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Dried Blood Spot Collection Device

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Presentation on theme: "Dried Blood Spot Collection Device"— Presentation transcript:

1 Dried Blood Spot Collection Device
Touch Spot Dried Blood Spot Collection Device Collaboration between Simplexity Product Development and Oregon Health & Science University Confidential. All Rights Reserved

2 Executive Overview Touch Spot
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. Current Proposed Repeated Venipuncture draws: Technically difficult Painful Traumatizing Expensive Interfere with daily activities Touch Spot

3 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 Barrier to entry is therefore low Affordable Care Act – This is a worldwide concern Red portion – Could it read, “dried blood spot (DBS) testing in newborns and at-home glucose monitoring common since the 1970s”??? Potential market far exceeds current target segment of solid organ transplants Touch Spot

4 Comparison to the Competition
1. DMPK paper cards 2. Phenomenex Mitra 3. Spot On Science Hemaspot 4. Touch Spot 4 3 2 1 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 No Yes 2 Mitra 3 Hemaspot Many drops 4 Touch Spot Less than one drop Touch Spot

5 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% Touch Spot: Key to collecting accurate and precise volume and eliminating touch failures. Current DBS Card – Poor spots Touch Spot

6 The Team is in Place, and Well Rounded
Dr. Amira Al-Uzri Pediatric Transplant Physician OHSU Dr. Dennis Koop Pharmacokinetics Lab Director OHSU Dorota Shortell, MSME President, Simplexity Product Development Andrew Chitty, MBA Program Manager OHSU Cores Ethan Vella Senior Mech Engr. Simplexity Trina Voss OHSU Tech Transfer Jonathan Jubera OCTRI Project Manager Colleen Lay OCTRI Program Director Transplant Doctor Phamacokinetics Laboratory Fluidics Engineering & New Product Development Laboratory Products Business Legal, Contracts Touch Spot

7 Milestones, Momentum/Traction
Stage 1 Proof of concept Assays tested Summer 2012 Stage 2 First three Prototypes Successful testing, redesign Stage 3 Build, Test, evaluate, refine Multiple iterations Stage 4 Preproduction, FDA Approval Marketing, Distribution Stage 5 Production Product Launch WE ARE HERE 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 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

8 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


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