Cyrcadia Health - Health & Wearable Singapore 2015 - The Propell Group
1. The Internet of Things (IoT)
Wearable Breast Cancer Screening
Enabling personalized wellness screening through
telemedicine and improved patient access
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2. 2
Julien
de SALABERRY
Experienced regional head and
GM. 15+ years in healthcare with
leading brands including Eli Lilly,
Boston Scientific, Baxter, GSK,
Merck & Co. Significant Asia Pacific
Experience.
The Propell Group is a boutique
venture investor and adviser firm
focused on early stage companies
in healthcare technology
Co-Author of iDisrupted
Founder & CIO Ÿ The Propell Group
M: +65 9488 7334
julien@propellgroup.biz
@enquirepropell
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
3. • Breast cancer is the 2nd
most common cancer in
the world and, by far, the
most frequent cancer
among women with an
estimated 1.67 million
new cancer cases
diagnosed in 2012 (25%
of all cancers)
• Early detection
screenings are critical to
saving lives, but often fail
to catch the disease
before it’s too late
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
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Quick Facts
4. The Innovation A bra insert.
Using sensor technology
connected to the Internet,
this bra can detect the
earliest signs of breast
cancer.
Much like a Holter monitor,
sensors detect circadian
metabolic changes over
time which are associated
with breast cancer.
This wearable technology
and the data it collects,
represents the power and
potential of Connected
Wearable Devices.
32015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
5. Wearable Grid
(2 to 24 hours)
What We Do
Patient and/or
Doctor
Big Data
Cancer
Analytics
VS.
Mammography
Compression/Radiation 5
Cyrcadia Health
Proprietary Collection Grid
manufactured by:
Smart Device Enabled
Monetizable Global Breast
Cancer Database
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
6. Greatly Improved Dense Tissue
Screening Accuracy
Significant Reduction in
Unnecessary Biopsy Procedures
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
77% 71%
20%
% of False Positive Findings
True Cancer Non-Cancerous Biopsies
83% 83%
60%
83%
48%
83%
MAMMOGRAPHY CYRCADIA HEALTH
% Accuracy
Fatty Tissue Moderate Density High Density
Key Medical Improvements
• 1.2M biopsies on normal tissue @ $1,500 average
cost occurs as a result of mammography annually
• 57% improvement by CH = $1.026B Annual Savings
and 684,000 less biopsies in the US
• Women with dense breast tissue have a significantly
higher propensity for cancer
• Mammography accuracy is greatly reduced with density,
down to 48% accuracy with the densest of tissue
• Cyrcadia provides a tissue agnostic solution
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2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
7. 1. Personalized Medical Health Care Screening
– Automated discrete physician alert to early cancer state
– Dense tissue screening alternative for 45% of female population
– Additive screening source to reduce 80% unnecessary biopsies
2. Replaces Monthly Self Breast Health Exam
– Non-compressive, non-irradiative screening
– Home-based breast screening for earliest possible detection
– Connected health to physician, family and friends ensures use
3. Cyrcadia Health Breast Cancer Research Portal
– Global breast cancer screening BIG Database is highly valuable
to insurance, research, medical industry and university settings
– Early detection data combined with existing commercial
databases will yield greater understanding of cancer inception
and treatment alternatives
Why Cyrcadia Health
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2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
8. The Product Roadmap
Correlation Sensor Grid
Clinical Trials
Life Science (Hospital) – Screening
Wellness (Over The Counter) - Screening
Life Science – Localization
Correlation Sensor Grid
Correlation Sensor Grid
Localization Sensor Grid
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Screen Normal/Abnormal Finding
Original FDA
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
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• Global Genotype / Phenotype Differential
• Familial History Trending
• % Patient Increase via. Personalized Screening
• Global Fatty vs. Dense Breast Tissue Data
• Earliest Predictive Outcomes – All Ages
• Earliest Biomarker Indication Coordination
Cancer Research Portal
Cyrcadia Health Data Repository
*Reference 23andME Recent Partnership with
Genentech / Pfizer and 13 others
The Value is in the Data*
Interested Insurance Partners
Allianz – Germany
Apollo Munich – India
Industry
UniversityGovernment
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
10. Ø 5 Years of Predictive Analytics Research
Ø 3 Patents Issued in 2012 for Analytics
Ø 500 Historical Patient Trials Completed
Ø Original FDA 510K Clearance Achieved
Our Foundation
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2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
11. How We Do…Machine Learning
Big Data
Cancer
Analytics
Engine
Computational Intelligence leverages data sets and statistical
algorithms to create models that predict future outcomes
Case Data
Collection
Training Data
Aggregation
• Historically collected
clinical data–
Demographics,
Circadian Breast
Cancer Profile
(Predictive Attributes),
Biopsy Results (Target
Outcome)
• Preprocess Data –
handle univariate and
multivariate outliers
Model
Development
• Develop the best
model that most
accurately relates
the predictive
attributes and the
target outcome
• Extract the Predictive
Attributes -
Demographics,
Circadian Breast
Cancer Profile
Cyrcadia Library New Case
Case
Characterization
• Apply the best model
derived from the training
data on the case
predictive attributes and
determine the outcome
(cancerous/non-
cancerous)
Performance
Capture
• Calculate prediction accuracy
• Populate big data cancer database
• Improve the current model with the new data – More data
=> better model tuning => higher prediction accuracy!
