THE FULL SERVICE

MEDICAL DEVICE CRO

MedPass is the leading full service Medical Device CRO in the EU assisting clients in the quick, efficient and cost effective clinical development and market access of emerging

technologies. Our unparalleled regulatory and reimbursement expertise adds value by significantly reducing development timelines.

Europe remains the most attractive location for medical device clinical development, a springboard to access emerging markets in Asia Pacific and

South America, and a cost effective location for conducting trials for US FDA.

Our multinational clients appreciate our flexibility, speed and willingness to work on an as needed basis, setting us apart from global CROs. Our start up clients benefit from a single, trusted vendor providing all clinical and regulatory needs from route to market roadmaps to first in man studies, clinical evaluations, Notified Body selection

and CE marking, post market clinical follow-up, quality assurance, support during the post-market phase and reimbursement for a seamless development program.

Since 1991, the company has participated in the successful development of hundreds of innovative technologies from the first fully functional cervical disc replacement in

the late 1990’s through dedicated interventional neuroradiology devices to treat stroke in the early 2000's to the first CE marking of a transcatheter aortic valve. Most recently,

MedPass was regulatory consultant and CRO for the first leadless cardiac pacemaker.

OUR SERVICES

n Strategic Consulting: Regulatory and Reimbursement Roadmaps

n Clinical Design and Planning

n Regulatory affairs representation and execution

n Clinical Investigations, Post Market Studies, Registries

n CRO Services, Biometrics: eCRF, Data Management and Biostatistics

n Market Access, Pricing and Reimbursement

n European Authorized and Legal Representative

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QUALITY MANAGEMENT SYSTEMS – ISO 9001/ISO 13485

Preparation of EU Design

Dossiers, Technical Files

or STED Literature Review

Clinical Evaluation

Plan

ReimbursementPre- / PostInspection

Audit AR

Regulatory Strategy and Classification

Risk Management(ISO 14971)

Class IIa, IIb and III Submission for

Product Assessment Risk Management(ISO 14971)

R&D CLINICALEVALUATION APPROVAL COMMERCIALISATION

ISOInspections

MedPass International – publishing 2015

ABOUT US

PMS

PMCF

QUALITY

MedPass operates to a full Quality Management System, compliant with ISO 13485. MedPass can

therefore perform CE marking trials for its clients without the need for the client to develop a clinical QMS.

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STRATEGIC CONSULTING

MedPass assists companies in developing integrated, regulatory, clinical and reimbursement strategies for Europe much appreciated by life science investors and early stage companies.

Our senior consulting staff are diversely skilled and professionally trained in the areas of risk management, animal tissues, toxicology and biocompatibility, engineering, quality management systems, medical writing, drug/device combination products, biostatistics, healthcare economics, reimbursement and pricing.

SERVICES OFFERED INCLUDE:

n Regulatory roadmaps

n Selection of and liaison with Notified Bodies

n Quality assurance advice

n Reimbursement feasibility studies

n Clinical trial strategies for CE marking and reimbursement

n Risk management for major adverse events

CONSULTING

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STRATEGIC CONSULTING

MEDPASS IN EUROPE

CLINICAL EVALUATIONS

Clinical evaluations are one of the most important aspects of obtaining – and maintaining CE marking.

MedPass has unrivalled expertise in Clinical Data Requirements for CE marking and all services are in full

compliance with EU requirements. Our close involvement in the revision of MEDDEV 2.7/1 means that we can anticipate

the requirements of future medical device regulations.

Our Clinical Evaluation Services can be tailored to specific client needs and include:

n Regulatory roadmaps

n Literature reviews and updates

n Preparation of clinical strategy plans for Notified Bodies

n Clinical evaluation reports

n PMS and PMCF Plans

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CLINICAL EVALUATIONS / REGULATORY AFFAIRS

REGULATORY AFFAIRS

An in-depth understanding of the regulations applicable to medical devices and the ability to work effectively within this complex environment is vital for successful medical device development.

