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OsseoWave

Development of an ultrasonic device for the estimation of implant osseointegration
Funder: French National Research Agency (ANR)Project code: ANR-13-PRTS-0015
Funder Contribution: 322,032 EUR

OsseoWave

Description

The increases of population lifetime and of the accidents are the two main reasons explaining the growing interest of the scientific community in studying the osteoarticular system. Although implant and osteoarticular prostheses have been widely used in clinical routine since more than 30 year and have allowed considerable therapeutic and esthetic improvements, a lot of optimizations and developments of their performances remain to be done. In particular, dental implants are widely used for maxillofacial rehabilitation purposes, with more than 400 000 implant surgery per year in France. Many cases of failure still happen due to a bad timing in the implant loading with the prosthesis. This is due to the fact that a reliable tool capable of verifying the quality of osseointegration is still missing. Such failures induce pain, degraded mastication conditions for patients and increased costs for dental surgeons. It still remains difficult to assess the stability of a dental implant and in particular the biomechanical properties of newly formed bone tissue around the implant. OsseoWave aims at developing an evaluation tool to assess the implant stability and to follow the implant osseointegration in the osteoarticular system. The first application to be transferred will be dental implants. The MSME laboratory of University Paris-Est has developed a new method for the follow-up of implants, which is sensitive to the bone-implant interface quality, the only accurate criteria for the implant surgical success. The system uses quantitative ultrasound analysis, which is a non invasive, non radiating and relatively cheap approach. A proof of concept has been demonstrated ex vivo and in vivo, which has allowed a French and PCT patent application and a new statement of invention. We intend to keep on working on in vivo validation experiments in rabbits and to start new ones in dogs in conditions closer to the clinical situation. Moreover, the development of numerical simulation tools will lead to the optimization of the signal processing methods used in the software of the device, which will improve the overall performances of the device. An industrialization study aim at conceiving and manufacturing the final version of the device. Then, the device will be validated in the framework of a preliminary clinical study and the results will be protected through new patent applications. The present project will bring the technology to the CE certification, which is necessary in order to carry out a clinical investigation at a larger scale in the framework of a PHRC funding. The present project will pave the way towards for other applications (ankle, hip and spine among others). The team is constituted by members with complementary skills (dental surgeons experts in oral biology of bone remodeling and researchers specialized in quantitative ultrasound imaging). The project has won the concours national de Création d’entreprise in Emergence and was founded through an Aima project by the Centre Francilien pour l’Innovation and through the ANR project WaveImplant (end: September 2013). These funding have been used to realize an intellectual property study which has shown the freedom to operate of the device and a first in vivo validation. Moreover, the laboratory has been contacted by two leading companies of the dental field (Septodont and Zimmer Dental) for the realization of a dedicated study. The developed technology has been under industrial transfer since mid-2009 which will be concretized through a grant of patent and know-how license to a company to be created and already incubated. The developed technology has the potential to justify a start-up creation because of: - An important, international and growing market with no effective competitors - Multiple possible applications of the technology - Need for a technical expertise but also for a strong industrial and marketing environment

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