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FastForm Fit... Aerated Comfort from Injury to Recovery

FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery. FastForm Fit... Aerated Comfort from Injury to Recovery. Advancing technologies in Orthopaedic trauma management. FastForm ... Custom-Moulded Fit, Breathability

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FastForm Fit... Aerated Comfort from Injury to Recovery

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  1. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery Advancing technologies in Orthopaedic trauma management HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  2. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery FastForm and the HIH What we do Brief overview of FastForm What we have achieved Participating in the HIH initiative: Our Objectives No Sites in Ireland currently using our products Our Experience so far Learning's Progress and status of Clinical Evaluations FastForm – HIH next steps HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  3. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery What we do • FastForm Research is an innovative life sciences company based in Waterford. • Our goal is to change the way physicians immobilize and cast patients through the introduction of our uniquely-designed, pre-formed and breathable devices which mould precisely to the body contours of the patient. Mission: • To be the leading supplier of Custom moldable therapeutic solutions for Advanced Fracture Management and Sports Medicine HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  4. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery FastForm Research Overview Founded by David Sheehan Initial funds raised to develop state of the art Splinting & Bracing products Key Business components in place to bring differentiated products to the market - Technology – Products – IP – Clinical study – Manufacturing Capacity – Initial sales – Lean & experienced team Funds raised in August 2013 from US investors to fund commercialization phase FastForm Medical , a wholly owned subsidiary established in AZ, USA in 2013 HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  5. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery What we have achieved Invented and developed • A patent protected platform technology - PolyTrexX™ & DermaWick™ • Highly differentiated, ready-for-market products that: - Are Clinically Trialled, CE marked & FDA registered - have IP Protected through patents & Know-how - are in the market and being sold in the USA and Asia Lean Organisation with stringent ISO13485 quality system • Innovative team in place to deliver success • Know-how, Manufacturing tooling & equipment & capacity • Manufacturing leveraged out to local Waterford company • R&D initiated on a range of follow on products • FastForm subsidiary established in AZ, USA to accelerate commercialization • Scoi clinic in LA using FastForm; being rolled out in other clinics across USA • KOL advisory committee in place

  6. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery Our Solution…“Custom Mouldable Therapeutic Solutions” forAdvanced Fracture Management and Sports Medicine • Innovative Orthopaedic Casts and splints for immobilisation & body protection • Unique,platform polymer technology- PolyTrexXTM • Highly mouldable, aerated multi-functional cast system with integrated breathable padding- DermaWickTM • Clear Benefits: clinical, functional and economic • Latent Market Demand • FastForm’s unique solution is a potential game changer and will create a new market segment

  7. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery • FastForm – Health Innovation Hub Project Overview and Objectives: • Access to orthopaedic professionals and supporting teams to introduce FastForm’s Products in order to demonstrate: • Usage of our products in Ireland • Clinical study on Thumb Spica and SAMO SCB reporting: • - Equivalency • - Patients benefits • - Cost of procedure advantages • Usage of our SAMO SCB at the primary phase of Fracture management • Clinical Input for New product development • Clinical feedback on trials of New products • Clinical feedback on Sales and Marketing Collateral and messaging HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  8. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery Project Plan overview HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  9. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery • Learning's: • Guidance and Input on submitting a study protocol to Ethics for approval • Collaboration on study design with clinical study team and CUH clinicians • Guidance from CUH staff to resolve site initiation issues and to improve our training procedures away from the pressure of a commercial setting. • On-site access to technicians and hands on-users of our devices • Valuable data received on usage numbers and breakdown of treatments at CUH • CUH clinicians provided valuable insights and guidance on splinting and immobilization techniques for fracture management practiced at CUH. • The CUH staff were extremely professional, helpful, approachable, insightful and conscientious with regard to clinical management and patient care. HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  10. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery • Progress and status of Clinical evaluations: (Spica and Samo products) • Initiation of clinical studies delayed • Site initiation and training modified to meet CUH requirements. The application environment in US clinics for our products differs significantly to CUH. • Modification of our product application protocol to suit CUH requirements • Equipment adapted to suit settings and requests from CUH staff • Consultation requested and established with our US KOLs to discuss their experience, usage of our products and outcomes. HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  11. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery • FastForm – HIH Next Steps • Optimistically all outstanding issues can be resolved to enable pending evaluations get under way in the coming weeks. • Given the level of preparatory work already completed and commitment from all stakeholders so far we are optimistic the evaluations will run smoothly and that outcomes will be positive • Assuming we have positive outcomes from the current pending evaluations we would hope to do a follow on study to evaluate usage of our SAMO at the primary treatment phase of fracture management. • We look forward to receiving further advice and input from the CUH clinical teams with our gutter products under development and future new products. HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  12. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery • Summary • Participation on the HIH initiative has been very useful for FastForm so far • We have expanded our clinical knowledge through our exposure to clinicians at CHU • Key insights enabled us to improve our training procedures and marketing literature • We have a much better understanding of what’s needed to execute a clinical evaluation • A lot of good work has been completed during the preparation phase for the clinical evaluations • CUH staff have been very supportive and insightful and our positive interactions bode well for future collaboration. HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

  13. FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery FastForm Fit... Aerated Comfort from Injury to Recovery Thank You ! HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

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