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First Warning Systems, Inc. Breast Health Predictive Analytics Medical Device US/EU/Russia Business Plan September 2012. Confidential & Proprietary . Women’s Breast Health Screening Technologies Problem Overview Current Technologies.
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First Warning Systems, Inc. Breast Health Predictive Analytics Medical Device US/EU/Russia Business Plan September 2012 Confidential & Proprietary
Women’s Breast Health Screening TechnologiesProblem OverviewCurrent Technologies • Breast Health Screening Process Broken using Screening Mammogram • Not Effective: < age 40 because of dense tissue • Mammogram 70% accurate published statistic for limited population ages (40-70) • 6.4% of women under age 44 (NCI data) die from breast cancer • 37.5% of women over age 70 (NCI data) die from breast cancer • Uncomfortable: 33% do not test according to ACOG/ACS recommendations • Toxic: repetitive mammogram screening causes excessive radiation exposure • Over 750,000 potentially unnecessary biopsies annually US • Accessibility • Imaging center economics limit number of locations • Too expensive for developing countries • Thermography & Screening Mammogram rely on: • Static Imaging with subjective interpretation • Skin Surface Temperature or Image is not Deep Tissue Cell Microenvironment • Surface Skin Screening Misses Typical Tumor: approximately12 years old when large enough to image
Women’s Breast Health Screening TechnologiesUnmet MarketUS, EU, Russia • Total Addressable Annual Market: $12.8B • Total Available Market: $11B • Total Capturable Market: $540M (Reference LSSG Market Research & Sales Forecast) • Plus Asia, India and South America • Plus Developing Countries • Reusable Garment Technology • Telemedicine
Women’s Breast Health Screening TechnologiesStrategy to Capture Unmet Market • Expand Screening Market to women ages 20-40 and Over 70 • Expand Screening through Clinicians • 90% of current screening done by OBY/GNs (37,000-US) • Primary Care (82,000-US) & Internists (106,000-US) could use FWS—no special training required • Predictive Analytics Software Delivers Objective & Quantified Clinical Decision Support • Can order more Frequent Monitoring because not Toxic • Expand Market for Repetitive Use • 33% of Women Do Not Complete Mammography Clinical Order in Annual Physical • Non-toxic Comfort Encourages Repetitive Use Beyond Physical • Breast Health Subscription Service Tracks Repetitive Use
Women’s Breast Health Screening Technologies First Warning Systems Problem SolutionTechnology • Dynamic Cell Chaos Measurement • Abnormal cell deterioration in Circadian Clock Function • 9,600 deep tissue temperature data points • Currently at a 12 hour measurement period of cell Microenvironment • Temperature change over the testing period • Predictive Analytics Software Develops Comparison Classification of Deep Tissue Cell Microenvironment • Predicts Cancer Probability with 90% Accuracy in Clinical Trials • Secure Internet Delivery (HIPPA Compliant) of Predictive Analytics Report • Non-Invasive, Non-Toxic, No Compression & No Radiation
Women’s Breast Health Screening Technologies First Warning Systems Problem SolutionProcess • Predictive Analytics Minimizes Human Subjectivity • Has Been Shown to Predict Six Years Prior to Imaging Technologies • Increased Usage • Can be used monthly from ages 20-70 • Increased Annual Physical Usage because discrete, more comfortable and affordable • Secure Internet Delivery (HIPPA Compliant) of Predictive Analytics Report • Remote Unserved Population Availability • Imaging Center Not Needed—Both Domestic & Developing Country Economics • Telemedicine Can be Used
Technology Status • Patents • One Hardware, Three Software: Device, Method, & System • FDA 510K Approval on Hardware • Three Clinical Trials Completed • Over 650 Women • Achieved 90% Accuracy • Fourth Generation Upgrades in Process • Device for Modified 510(k) Currently in Place • Integrated Software with Predictive Analytics • Cloud Computing Service Model Designed • European Market CE Mark • No Further Clinical Trials Required • Technical File Completion in Process for CE Application • CE Approval Process to be Managed by Identified EU Market Strategic Partner • FDA Limited Trial for US Market After EU Revenues
