Periodic Reporting for period 1 - MYTI (MYokinetic Towards Innovation)
Okres sprawozdawczy: 2024-05-01 do 2025-10-31
Upper-limb amputation profoundly affects daily life, limiting functional independence, social participation, and overall well-being. Although prosthetic technologies have evolved, a key challenge remains unresolved: enabling intuitive, reliable and simultaneous control of multiple movements of an artificial hand. Current clinical systems often provide limited functionality, leading many users to experience frustration or abandon their devices. The MYTI project builds on the results of a previous ERC grant that introduced the myokinetic interface, an innovative human–machine interface based on small permanent magnets implanted in the user’s muscles. These magnets move naturally during contractions and are tracked by external sensors to decode motor intention. A first short-term human study showed that this approach can provide intuitive and precise control while requiring only minimally invasive surgery. MYTI aimed to take this promising concept a step closer to real-world use by addressing two crucial technological gaps (equivalently, Innovation Objectives – IOs): (IO1) identifying a coating that makes the implanted magnets safe and stable for long-term use, and (IO2) developing a dedicated surgical injector that allows accurate, minimally invasive insertion of the magnets into target muscles. At the same time, the project supported early steps toward future translation, including initial market analysis, intellectual property protection and the development of entrepreneurial skills (IO3).
The results of MYTI strengthen the path toward long-term clinical trials and, in the future, market deployment. The myokinetic interface has the potential to enable a new generation of prosthetic and assistive technologies that are reliable, easy to control and more responsive to the needs of people living with motor impairments.
The results of MYTI strengthen the path toward long-term clinical trials and, in the future, market deployment. The myokinetic interface has the potential to enable a new generation of prosthetic and assistive technologies that are reliable, easy to control and more responsive to the needs of people living with motor impairments.
The project concentrated on the technical advances required to prepare the myokinetic interface for chronic implantation.
Innovation Objective 1 – Long-Term Magnet Coating
A key activity was the selection and testing of a coating able to ensure long-term biocompatibility and mechanical stability. In collaboration with an external company specialised in medical coatings, a multilayer solution was developed combining Parylene C, ceramic materials and an outer layer of medical-grade silicone. This structure protects the neodymium magnet from corrosion when implanted inside the body and from mechanical damage during implantation.
The coating was produced following validated manufacturing procedures and evaluated through several in-vitro tests, specifically: mechanical integrity tests, applying repetitive loads to simulate the forces occurring during muscle contractions over one year; accelerated aging tests, exposing magnets to controlled heat and humidity to reproduce long-term implantation conditions; vibration tests, replicating the stimuli used for sensory feedback in future applications. In all cases, the coating remained intact and effective. In-vivo biocompatibility tests (ISO 10993) have been planned with certified external facilities to complete the safety assessment.
Innovation Objective 2 – Surgical Magnet Injector
To ensure accurate placement of the magnets, the project designed a dedicated surgical injector inspired by existing CE-marked tools. In collaboration with an ISO 13485-certified manufacturer and experienced hand surgeons, a three-component titanium device was developed, enabling controlled insertion of the magnet through a small incision and under ultrasound guidance. Production of the prototype is ongoing, after which validation on synthetic muscle models and ex-vivo tissues will follow.
The project also established testing protocols, physical demonstrators and improved planning procedures to optimise magnet placement and ensure high signal quality. These developments further reinforce the technical readiness of the system. Overall, MYTI successfully delivered a validated coating solution and a first prototype of the surgical injector, marking a substantial step forward toward long-term clinical trials and wider application of the myokinetic interface.
Innovation Objective 1 – Long-Term Magnet Coating
A key activity was the selection and testing of a coating able to ensure long-term biocompatibility and mechanical stability. In collaboration with an external company specialised in medical coatings, a multilayer solution was developed combining Parylene C, ceramic materials and an outer layer of medical-grade silicone. This structure protects the neodymium magnet from corrosion when implanted inside the body and from mechanical damage during implantation.
The coating was produced following validated manufacturing procedures and evaluated through several in-vitro tests, specifically: mechanical integrity tests, applying repetitive loads to simulate the forces occurring during muscle contractions over one year; accelerated aging tests, exposing magnets to controlled heat and humidity to reproduce long-term implantation conditions; vibration tests, replicating the stimuli used for sensory feedback in future applications. In all cases, the coating remained intact and effective. In-vivo biocompatibility tests (ISO 10993) have been planned with certified external facilities to complete the safety assessment.
