Otoimplant – Polish product of the future

Photo from the archives of the Polish Agency for Enterprise Development

Technical model of the implant

Otoimplant, a prosthesis of the middle ear with bactericidal effect, has won the main prize (PLN 100,000) in the category “Product of the future designed by an institution of higher education and science” in the 22nd competition “Polish Product of the Future”. Designed by a team of scientists from AGH UST, headed by professor Magdalena Ziąbka of the Faculty of Materials Science and Ceramics, the innovative prosthesis has also been awarded the special prize of the Minister of Science and Higher Education. 

The developed otolaryngological prosthesis has already been subject to medical tests, and it can shorten patients’ recovery period and limit the risk connected with the complications in a bacterial infection, as well as make it possible to reproduce the construction and functions of the middle ear structures by means of the restoration of a correct resonance of auditory ossicles. Thanks to the use of this type of implant, it is possible to improve the hearing capabilities of patients with a damaged chain of auditory ossicles being a result of an inflammatory condition, injuries, congenital disorders, or otosclerosis. 

A varied range of sizes enables the reconstruction of a chain of auditory ossicles in the case of many patients suffering from the loss of hearing. The prosthesis is made of a medical polymer with the use of the injection technology and by means of introducing a modifying bactericidal additive (silver nanoparticles) into the polymer structure. It can be used as a full or partial prosthesis. The innovativeness of the prosthesis is connected both with its shape as well as the bactericidal properties towards gram-positive and gram-negative bacteria, which are usually found in the middle ear. At the same time, it is safe for the human body, which has been first confirmed in vivo on laboratory animals, and then in medical tests on patients. 

The market of medical devices and products offers a wide range of middle ear prostheses. There is, however, a lack of one made of plastic and with bactericidal properties. Otoimplant also enables performing medical imaging (tomography and magnetic resonance) without artefacts, demonstrates high biocompatibility, is of a low weight, and has properties similar to the replaced tissues. None of the competitive products combines these features, and each of them is required. 

The innovative prosthesis solves the problem of deafness or a partial loss of hearing, which are a reason for exclusion from the society. After the implantation of Otoimplant, individuals can function properly, both in day-to-day situations, as well as in developing their passions and doing sports.   

Otoimplant is at the 8th level of technological readiness (TRL). It has gone through laboratory tests in vitro, clinical tests in vivo on animals, and medical tests with the participation of patients. The objective behind the prosthesis of the middle ear is the restoration of hearing capabilities in the case of patients who suffer from the loss of hearing caused by a damaged chain of auditory ossicles being a result of otitis media, illnesses, congenital disorders, and injuries. The production technology and the form of the medical product have been finalised. Tests have confirmed that the target technological level has been reached, and that the implant can be used in the anticipated conditions. The team of scientists are in the phase of negotiations with potential investors who are ready to collaborate in the last phase of the product development, i.e. taking the solution to the last, 9th level of TRL, thus offering Otoimplant as a ready, fully-working product which can, for example, obtain subsidising from the National Health Fund (NFZ). For the purpose of securing intellectual property, the product is covered by the Polish and European patent, and identified by the registered trademark “Otoimplant”. 

The first implantation of the product was performed in April 2017. 

The competition “Polish Product of the Future” is organised by the Polish Agency for Enterprise Development and the National Centre for Research and Development. Its aim is the promotion of innovative products and technologies developed in Poland that have a potential to become present not only on the Polish market, but also on the international arena. Its organisers offer regular support to enterprises and scientific institutions that intend to carry out innovative projects, and want to develop innovative products and services. 

The competition is becoming more and more popular – this year’s edition registered 96 projects (24 more than in the previous year) in the fields of medicine, chemistry, electronics, and biotechnology. The three main prizes of PLN 100,000 each, as well as distinctions and special prizes were competed for by entrepreneurs, science institutions, and their consortia.