Periodic Reporting for period 1 - SENSY (Restoring complete motor and sensory ability for natural walking of amputees) Reporting period: 2017-08-01 to 2017-12-31 Summary of the context and overall objectives of the project There are an estimated 3.18 million lower limb amputees in the EU with a further 295,000 amputations performed annually. Lower limb amputees do not have sensory feedback from their currently available prostheses and therefore do not feel it as part of their body. This results in falling risks with consequent lack of confidence in the prosthesis and then reduced mobility, increased fatigue (with consequent health complications), phantom limb pain, low prosthesis acceptance and consequent abandonment, and reduced quality of life. SensArs has developed SENSY, a disruptive system that restores the complete sensory-motor link between peripheral and central nervous system in lower-limb amputees. SENSY enables prosthesis users to feel their prosthesis as part of their own body. Having had their senses restored, users reduce the risk of falling, overcome phantom limb pain, and improve their overall quality of life. The system has been tested with the first upper limb amputees and now SensArs is adapting it for use by lower limb amputees. SensArs will then perform a preclinical and clinical trial to achieve clinical validation and advance to CE Mark certification. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far SensArs undertook a full analysis of both the technical and business potential of the SENSY system. SensArs reviewed results from the studies performed so far and defined the specifications for the upgraded system, the remaining engineering and software development required, and the validation required. SensArs explored in detail regulatory requirements, and defined the commercialisation strategy accordingly. SensArs also scouted and initiated discussions with various key stakeholders including hospitals, suppliers etc. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The expected outcome of the project is to successfully execute the preclinical and clinical trial and demonstrate the safety and sensory feedback achieved with the SENSY system. The results will be used to apply for the CE Mark certification and enable commercialisation in Europe. The SENSY development will boost economic growth and create jobs within SensArs and indirectly with medical device distributors, manufacturers and component suppliers. sensars-product-2.jpg
