Nanoker has up-scaled the manufacturing process of INPERIO in an upscaled pilot production plant, where components have been produced for validation. After several months of in vivo preclinical tests and clinical trials in humans, 100% of the implanted systems show perfect viability and osseointegration. The mechanical tests performed show impressive results, never seen before for any ceramic implant system in the market. Several NDAs have been signed with some of the main players in the market, and several contacts have already been initiated in Spain, France, Sweden, Israel and the USA towards the possible future distribution of our implant system. Other stakeholders were approached in important key events (IDS) to evaluate the degree of acceptance of this new solution.
The main characteristics of this new implant system are its titanium-like prosthetic versatility (the mechanical advantages of INPERIO allow for significant design-related improvements when compared to conventional ceramic materials/implants: bone-level and tissue-level design, high torque forces admitted, high fatigue resistance, anatomic-concave-transgigngival emergence profile for better aesthetics, platform switching, screw-retained system, multiunit termination, reduced diameter designs, etc.) and its ceramic-like biological properties. Furthermore, Nanoker's exclusive manufacturing process ensures that the implants come out of the sintering furnaces with their final morphology, needing no subsequente surface modification, which prevents the adhesion of organic and inorganic impurities, avoiding potential intolerances and implant osseointegration failures.
An antibacterial glassy coating can be located on the implants/abutments to prevent bacterial biofilm adhesion to/in the peri-implant groove, reducing the risk of peri-implant infections, even in the case of high-risk patients.
Since May 2018, over 10,000 units of INPERIO have been produced and extensively validated at industrial scale, both mechanically and biologically. Its properties, design and antimicrobial coating imply a new generation of products that can solve the dental burdens not yet covered by the market.
The new Medical Device Regulation (MDR) implementation is making medical device deployment more difficult (clinical evidence requirements); however, INPERIO is already in the process of CE Mark achievement.
As a general result, all workpackages have been/are being developed following the timing proposed, including all the tasks related to general coordination and management. Dissemination was early on identified as one of INPERIO’s main market barriers. Nanoker is following a Dissemination Strategy to raise awareness regarding INPERIO’s potential, gain access to suppliers and distribution channels and facilitate future market access. The actions implemented in this sense include: demonstrations in key events, labelling and training material, dissemination and promotion, IP management, technology watch and innovation management.
