Community Research and Development Information Service - CORDIS

H2020

Implant maintenance Report Summary

Project ID: 672075

Periodic Reporting for period 1 - Implant maintenance (Novel dental implant maintenance instrument; Production scaling up and European market expansion)

Reporting period: 2015-06-01 to 2015-11-30

Summary of the context and overall objectives of the project

"Peri-implant disease (Peri-implant mucositis and peri-implantitis) is a major and growing clinical problem in odontology, affecting 20-40 million patients in Europe, and about the double world wide. The clinical community is searching actively fr solutions to the problem, but no good solutions have emerged so far. Labrida AS has developed, clinically documented, patented and CE marked a novel maintenance instrument for management of peri-implant disease ("BioClean"). This is a non-surgical revision brush with bristles made of the biocompatible, resorbable material monofilament chitosan (Originally developed bu Medovent GmbH as surgical sutures). It offers safer, more effective, less painful and faster treatment of peri-implant disease. The instrument addresses a market potential of Euro 1-2 billion annual turn-over with the current indication area, and possibly several fold more should more indications be included.
Use of biopolymers in surgical revision is a new concept in odontology, the closest comparison is chitosan dressings used in field wound dressing (US army), based on the reported properties of chitosan being biocompatible, anti-inflammatory and bacteriostatic.
The device is in small scale production and sold commercially in Scandiavia with most promissing market response, and distribution arrangements are in process in Israel and several other European countries.
To meet the market opportunity, we need to scale up production processes of monofilament chitosan fibers and automatize the assembly of the instrument. This is critical both to meet volume requirements, and to maintain stable production quality. We have experienced that we are "pushing the technological limits" of biopolymer technology with our product. In addition, we have initial clinical pilot data showing that BioClean in combination with bioactive compounds (Tetracycline and "Peri-Solve" from RLS Global in Sweden) may hav additional effect on challenging clinical cases, with tetracycline even on therapy resistant periodontitis. This may pave the way for a new 2nd generation product, combining the bioactive compounds in the chitosan fibers. This combination product would also be covered by our patent (Granted in Sweden, far in the PCT process). Both this next generation product, as well as expanding indication areas for the 1st generation product, would constitute a substantial market replication. Shuold we be able to show effectiveness also in the management of periodontitis, we would be addressing one of the larger clinical challenges in odontology afeter the caries epidemics have been partly contained by fluoride prophylaxis.
In addition, this concept of chitosan and bioactive combinations could have applications in general medicine and implant infection mainteneance, but that is far beyond our scope.
The market dynamics in the odontology sector is opaque, convoluted with many local variations and rapidly changing. Therefore, to build a fairly robust marketing strategy, it is key to map the players fairly well, which we have focused on.

The overall objectives of this phase 1 project has been to:
1) Prepare for scaling up of the BioClean production, including large scale production of monofilament chitosan fibers
2) further map key players (sales and distribution organizations, KOL's and end customers) to develop a refined market expansion plan
3) assess the commercial attractiveness and viability of developing a 2nd generation combination product
4) plan and cost assess for the development of a 2nd generation product
5) compile the findings above to develop a business development plan and if appropriate a phase 2 Horizon 2020 application."

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

"Many of the results are not reported here in detail in the publishable version for commercial reasons.

The work performed in the phase 1 project has, structured along the overall objectives, been:
1) Prepare for scaling up of the BioClean production:
-Developed a two step upscaling plan for chitosanfibers with Medovent
-Established partnership with additional (industrial scale) chitosan manufacturer, and conducted tech transfer of the monofilament technology to them.
-Investigated possibilities for automation of brush assembly
-An improved blister package is in the process of being designed at Steripac
-Identified critical "break pints" for initiating larger scale production.
The main results are an additional supplier of chitosan fibers, and a cost assessed up-scaling plan

2) further map key players in Europe to develop a refined market expansion plan:
-Market reports, industry experts, customers, KOL's and public bodies have been examined / interviewed
-Active negotiations have been conducted with distributors
-Alliances with dental services chains developed
-BioClean has been presented at various conferences to obtain customer feed back
-Customer experiences has ben actively collected.
The results are a substantially more detailed understanding of the European market structure and dynamics, to support the market development.

3) assess the commercial attractiveness and viability of developing a 2nd generation combination product.
-Workshops have been conducted with key academics to refine hypothesis on most likely candidate compounds and indications fro a "bioactive product"
-Several clinical pilots with a combination of BioClean and bioactive substances have been initiated.
-Pharmacologists have been recruited and involved in further planning of a possible 2nd. generation product
-Based on epidemiology, market potentials for a 2nd generation product have been estimated roughly.
Preliminary clinical results are promising, and stronger hypotheses on choice of active compound have been developed.

4) plan and cost assess for the development of a 2nd generation product.
- Further physical properties of monofilament chitosan fibers alone and in the twist brush have been mapped
- Chemical and radiation sensitivity of various compounds considered
- Regulatory requirements and costs to meet these roughly assessed
Based on this, prerequisites for developing a 2nd. generation product have been set as decision criteria.

5) compile the findings above to develop a business development plan and if appropriate a phase 2 Horizon 2020 application.
- Results above have been compiled into relevant decision points
- data basis for a dynamic business plan have been developed
The study has resulted in the basis for a phase 2 application and a far more refined market understanding, which is both key to business planning and in day to day business activities, especially in marketing."

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This being a phase 1 project of limited size, developments are similarly modest.
Our BioClean dental implant revision tool is however a new concept deploying advanced biopolymers in odontology, and we have ben exploring the physical bounderies of what this technology can do mechanically (The biology of non-monofilament chitosan is reported earlier). This needs to be resolved to industrialize and large scale produce our product, which evidently meets a large market demand. It is possible that we are about to introduce a new treatment concept in odontology and implant maintenance. This alone has substantial socio-economic impact and societal implications, due to the fact that peri-implant disease is affecting 40-80 million patients world wide, and it is an unsolved clinical challenge to contain it well.
Our next generation bioactive revision tool appears to be even more clinically effective than the first generation product. we have indications that it may also be effective in treatment of challenging cases of periodontitis. If these findings are confirmed, and we have developed an improved method for containing and treating periodontitis, we are addressing one of the major challenges in odontology in the developed world, indicating substantial societal implications.

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