Innovation Objective 2 – Surgical Magnet Injector
To ensure accurate placement of the magnets, the project designed a dedicated surgical injector inspired by existing CE-marked tools. In collaboration with an ISO 13485-certified manufacturer and experienced hand surgeons, a three-component titanium device was developed, enabling controlled insertion of the magnet through a small incision and under ultrasound guidance. Production of the prototype is ongoing, after which validation on synthetic muscle models and ex-vivo tissues will follow.
The project also established testing protocols, physical demonstrators and improved planning procedures to optimise magnet placement and ensure high signal quality. These developments further reinforce the technical readiness of the system. Overall, MYTI successfully delivered a validated coating solution and a first prototype of the surgical injector, marking a substantial step forward toward long-term clinical trials and wider application of the myokinetic interface.
The MYTI project has delivered essential technical and strategic results that significantly advance the myokinetic interface toward clinical and commercial viability. Building on the achievements described in the previous sections, the project has consolidated the scientific, technological, and translational foundations needed for the next steps in bringing this disruptive human–machine interface to end users.
The long-term impact of MYTI lies in enabling a new class of human-machine-interfaces for the control of assistive devices that are intuitive, minimally invasive, and capable of providing reliable, multi-Degree of Freedom control. By overcoming key technical barriers that previously limited the myokinetic interface to short-term applications, the project opens the path toward chronic implantation and meaningful real-life use by individuals with limb loss or, potentially, other types of motor disabilities.
Moreover, a central component of the project broader impact was the strengthening of the team entrepreneurial and translational competences. To fulfill this commitment, the MYTI team attended intensive programs designed to introduce young researchers and innovators to the fundamental aspects of technology entrepreneurship. The latter aimed to equip participants with the skills needed to transform scientific ideas into viable business ventures by covering topics such as opportunity recognition, market validation, business modelling, financial strategy, and investor communication. Regarding IP protection, a patent application was submitted and is currently under evaluation, which represents a background patent for the technology developed. All technical activities in the project were conducted in alignment with the Medical Device Regulation (MDR) and relevant international standards governing medical devices and implantable components. This compliance ensures that the results generated by MYTI fit seamlessly into the future regulatory pathway toward CE marking and clinical deployment. In the future, activities will aim at completing the certification process and conducting extended clinical trials for the technology safety and efficacy validation, other than pursuing a continued refinement and testing of implantation protocols, aiming to optimize surgical workflow, patient comfort, and system performance, in continuous collaboration with expert clinicians. Not least, to extension of the myokinetic interface to additional anatomical regions or applications, increasing its commercial attractiveness and patient impact, will be investigated.
These results collectively position the myokinetic interface closer to real-world clinical adoption and create a solid foundation for the next translational phase.
The long-term impact of MYTI lies in enabling a new class of human-machine-interfaces for the control of assistive devices that are intuitive, minimally invasive, and capable of providing reliable, multi-Degree of Freedom control. By overcoming key technical barriers that previously limited the myokinetic interface to short-term applications, the project opens the path toward chronic implantation and meaningful real-life use by individuals with limb loss or, potentially, other types of motor disabilities.
Moreover, a central component of the project broader impact was the strengthening of the team entrepreneurial and translational competences. To fulfill this commitment, the MYTI team attended intensive programs designed to introduce young researchers and innovators to the fundamental aspects of technology entrepreneurship. The latter aimed to equip participants with the skills needed to transform scientific ideas into viable business ventures by covering topics such as opportunity recognition, market validation, business modelling, financial strategy, and investor communication. Regarding IP protection, a patent application was submitted and is currently under evaluation, which represents a background patent for the technology developed. All technical activities in the project were conducted in alignment with the Medical Device Regulation (MDR) and relevant international standards governing medical devices and implantable components. This compliance ensures that the results generated by MYTI fit seamlessly into the future regulatory pathway toward CE marking and clinical deployment. In the future, activities will aim at completing the certification process and conducting extended clinical trials for the technology safety and efficacy validation, other than pursuing a continued refinement and testing of implantation protocols, aiming to optimize surgical workflow, patient comfort, and system performance, in continuous collaboration with expert clinicians. Not least, to extension of the myokinetic interface to additional anatomical regions or applications, increasing its commercial attractiveness and patient impact, will be investigated.
These results collectively position the myokinetic interface closer to real-world clinical adoption and create a solid foundation for the next translational phase.