1. Page - 1 Medical Devices & Diagnostics Global Strategies Strategies and Operational Management for: Product Development – Concept through Commercialization Global Regulatory Strategies and Submission Clinical Trial Design and Clinical Development Medical Device and Diagnostics Budget Models Medical Device and Diagnostics Biostatistics Models Quality Management including Audits Consulting and Contracting to Other CRO’s and Sponsors Strategic Guidance When It Counts “Get it right the first time”™

2. Page - 2 Medical Devices & Diagnostics Global Strategies Specialty sectors:  Wound Care and Ophthalmology Device and Pharma  Neurology and Oncology Diagnostics and Devices  Women’s Health Diagnostics and Devices  Infectious Disease Diagnostics  Biomarkers Sample Collection and Nanotechnology  Drug Delivery Device Studies – Combination Products, Human Factors Engineering, Instructions for Use  Feasibility and Site Qualification Expertise - SiteID™  Pre-FDA Inspection Audits,and QMS Audits  Clinical Trial Supply Chain Audits Strategic Guidance When It Counts “Get it right the first time”™ S

3. Page - 3 “Get it right the first time” TM Value Added Expertise –We make you money Aligning Business, Regulatory and Clinical Trial Objectives Our mission is to support your company to build the Value Proposition We provide direct access to C-level experts for the Sponsor We provide a senior team from Product Development through Regulatory Review, Clinical Trial, Submission and Post-Market We imbed with your team early to assess how the technical mission is designed to support the ultimate Value Proposition goals We also provide Strategic Guidance on a selected basis We build the specific Value Proposition sequence of stakeholder needs We provide the infrastructure to carry out the regulatory and clinical trial mission interfacing with the appropriate Sponsor team members We build the cost-effective Roadmap “up the Pyramid” We are on your side - the strategic and operational glue for you to: “Get it right the first time”

4. Page - 4 Claim Device Functionality Literature Background and Technical File Longitudinal, non- interventional to establish Sensitivity & Specificity Case Control and/or Cohort studies (healthy/afflicted), depending best applicability of either Usability, Reliability and Device Accuracy Design, Manufacturing & Engineering Data Literature, Background and Technical File Clinical utility Standard of Care Typical deliverable*: Value Dossier Increasingly strong claims Typical deliverable: ROC curve Typical deliverable: Descriptive statistics and correlation of device readings to confirmed conditions Typical deliverable: inter-device and inter-operator coefficient of variation Typical deliverables: Bench test & regulatory standards data Typical deliverables: Clinical Evaluation Report, per MedDev 2.7.1 Rev 3 Increasing Value Decreasing Risk Value Proposition 2 Prong Comparison and intervention vs. Gold Standard Evidence Convert Development into Organized Success Lean & Flexible Program Management - When it Counts BUILDING THE RISK BASED VALUE PROPOSITION

5. Page - 5 Dr. Alan J. Touch Over 35 years senior-level multi-national and entrepreneurial operating management and consulting experience including global CRO executive leadership Device, Diagnostics, Wound Care and Ophthalmology Product Development Strategist ‒Founder, CEO and Principal Strategist of Avodex Partners ‒Prior Principal Strategist, INC Research Biographical Details Device and IVD and pharmaceutical development, regulatory strategies and clinical trials Discovery, design, development, design control and validation, clinical trial, regulatory submissions Ophthalmology drug development including formulation and bioavailability Ophthalmology medical device and IVD clinical trial protocol development and oversight Medical device and diagnostics developer at the operational and C-Level Device and drug manufacturing scale-Up, QMS and production oversight Understanding of cGMPs, GCPs, essential principles and MDD compliance Post-approval CLIA, US and EU reimbursement strategies and management Drug Delivery Device Related Issues – Human Factor, Dosing, Design, Instructions for Use Clinical trial management and oversight Expertise

