Document 335676
(Nasdaq: ECTE) Corporate Presenta,on October 2014 © 2014 Forward Looking Statements Any statements contained in this presenta?on that do not describe historical facts may cons?tute forward-‐ looking statements as that term is defined in the Private Securi?es Li?ga?on Reform Act of 1995. Any forward-‐ looking statements contained herein are based on current expecta?ons of Echo Therapeu?cs, Inc. ( Echo ), but are subject to a number of risks and uncertain?es. The factors that could cause actual future results to differ materially from current expecta?ons include, but are not limited to, risks and uncertain?es rela?ng to Echo's ability to develop and obtain FDA approval of its Symphony® CGM System; the availability of substan?al addi?onal equity capital to support Echo’s research, development and product commercializa?on ac?vi?es; and the success of Echo’s business, research, development, regulatory approval, marke?ng and distribu?on plans and strategies. These and other factors are iden?fied and described in more detail in Echo’s filings with the SEC, including, without limita?on, its annual report on Form 10-‐K for the year ended December 31, 2013, its quarterly report on Form 10-‐Q for the quarter ended June 30, 2014 and its current reports on Form 8-‐K. Echo disclaims any intent or obliga?on to update these forward-‐looking statements. 2 © 2014 Confidential and Proprietary Echo Overview Echo Therapeu?cs is a publicly traded (Nasdaq: ECTE) medical device company with exper?se in the u?liza?on of non-‐invasive and wireless technologies Symphony® CGM System § Non-‐invasive skin permea?on § Wireless data transmission § Con?nuous glucose display Poten,al Applica,ons: § Hospital-‐based glucose control § Type1/Type 2 Diabetes § Drug penetra?on enhancement § Other analyte measurement 3 © 2014 Confidential and Proprietary Echo Highlights § Strategic plan to transform Echo and posi?on it for long-‐term growth § Significant and growing global market opportunity § $1+ billion in hospital-‐based glucose monitoring § ~$10 billion global outpa?ent glucose monitoring market § Addi?onal opportuni?es in other diagnos?cs and drug delivery § Clinically validated § Mul?ple studies with consistent, favorable results § Extensive U.S. and interna?onal IP porjolio § Partnership opportuni?es 4 © 2014 Confidential and Proprietary Clinical Need: Glycemic Control § Hyperglycemia is common in cri?cally ill pa?ents (stress hyperglycemia), even in those with no previous history of diabetes, including: § Approximately 28% glucose values >180mg/dL in cri?cally ill pa?ents1 § Post-‐surgical pa?ents, sep?c pa?ents, trauma pa?ents § Hyperglycemia contributes to poor pa?ent outcomes and higher pa?ent mortality § Tight Glycemic Control (TGC) significantly reduces: § Pa?ent mortality2 § Complica?ons and infec?on rates3 § Hospital stays, services and overall hospital costs2 § Current episodic methods limit the ability to detect and avoid dangerous hypoglycemic excursions 5 1 Alere Annual Hospital Glucose Audit 2013 2 Van der Berghe et al, NEJM 2001; 345 1359-1967 3 Sadhu A.R. et al, Diabetes Care. 2008 August; 31(8): 1556-1561 © 2014 Confidential and Proprietary Glucose CGM: Mee?ng an Unmet Need Target Range CGM Threshold Alarms Intermiment glucose measurements Glucose Excursions Time § § § § § Intermiment blood glucose measurements leave gaps of ?me and data between measures CGM gives a greater view of glucose trends and the direc?on glucose levels are going Threshold alarms help reduce hypo-‐ and hyperglycemic events. CGM serves as a tool to detect and/or avoid dangerous