At all stages in the product life cycle, from pre-clinical assessment and clinical trials through CE marking to post market surveillance, MedPass International provides the expert regulatory advice you need, whether your objective is:

n To initiate or conduct a clinical investigation,

n To obtain CE marking for Europe or market authorization elsewhere,

n To carry out post market evaluations or meet reimbursement conditions, or

n To comply with requirements for post-market surveillance and risk management.

REGULATORY CONSULTING

n Regulatory strategy

n Classification determinations

n Risk assessment and management

n Biological safety (biocompatibility) assessments

n CE marking process and compliance assessment

n Human/animal tissue products (including ATMPs)

n Vigilance and SAE reporting

n Communication with CAs and Notified Bodies

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CLINICAL OPERATIONS / DATA MANAGEMENT & BIOSTATISTICS

DATA MANAGEMENT AND BIOSTATISTICS

MedPass has full biometrics capabilities offering flexible data management solutions adapted to the specific needs of the trial and the client.

DATA MANAGEMENT

n Paper-based and/or EDC database development

n Case report form design

n Data management plan

n Database documentation

n Database validation, edit checks and self evident corrections

n Data cleaning and query management

n Medical coding (MeDRA and WHODrug)

n SAE reconciliation

n Database transfers (required format)

STATISTICS

n Study design development

n Sample size calculations

n Protocol statistics

n Statistical analysis plans

n DSMB meetings, preparation and attendance

n Statistical reports

n Communication support (articles, abstracts, posters)

CLINICAL OPERATIONS

MedPass’ core activity is our CRO service. Our Clinical Operations Group includes highly skilled

project managers and clinical monitors with significant medical device experience. Project teams are assembled to meet the needs

of the trial in terms of therapeutic area and geographical location of investigational sites. Project managers coordinate internally with

other specialized departments within MedPass as required providing a single point of contact and a seamless service to the client.

TRIAL MANAGEMENT

n Clinical investigational plan

n Informed consent

n Investigator brochure

n Safety Management

n Core laboratory management

n DSMB/CEC management

n Investigator meeting planning

SITE MANAGEMENT AND MONITORING

n ICH/GCP- ISO 14155 compliant

n Site identification and qualification

n Monitoring plans

n Site initiation including training on clinical investigational plan and specific study procedures

n Site management during study start-up and enrolment

n Site monitoring and site close-out

n Extensive knowledge of medical devices across a wide range of therapeutic areas

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health&safety

AUTHORIZED REPRESENTATIVE

MedPass has the expertise to assume all of the responsibilities required by the EC Directives on behalf of

AR Clients. Furthermore, the Competent Authority experience (with MHRA and ANSM) of our regulatory staff is particularly important

when it comes to dealing with adverse events and reporting vigilance cases to Competent Authorities and field safety corrective action.

MedPass AR staff have considerable experience in dealing efficiently with the complex but routine aspects of the work, such as

product registrations in the various member States. We offer AR services for CE marked medical devices and those in clinical investigations.

What makes our AR service different is our ability to respond swiftly and effectively in the appropriate national language to unforeseen or

out of the ordinary circumstances, all the resources of the Regulatory Affairs Department being at the disposal of AR clients as needed.

n Legal presence in EU for non-EU manufacturers

n Single point of contact for Competent Authorities

n Registration of products with CAs

n Maintenance of basic product information

n Immediate access to the whole range of services offered by MedPass International

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AUTHORIZED REPRESENTATIVE / LEGAL REPRESENTATIVE

LEGAL REPRESENTATIVE

The requirement of a European Legal Representative (LR) for clinical investigations is seen in DIRECTIVE 2001/20/EC (the clinical trials Directive).

Whilst this directive applies to medicines, it has been transposed into national laws relating to medical devices in many European countries. These laws have recently come to the forefront and are being enforced across Europe.

The responsibilities associated with the role as European LR vary, with the greatest responsibility being complete liability. In addition, the UK and Switzerland require an in-country LR.

