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Restoring of SENSAtions from Lost LeGs for health And qualIty of life augmeNtation in amputees

Periodic Reporting for period 1 - SensAgain (Restoring of SENSAtions from Lost LeGs for health And qualIty of life augmeNtation in amputees)

Berichtszeitraum: 2017-09-01 bis 2019-02-28

During the FET NEBIAS we developed and clinically validated novel and effective restoration of sensory feedback from missing hand in upper-limb amputees. They felt natural sensations, used to ameliorate control and acceptance of prosthesis, and diminish phantom limb pain. The goal of SensAgain is to exploit these results commercially. In particular, we aim at verifying whether the innovation generated during NEBIAS could be used to provide valuable device for lower-limb amputees. We target them because they represent a larger population and suffer health problems related to absence of sensations from prosthesis. Indeed, because of the lack of sensory feedback from available prostheses, they suffer: falls due to unexpected perturbations, with consequent loss of confidence of use, asymmetric walking and balance which induce arthritis, osteoporosis and back pain, higher power consumption (with occasional hearth failures), feeling the prosthesis as a foreign body (with consequent abandonment) and phantom pain. First, we will validate the business case with market stakeholders, which will enable the identification of the minimum features of a product accepted by the market, and the development of a strategic partnership with manufacturers, which will speed up the realization of a device compliant with CE standards. Then, we will define a clear market penetration strategy. Together with providing disabled persons with a unique device for rehabilitation, SensAgain will boost prosthetic adoption, with the consequent growth of the prosthetics and rehabilitation industries, which at its turn will create new jobs. