Starting a Clinical Investigation in Ireland: The SME experience

1. Starting a Clinical Investigation in Ireland: The SME experience

2. Agenda • Overview of company and technology. • Clinical Investigation design. • Selection of a Clinical Investigation Site. • MM experience of setting up a Clinical Investigation in Ireland • Conclusions and Recommendations

3. Overview of Marvao Medical • Founded in November 2005; located at GMIT Innovation in Business Centre, Galway. • Currently has 6 employees working in product design, quality and regulatory affairs, finance and business development. • Company is funded by private investors and venture capitalists. • Our mission is to develop novel devices that significantly reduce the incidence of Catheter Related Bloodstream Infection. Marvao Medical has developed NexSite technology which focuses on catheter exit site healing and has also licensed technology to develop a Catheter Locking Solution for intraluminal infection.

4. Overview of NexSite technology NexSite Technology • Promotes Tissue Growth to facilitate healing of the Catheter Exit Site

5. Clinical Investigation Design • NexSite - Class III device - implantable for >30days. • Clinical Investigation was required to generate clinical data to demonstrate the safety and performance of the device. • Designed as a single arm non-inferiority clinical investigation. • Clinical Investigation was designed to comply with the requirements of ISO 14155.

6. Selection of a Clinical Investigation Site (s) Marvao Medical Requirements: • Facilities to support the investigation. • Principal Investigator with experience in Medical Device Investigations. • Access to support nurses to: • Complete patient follow up. • Review patient files for adverse events • Appropriate Infrastructure .. Laboratory supports etc. • Close proximity to the Marvao Medical support staff.

7. Selection of a Clinical Investigation Site (s) Marvao Medical Site Selection: • Selected GUH as the initial site for the Clinical Investigation; extended study to Galway Clinic to expand potential patient population. • Dr Gerry O’Sullivan, Interventional Radiologist as PI. • Clinical Research Facility contracted to provide statistical analysis and nursing support for Clinical Investigation. • Contracted Java Clinical Research to monitor Clinical Investigation.

8. Regulatory Requirements – MM experience Competent Authority (IMB) • Facilitated pre-filing meetings. • Approval to complete Clinical Investigation was received from IMB within 60 days of filing. Ethics Committee • Obtained approval to undertake the Clinical Investigation from GUH Ethics Committee with very quick turnaround. • Accepted applications as per the standard HSE form, with no hospital specific requirements.

9. Hospital Administration - MM experience Post Ethics and Competent Authority approval and prior to starting the study, Marvao Medical had to address GUH administrative requirements. • Site Specific Assessment to outline the resources required within the hospital to complete the Clinical Investigation. • Contracts and insurance details required. At GUH administrative requirements are reviewed by Finance personnel – … no time period for review , no detailed list of requirements for review with regard to contracts, insurance levels etc.

10. Clinical Research Facility – MM experience • Clinical Research Facility Staff completed the following activities for the Clinical Investigation • Development of Clinical Investigation Plan. • Pre-enrolment screening with referring physician. • Assisting at device placement procedure • Maintaining device traceability • Scheduling and completing monitoring sessions and completing Case Report Forms. • Preparing documentation & following up with labs etc for adverse events • Facilitating monitoring visits. • CRF nurses ensured that patient monitoring was standardised and co-ordinated. Training costs for investigation monitoring were minimised

11. Conclusions: • Possible to set up a small / FIM study in close proximity to supporting company personnel. • Principal Investigators in Ireland are widely published and interested in getting involved in research. • Positive interaction with Competent Authority and Ethics Committee. • Excellent training opportunity for SME . • Cost effective . • There are areas in the infrastructure that could be improved.

12. Recommendations • CRF: • Expertise in medical device clinical investigations. • Ability to work with all hospitals in a region (including private health care facilities). • Flexible & aligned requirements nationally across all CRFs. • Hospitals: • Transparency regarding requirements to obtain hospital approval for the Clinical Investigation and for approval of same. • Maintain electronic databases for patient profiles to assess available patient populations. • Encourage staff to be supportive of Clinical Investigations. • Highlight the positive aspects of participation to patients.