Marketing Status • Independent Primary Market Research Completed by Life Sciences Strategy Group focused on U.S. Market only • 83% of consumers stated they would use the device • 60% of Clinicians stated they would use Overall • 87% of Clinicians stated they would use with High Risk Patients • Average Clinician usage 126 times per year • EU & Russia Marketing & Distribution Partner Identified • Negotiations to be completed Q4, ‘12
Team and Advisors • COB, CFO, Acting CEO - Jim Holmes • Director Research, Chief Scientist, and Founder - Dr. Bill Reeves, Ph.D • VP & Medical Director - Dr. Louis Keith, M.D., Ph.D. • Senior Medical Advisor - Kefah Mokbel, M.D., M.A. • Senior Business Advisor – Nola Masterson of Science Futures, Inc. • Senior Business Advisor – Larry Udell of Licensing Executives Society • Technical and Operations Consultant - Matthew Benardis • Marketing and Risk Management Consultant - Dave Wertzberger • Controller - Fred Schiemann • Chief Software/Technical Consultant - Roger Warren • Predictive Analytics Software Consultants - Lytix Inc.
Team Gaps • CEO Expertise • Medical Device • Worldwide Device Marketing • Female • VP Marketing • Medical Device • Worldwide Device Marketing • Female • Chief Technology Officer • Software Executive • Cloud Computing Database • Key Opinion Leaders • Europe • US
Clinical Channel Capture Rate* % Capture per Independent LSSG Primary Market Research Survey 126 uses per Yr per Clinician*
Physicians are somewhat likely to include Product X in their current screening regimen, most likely use it in parallel with mammography or CBEs, but not as a replacement. The Avg. shows 60% acceptance. 2015 revenues of $200M based on 3% acceptance. LIKELIHOOD TO USE PRODUCT X IN CURRENT SCREENING REGIMEN 2.9 PCP (n=10) 1 Not at All 5 Def. Avg. 3.2 OB/GYN (n=14) 1 Not at All 5 Def. Avg. N=24 Percentage of Respondents Using a scale of 1 to 5 (1 = Not at All, 5 = Definitely), how likely would you be to use Product X as part of your breast cancer screening algorithm? Where would Product X fit into your breast examination algorithm? Source: Life Science Strategy Group, LLC; Primary Interviews, Web Surveys
Approximately 87% of physicians would recommend high-risk patients use Product X at least once a year, compared with 42% for low-risk patients. USE OF PRODUCT X IN HIGH VS. LOW RISK PATIENTS Percentage of Respondents N=24 How often would you recommend a LOW-risk patient to use Product X? How often would you recommend a HIGH-risk patient to use Product X? Source: Life Science Strategy Group, LLC; Primary Interviews, Web Surveys
Comments on Product X are generally positive or neutral and reiterate the need for additional clinical data as well as support from ACS and ACOG. FINAL COMMENTS ON PRODUCT X “I've not heard of this technology. I hope this technology comes to market.” - OB/GYN “It sounds like a promising technology, but I think it needs more clinical trials and it needs to show that it changes outcomes. I would love to see that it does those things! If it does, then I would welcome a non-invasive, painless, radiation-free technology.” - Primary Care Physician “Niche product, need to see more long term data.” - OB/GYN “I would LOVE to try this technology!” - Primary Care Physician “Interested in further info. Need studies to back up and need endorsement of American Cancer Society and ACOG.” - OB/GYN Do you have any final comments regarding Product X? Source: Life Science Strategy Group, LLC; Primary Interviews, Web Surveys
Additional Information Jim Holmes – CEO jholmes@FirstWarningSystems.com 775-852-3222 First Warning Systems, Inc. 1325 Airmotive Way, Ste. 175 Reno, NV 89502 775-324-3822 www.FirstWarningSystems.com info@FirstWarningSystems.com Confidential & Proprietary