XP- TnI) Wayne State University 200 patients Results expected Q1/Q2 2016 Wayne State University Results expected Q2/Q3-2016 19
Slide 20: The QL Care Analyzer Path to Market
THE QL CARE™ ANALYZER PATH TO MARKET Q4 Q1 Q2 Q3 Q4 Complete in-house test adaptation Manufacturing agreement Pilot Testing of QL Care Analyzer TnI Study under FDA Protocol File 510K for US FDA Approval Distribution partner agreement Commercial Launch of TnI (QL Care Analyzer) 20
Slide 21: CardioGenics' Pipeline
CARDIOGENICS’ PIPELINE PRODUCT PILOT TEST 510K TEST COMMERCIAL QL CARE TM Analyzer Troponin-I Follow-on tests 21
Slide 22: Chemiluminescence + Whole Blood + solution phase
THE QL CARE™ ANALYZER Chemiluminescence + Whole Blood + solution phase First Point- Of-Care (POC) testing Platform to provide Lab-Like testing results at the POC 22
Slide 23: Leading In Vitro Diagnostics Company Focused on the POC Market
LEADING IN VITRO DIAGNOSTICS COMPANY FOCUSED ON THE POC MARKET Yahia A. Gawad, MB. Ch.B, MD, MSc Chief Executive Officer 2015