Post on 23-Jan-2018
Leading the way to the earliest possible diagnosis of Lung Cancer with new technology for breath analysis.
C O N F I D E N T I A L
Elemental Breath CONFIDENTIAL All Rights Reserved
LUNG CANCER: THE BIGGEST KILLER
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160,000Mortalities every year in US / 1.6M Worldwide
63 millionAt risk in US
318 Million US ADULTS
63M Regular Smokers
20%smokers
Sources: American Lung Association and CDC
2011 data
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EXPENSIVE AND DANGEROUS SCREENING
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Lung Cancer typically has no symptoms until later stages of the disease.
The most common preliminary screening is a low dose CT scan every 3 or 6 months. It is a flawed test that is expensive and introduces radiation. AVERAGE COST: $1500
CT scan is the only currently FDA approved screening test.
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TRAGEDY: 85% NOT CAUGHT UNTIL IT’S TOO LATE
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Stage 1 5 Year Survival70%
Stage 4 5 Year Survival5%
85% OF LUNG CANCER IS DETECTED AT ABOUT STAGE 4 95% DIE WITHIN A YEAR OF DIAGNOSIS
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VOC ANALYSIS IS PROVEN BUT NOT SCALEABLE
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• Microanalysis of breath using mass spectroscopy invented in 1970s and is now a predictably repeatable and accurate science.
• Results take more than 10 hours
• Expensive: Require high vacuums, radioactive sources and pure gases
• Not scaleable, requires lab work with expensive equipment
Studies show breath test to be as accurate as chest CT for predicting lung cancer. Possibly better
REFERENCES: Nature (2015), Analytical Chemistry (2014), Cancer Medicine (2013),
Cancer Cell (2012), American Chemical Society (2012), Nanomedicine (2012), Bristish Jounal of Medicine (2010), British Journal of Cancer (2010), BioMed Central
(2009), Clinica Chimica Acta (2009), American Cancer Society (2007), Journal of
Chromatography (2005)
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PROPRIETARY TECHNOLOGIES
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• 3 International PCT Patents filed• Unique hyper-stable liquid concentrator technology• Already measuring lung cancer targets• Highly accurate tests can detect 100s of targets• Concentrator allows for volume information (critical data) • Ambient / environmental sampling reduces false positives
VOC Activator
VOC Concentrator
VOCSorter
DataAnalytics
We have technology that identifies the broadest range of key markers more reliably, rapidly and cost-effectively than any other methodology.
Elemental Breath CONFIDENTIAL All Rights Reserved
DEFINING LEADERSHIP IN BREATH ANALYSIS TECHNOLOGY
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Elemental(Mass(
Spectroscopy( Colorimetry(Ion(Mobility((Spectroscopy(
Carbon((Nanotube( Metal(Nanopar7cle(
Company(Elemental(Sensor(CA(
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Zenosense(((Spain)(Owlstone(((UK)(
AlphaSzenszor(((Boston)(
Technion(University((Israel)(and(University(of(Denver(Cancer(Center(
Stage( Development( Clinical(Studies( Development(Clinical(Studies( Development( Clinical(Studies(
Ease(of(Use( ✓( 𐄂(( ✓( ✓( ✓( ✓(Instant(results( ✓( 𐄂(( ✓( ✓( ✓( ✓(Detect(specific((VOCs( ✓( ✓( ✓( ✓( 𐄂(( 𐄂((Can(target(all(VOCs( ✓( ✓( ✓( 𐄂(( 𐄂(( 𐄂((Measure(VOC(levels( ✓( ✓( 𐄂(( ✓( 𐄂(( 𐄂((Accuracy( ✓( ✓( 𐄂(( ✓( 𐄂(( 𐄂((
Standardized collection and handling of breath samples is key.This is a core technology unique to Elemental Breath
Series A late 2016 / 2017 Series B 2018
1. Working Model
We are already capturing, concentrating and measuring lung cancer targets.
R&D- Complete prototype concentrator- File additional patents- Complete testing LC molecules- Pilot study at El Camino Hospital
Business Development- Develop medical protocol- Establish pilot study protocol- Locate pilot study partner- Start conversation with FDA
R&D- Develop pre-production prototype- Design clinical trials- Develop data warehouse
Business Development- File PMA request with FDA- CPT- Conduct pilot study- Refine medical protocol- License technology vs.
manufacture product- Possible strategic capital
CAPITAL REQUIREMENTS: $1M (20% discount / 7% Int.)
Seed 2016
2. Adjunct Test Applications
3. Clinical Trials / FDA 4. Diagnostic Test
R&D- First pilot builds- Refinement of software
Business Development- Sales team in place- Get doctors excited- Insurance coverage supported- Build supply chain- Device manufacturing- Techs and trainers setup- Establish CLIA certified lab- Development of ISFET chip- Possible strategic capital / exit
TIMELINE MILESTONES
CAPITAL REQUIREMENTS: $3-5 M Institutional
CAPITAL REQUIREMENTS: $ 5+ M Institutional
Elemental Breath CONFIDENTIAL All Rights Reserved
TEAM
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Oliver King-Smith, PhDFounder and CEO
Greg JamesCo-founder Business Development
Eric Hoobler, PhDChief Chemist
Bernard SmitVP, Engineering
Murat YukselProject Manager
David LaoneLead Software Developer
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John BarrettMedical and FDA regulatoryCEO CoAlign(Acquired by Stryker)Abbott, Baxter
ADVISORS
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Surendra AroraVice PresidentInFocus
David Cummings Ph.D. Glasgow University and Leader Microsystem Technology Group
Michael Hurlston Executive Vice President, Worldwide Sales, Broadcom
Scott Oliver Ph.D. Professor of Chemistry UCSC,Thin film and surface chemistry
David ShantzEarly Stage New Product MarketingMultiple medical, consumer and tech ventures 15+ exits
Jeannie Chen, MD, MBAActing Chief Medical Officer
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EXPERIENCE
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Management team has a long track record togetherdesigning and launching medical devices
Ventilator Home Health Monitor Glucometer Portable Assay
FlowCytometry
Intravascular Imaging
Portable Ultrasound
VisionTesting
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$4.5B US MARKET / 13B WORLDWIDE
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PHASE ONE: ADJUNCT TESTPrimarily 9,000 Radiologists and Pulmonologists$500 testSimpler 510k FDA regulatory
PHASE TWO: GENERAL SCREENING TEST200k Primary Care Physicians$100 testPart of annual checkup for smokers and over 50
20M at RiskPossible test candidates
9MHigh Risk
65M at General Risksmokers etc.
102Mover 50 years age
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FUTURE VERTICAL MARKETS / APPLICATIONS
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Breast CancerParkinson’s Disease
Pulmonary TuberculosisHeart Disease
Small Intestine Bacterial OvergrowthNecrotizing Enterocolitis
There are a broad range of possibilities for the use of the technologies. Elemental can lead the medical testing market with this minimally invasive testing methodology. Breath can function to give doctors cost-effective and
actionable information that could prove as valuable as genetic or blood testing.
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FINANCIAL PROJECTIONS
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