"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."
