fastform fit... aerated comfort from injury to recovery

FastForm Fit... Aerated Comfort from Injury to Recovery

Advancing technologies in Orthopaedic trauma management

FastForm ... Custom-Moulded Fit, Breathability and Comfort from Injury to Recovery

HEALTH INNOVATION CONFERENCE 6th NOVEMBER 2014

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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





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


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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




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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


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Our Solution… “Custom Mouldable Therapeutic Solutions” for Advanced 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




FastForm – Health Innovation Hub Project Overview and Objectives:

Access to orthopaedic professionals and supporting teams to introduce FastForm’s Products in order to demonstrate:

1. Usage of our products in Ireland2. Clinical study on Thumb Spica and SAMO SCB reporting:

- Equivalency - Patients benefits - Cost of procedure advantages

3. Usage of our SAMO SCB at the primary phase of Fracture management4. Clinical Input for New product development 5. Clinical feedback on trials of New products6. Clinical feedback on Sales and Marketing Collateral and messaging




Project Plan overview

Task - Sub Task May June July Aug Sep Oct Nov Dec Jan-15 Feb Mar April May

1 Access to Orthopaedic Expertise Establish Relationships with Orthopaedic professionals

Obtain initial Clinical feedback on FF productsGain Access to personnel at "Friendly" HSE siteExpand to other HSE sites

2 Marketing & Sales Marketing & Sales collateral - Feedback from Clinicians

Establish "Online" clinical focus group for surveys?

3 New Product Development Input Provide Clinical input for Ulnar Gutter splint

Provide Clinical input for Radial Gutter splint

4 Thumb Spica SCB clinical evaluation Evaluate equivalency of FastForm Thumb Spica

Evaluate & quantify Cost of procedure benefitsReport clinical benefits for patients

5 Short Arm SCB Clinical evaluation Validate use at primary fracture treatment phase

Evaluate & Quantify Cost of procedure benefitsReport clinical benefits for patients

Estimated Completion Date




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.




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.

Task - Sub Task May June July Aug Sep Oct Nov Dec Jan-15

5 Short Arm SCB Clinical evaluation Validate use at primary fracture treatment phase

Evaluate & Quantify Cost of procedure benefitsReport clinical benefits for patients




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.




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.




Thank You !



fastform fit... aerated comfort from injury to recovery

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place fastform

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custommoulded fit

aerated comfort

market products

differentiated products

advanced fracture management