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First Warning Systems, Inc. Breast Health Predictive Analytics Medical Device US/EU/Russia Business Plan September 2012 Confidential & Proprietary.

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Presentation on theme: "First Warning Systems, Inc. Breast Health Predictive Analytics Medical Device US/EU/Russia Business Plan September 2012 Confidential & Proprietary."— Presentation transcript:

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2 First Warning Systems, Inc. Breast Health Predictive Analytics Medical Device US/EU/Russia Business Plan September 2012 Confidential & Proprietary

3 2 Women’s Breast Health Screening Technologies Problem Overview Current 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

4 3 Women’s Breast Health Screening Technologies Unmet Market US, 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

5 4 Women’s Breast Health Screening Technologies Strategy to Capture Unmet Market Expand Screening Market to women ages 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

6 5 Women’s Breast Health Screening Technologies First Warning Systems Problem Solution Technology 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

7 6 Women’s Breast Health Screening Technologies First Warning Systems Problem Solution Process Predictive Analytics Minimizes Human Subjectivity Has Been Shown to Predict Six Years Prior to Imaging Technologies Increased Usage –Can be used monthly from ages –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

8 7 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

9 8 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

10 9 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.

11 10 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

12 11 Milestones DateMilestone Q4, ’12Finalize Distribution Partners Q4, ’12Complete Product Upgrades Q4, ’12Finalize Technical File Q4, ’12Submit CE Mark Application Q4, ’12Secure Hungary & UK Clinical Locations Q1, ’13Begin Clinical Limited Use Q2, ’13Document Clinical Results Q2, ’13Begin Manufacturing Q2, ’13Complete CE Application Q2, ’13Begin EU/Russia Sales

13 12 Milestones (Cont.) DateMilestone Q3, ‘13Secure Grant for US FDA Trial Q4, ‘13Start Limited FDA Clinical Trial Q4, ’14Complete US Market Clinical Trial Q4, ’14Sign US Distributor(s) Q4, ‘14Submit 510 (k) Application (3-6 Mo. Clearance) Q1, ’15Start US Sales or Liquidity/Exit Potential

14 13 Clinical Channel Capture Rate* % Capture per Independent LSSG Primary Market Research Survey 126 uses per Yr per Clinician* ’13’14’15‘16 # of Docs-EU 2,5087,45321,26732,429 # of Russian1,7555,21714,88722,700 % Docs Capture-EU* 1.6%5.2%11.1%14.7% # of Docs-US 3,60611,721 % Docs Capture-US* 1.6%5.2% # Uses: EU & US* 84,950798,2452,504,8984,211,578

15 14 Pro Forma Projections Europe, Russia & US ($ M) ‘12’13’14’15‘16 Sales $ 11,851$101,545$319,656 $539,783 Expenses $12,544$ 70,818 $215,071$359,285 EBITDA $ (693) $ 30,718 $104,584 $180,499

16 15 Source: Life Science Strategy Group, LLC; Primary Interviews, Web Surveys 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? LIKELIHOOD TO USE PRODUCT X IN CURRENT SCREENING REGIMEN 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 revenues of $200M based on 3% acceptance. 1 Not at All 5 Def. 2.9 Avg. PCP (n=10) 1 Not at All 5 Def. 3.2 Avg. OB/GY N (n=14) Use in parallel with screening mammography Use in parallel with CBEs Use to determine need for screening mammography Use to determine need for CBE Use as replacement for screening mammography Use as replacement for CBEs Percentage of Respondents N=24

17 16 Source: Life Science Strategy Group, LLC; Primary Interviews, Web Surveys 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? USE OF PRODUCT X IN HIGH VS. LOW RISK PATIENTS Approximately 87% of physicians would recommend high-risk patients use Product X at least once a year, compared with 42% for low-risk patients. N=24 Percentage of Respondents

18 17 Source: Life Science Strategy Group, LLC; Primary Interviews, Web Surveys Do you have any final comments regarding Product X? FINAL COMMENTS ON PRODUCT X 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. “I would LOVE to try this technology!” - Primary Care Physician “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 “I've not heard of this technology. I hope this technology comes to market.” - OB/GYN “Niche product, need to see more long term data.” - OB/GYN “Interested in further info. Need studies to back up and need endorsement of American Cancer Society and ACOG.” - OB/GYN

19 18 Jim Holmes – CEO First Warning Systems, Inc Airmotive Way, Ste. 175 Reno, NV Confidential & Proprietary Additional Information


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