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Touch Spot
Dried Blood Spot Collection
Device
Collaboration between Simplexity
Product Development and Oregon
Health & Science University
1
Confidential. All Rights Reserved
Executive Overview
Touch Spot is a simple device to collect a small, accurate volume of
blood with precision from a single finger/heel prick.
•
Can be easily used by patients of all ages and still works even if the skin
touches the device.
Chronic diseases require repeated blood tests (most often using venipuncture)
to monitor success of therapeutic interventions.
Proposed
Current
Repeated
Venipuncture draws:
• Technically difficult
• Painful
• Traumatizing
• Expensive
• Interfere with daily
activities
Touch Spot
Confidential. All Rights Reserved
2
Unmet Need – A Better Way to Collect Blood
•
People need a way to collect blood for
therapeutic monitoring other than
venipuncture.
•
Dried blood spot (DBS) testing common in
newborns since the 1970s and is similar to
at-home glucose monitoring.
•
Over 800,000 clinical visits per year
eliminated using DBS testing in solid organ
transplants in the USA alone. Number is
dwarfed by total blood collection market.
•
Affordable Care Act mandates changes: low
cost monitoring of patients to prevent
hospitalizations and improve outcomes
(lowering medical costs).
•
Other DBS devices exist but are suited for
use in the lab, not home use.
Other uses:
• Cancer
• Infectious diseases such as:
• HIV/Aids
• Ebola
• Chronic diseases such as:
• Epilepsy
• Cystic Fibrosis
• Drug rehabilitation
• Epidemiological purposes
• Research
• Remote Testing
• Developing Countries
• Veterinary medicine
Potential market far exceeds
current target segment of
solid organ transplants
Touch Spot
Confidential. All Rights Reserved
3
Comparison to the Competition
1. DMPK paper 2. Phenomenex Mitra
cards
4. Touch Spot
3. Spot On Science
Hemaspot
4
2
1
3
Device
Precise
blood
volume
Amount of
blood needed
Quantitative
results
Prevents
touch
failures
Home
use
Lab
use
1
DMPK
cards
Only after
punch
A few drops
Only after
punch
No
No
Yes
2
Mitra
Yes
A few drops
Yes
No
No
Yes
3
Hemaspot
No
Many drops
No
Yes
Yes
No
4
Touch
Spot
Yes
Less than one
drop
Yes
Yes
Yes
Yes
Confidential. All Rights Reserved
Touch Spot
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Disruptive Device – The Science
Why Disruptive?
-
Collect an accurate and precise sample at home or on the go
Send to lab via regular air mail for mass spectrometry analysis
Determines the blood/drug levels independent of the hematocrit
Permits small sample collection made possible by sensitive LC-MS/MS
Eliminates touch failures associated with traditional method – 50%
Current DBS Card – Poor spots Touch Spot: Key to collecting
accurate and precise volume and
eliminating touch failures.
Touch Spot
Confidential. All Rights Reserved
5
The Team is in Place, and Well Rounded
Dr. Amira Al-Uzri
Pediatric Transplant
Physician
OHSU
Andrew Chitty, MBA
Program Manager
OHSU Cores
Ethan Vella
Senior Mech Engr.
Simplexity
Transplant Doctor
Confidential. All Rights Reserved
Phamacokinetics
Laboratory
Dr. Dennis Koop
Pharmacokinetics
Lab Director
OHSU
Trina Voss
OHSU
Tech Transfer
Fluidics Engineering
& New Product
Development
Jonathan Jubera
OCTRI
Project Manager
Laboratory Products
Business
Touch Spot
Dorota Shortell, MSME
President,
Simplexity Product
Development
Colleen Lay
OCTRI
Program Director
Legal, Contracts
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Assays tested
Summer 2012
Successful
testing,
redesign
Multiple
iterations
WE ARE HERE
 Successful interdisciplinary
partnership for three years
 Technology to analyze accurate and
precise DBS in place - LC-MS/MS
 Successful early prototypes
 Transplant market first of a large
dried blood spot collection market
 Market opening now
Touch Spot
Confidential. All Rights Reserved
Preproduction,
FDA Approval
Stage 5
Build, Test,
evaluate, refine
Stage 4
First three
Prototypes
Stage 3
Proof of
concept
Stage 2
Stage 1
Milestones, Momentum/Traction
Production
Product Launch
Marketing,
Distribution
TECHNOLOGY/IP
• The IP is co-owned by
OHSU and Simplexity
(agreement already in
place)
• Provisional Patent
application 62/037,068
was filed 8/13/14.
• Utility patent application
will be filed in Aug. 2015
7
Looking For
Funding: $250,000 to $500,000 for development and testing
 Open to a variety of options that advances the device to a market-ready stage
 Grants
 Partnerships
 Philanthropy
 SBIR/STTR
 Investment capital
Goal: Be the first to market with a comprehensive marketing/distribution plan and
a design that meets the needs of targeted populations such as transplant
patients.
Options considered:
 Create a new Start Up to commercialize technology
 Licensing agreement with established medical device organization
Touch Spot
Confidential. All Rights Reserved
8