first warning systems, inc. breast health predictive analytics medical device us/eu/russia business...
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First Warning Systems, Inc.Breast Health
Predictive Analytics Medical DeviceUS/EU/Russia Business Plan
September 2012
Confidential & Proprietary
2
Women’s Breast Health Screening TechnologiesProblem 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
3
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
4
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
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
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 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
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
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
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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.
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
11
Milestones
Date Milestone
Q4, ’12 Finalize Distribution Partners
Q4, ’12 Complete Product Upgrades
Q4, ’12 Finalize Technical File
Q4, ’12 Submit CE Mark Application
Q4, ’12 Secure Hungary & UK Clinical Locations
Q1, ’13 Begin Clinical Limited Use
Q2, ’13 Document Clinical Results
Q2, ’13 Begin Manufacturing
Q2, ’13 Complete CE Application
Q2, ’13 Begin EU/Russia Sales
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Milestones (Cont.)
Date Milestone
Q3, ‘13 Secure Grant for US FDA Trial
Q4, ‘13 Start Limited FDA Clinical Trial
Q4, ’14 Complete US Market Clinical Trial
Q4, ’14 Sign US Distributor(s)
Q4, ‘14 Submit 510 (k) Application (3-6 Mo. Clearance)
Q1, ’15 Start US Sales or Liquidity/Exit Potential
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 2,508 7,453 21,267 32,429
# of Russian 1,755 5,217 14,887 22,700
% Docs Capture-EU* 1.6% 5.2% 11.1% 14.7%
# of Docs-US 3,606 11,721
% Docs Capture-US* 1.6% 5.2%
# Uses: EU & US* 84,950 798,245 2,504,898 4,211,578
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Pro Forma ProjectionsEurope, 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
15Source: 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. 2015 revenues of $200M based on 3% acceptance.
1Not
at All
5Def.
2.9
Avg.
PCP(n=10)
1Not
at All
5Def.
3.2
Avg.
OB/GYN
(n=14)
0% 10% 20% 30% 40% 50%
4%
8%
13%
17%
42%
46%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
16Source: 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
LOW Risk HIGH Risk0%
20%
40%
60%
80%
100%
120%
29%
8%
42%
50%
17%
8%4%4%
8%
29%
Once every > 3 years
Once every 3 years
Once every 2 years
Annually
Biannually
>2 per year
Would not recommend
Perc
enta
ge o
f R
esp
ondents
17Source: 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
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Jim Holmes – CEOjholmes@FirstWarningSystems.com775-852-3222
First Warning Systems, Inc.1325 Airmotive Way, Ste. 175Reno, NV 89502775-324-3822
www.FirstWarningSystems.cominfo@FirstWarningSystems.com
Confidential & Proprietary
Additional Information
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