Lower-limb amputees use prostheses that do not restore sensory feedback during walking. Because of this, they risk falls, thus losing confidence in the prosthesis and overusing the healthy leg, which causes increased fatigue, and reduced mobility. Because of these reasons, users abandon the prosthesis, with consequent difficult rein- sertion into the working society.
MYLEG is a unique device that restores sensory feedback to amputees by gently stimulating with pulses of cur- rent the skin of their remaining leg. Restoring sensations will enable users to avoid falls, to increase confidence in the device, which will reduce counterbalancing movements, and fatigue. MYLEG is an add-on to any com- mercially available prostheses. There are no commercial devices similar to the one proposed by MYLEG.
The long-term vision of MYLEG is to improve mobility and prosthesis cognitive integration, by restoring sensory feedback, in people with leg amputation where they matter the most to them, during their daily life. The MYLEG neuroprosthesis would enable the National Health Systems to save up to €330’000 per amputee, connected to a sedentary lifestyle following prosthesis abandonment. The sensory feedback system will represent a new product in the prosthetics market (valued €9.2 billion in 2020), allowing its further expan- sion.
MYLEG will promote a general improvement of the amputees’ quality of life ant it will also increase the revenue of prosthesis manufactures thanks to the decrease prosthesis abandonment and increase of prosthesis use. Finally, also the clinical centres will treat more patients thanks to the reduction of the rehabilitation phase and
hospitalization time promoted by using MYLEG-Rehab with multiple patients wearing a prosthetic device.
MYLEG has concluded its POC and it is ready for the transition towards the Venture-Funded stage. MYLEG has a three years roadmap to take an effective technology to the market. After the InnoBooster interim stage of the project, we have now achieved the finalization of the MYLEG design completing the in-house tests and the pilot tests with amputees (multiple publications). MYLEG is now ready to freeze the prototype design and pro- ceed to the V&V testing. MYLEG has moreover achieved a huge support from many key actors (industrial and commercialization partners) that will be essential for the CE mark and therefore market entry.
The next phase of the roadmap to market requires additional funding considering the financials. In particular, after obtaining around €0.5M for completing the PoC, we will need, in the next round of fund raising about €1.9M for design plan, prototyping, device developing, ethical application, and to perform the clinical trials and the regulatory clearance. The next year is going to be crucial for certifying the device in Europe and US. This funding will be used for financing high specialized engineers for performing the mechanical and electrical tests and, together with regulatory experts, for preparing the documentation for the clinical trial.
Persons involved in the project
Last update to this project presentation 11.05.2023