Service Package for Life Science Start-Ups

1. Service Package for Life Science Start-Ups Regulatory, Reimbursement, Quality and Clinical Research In Europe and the USA Amir Inbar, CEO Mediclever Ltd. amir@mediclever.com www.mediclever.com UK Office: 27 Old Gloucester St., London WC1N 3AX uk@mediclever.com +44.208.099.7435 Israel Office: 6 Ha-Teena St., Modiin 71799 il@mediclever.com +972.50.837.1711

2. 9. Implementation 8. Prep. / App. • Establish user base, Obtain stakeholders’ support Main Decision Makers • Technical file Healthcare Providers • Utilize existing reimbursement mechanisms or: 7.Quality Manag. System 5. Clinical Study Protocol 6.Perform Clinical Study • Design dossier Payers • Apply for new reimbursement mechanisms More Info / Pricing More Info / Pricing • PMA • 510(k) EU 4. Evidence Planning Class I (NS/M) • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report Class I (S/M) 3. Quality Management System Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance Class III • Review and/or write protocol US Class III Class II Class I In a nut shell… Reimbursement 2. Regulatory Landscape Report • Regulatory status • Device classification • Intended use & indications for use • Regulatory route Regulatory, Quality and Clinical Research • Clinical Eval. Report • FDA QSR / ISO 13485

3. In a nut shell… Mediclever provides Reimbursement consulting services in Europe and the USA. Reimbursement Our partners coordinate and manage the provision of Regulatory, Quality,and ClinicalResearch services in Europe and the USA, in collaboration with Mediclever. Regulatory, Quality and Clinical Research

4. In the Reimbursement Landscape Report we: • Analyze the relevant market/s, providing numbers of currently conducted procedures, type of Payers (insurance companies) that finance them and overall spending. More Info / Pricing • Find out whether there are any existing codes, coverage policies and payment mechanisms that could be utilized or compared to, by the new medical product. 1. Reimbursement Landscape Report • Relevant, codes, coverage & payment • Reimbursement strategy Reimbursement Landscape Report • In order to define the existing reimbursement scenario for a new product (drug or device), we start with the Reimbursement Landscape Report. Reimbursement

5. Main Decision Makers Healthcare Providers Payers More Info / Pricing 1. Reimbursement Landscape Report • Relevant, codes, coverage & payment • Reimbursement strategy Decision Makers and Initial Strategy • This enables us to: • Define the most relevant Decision Makers for the reimbursement of your new product. • Formulate an initial reimbursement strategy for your new product in the selected markets (Europe, US). Reimbursement

6. 2. Regulatory Landscape Report • Regulatory status • Device classification • Intended use & indications for use • Regulatory route Main Decision Makers Healthcare Providers Payers More Info / Pricing EU Class I (NS/M) 1. Reimbursement Landscape Report Class I (S/M) Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb Class III US Class III Class II Class I Regulatory Landscape Report • In parallel, or immediately after the Reimbursement Landscape Report is submitted, our partners provide the Regulatory Landscape Report to determine the product’s classification, intended use, indications for use and the anticipated regulatory route. Reimbursement • Sometimes regulatory status and classification are different between EU and US, and this needs to be taken into account when formulating regulatory, reimbursement and marketing strategies. Regulatory, Quality and Clinical Research

7. 2. Regulatory Landscape Report • Regulatory status • Device classification • Intended use & indications for use • Regulatory route Healthcare Providers 5. Clinical Study Protocol Payers More Info / Pricing EU Class I (NS/M) 1. Reimbursement Landscape Report Class I (S/M) 3. Quality Management System Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance Class III • Review and/or write protocol US Class III Class II Class I Preparations for Clinical Study At the next stage, when the company prepares for its clinical study (if needed, see chart below), it typically: Main Decision Makers • Implements the relevant parts of its Quality Management System (e.g., Design Controls and other QS aspects essential for US and EU pre-study compliance). • Writes its clinical study protocol. Reimbursement Regulatory, Quality and Clinical Research

8. 2. Regulatory Landscape Report • Regulatory status • Device classification • Intended use & indications for use • Regulatory route 3. Quality Management System Healthcare Providers 5. Clinical Study Protocol • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance Payers More Info / Pricing More Info / Pricing EU 4. Evidence Planning Class I (NS/M) • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report Class I (S/M) Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb Class III US Class III Class II Class I Evidence Planning At this stage, long before the clinical study actually begins, we will plan the required ‘evidence’ for the reimbursement of your new product: Main Decision Makers Reimbursement • Value Story: Lay out the clinical AND economic benefits of using your new product, from the identified Decision Makers’ perspective. • Economic Model: Quantify the economic benefit, allow for sensitivity analysis and later on, use it as a sales tool. • Reimbursement Related Parameters: Integrate in the study protocol. • Stakeholders’ Feedback: Don’t gamble. Verify with our network partners, representing relevant Decision Makers, that they will indeed finance the use of your new product if the claims in the Value Story are proven according to the presented clinical study protocol. Regulatory, Quality and Clinical Research • Review and/or write protocol

