Emergence - Emergence de produits, technologies, ou services à fort potentiel de valorisation

Development of a monitoring device of the osseointegration of implants in the osteo-articular system – WaveImplant

Development of a medical device to monitor endosseous implant osseointegration

WaveImplant aim at developing a medical device to assess implant stability. The first application considered will focus on dental implants.

The aim is to promote the valorization of the results obtained in MSME.

The aim of this work program is to be ready for the clinical development of the technology using a prototype in line with the market expectations.

The project is led by the MSME laboratory, inventor of the technique and active in the domain of valorization. The aim is to create a start-up company. The clinical aspect is brought by the B2OA laboratory (dental surgeons) who will realize the surgical interventions.
The consortium is also constituted by the cellule de valorisation de l’UPEC, where is located the laboratory of the coordinator and who is in charge of the patent applications.
A particular attention will be brought to the coordination between the experimental and theoretical works. The consortium being of relatively small size, the coordination will be easier.

The program is going on as expected and no particular difficulty is met. Two persons have been hired and two master students work on the subject. An important work of industrialization has been made in close relation with the cellule de valorisation de l’UPEC.
The project is now incubated by the incubateur Marne-la-vallée Descartes Innovation (Champs sur Marne, 77, www.incubateur-descartes.com).
A bibliographic work has been made to identify all pertinent articles in the literature.
A multimodality approach has been carried out with the objective of a better understanding of the physical determinants of the biomechanical properties of the bone-implant interface.
First interesting results have been obtained.by comparing the results obtained just after surgery and after osseointegration.

Since the project is going on as expected, we would like to follow the development initially determined in the scientific document for the rest of the project.
The perspective corresponds to a start-up creation.

- Vayron R., Barthel E.., Mathieu V., Soffer JE, Anagnostou F, and Haiat G., “Variation of biomechanical properties of newly formed bone tissue determined by nanoindentation as a function of healing time”, Computer Methods in Biomechanics and Biomedical Engineering 14(S1) (2011) pp 139-140.
- Vayron, R., Barthel, E., Mathieu, V., Soffer, J.E., Anagnostou, F. and Haïat, G., “Nanoindentation Measurements of Biomechanical Properties in Mature and Newly Formed Bone Tissue Surrounding an Implant”, in press to J Biomech Eng. Ces deux études permettent de mieux comprendre les variations des proprieties biomécaniques de l’os néoformé à proximité de l’interface os-implant.
- Mathieu, V., Vayron, R., Barthel, E., Dalmas, D., Soffer, J.E., Anagnostou, F., and Haïat, G., “Mode III cleavage of a coin-shaped titanium implant in bone: effect of friction and crack propagation”, J Mech Behav Biomed Mater 8 (2012) pp 194-203. Cette etude a mis en evidence le taux de restitution d’énergie élastique de l’interface os-implant.
- Mathieu, V., Soffer, J.E., Anagnostou, F., and Haïat, G., “Influence of healing time on the ultrasonic response of the bone-implant interface”, Ultrasound Med Biol 38(4) (2012) pp 611-618. Cette étude permet de quantifier pour la première fois l’influence du temps de cicatrisation sur la réponse ultrasonore de l’interface os-implant.
- Mathieu, V., Vayron, R., Richard, G., Lambert, G., Naili, S., Meningaud, JP and. Haïat, G., “Biomechanical determinants of the stability of dental implants: influence of the bone-implant interface properties” submitted to Med Eng Phys. Cette etude bibliographique de revue s’attache à decrire l’état de l’art dans le domaine et à mettre en évidence l’originalité de l’approche menée dans WaveImplant.

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 100 000 surgical operations per year in the USA. 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 failure 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.
WaveImplant 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, which has allowed a French and PCT patent application and a new statement of invention. The first in vivo validations are currently in process.
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 optimizing the manufacturing cost of the device and the results will be protected through new patent applications. The present project will bring the technology on the path of human clinical investigations and will pave the way 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 PI is the winner of the concours national de Création d’entreprise in Emergence. The project was founded through an Aima project by the Centre Francilien pour l’Innovation. Theses funding have been used to realize an intellectual property study which has shown the freedom to operate of the device and a first industrialization study is under way. Moreover, the laboratory has been contacted by a leading company of the dental field (Septodont) 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 licence to a company to be created by the PI.
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
- The industrial dental sector of this type is not well developed in France and there is a great interest for France to be positioned in this sector.
- Several companies in the dental sector are however present in France and could constitute interesting partners.

Project coordinator

Monsieur Guillaume Haiat (UNIVERSITE PARIS-EST CRETEIL VAL DE MARNE) – guillaume.haiat@univ-paris-est.fr

The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.

Partner

UPEC/MSME UNIVERSITE PARIS-EST CRETEIL VAL DE MARNE
UPEC UNIVERSITE PARIS-EST CRETEIL VAL DE MARNE
B2OA CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE - DELEGATION REGIONALE ILE-DE-FRANCE SECTEUR PARIS B

Help of the ANR 262,596 euros
Beginning and duration of the scientific project: September 2011 - 18 Months

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