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Non-invasive solution for periodontal and peri-implant diseases

Periodic Reporting for period 2 - INPERIO (Non-invasive solution for periodontal and peri-implant diseases)

Okres sprawozdawczy: 2019-05-01 do 2020-04-30

In 2011, NANOKER identified a potential business in developing a solution specifically addressed to patients with periodontal or peri-implant disease, the most prevalent form of bone pathology in humans, which affects 50% of adult population.

The tremendous effects of periodontitis/peri-implantitis can be avoided if we prevent the formation of plaque/biofilm. The different options being proposed present serious drawbacks (they consist of repetitive and painful treatments and/or encourage antibiotic resistance).

INPERIO is a revolutionary solution based on patented technology: it combines an advanced bioceramic nanocomposite and an eco-friendly and resistance-free bioglass. The bioglass can be sleekly located, as the filler of a polymeric coating, over nanocomposite-based implants and abutments to prevent (or at least restrict) the adhesion of bacteria.

INPERIO provides a solution demanded by patients: a solution to periodontitis (Pyorrhoea) and peri-implantitis, problems aggravated by the aging population and the burden of antibiotic resistance. INPERIO represents a high-value solution that will greatly improve the quality of life of many people, by reducing disease occurrence and treatment invasiveness.

The project’s main objectives were: a) the industrial-scale development of a set of dental prosthetic components; b) performing a clinical validation to support the potential of INPERIO and help raise awareness ; c) business growth in the main markets; and d) the product’s worldwide launch.

The overall conclusions include that, before INPERIO, our end users, patients with severe periodontitis/peri-implantitis, required an up-to-date inexistent solution. Additionally, direct customers, including dental clinics and distributors, needed strategies to differentiate their businesses from the competition. Nanoker, now, after INPERIO, offers all interested parties a novel, highly demanded, reliable and long-lasting solution to prevent the consequences of severe periodontitis and peri-implantitis.
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.
At present, the dental market’s state of the art technology does not include an effective solution directed at preventing or solving periodontitis and peri-implantitis or a ceramic solution with the versatility of the metal-based products.

The overall implications of INPERIO are:

Poor oral health noticeably decreases quality of life. A non-metallic (1.8% of population is allergic to titanium), preventive solution to periodontal/periimplant disease has become imperative. Moreover, dentists have limited therapeutic options to offer and cannot guarantee success – the only available procedures imply undertaking invasive, painful, repetitive and merely retardant therapies such as scaling, root planning and aggressive antibiotic treatments that do not solve the problem. Moreover, one of our target markets, the Middle East (and North Africa), has a very important diabetes problem (10-20% of population, including children, live with diabetes) - diabetes and periodontitis are two closely related diseases.

The dental implant market offers patients products, instead of solutions. Moreover, these products do not tend to last long-term and imply many and continuous visits to the dentist, which entails a high expenditure for the patient, the healthcare systems and society.

Citizens need educating to solve the current cultural problem. The dental implant market, mainly titanium-based, is in the hands of multinationals that behave defensively, they are not interested in changing their strategy because they earn a lot of money selling titanium implants and the so-called solutions (therapeutic, not preventive) to the problems caused and/or unsolved by them. The commercial interest of the big players slows down the road towards the diffusion and market release of new and better solutions.
Our end users, patients with severe periodontitis or peri-implantitis, require an up-to-date inexistent solution to their disease. Additionally, direct customers, including dental clinics and distributors, need strategies to differentiate their businesses from the competition and to broaden their product portfolio in order to access the largest possible customer database. Nanoker can offer all interested parties a novel, highly demanded, reliable and long-lasting solution to prevent the consequences of severe periodontitis and peri-implantitis at a competitive price.
INPERIO - images
INPERIO - in vivo trial in dogs
INPERIO - in vivo trial in dogs
INPERIO - Leaflet