CRE Medical Final NSF I-Corps Presentation

1. CREmedical
C
What can CREmedical do?
•Bring EEG into the 21
st
century with a new platform.


•194 individuals talked to.
•Changed from one main product to product mix.
CREmedical
“Seeing the Unseen”
Then
Now

2. CREmedical
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Principal Investigator – Walter Besio
Over 12 years industry experience
Over 14 years CRE experience
Entrepreneurial Lead – Xiang Liu
Worked with tEEG since 2008
M.S. in Physical Electronics
Mentor – Jim Petell
Over 20 years of business experience
Start-up to large corporate companies

3. CREmedical
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Initial Idea –
Manufacture, sell, and service tEEG front-end
By 2015
•Total physiological monitoring
equipment (TAM): $4.6 B
•EEG & EMG (SAM): $1 B
•EEG: $500M
SAM $1 B
TAM $4.6 B
EEG
Target
$500 M

4. CREmedical
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The Business Model Canvas V1
Manufacturers
Distributors
Parts Suppliers
Product
Development
End User
Acceptance
FDA Approval
IP Protection
ISO Certified
Manufacturing
Product
Development Team
Financing
Improved Product
Performance
Unmet Needs
Usability
End Value to
Customers
End User Clinicians
Hospitals
Distributors
Device Distributors
Medical Supply
Distributors???
Electrodes???
Physiological
Signal Systems
Sensors???
Development Costs
Cost of Production
Regulatory
Legal
Marketing
Device Systems
Sales
Electrodes: Low
Value???
Sensors : Any
Value?
Existing EEG
Markets

5. CREmedical
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Who Did We Talk To…
•Robert Fisher – Head Epilepsy Center Stanford
•Andrei Medvedev – Director EEG and Optical Imaging
Laboratory, Georgetown University
•EEG electrodes distributor
•Research/Education neurophysiology equipment
distributor
•Sales Manager Electro-Medical
•Electrodes and sensor manufacturer
•Steve Schachter – Past President American Epilepsy
Society
Customers
175
Channels
15
Partners
4

6. CREmedical
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Why are we better than competition…
Movement artifact eliminated
•Fact: EEGs are not used as a stand alone.
•Proprietary tripolar interface exceeds
traditional disc electrode performance:
Improved signal to noise ratio (375%).
Improved spatial selectivity (257%).
Reduced overlap information (only 8.3%).
Them Us

7. CREmedical
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The Business Model Canvas V4
Manufacturers
Value Added
Resellers
Parts Suppliers
Product
Development
End User
Acceptance
FDA Approval
IP Protection
ISO Certified
Manufacturing
Product
Development Team
Financing
End User Clinicians
Hospitals
Development Costs
Cost of Production
Regulatory
Legal
Marketing
Foundations
Associations
Societies
Early Adoptors
Improved SNR
Improved Specificity
Improved Spatial
Resolution
Improved Sensitivity
End User
Researchers
Device Value
Added Resellers
Device Retailers /
Resellers
Neurologists,
Neurosurgeons,
Psychologists,
Audiologists,
Neuroscientists
Anesthesiologists
Existing EEG
Markets
Research Systems
Tripolar EEG Front End
Retrofit Sales
Tripolar EEG Front End
New Sales
Electrode
Replacement Sales
Device Value
Added Resellers
Medical Supplies
Retailers DMS
Distributors
Improved Product
Performance
Unmet Needs
Usability
End Value to
Customers
Distributors
Clinical Systems

8. CREmedical
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Neurologist
EEG
Diagnostic
Neurology
Dept
Hospital
Admin
Insurance
Patient
Workflow for Clinic But… Pivot???
•EEG device replaced 5-10 years..
•Our interface price is $3,300. Electrode set price is $600.
•Hospital insurance billing: >$300,000 annually per EEG.
•Question: How can you capture revenue from each test?

9. CREmedical
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Neurologist
?
EEG
Diagnostic
OR Surgery –
Anesthesiologist
Hospital
Admin
Patient

10. CREmedical
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Neurologist
EEG
Diagnostic
OR Surgery –
Anesthesiology
Hospital
Admin
DMS
Disposable
Patient
“New Market Segment”– Pivot
•EEG used in OR require sterility >>> sterile sensors.
•Over 4,000 ORs in the US.
•Disposable sterile sensors are replaced every test!
•Hey… we are in the “ink jet printer / cartridge business”.

11. CREmedical
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How Pivot changed the market opportunity …
•Gross revenue increased to $163MM at Year 10 with
21% margin.
924,000 units sold Yr 10
18,000 units sold Yr 10
BUT….
75,000 units in use
& more counting

12. CREmedical
C
The Business Model Canvas V5
Manufacturers
Value Added
Resellers
Parts Suppliers
Product
Development
End User
Acceptance
FDA Approval
IP Protection
ISO Certified
Manufacturing
Product
Development Team
Financing
End User Clinicians
Hospitals
Development Costs
Cost of Production
Regulatory
Legal
Marketing
Foundations
Associations
Societies
Early Adoptors
Improved SNR
Improved Specificity
Improved Spatial
Resolution
Improved Sensitivity
End User
Researchers
Device Value
Added Resellers
Device Retailers /
Resellers
Neurologists,
Neurosurgeons,
Psychologists,
Audiologists,
Neuroscientists
Anesthesiologists
Existing EEG
Markets
Research Systems
Tripolar EEG Front End
Retrofit Sales
Tripolar EEG Front End
New Sales
Electrode
Replacement Sales
Device Value
Added Resellers
Sterile Disposable
Sensor Sales
Medical Supplies
Retailers DMS Sterility
Distributors
Improved Product
Performance
Unmet Needs
Usability
End Value to
Customers
Distributors
Operating Rooms
Clinical Systems

13. CREmedical
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Distribution Channels
Contract
Manufacturer
Laboratories
Scientists
VAR
Interface
VAR / DMS
Electrodes
Hospitals
Admin
Neurologist
Anesthesiologist
Stock
Product
CREmedical
DMS
Disposable
Channel Customers

14. CREmedical
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•Our platform is readily used for ECG in cardiac
diseases and for EMG in neuromuscular disorders.
•The total neurophysiological market in 2015 grows
to $4.6 B for all “E-testing” (TAM).
TAM $4.6 B
Initial
Target
$500 M

15. CREmedical
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Why Invest
Increased sensitivity and performance over current
products.
Customers, VARs and DMSs want product.
Diverse revenue streams.
Scalable, platform technology.
Fast time to market (<2 years).
Platform potential for treatment of epilepsy, pain and
neurological disorders.

16. CREmedical
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“What We Are Going To Do”
Build 20 prototypes for early adopters and
earlyvangelist to validate product.
Submit SBIR.
Finalize VARs and DMSs partners to sell product.
Work with key manufacturing partners to scale up
production.
FDA 510k.
Go after new opportunities for treatment.