glucose excursions CGM ICU studies have shown 10% reduc?on in hypoglycemic episodes1 1 6 © 2014 Confidential and Proprietary Holzinger, U. Diabetes Care 33: 467-‐472, 2010 Hospital CGM – Market Need § Current TGC methods are burdensome and costly: ~2 hours/day1 and $200/day per pa?ent2 § Improved pa,ent outcomes with Tight Glycemic Control (TGC)3: § § § § 46% reduc?on in incidence of sepsis 41% reduc?on in renal failure 50% reduc?on in blood transfusions 34% reduc?on in mortality § Financial benefit to hospital of cri?cal care glucose control: § $1,5804 to €2,6385 per pa?ent 1 2 3 4 5 7 © 2014 Confidential and Proprietary Aragon D. Am J Crit Care. 2006 Hilleman D. Semin Thorac Cardiovasc Surg. 2006 Van den Berghe. NEJM. 2001 Krinsley JS. Chest. 2006 Mar;129(3):644-‐650 Van den Berghe. Crit Care Med. 2006 Mar;34(3):612-‐6 $1+ Billion Hospital Market Potential Es?mated global market for hospital-‐based CGM of $1+ Billion ~80% 30 million 100,000 18 million 60,000 40% 8 © 2014 of U.S. and EU hospitals have TGC protocols1,2 U.S. cri?cal care pa?ent days/year3 U.S. cri?cal care beds4 EU cri?cal care pa?ent days/year3 EU cri?cal care beds4 of ICU pa?ents are poten?al target for CGM Confidential and Proprietary § Es?mate assumes $100/day cost 1 Boston Biomedical Consultants (BBC) 2007 Survey 2 Sharpe et al., ESICM Poster. 2011 3 Assumes 80% occupancy 3 Halpern et al., Crit Care Med. 2010 4 Pearce, R (EUSoS). Lancet. 2012 Symphony® CGM Glucose Monitoring System Symphony® SkinPrep Glucose Sensor & TransmiHer § Removes outer-‐layer of dead skin, or stratum corneum, to access glucose § Electro-‐chemical glucose sensor § Patented feedback control mechanism for op?mal skin permea?on 9 © 2014 § Bluetooth transmimer § Affixed to prepared skin § Non-‐invasive and wireless Confidential and Proprietary Wireless Remote Monitor § Graphical display of glucose trend data § Customizable early-‐warning alarms for hypo-‐ and hyperglycemia Ideal CGM* § Rapid: very limle lag between blood glucose and the measured value § Accurate: within FDA accuracy guidelines Symphony -‐-‐-‐ Stratum Corneum § § Free of interferences: no interferences such as drugs or physiologic perturba?ons Inert: no reac?on with the ?ssue or forma?on of coa?ng rendering the device inaccurate over ?me § Robust: ability to perform within dynamic and busy intensive care unit and opera?ve setng § Lack of invasiveness: minimally to § Capillary Bed noninvasive to eliminate risk of infec?on, thrombosis, etc. -‐-‐-‐ Epidermis -‐-‐-‐ Dermis Other --- approved subcutaneous CGMs -‐-‐-‐ Subcutaneous Fat Cost-‐effec,ve: inexpensive in comparison with frequent laboratory glucose measurements * Rice/Coursin. Anesthesiology. 2012 10 © 2014 Confidential and Proprietary Symphony – Clinical Summary § November 2013 Clinical Trial: § § § § § § 32 post-op surgical patients in four hospital ICUs 634 data points compared to YSI analyzer reference glucose measurements 12.5% Mean Absolute Relative Difference (MARD) Accuracy consistent in 0-8 hr, 8-16 hr and 16-24 hr ranges 99.4% combined A+B zones, Continuous Glucose-Error Grid Analysis (CG-EGA) Posters presented at ISICEM conference, March 2014 and ADA, June 2014 § Multiple studies completed in healthy, diabetes & critically ill § More than 100 patients monitored § ~900 data points § 11.9% average MARD § 98.2% CG-EGA average A+B § No safety concerns identified 11 © 2014 Confidential and Proprietary Gen 2 Enhancements § Update algorithm and calibration schedule specific to ICU § Sensor modification to address IV Acetaminophen interference § Skin-Sensor interface upgraded to improve consistency § Maximize warm-up period and calibration frequency § Maintained consistent responsiveness for at least 24 hours, and eventually longer (48/72 hours) 12 © 2014 Confidential and Proprietary Symphony CGM System Revenue Model Disposable Components § Sensor Module (sensor/transmimer/base) § SkinPrep Tip § Expected main revenue driver Monitor Tip Durable Components 13 § Monitor § SkinPrep © 2014 Sensor Module Confidential and Proprietary SkinPrep Posi?ve reac?ons to Symphony ® CGM in EU and U.S.