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 (http://www.my-leg.com
) 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 just concluded its POC and it is ready for the transition towards the Venture-Funded stage.MYLEG has a three yearsroadmap to take an effective technology to the market. During the Innoboosterprogram, we will fund the spin-off company MYLEG, identify more clinical partners, submit the approvals for a clinical trial to get CE/FDA, recruit patients and start the clinical trial. The next 2-years roadmap to market to start requiresadditional funding considering the financials. In particular, after obtaining around €0.5M for completing the PoC, w e w i l l n e e d , i n t h e n e x t r o u n d o f f u n d r a i s i n g a b o u t €1 . 9 M f o r d e s i g n p l a n, prototyping, device developing, ethical application, and to perform the clinical trials and the regulatory CE/FDAclearance. The next year is going to be crucial for freezing the design and then for certifying the device. This funding will be used for financing high specialized engineers for performing the mechanical and electrical tests and, together withregulatory ex-perts, for preparing the documentation for the clinical trial.
Am Projekt beteiligte Personen
Letzte Aktualisierung dieser Projektdarstellung 19.05.2022