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Carl Deirmengian, MD Scientific Founder and Chief Scientific Officer January 18, 2011 - PCCI

Carl Deirmengian, MD Scientific Founder and Chief Scientific Officer January 18, 2011 - PCCI. Overview. Two Epidemics. 1 - Arthritis. 2 - Infection. Periprosthetic Joint Infection: The Economic Impact of Methicillin -Resistant Infections Journal of Arthroplasty

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Carl Deirmengian, MD Scientific Founder and Chief Scientific Officer January 18, 2011 - PCCI

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  1. Carl Deirmengian, MD Scientific Founder and Chief Scientific Officer January 18, 2011 - PCCI Overview

  2. Two Epidemics 1 - Arthritis 2 - Infection Periprosthetic Joint Infection: The Economic Impact of Methicillin-Resistant Infections Journal of Arthroplasty The orthopedic community has begun to witness a worrisome rise in the incidence of periprosthetic joint infections (PJIs) caused by resistant organisms. Cost: $107,000 per case Joint Replacement need

  3. The Problem Infections are not obvious Antibiotics alone do not cure deep joint infections The U.S. standard of care involves a two-stage surgical procedure over three months

  4. Standard Diagnostics • Blood tests – CRP, ESR • Intuitively suboptimal • Joint Tests – WBC count, Cultures • Subjective, inconsistent • Radiographic – MRI, Bone scan, PET scan • The surgeon is left without confidence

  5. Cygnasurer • Addresses an unmet clinical market need • Tests the local joint fluid • Objective analytic laboratory test • Rapid point-of-care • Improved accuracy

  6. Technology • Based on antibody technology (ELISA) • > 25 year history • No technological barriers • Multiple platforms • Low cost of development

  7. 3 Clinical Studies #1 – Coventry Award Publication 12 knees – defined genetic signature for infection #2 – Confirmation study 16 knees – confirmed genetic signature #3 – Clinical Orthopaedics 51 knees – ELISA benchmark study

  8. The Technology

  9. The Technology

  10. Clinical Awards • 2006 American Academy of Orthopaedic Surgery Poster Award • 2005 The Knee Society, Mark Coventry National Award (1st) • 2005 OREF/Zimmer Career Development Award • 2004 OREF Resident Research Grant/Award • 2004 The Smith & Nephew National Research Award (1st) • 2004 National Arthroscopy Association Resident Award (1st)

  11. Intellectual Property USPTO # 7598080 October 6, 2009 Diagnostic Assay for the Source of Inflammation

  12. Management Team

  13. Board of Directors

  14. Scientific Advisory Board Javad Parvizi, MD – International Leader in Orthopaedic Infection BOD – Orthopaedic Research Society and Musculoskeletal Infections Jess Lonner, MD– International Leader in Orthopaedic Infection BOD – Orthopaedic Research Society Craig Della Valle, MD – International Leader in Orthopaedic Infection Chairman AAOS Infection Guidelines Committee Alan Wu, Ph.D. – Chief Clinical Chemistry, UCSF >20 awards in the field of molecular diagnostics, protein biomarkers Sam Niedbala, Ph.D. – Founder and Chief Scientific Officer, Orasure

  15. Market Potential Synovial fluid – second most tested body fluid Primary Joint Replacements – 2010 – 1 million Revision Joint Replacements – 2010 – 100K Operating room, Emergency room, MD office, Hospital Laboratory ($50-125 per test)

  16. Market Potential Synovial fluid – second most tested body fluid Rheumatoid arthritis, Lupus, Lyme disease, Gout, pseudoseptic infection, pseudogout

  17. Funding Strategy

  18. Successful Exit • CD Diagnostics – The Synovial Fluid Company • - Intellectual property portfolio • Inflection point – FDA approval • Licensing to a corporate partner • - large diagnostics • Strategic buyer • - mid-range diagnostics, orthopaedics • IPO

  19. Next Step • Identify and hire CEO • Create and Execute • - Product development plan • - Clinical trial plan • - Regulatory strategy • Close additional financings

  20. Questions 1.                 CD Diagnostics has a solid technology with a strong patent that might increase in scope with a patent continuance that looks promising.  Is it a better idea for CD Diagnostics to put all of it’s energy into developing one product and selling the company, with it’s technology, to a potential buyer or would it be better to develop an extended line of applications for this technology and then approach a potential buyer/partner? 2.                 CD Diagnostics has been approached by a couple of  large companies that might be interested in a strategic partnership.   Is a strategic partnership a good idea at this point for CD Diagnostics?  What models for a strategic partnership would make sense? 3.                 CD Diagnostics is looking at models for pricing of Cygnasure®.  What models exist to determine an appropriate price for a product like Cygnasure®?  How should we begin to determine a price for Cygnasure®. 

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