9. 2. Regulatory Landscape Report Round A Seed Funding • Regulatory status • Device classification • Intended use & indications for use • Regulatory route 3. Quality Management System Healthcare Providers 5. Clinical Study Protocol • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance Payers More Info / Pricing More Info / Pricing EU 4. Evidence Planning Class I (NS/M) • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report Class I (S/M) Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb Class III US Class III Class II Class I Evidence Planning Raise funding: • At this stage, in order to finance their clinical trial, many companies raise their growth funding round (also referred as Series A round). Main Decision Makers Reimbursement Regulatory, Quality and Clinical Research • Review and/or write protocol

10. 2. Regulatory Landscape Report • Regulatory status • Device classification • Intended use & indications for use • Regulatory route 3. Quality Management System Healthcare Providers 5. Clinical Study Protocol 6.Perform Clinical Study • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance Payers More Info / Pricing More Info / Pricing EU 4. Evidence Planning Class I (NS/M) • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report Class I (S/M) Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb Class III US • Clinical Eval. Report Class III Class II Class I Clinical Study Round A Seed Funding Now, the clinical trial may be conducted and the resulting ‘evidence’, substantiating the claims in the Value Story, should be published. The Clinical Evaluation Report (CER) should now be prepared, based on official European guidance. CER may also be useful for US submissions. Main Decision Makers Reimbursement Regulatory, Quality and Clinical Research • Review and/or write protocol

11. 2. Regulatory Landscape Report • Regulatory status • Device classification • Intended use & indications for use • Regulatory route 3. Quality Management System Healthcare Providers 6.Perform Clinical Study 5. Clinical Study Protocol 7.Quality Manag. System • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance Payers More Info / Pricing More Info / Pricing EU 4. Evidence Planning Class I (NS/M) • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report Class I (S/M) Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb Class III US • FDA QSR / ISO 13485 Class III Class II Class I Completion of Quality Management System Round A Seed Funding Completion of QMS At this stage, if the company has not already done so, the quality management system can be completed to ensure it complies with US and/or European requirements. Main Decision Makers Reimbursement Regulatory, Quality and Clinical Research • Review and/or write protocol • Clinical Eval. Report

12. 2. Regulatory Landscape Report 8. Prep. / App. • Regulatory status • Device classification • Intended use & indications for use • Regulatory route • Technical file 3. Quality Management System Healthcare Providers 6.Perform Clinical Study 5. Clinical Study Protocol 7.Quality Manag. System • Design Control procedures • Other QS aspects essential for US and EU pre-study compliance • Design dossier Payers More Info / Pricing More Info / Pricing • PMA • 510(k) EU 4. Evidence Planning Class I (NS/M) • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report Class I (S/M) Class IIa • Relevant, codes, coverage & payment • Reimbursement strategy Class IIb Class III US Class III Class II Class I Regulatory Application Round A Seed Funding At this point the company may submit the Technical File or the Design Dossier (in Europe) or apply for FDA Clearance / Approval (in the US). If granted, it could start selling its products. To obtain reimbursement, see the next slide… Main Decision Makers Reimbursement Regulatory, Quality and Clinical Research • Review and/or write protocol • Clinical Eval. Report • FDA QSR / ISO 13485

13. 9. Implementation 8. Prep. / App. • Establish user base, Obtain stakeholders’ support • Technical file Healthcare Providers • Utilize existing reimbursement mechanisms or: 7.Quality Manag. System 6.Perform Clinical Study 5. Clinical Study Protocol • Design dossier Payers • Apply for new reimbursement mechanisms More Info / Pricing More Info / Pricing • PMA • 510(k) 4. Evidence Planning • Value story • Economic model • Reimbursement issues for clinical study protocol • Stakeholders’ feedback 1. Reimbursement Landscape Report • Relevant, codes, coverage & payment • Reimbursement strategy Reimbursement Application Round A Seed Funding Main Decision Makers Reimbursement In case existing reimbursement mechanisms (Codes, Coverage, Payment) were allocated in the Reimbursement Landscape Report, we will • Compile the Value Story, Economic Model and the published ‘evidence’ into a dossier that would be used to convince Healthcare Providers to purchase your new product. Regulatory, Quality and Clinical Research Otherwise: • Review and/or write protocol • Clinical Eval. Report • FDA QSR / ISO 13485 • After verifying a sufficient user-base and support from the medical community, we will apply for new codes, coverage policies and favorable payment rates.

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