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MARKET ACCESS, PRICING & REIMBURSEMENT

MARKET ACCESS, PRICING AND REIMBURSEMENT

MARKET ACCESS / REIMBURSEMENT INVESTIGATIONS ACROSS EUROPE

STRATEGIC ANALYSIS FIELD ASSESSMENT IMPLEMENTATION

uNew Technology:nClinical and economic

state of the art (literature review)

nSafety, Effectiveness, Health Economics

nPotential market positioning

uReimbursement/Funding Opportunities:

nReimbursement landscape / existing codes & payments

nStrategy to improve reimbursement / pricing

uField validation of stakeholders’ expectations:

nPreparation of value proposition

nInterviews with KOLsnEarly dialogue with

policymakers and HTA bodies

nExpert advisory boards and focus groups

nWillingness to pay

uReimbursement actions:

nPreparation of reimbursement applications

nAssistance with hospital procurement / call for tenders

nAdvice on Health Economics and Outcomes Research

nSubmissions for public funding of clinical trials

MARKET ACCESS / REIMBURSEMENT SERVICES

MedPass International – publishing 2015

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MARKET ACCESS, PRICING AND REIMBURSEMENT

The first step to obtaining reimbursement/funding for a new medical technology in Europe is to understand the reimbursement

environment specific to the device in each of the target markets.

MedPass performs in-depth, product specific research establishing the strategy for market entry before a reimbursement application is

made or a core value dossier prepared. Furthermore, MedPass maintains up to date, country by country knowledge that is crucial in mapping out successful EU market penetration strategies for new medical devices.

OUR CUSTOMIZED REIMBURSEMENT SERVICES INCLUDE:

n In-depth, customized Reimbursement Roadmaps for key EU markets including short term strategies for obtaining reimbursement by identification of existing codes / funding and payment mechanisms for competing products and identification of fast track reimbursement procedures for innovative technologies,

n Health Technology Assessment (HTA) reviews,

n Key Opinion Leader interviews,

n Recommendations on the potential opportunity and challenges of the product’s market access.

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MEDICAL DEVICE EXPERTISE

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MEDICAL DEVICE EXPERTISE

CARDIOVASCULAR

n Transcatheter heart valve replacements

n Artificial heart valves (surgical)

n Heart valve repair systems

n Left Ventricular Assist devices

n Transmyocardial revascularization systems

n Robotic surgical systems for coronary bypass surgery

n Cardiac support devices

n Coronary Stents

n Drug-eluting balloons

n Thrombectomy devices

n Cryoplasty systems

n Embolic protection devices

n Ultrasound devices to enhance thrombolytic therapy

n PFO Closure devices

n Coronary surgery devices

n Pleural sealant systems for thoracic surgery

n Pulmonary artery pressure measurement devices

n Coronary sinus pressure management devices

n Radiofrequency ablation systems

n Implantable cardioverters-defibrillators

n Renal denervation systems for treatment of resistant hypertension

PERIPHERAL VASCULAR

n Guidewires for peripheral total occlusions

n Peripheral stents

n Drug-eluting balloons

n Atherectomy devices

n Laser system for treatment of endovascular clots

n Arterial closure systems

n Vascular sealant for anastomosis sutures

n Endovascular devices for the treatment of abdominal aortic aneurysms

NEUROLOGY – NEUROVASCULAR

n Intra-cranial stents

n Embolic protection devices

n Intra-aortic device for treatment of stroke

n Neurovascular thrombectomy systems

n Intracranial aneurism occlusion systems

n ACL replacement devices

n Dural sealant systems for neurosurgery

n Implantable neuromuscular stimulation systems

ORTHOPAEDICS

n Vertebral disc arthroplasty system

n Cervical spinal disc replacement and other spinal implants

n Vertebral disc nucleus replacement device

n Vertebroplasty and Spinal stabilization systems

n Neuromuscular electrical stimulation

n Dural sealant system

n Osteosynthesis devices

n Intra-osseus nerve ablation

n Bone growth stimulation

n Bone stalilization system

n Bone void fillers

n Joint replacements (knee, hip)

