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 Joint Replacement need 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 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 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 Cygnasure r Addresses an unmet clinical market need • Tests the local joint fluid • Objective analytic laboratory test • Rapid point-of-care • Improved accuracy Technology Based on antibody technology (ELISA) • > 25 year history • No technological barriers • Multiple platforms • Low cost of development 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 The Technology The Technology Marker Candidates Fold Elevation Accuracy 1 258 1.00 2 27 1.00 3 120 0.96 4 112 0.94 5 2 0.86 6 24 0.94 CRP 13 0.82 ESR 3 0.76 WBC 31 0.86 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) Intellectual Property USPTO # 7598080 October 6, 2009 Diagnostic Assay for the Source of Inflammation Management Team CEO Search Underway January, 2010 Carl Deirmengian, MD CMO COO CFO -Scientific Founder -Princeton University, Harvard Medical School, -Rush Presbyterian Orthopaedic Surgery Fellow Mike Behr -20 years in medical device industry - J&J, Zimmer -CEO of CD Diagnostics since founding in 2008 Greg Lumpkin -25 years as operations/finance manager -Tarsa Therapeutics, Tobira Therapeutics, Cortria Board of Directors Richard P. Schwarz, Ph.D. Chairman Member Member -32 years in the Pharmaceutical & Biotech industry -Senior Management Experience -Immunomedics, Astra Pharmaceutical, Texas Bio -Interim CEO for numerous start-up companies Dave Pfeiffer -20 years in the life sciences industry -COO, Nitric Bio -VP, Collagenix. -SmithKline Beecham, Zeneca. Robert E. Booth Jr., MD -International leader in total joint replacement surgery -Lead designer of the Legacy® total knee system -Sir John Charnley Award 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 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) Market Potential Synovial fluid – second most tested body fluid Rheumatoid arthritis, Lupus, Lyme disease, Gout, pseudoseptic infection, pseudogout Funding Strategy $700K Convertible notes Research and Development, Legal fees, Operations $2.7M venture/grants Product Development Regulatory Strategy CMS strategy FDA study design and pre-meeting Clinical Trial Completion, $4.6M Corporate Partners Regulatory submission, Completion of licensing/partnering deal Successful Exit CD Diagnostics – The Synovial Fluid Company - Intellectual property portfolio Inflection point – FDA approval 1. 2. 3. Licensing to a corporate partner - large diagnostics Strategic buyer - mid-range diagnostics, orthopaedics IPO Next Step • Identify and hire CEO • Create and Execute - Product development plan - Clinical trial plan - Regulatory strategy • Close additional financings 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®.