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Commercial feasibility of a quantitative ultrasound medical device: a patient-specific decision support system for the estimation of dental implant stability

Periodic Reporting for period 1 - OsseoWave (Commercial feasibility of a quantitative ultrasound medical device: a patient-specific decision support system for the estimation of dental implant stability)

Reporting period: 2020-09-01 to 2022-02-28

OsseoWave has allowed the development of the company WaveImplant. In a rapidly growing market, WaveImplant is developing ImplantUS, an innovative and patented ultrasound medical device for which the preclinical validation has been obtained. The objective of ImplantUS, a Class IIa medical device, is to provide dental surgeons with a decision support system in order to conduct and manage optimal surgical procedures in dental implantology. This new medical device addresses an unmet and perfectly identified need to retrieve a reliable estimate of dental implant stability that is the main determinant of the surgical success. ImplantUS will reduce the implant failure rate (currently around 15%) of these surgical procedures which has a very negative impact in particular in terms of cost and image for surgeons and their insurers, but also for patients.
WaveImplant was created by Guillaume Haiat (Scientific Director) and is headed by Stéphane Perche (CEO). Graduated from the Ecole Polytechnique and Research Director in the CNRS (National Center for Scientific Research), Guillaume Haiat, the inventor of the technology, has 15 years of experience in academic and industrial research in the domain of implantology. Stéphane Perche is a successful entrepreneur in various domains (Fintech, IT, Agritech, design) in EU & USA. He has experience in general management, finance and strategy. He also graduated from the Ecole Polytechnique. He is the former managing director of Deutsche Bank, London. Thierry Toubiana has a 28 years of experience in the Medical Device Industry in general and in dental implantology in particular since he was the general manager France of BioHorizon, part of the 5th implant manufacturer worldwide. He has experience in start-up and international companies. He successfully penetrated and built direct sales organizations or distribution network at local/country subsidiary level, as EMEA level or International Level. The Scientific Advisory Board, of international dimension, is already set up and comprises around 10 KOLs. The team is completed by two young engineers for Ecole Centrale and Ecole des Mines, who are working as project leaders.
The technology is based on the analysis of ultrasound waves reflected at the interface between the implant and bone tissues, the ultrasonic waves being emitted by a probe placed in contact with the implant. It has been validated in vitro, in silico and in vivo in rabbits and sheep. The reflected acoustic energy makes possible the quantification of the stability of the implant which is inversely proportional to it. Signal processing techniques based on deep learning approaches have been developed. We are now working on the preliminary clinical trials.
Our group was the first to demonstrate the interest of quantitative ultrasound for the analysis of the biomechanical properties of the bone-implant interface and for monitoring the evolution of the osseointegration process. The originality of this technology is based on the analysis of the reflection of ultrasonic waves at the bone-implant interface. An increase of implant stability leads to a greater bone quality and quantity in direct contact with the implant, and to a lower reflection coefficient of the bone-implant interface. Thus, the reflected acoustic energy makes it possible to quantify the implant stability, which is inversely proportional to it. Signal processing techniques based on deep learning approaches have been developed to optimize the performance of ImplantUS.
Our market study indicates that the cost of a failure for the surgeon is comprised between 2 and 4.5 k€, corresponding mostly to “chair time”. Moreover, an implant failure is very detrimental in terms of reputation. Eventually, ImplantUS allows to load the implant earlier, leading to the possibility to bill the patient faster. The surgeons and their insurance companies are also subject to an increasing number of law suits or class actions from patients, with an average cost of $68,000 per patient in the USA.