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
12. Ø $26B Medical Device Manufacturer
Ø Largest Supplier of Wearable Devices
Globally
Ø ISO 13485 and FDA Certified
Ø Intensely Focused on Timing and
Deliverables – Excellent Partnership
Ø Clinical Validation Product
Released – 10/2014
Ø Commercial Product Release –
Prototype projected 8/2016
Product Development
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2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
13. Ø Complies with FDA Early Feasibility
Investigational Device Exemption
Ø Projecting H2 2016 FDA Clearance
Ø 173 BI-RADS 4/5 Patient Trial
Ø To Begin Q2 2015
Ø Project 4-6 Months for Initial Trial
2015 US Final Validation Trial
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2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
14. Asia / European Union
1. CE Regulatory Process
- Defined Time line
- Earliest Revenue Pathway
- Significant Need Exists
2. Distribution Established
- Key Clinical Support Established
3. Interested Insurance Providers
- Apollo Munich Well Care
- Allianz Asian Wellness Link
4. Breast Cancer is #1 Epidemic
- Represents Highest Cancer
Mortality for All Women in Asia
5. Immediate High Scan Volume
- Improved Geno/Phenotype
Valuation to CH Cancer Library
- Significant Value-add to Global
Valuation of CH Core Lab Data
North America
1. FDA Regulatory Clearance
- FDA Improved Process
- Driving to Keep Innovation in US
- Out of Pocket Less than Mammo
2. US Density Legislation has no
screening solution
- Affects 50% of the Population
3. $1.6B current market exists for
improved biopsy screening
- 1.2M Unnecessary Biopsies/yr.
4. Monthly breast exam
suggested by ACS
- Effective Screening Solution
Non-existent Today
- Early Cancer Detection is Key to
Improved Survival Rates
Insurance Reimbursement
1. Dense Tissue Screening
Precedent CPT Codes
- 76645 Ultrasound/Mammo
- Cyrcadia Dense Tissue
- CH Screening Impacts 50% of
Female Population - Pending
FDA Clearance
2. Improved Surgical Outcomes
Precedent CPT Codes
- 77061 Tomosynthesis/Mammo
= 6% Reduction in Biopsy Rate
- With Cyrcadia + Mammo
= 50%+ Reduction in Biopsy
Rate
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Global Launch Sequence
H1 2016
H2 2016
H2 2016
2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
15. Na#onal
University
Hospital
Singapore
LIMITED VALIDATION TRIALS Q4 2015 - Q1 2016 LAUNCH
• TARGETED SCREENING TRIAL AGE 65 AND UP – NATIONAL
UNIVERSITY HOSPITAL (NUH), SINGAPORE
– INTEREST IN PER1 / PER2 REDUCED EXPRESSION IN PRESENCE OF FAMILIAL
OR GENETICALLY PREDISPOSED
• DIRECTED TOWARD ASIAN BREAST CANCER CONSORTIUM –
7 COUNTRIES PARTICIPATING:
– SG, MY, INDO, PH, KR, IN & BRUNEI
• MASS RANDOM SCREENING TRIAL Q4 2015 – APOLLO
HOSPITALS, CHENNAI INDIA
• DISTRIBUTION ESTABLISHED IN SE ASIA, AUSTRALIA AND
THE EUROPEAN UNION
– Advanced Medical Systems in SG
Apollo
Hospital
Group
India
Commercial Launch – Asia
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2015 Cyrcadia Health - www.cyrcadiahealth.com - Proprietary & Confidential
16. Thank
you
&
Apologies
Rob Royea – CEO
rroyea@cyrcadiahealth.com
(408) 334-3496
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