January 18 2011 PCCI Overview Two Epidemics Joint Replacement need 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 ID: 1031916
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1. Carl Deirmengian, MDScientific Founder and Chief Scientific OfficerJanuary 18, 2011 - PCCIOverview
2. Two EpidemicsJoint Replacement needPeriprosthetic Joint Infection:The Economic Impact of Methicillin-Resistant InfectionsJournal of ArthroplastyThe 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 case1 - Arthritis2 - Infection
3. The ProblemInfections are not obviousAntibiotics alone do not curedeep joint infectionsThe 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 scanThe surgeon is left without confidence
5. Cygnasure rAddresses 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 TechnologyMarkerCandidatesFoldElevationAccuracy12581.002271.0031200.9641120.94520.866240.94CRP130.82ESR30.76WBC310.86
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 PropertyUSPTO # 7598080October 6, 2009Diagnostic Assay for the Source of Inflammation
12. Management TeamCEOSearch UnderwayJanuary, 2010CMOCarl Deirmengian, MD -Scientific Founder -Princeton University, Harvard Medical School, -Rush Presbyterian Orthopaedic Surgery FellowCOOMike Behr -20 years in medical device industry - J&J, Zimmer -CEO of CD Diagnostics since founding in 2008CFOGreg Lumpkin -25 years as operations/finance manager -Tarsa Therapeutics, Tobira Therapeutics, Cortria
13. Board of DirectorsChairmanRichard P. Schwarz, Ph.D. -32 years in the Pharmaceutical & Biotech industry -Senior Management Experience -Immunomedics, Astra Pharmaceutical, Texas Bio -Interim CEO for numerous start-up companiesMemberDave Pfeiffer -20 years in the life sciences industry -COO, Nitric Bio -VP, Collagenix. -SmithKline Beecham, Zeneca.MemberRobert E. Booth Jr., MD -International leader in total joint replacement surgery -Lead designer of the Legacy® total knee system -Sir John Charnley Award
14. Scientific Advisory BoardJavad 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 SocietyCraig Della Valle, MD – International Leader in Orthopaedic Infection Chairman AAOS Infection Guidelines CommitteeAlan Wu, Ph.D. – Chief Clinical Chemistry, UCSF >20 awards in the field of molecular diagnostics, protein biomarkersSam Niedbala, Ph.D. – Founder and Chief Scientific Officer, Orasure
15. Synovial fluid – second most tested body fluidPrimary Joint Replacements – 2010 – 1 millionRevision Joint Replacements – 2010 – 100KOperating room, Emergency room, MD office,Hospital Laboratory ($50-125 per test) Market Potential
16. Synovial fluid – second most tested body fluidRheumatoid arthritis, Lupus, Lyme disease, Gout, pseudoseptic infection, pseudogoutMarket Potential
17. Funding StrategyFunding & SourceUse of Funds2010$700KConvertible notesResearch and Development, Legal fees, Operations2011$2.7M venture/grantsProduct DevelopmentRegulatory StrategyCMS strategyFDA study design and pre-meeting2012-2013$4.6M Corporate PartnersClinical Trial Completion, Regulatory submission, Completion of licensing/partnering deal
18. Successful ExitCD Diagnostics – The Synovial Fluid Company - Intellectual property portfolioInflection point – FDA approval Licensing to a corporate partner - large diagnostics Strategic buyer - mid-range diagnostics, orthopaedics IPO
19. Next StepIdentify and hire CEOCreate and Execute - Product development plan - Clinical trial plan - Regulatory strategyClose additional financings
20.
21. Questions1. 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®.