BioMedica Diagnostics Inc' Rapid Diagnostic Systems

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BioMedica Diagnostics Inc.Rapid Diagnostic
Systems

• A TWO-PRONG MARKET APPROACH TO COMMERCIALIZATION

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Home of the Worlds Largest Pumpkins
Annual Pumpkin Regatta
Local Golf Course in Summer
BioMedica January 2005
Birthplace of Hockey
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Company Overview Founded June,
1999 Ownership Private Subiaco Holdings
Ltd. Scotia Investments Ltd. Industry
Sector Biotechnology (Medical Devices) Business
Focus Affordable diagnostics solutions for
point of care and cost-sensitive clinical
settings Development Status In early stage
commercial production
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L2B - Starting Out Of TheUniversity Walls.

• Academia vs. Industry Interactive Syndrome.
• From Lab to business - A Five Step progression
  model
• R D Lab gt Platform Technologies
• Science Resource Centre gt Contract Research
• Technology Resource Centre gt Prototypes
• Product Development Manufacturing Company
• Product Dev, Manufacturing, Marketing Company.

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• Platform Technologies
• Dry reagent chemistry
• Chemiluminescence and bioluminescence
• Synthetic diagnostic molecular mimics
• Particle - enhanced immunodiagnostics
• Accelerated Duplex DNA Probing (ADDP)
• Microelectronics and portable instrumentation

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Global Market Trends in Point-of-Care Diagnostics
Introduction of high-throughput lab systems
creates expansion in the point-of-care diagnostic
market
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Global Market Demographics for Point-of-Care
Diagnostics
A growing middle-class in emerging economies
creates a shift in diagnostics demand world-wide
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Business FocusAffordable Diagnostic Solutions
for Decentralized Testing Sites

• Portable Diagnostic Instruments
• Self-Contained Diagnostic Kits
• Ready-to-use Reagents
• Small Laboratory Systems
• OEM and Technology Licensing

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BioMedicas Complete Lab Solution
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System Test Capabilities

• Over Ninety Assays, Diagnostic Test Menu
• 35-40 Blood Chemistries
• 5-7 Blood Clotting Assays
• 8-18 Cell Counting Parameters
• 25-30 Immunodiagnostic Tests
• 10-15 Latex Agglutination Tests
• Process 100-150 Assays (50-75 Patients) per day
• Net Return Estimate 300-500 per day

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Basic Laboratory Configuration
Reception/Waiting Area
Phlebotomy
Office
WC
Fridge Storage
Laboratory
Clin Chem Coag Hematology Immuno Microscopy
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Typical Lab Return
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Target Markets

• Private healthcare practices
• Rural healthcare decentralization
• Lab Rehabilitation Programs
• International aid agencies (WHO)
• Military hospitals and clinics
• Medical training schools
• Industrial health centres
• Veterinary Clinic Labs

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Key Market Drivers

• Demand by a growing middle class for improved
  healthcare
• Complete breakdown of parastatal laboratory
  services
• Increasing trend towards healthcare privatization
• Growing sponsorship of healthcare rehabilitation
  programs by UN, WHO, G-8 nations (NEPAD)
• Absence of competition from conventional suppliers

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Risk Assessment

• Bureaucratic regulatory constraints
• Business cultural variations
• Complex transaction systems
• Poor distribution channels
• Basic infrastructure deficiencies
• Frontier status of diagnostics

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MINIMIZING COMMERCIALIZATION RISK A TWO PRONG
MARKET POSITIONING

• Type 1 Markets
• Canada, USA
• Europe, Oceania
• Type 4 Markets
• Sub-Saharan Africa
• Caribbean, Latin South America
• North Africa/Middle East

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Finding A Niche For QuikCoag

• Increasing Incidence of Thrombosis
• Upsurge in Surgical Procedures
• Routine Management of Cancer
• and Cardiac Patients
• Misdiagnosed Thrombosis Mal-practice
• Monitoring of New Medications
• Aging Patient Populations
• In vitro Device Implantation

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QuikCoag Reagents The New Kit on the Block
for Thrombosis and Heamostasis Diagnostics
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Functional Hemostasis
Injured Vessel
Platelet Plug
Fibrin Clot
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Dysfunctional Hemostasis
Thrombosis
Inadequate Hemostasis
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Clinical Manifestations

• Common Thrombotic Disorders Predispositions
• Deep vein thrombosis
• Arterial thrombosis
• Pulmonary embolism
• Thrombotic stroke
• Malignancy
• Obstetric hemorrhage and thrombo embolism
• Amniotic fluid embolism
• Cardiopulmonary by-pass
• Artificial intra-vascular devices
• Disseminated intravascular coagulation

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Clinical Manifestations

• Common Bleeding Disorders Predispositions
• Anti-Coagulant Therapy
• Heparin
• Coumadin
• Hereditary Disorders
• Hemophilia A (Factor VIII) 125K
• Hemophilia B (Factor IX) 1100K
• Hemophilia C (Factor XI) 11,000K
• Acquired Disorders
• Liver disease
• Vitamin K deficiency
• Autoimmune disease (e.g. Lupus)
• Prostate surgery

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Global Coagulation Market Segmentation Total
980,000,000
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Competitive Environment

• Demand for Coag Reagents continually on the Rise
• Consolidation left 5 Multinationals with over
  90 Share
• Restrictive Reagent Contract Sale Models Are
  Failing.
• Medium Sized Labs and Hospitals Looking for
  Alternatives
• Alternative FDA Approved Suppliers are Limited
• There is a Perceivable Shortage of Coag Reagents
  Supply
• Geographical Consolidation has Created New Export
  Opportunities in Latin America and Far East.
• A Clear Opportunity For BioMedica.

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Capturing Our Opportunity

• Timely Development - Full Product Line
• US FDA / ISO 13485 Certification
• Product Liability Insurance
• Minimized Production Costs
• Global Marketing Network
• Private Label Offerings

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Technology Manufacturing
New Products New Ideas Market Share Profits
Marketing
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BIOMEDICAS LEAD DISTRIBUTORS

• HemoDiagnostica - Europe
• CentreChem USA Hospital Sector
• Clinical Data USA (POL) Sector
• TECO China South America
• Vital Diagnostics - (Australia)
• UN WHO

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Key Success Factors

• University Roots
• Regulated Five Step L2B Evolution
• Rationalized Business Focus
• Commercialization Risk Management
• Market Partnering Model

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Conclusion

• A Successful L2B Transition Model
• Bona Fide Manufacturing Business
• High Demand Product Niche
• Lowest Production Cost
• Established Distribution Channels
• Growing Export Business
• Conservative Cash Burn Rate

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BioMedica at The Cross Roads