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Accelerating the Dissemination of Agluna(R), a clinically proven innovative silver ion based anti-microbial surface technology, from orthopaedics sector into the dental implant sector

Periodic Reporting for period 1 - ADA (Accelerating the Dissemination of Agluna(R), a clinically proven innovative silver ion based anti-microbial surface technology, from orthopaedics sector into the dental implant sector)

Reporting period: 2015-02-01 to 2015-07-31

The project is to confirm the commercial application of Agluna®, an innovative silver ion based anti-microbial surface technology to dental implants. Agluna® has already demonstrated a significant reduction in the incidence of post-operative infection in clinical use within the EU limb salvage market, and is being actively commercialised within the wider global orthopaedic market.

Implant related infections are associated with the formation of biofilm on the surface of implanted devices. This is a global problem with socio-economic costs recognised across a range of medical device sectors. The dental implant sector is actively searching for solutions to the problem of post-operative implant related infection. With growing concern about antibiotic-resistant strains, the subsequent expected outcome following this project is for Agluna® to become commercialised in EU/global markets as a differentiated, cost effective and clinically proven technology utilising silver ions, a well-known biocide with very limited reported bacterial resistance.

Phase 1 will confirm a business plan for successful commercialisation of Agluna® in the dental implant sector. We seek confirmation of:

- the size and scope of the EU and global market opportunity in the dental sector;
- competing approaches to prevention and control of post-operative infection in this sector;
- market entry strategy taking account of EU and other international regulatory pathways;
- investment requirements, time to market, and return on investment.

Phase 1 is six months in duration; the principal deliverable is a fully substantiated business plan. This will provide the basis for Phase 2, in which Agluna® will be piloted on a dental implant product that is designed, manufactured and clinically tested in a human efficacy study.
Five principal project activities have been completed within the Phase 1 feasibility study:

1. Assessment of Market Opportunity
2. Review of Competitive Environment
3. Assessment of Regulatory Pathway and Market Entry Strategy
4. Analysis of Supply Chain Positioning and Commercialisation Risks
5. Financial Planning

The work is complete and final results achieved are reported below.
Five principal project activities have been completed within the Phase 1 feasibility study:

1. Assessment of Market Opportunity: the dental implant market is estimated to be >€3 billion, with Europe the largest global territory, and strong growth rates in other territories (notably North America and Latin America). There are strong drivers underpinning sustainable growth, notably the globally ageing population, increasing patient awareness of the benefits of dental implants, and expansion of the number of dental professionals placing dental implants. The market has to a significant degree become commoditised (particularly in Europe), and there is good potential for growth of a differentiated product offering targeting the problem of device related infection.

2. Review of Competitive Environment: Currently available techniques for addressing the problem of post-operative infection in dental implant surgery typically involve systemic or local delivery of antibiotics, though these have failed to prove viable or efficacious in clinical practice and are affected by concerns over resistant microbial strains. Various surface technologies are undergoing development involving a range of anti-microbial agents, though no technology has yet achieved regulatory approval or commercial uptake. A general challenge to be overcome is the delivery of a technology solution that meets clinical safety and efficacy requirements, as well as economic constraints of dental implant supply chains.

3. Assessment of Regulatory Pathway and Market Entry Strategy: A review has been carried out of the regulatory strategy for bringing to market, initially in the EU, an Agluna®-treated dental implant. Consultation is being undertaken with EU regulatory bodies to confirm the optimal regulatory pathway, taking account of the advanced regulatory position and positive clinical experience already achieved in the EU limb salvage market. For example, the METS Silver Agluna® Implant System was CE Marked by Stanmore Implants in 2011 and is being increasingly adopted by EU clinicians in this sector. Once commercial adoption and clinical performance is demonstrated in the EU market, wider globalisation is planned.

4. Analysis of Supply Chain Positioning and Commercialisation Risks: A number of alternative strategies are possible for positioning future supply of Agluna® into the dental implant sector. For example, licence and supply of Agluna® to implant manufacturers; joint commercial venture with existing implant manufacturer; or establishment of a dental implant enterprise for supply of Agluna®-treated implants. The final option is considered to provide the most attractive commercial model for dissemination of Agluna® into the dental implant sector.

5. Financial Planning: – overall investment requirement has been assessed to achieve early commercialisation of Agluna® into the dental implant sector over the next 3 years. Subject to satisfactory regulatory pathway, commercial revenues in the EU market will be generated in CY2018. Revenues >€15m p.a. are expected within five years of commercial adoption, and up to €30m p.a. within 10 years. This would represent a 15-30x return on investment and create up to 200 new manufacturing jobs.
Illustration of post-operative dental implant related infection
Schematic illustration of Agluna(R) silver ion antimicrobial surface
Illustration of post-operative dental implant related infection