* % Agree (sum) 80% 77% Symphony CGM would be an improvement on current glucose monitoring methods Symphony CGM would improve overall outcomes 83% 75% Symphony CGM would have a posi?ve impact on blood glucose control Symphony CGM’s needle-‐free and non-‐invasive Sensor is a highly valuable feature 0% 91% 91% 96% 90% 20% US Europe Europe: Crea?ve Medical Research Survey, June-‐July 2013. 20 minute online self-‐comple?on survey with N=100 ICU Nurses and Physicians. US: RNsights Survey, Sep 2013. Online survey with N=100 ICU nurses • 14 © 2014 Confidential and Proprietary 40% 60% 80% 100% Catalysts Milestone Gen 2 Clinical Study – Human Factors Gen 2 ICU Study Gen 2 Clamping Study CE Mark/FDA PMA Pivotal Trial Ini?a?on CE Mark Trial Comple?on/Technical File Submission CE Mark Approval EU Launch Ini?ate FDA PMA Pivotal trial Complete FDA trial and file PMA 15 © 2014 Confidential and Proprietary Poten?al Monitoring & Delivery Systems Hospital CGM Type 1/Type2 Diabetes Clinical Monitoring Wearable Health Tech Drug Delivery Insulin Pump Integra?on 16 © 2014 Confidential and Proprietary Strategic CGM Posi?oning Opportuni?es § Hospital CGM § Hospital (ICU/general wards/hospitalized diabe?cs) § Integra?on with vital signs monitors § Insulin dosing soxware § Type 1/Type 2 Diabetes CGM § Longer dura?on sensor life, reusable transmimer, mobile receiver/SmartPhone App, charging dock § Professional use (new CGM users, Endocrinologist offices) § Integra,on with insulin pump § Gesta,onal Diabetes 17 © 2014 Confidential and Proprietary Strategic Product Posi?oning Opportuni?es (Transdermal Drug and Analyte Applica?ons) § Transdermal drug penetra,on enhancement § § § § Rapid uptake of drugs axer skin prepara?on Combina?on product with high margin Lidocaine product tested with posi?ve clinical results SkinPrep customized for drug specific performance § Analyte Measurement (other than glucose) § Ideal for elements in inters??al fluid that change frequently § Custom sensor and user interface soxware § Leverage Symphony system design & many components 18 © 2014 Confidential and Proprietary Intellectual Property § Broad Intellectual Property Estate § 8 U.S. patents, ~70 foreign patents, ~25 patents pending worldwide § Most issued core patents expire mid-‐ to late-‐2020s § Method and Device Patents cover a broad range of applica?ons: § Glucose sensor and methods § Transdermal analyte extrac?on and measurement § Electronic feedback control mechanism for precise skin permea?on § Transdermal drug delivery 19 © 2014 Confidential and Proprietary Company Snapshot Ticker Headquarters Employees Market Capitalization Philadelphia ~6 ~$10 million Share Price (9/26/2014) $0.77 3-Month Average Volume ~99,000/day Common Stock 12.7 million Fully Diluted Shares 17.3 million Cash and Cash Equivalents (6/30/2014) $4.1 million Long-term Debt 20 Nasdaq: ECTE © 2014 Confidential and Proprietary $0.0 Thank you for more informa\on: visit www.echotx.com or Contact Investor Rela?ons: Chris?ne Olimpio – [email protected] 21 © 2014 Confidential and Proprietary
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