6. Page - 6 Regulatory Strategies and Business Outcome Objectives Design Control Development QSR and ISO Validation and Verification Testing Clinical Trial Mgmt Risk Assessment Regulatory Submissions and Approvals Post – Market Requirements or Actions Avodex Partners - Product Life cycle services © 2013 Avodex Partners, LLC 6 A seamless continuous process From concept through commercialization and post-market Experience & Expertise Product Life Cycle Indications Trials Regulatory Strategies/Submissions Human Factors and Usability Studies Capabilities Device and Diagnostics Biostatistics Models Clinical Trial Operational Oversight Cost Sensitive Medical Device Budget Models Expert Submission Medical Writing Expert Marketing Medical Writing

7. Page - 7 The Regulatory Continuum - Devices © 2013 Avodex Partners 7 INC Research Clinical Development Concept Design development Pre-IDE modelClinical Trial Regulatory Submission Regulatory Services Study Design with Historical Controls New Presentation New Indication Marketing Application Including Safety and Performance Dossier Post-Market Life Cycle Surveillance Medical Device Adverse Event Reporting Avodex Medical Device and Diagnostics Regulatory and Clinical Development Biostatistics protocol development SAP/ Study Biometrics Quality Assurance cGMP/QMS Design Control Hand-Off Regulatory Strategy and Intelligence Clinical Trial Design Usability Study Design pre-IDE prep Clinical Trial Applications or notifications to EC/IRB and Study Start Up 510(k)/PMA CE Mark Other Safety and Performance Dossier 510(k)/PMA CE Mark Other Safety and Performance Dossier

8. Page - 8 Medical Device Strategic Services Regulatory Consulting Services Design and Validation Consulting and Management Quality Management Systems Consulting Protocol Development and Review Clinical Development including project specific budgets Clinical Trials Management and Oversight Device and Diagnostics Internal Global Consulting Due Diligence and M&A Support – Consulting Post Approval Voluntary and Mandated Surveillance

9. Page - 9 Strategic and Operational Services for Diagnostics Safety and Performance Study Strategies ROC Curve / Verification Study Design and Budget Models Validation of Interventional Claims – Specialized Models Biomarker/ IVD Performance Sample Collection Models Biomarker/IVD Clinical Trial Models tied to Performance Global Compliance Regulatory Strategies and Tactics Device Centric Biostatistics/Data Management Models Risk Based Medical Monitoring Decisions and Rationale MDR Reporting requirements assessment and strategies

10. Page - 10 Clinical Development Services Study/Protocol Design and Review Sample size Calculations and Biometrics Site Selection Feasibility Questionnaires Assure that Prototype Sensitivity, Specificity and Reproducibility results can be carried over to the Manufacturing Floor Optimize Clinical Trial Design for Indication Establish Statistically Based Pre-Clinical and Clinical Trial Study Procedures Ensure world-wide device regulatory and clinical trial integrated processes

11. Page - 11 M&A, Product Development & IP Advisory Services: Due Diligence, Capital Formation, Acquisition or Exit Mergers & Acquisitions/Sales Strategic Acquisition Plan Formulation Business Plan Drivers Target List Development Target Valuation Analysis Risk Based Valuation Proposition Modeling Market Segment Analysis Major Customer Buyer Behavior Competitive Landscape SWOT Analysis Merger & Acquisition Due Diligence Financial Operations Engineering/Research Purchasing Marketing and Distribution Regulatory Status Analysis Go to Market Status Analysis Reimbursement Analytics and Strategies Product Development Planning Market Requirements Document Program Development Analysis and Budgets Cost Driver Analysis Bench Top to Commercialization Management Regulatory and Clinical Trials Management Protocol Development Clinical Trial Design Project Management Regulatory Strategies and Filings Technology Transfer/Acquisitions License Agreements Advisory Business Plan Assessment and Writing

12. Page - 12 Value Proposition Build ~ Speed to Market Specialists Strategic Interventional Management Time to Value Proposition Always a Factor Product Life Cycle Experience & Expertise Indications Trials Experience & Expertise Regulatory Strategies/Submissions Expertise Device and Diagnostics Biostatistics Models Clinical Trial Operational Oversight Capabilities Human Factors and Usability Studies Expertise Cost Sensitive Medical Device/Diagnostics Budget Models Submission and Marketing Medical Writing Ensure your critical front end decisions are made with knowledge BUILD THE RISK BASED VALUE PROPOSITION NOW Make Avodex Partners your “Speed to Market” Team Today