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Lisbon, January, 2015
Improving Clinical Decisions
TEAM
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Hugo Vicente MirandaPhD in Biochemistry
Expertise in Neurosciences, Molecular Biology & Proteomics
Deborah PenquePhD in Molecular Genetics
Expertise in Molecular Biology & Proteomics
Vukosava Millic TorresPhD in Pharmacy
Expertise in Toxicology & Mass Spectrometry
ADVISORS: Randall W Nelson, Dobrin Nedelkov,Biodesign, Molecular Biomarkers Lab, ASU, Tempe, AZ, USAJosé Maria Albuquerque, Member of Executive Board of INSA Ricardo Jorge, Lisbon, Portugal
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• Parkinson’s disease affects 2% of all population
with age >65- 10 M people worldwide are currently
diagnosed with Parkinson’s Disease
- Incidence will double by 20301
- Overall costs related to Parkinson´s are > 32 B€ / year1,2
1 The European Parkinson´s disease standards of care consensus statement, European Parkinson´s Diesase Association, 20122 O’Brien JA, Ward A, Michels SL, Tzivelekis S, Brandt NJ. Economic burden associated with Parkinson disease. Drug Benefit Trends. 2009;21(6):179-190
PROBLEM
• Current diagnosis:
– high degree of uncertanty
– only possible when disease is well
settled and non-reversible
• NO test for early diagnosis of
Parkinson’s
PROBLEM
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Early and Accurate diagnosis of Parkinson is a pressing unmet
medical need!!!
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NEED
1 Olanow CW, Rascol O, Hauser R, et al. A double-blind, delayed-start trial of rasagiline in Parkinson’s disease. N Engl J Med. 2009;361(13):1268-1278. 7
• Early diagnosis
• Early drug treatment
• Slow disease progression1
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SOLUTION
PDx/DDx blood test for Parkinson´s
PARK-Dx
• Accurate• Inexpensive• Fast• Non-invasive
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VALUE PROPOSITION
For Medical community involved in Parkinson's diagnosis and treatment
who seek to detect Parkinson's disease in early stage.
The PARK-Dx
is an immuno mass spectrometry-based test for detection of novel biomarkers
That can provide early and accurate diagnosis of Parkinson´s disease
Unlike current diagnosis which is subjective and highly uncertain
Our solution provides an accurate, inexpensive, fast (<2 days) test for the early diagnosis/follow up of Parkinson´s disease.
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TECHNOLOGY
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Genetic tests Imaging PARK-Dx
Early diagnosis P O PPP
Non-genetic Parkinson’s (>98%) O P PPP
Specificity PP P PPP Selectivity PP P PPP High throughput PPP O PPP Price 400 € 2 000 € 400 €
COMPETITORS
Omics2Clinic
12Prevention is the ultimate goal in Parkinson´s
PD score report – proprietary algorithm
BUSINESS MODEL
2015 2016 2017 2018 2019 2020 2021 2022 2023
PARK-Dx road to market
PARK-Dx roll on Europe
PARK-Dx U.S. market entry
Implementation in healthcare system as screening test
ISO 13485, ISO15189, CE
CLIA PARK Dx
CLIA certified O2C labFDA 510(k) clearance
Clinical studies in U.S.
Roadmap
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IP 280k€
Pilot VALIDATION
410k€
ID bimarkers
MS assay proof of concept
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WorldwidePopulation >45 years
1.9 B
45 – 64Every 5 years
65 – 80Every 3 years
Compliance 20% periodical screening
PARK-Dx3% 3M tests/year
TARGET MARKET
SALES EXPANSION
2015 2016 2017 2018 2019 2020
-€ 50,000,000.0
€ 0.0
€ 50,000,000.0
€ 100,000,000.0
€ 150,000,000.0
€ 200,000,000.0
€ 250,000,000.0
€ 300,000,000.0
EBITDASalesFCF accumulated
Years
break even
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REVENUE PROJECTION
Pharmaceutical industryFacilitate selection of patients for clinical
trialsTargeted drug development
PatientsImprove patients well being
Increase life comfort
Healthcare organisationsReducing medical costs
PhysiciansEarly PDx/DDx
Better therapy decisionMonitor disease progression
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STAKEHOLDERS
