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®.