www.cddiagnostics.com. management team ceo rick birkmeyer, ph. d. -founder and ceo of strategic...
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Management Team
CEORick Birkmeyer, Ph. D.-Founder and CEO of Strategic Diagnostics, Inc. (Nasdaq: SDIX) -Obtained funding, 12 corp partnerships, 6 strategic acquisitions-DIF Venture Board, DEDO Venture Board, 4 Corporate Boards
VP Marketing,Co-Founder
Mike Behr-20 years in orthopaedic industry -J&J, Zimmer (Sales & Marketing)
ChiefScientific
Officer,Co-Founder
Carl Deirmengian, M.D.-Practicing Orthopedic surgeon-Princeton University, Harvard Medical School
VP Corporate Development
*******-Co-Founder SDIX-Investment consultant for Delaware Innovation Fund
VP Research & Development
*****-direct involvement in the development of 15 FDA approved products-has been awarded four U.S. patents and has two pending applications.
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CD DiagnosticsStrategic Focus
Our mission is to be the leader in joint fluid
analysis by providing analytical tools which will
facilitate informed decisions in patient care. We
will bring these analytical tools to market through
corporate partnerships.
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Joint Pain• Many causes of joint pain frequently misdiagnosed• Unnecessary medical expenses
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1.50
6.10
0.40
27.00
1.50 1.00 0.04 0.97
RheumatoidGoutPseudogoutOsteoarthritisLupusPsoriatic ArthritisLymeInfection
www.cdc.gov
USA Patients with Joint Disease38.5 million total
100+ million with joint pain in 2009
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4.02
3.01
0.40
7.33
1.10
0.50 0.040.97
RheumatoidGoutPseudogoutOsteoarthritisLupusPsoriatic ArthritisLymeInfection
www.cdc.gov
USA Testing PointsAmbulatory care visits and hospitalizations
40 million+ for all joint pain17.4 million total for joint disease
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9.10
9.10
2.057.33
2.05
2.052.05
17.38RheumatoidGoutPseudogoutOsteoarthritisLupusPsoriatic ArthritisLymeInfection
USA Test Market Potential51.1 million tests for patients with joint disease
(Excluding negative results)
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37.19
37.19
7.2740.73
7.27
7.277.27
79.83 RheumatoidGoutPseudogoutOsteoarthritisLupusPsoriatic ArthritisLymeInfection
Global Test Market Potential224.03 million tests for patients with joint disease
(Excluding negative results)
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• Blood Tests– CRP, ESR– Uric Acid– Rheumatoid Antibody– Lyme Antibody
• Joint Tests– Formation of crystals– White Blood Cell Count– Gram Stain/Culture
Current Diagnostics
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Current Diagnostics
There are currently NO approved
analytic assays of synovial fluid for
the diagnosis of joint disease
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Clinical Utility
• Differentiation of chronic joint diseases will lead
to a specific therapeutic pathway more quickly.
• Prevent secondary complications
• Expedite decision regarding joint revision surgery
or treatment pathway
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Biomarkers
White Blood Cells Bacteria
Poly debris
Crystals
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Serum Test
Why Test Joint Fluid?
Local test
DilutionOther Biomarkers
ConcentrationNo Confounders
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Core TechnologyImmunoassay
• Immunoassay characteristics– Easy-to-Use– Accurate Results On-Site– Inexpensive
• Applied to Joint Fluid Analysis– Replaces ambiguous and inaccurate methods– Enables Rapid Analysis not Currently Possible
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Intellectual Property
USPTO# 7598080“Diagnostic Assay for the source of inflammation”
Issued 10/6/2009
Continuations• US20090318301
– Filed 8/28/2009– Amended 9/1/2011
• 13/231,647– Filed 9/13/2011
• 13/231,665– Filed 9/13/2011
USPTOOffice of Public Records
Document Services Division
Provisionals• Pseudogout 61/590,248• Rheumatoid Arthritis 61/590,246• Osteoarthritis 61/590,244• Gout 61/590,240• Infection 61/590,234
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Corporate Partnering
CD Diagnostics Core Strengths• Immunoass
ay Development
• GMP Manufacturing
Synergistic Partner• Market
Leader• Compli
mentary Products
MarketLeadership
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Proof of Concept
First study– Patient data– Compared Gout to Infection– Defined a genetic signature in joint fluid
Second study– Patient data– Confirmation of first study– Compared infection to aseptic loosening
Third study– Patient data– Multiple clinical symptoms– Elisa Testing
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Milestone Infection-Joint
Selection of Biomarkers Patent filed April 2012
Lab Developed Test August 2012
Investigational Use Kit January 2013
510(k) Approval November 2013
Technical & Clinical Milestones
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Commercialization Process
Laboratory Developed Test
• Regulated by CLIA
• No FDA Approval
• Can be reimbursed
• Can promote for detection
• Advertising not restricted
Investigational Use Only Kit
• Generation of data
• Results can be used by
clinicians as adjunct
• Charge buyer
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Funding
Angel Funding $1.5 million
State GrantState of Delaware $ .5 millionadditional $ .5 million available
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Corporate Partner Deals
• Company A• Infection Joint ($2.9 Million milestone payments)• Infection Native ($1.75 Million milestone payments)• Metal-metal• Metal-allergy
• Company B• Osteoarthritis
• Company C• Rheumatoid Arthritis
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Preferred Round
• $1.6 Million conversion of notes
• $1.1 Million Corporate Partner
• $2.0 Million new money