n Osteochondral grafts for cartilage lesions

n Tendon repair

n Tissue graft for the reconstruction of ruptured knee ligaments

OPHTHALMOLOGY

n Glaucoma drainage device

n Corneal implant

n Intraocular lenses

n Implantable retinal device to restore vision

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MEDICAL DEVICE EXPERTISE

MEDPASS TESTIMONIALS

GASTRO HEPATO ENTEROLOGY

n Implantable gastrointestinal device for treatment of obesity

n Gastric banding implants

n Gastric stimulation for treatment of obesity

n Intragastric balloon for treatment of obesity

n Robotic surgical system for laparoscopic cholesystectomy

n Bioartificial liver

n Devices for coelioscopic colon surgery

UROLOGY – GYNECOLOGY

n Urinary incontinence bulking agents

n Renal artery infusion systems

n Thermotherapy devices for benign prostatic hyperplasia

n Intrauterine radiofrequency system for ablation of uterine fibroids

ENT

n Implantable hearing devices

n Inner ear treatment of Tinnitus

n Obstructive sleep apnoea treatment devices

n Dental implants

n Periodontal bone fillers

ONCOLOGY

n Protection devices and localisation devices in radiation therapy

OTHER IMPLANTS AND DEVICES

MEDICAL DEVICE EXPERTISE

“Yes it was a pleasure working with the MedPass team; you are all true professionals! I would definitely keep you in mind for future activities.”

Director of Clinical Affairs, USA

“I can only say “wow” on this resolution! Thank you so much for your follow-up!”

Global Clinical Affairs, the Netherlands

“Your CRA’s efforts and clear focus on the priorities and objectives of our interim database freeze allowed us to collectively complete an enormous amount of data collection and query resolution in the last three weeks. I write this email in the air as I return from London, feeling much more at ease about the status of our UK sites. This is a luxury to say the least, especially in the midst of significant company deadlines. What a pleasure to communicate the good things that happen during the course of our battles that can sometimes compromise clinical research! Thank you for assigning her to our study.”

Director, Clinical Affairs, USA

“I am writing to share with you my feedback on the EXCELLENT work that was done by the Director of the reimbursement department today in Strasbourg. It is a true privilege to work with your reimbursement team! Their proactive attitude is refreshing and their work is world-class.”

President & CEO Class III medical device start-up, USA

MEDPASS TESTIMONIALS

14 | | 15

“We received our CE marking certificates from the notified body this morning. Thank you for all of your support and assistance, which were indispensable for this timely approval.”

Co-founder, medical device start-up

“Thank you all for your commitment and dedication. This has been orchestrated and executed flawlessly. Getting those MRIs today was critical for us.”

President & CEO, Class III medical device start-up, Israel

“I was approached by 2 research coordinators from Bonn. They reported to me that they “loved” the MedPass database. They even commented to me that in their impression, it is easier to use and a bit better than my Study data base. With that I said to them this is all thanks to you and your team!”

Vice President, Clinical Affairs, USA

MEDPASS TESTIMONIALS

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“Our notified body has granted the CE mark for our [device]. We would like to express our greatest appreciation for the support that MedPass has give to us for this difficult task. Without your suggestion (at the beginning) to try to get the CE mark only with the Japanese clinical data, it would have never been achieved. In fact, it may be considered historical to receive the CE mark only with the Japanese trial data, which will be noted by the Japanese agency and investigators.”

Director of Multinational, Japan

“I wanted to let you know that I was really impressed with your CRA here in Basel the last 2 days. We had 1 day of monitoring today and I felt that she asked excellent questions and interacted very professionally and positively with the site staff. It is a pleasure to work with her.”

Clinical Research Associate, III, USA

MEDPASS TESTIMONIALS

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CONTACT US:New Business Development Medpass-NBD@medpass.org

MedPass International 95 bis Boulevard Pereire

75017 Paris - France Phone: + 33 (0)1 42 12 83 30

Fax: + 33 (0)1 40 53 81 11 www.medpass.org