Carl Deirmengian, MD Scientific Founder and Chief Scientific Officer January 18, 2011 - PCCI OVERVIEW
Dec 25, 2015
Carl Deirmengian, MDScientific Founder and Chief Scientific Officer
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 periprosthetic joint infections (PJIs) caused by resistant organisms.
Cost: $107,000 per case
1 - Arthritis 2 - Infection
The Problem
Infections are not obvious
Antibiotics alone do not curedeep 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 Publication12 knees – defined genetic signature for infection
#2 – Confirmation study16 knees – confirmed genetic signature
#3 – Clinical Orthopaedics51 knees – ELISA benchmark study
The Technology
The TechnologyMarker
CandidatesFold
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 TeamCEO
Search UnderwayJanuary, 2010
CMOCarl Deirmengian, MD -Scientific Founder -Princeton University, Harvard Medical School, -Rush Presbyterian Orthopaedic Surgery Fellow
COOMike Behr -20 years in medical device industry - J&J, Zimmer -CEO of CD Diagnostics since founding in 2008
CFO Greg Lumpkin -25 years as operations/finance manager -Tarsa Therapeutics, Tobira Therapeutics, Cortria
Board of Directors
Chairman
Richard 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 companies
MemberDave 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
Scientific Advisory Board
Javad Parvizi, MD – International Leader in Orthopaedic InfectionBOD – Orthopaedic Research Society and Musculoskeletal Infections
Jess Lonner, MD – International Leader in Orthopaedic InfectionBOD – Orthopaedic Research Society
Craig Della Valle, MD – International Leader in Orthopaedic InfectionChairman 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
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
Market Potential
Funding Strategy
Funding & Source Use of Funds
2010
$700KConvertible notes
Research and Development, Legal fees, Operations
2011
$2.7M venture/grants
Product DevelopmentRegulatory Strategy
CMS strategyFDA study design and pre-meeting
2012-
2013
$4.6M Corporate Partners
Clinical Trial Completion, Regulatory submission, Completion
of licensing/partnering deal
Successful Exit
CD Diagnostics – The Synovial Fluid Company- Intellectual property portfolio
Inflection point – FDA approval
1. Licensing to a corporate partner - large diagnostics
2. Strategic buyer - mid-range diagnostics, orthopaedics
3. IPO
Next Step
• Identify and hire CEO
• Create and Execute- Product development plan- Clinical trial plan- Regulatory strategy
• Close additional financings
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®.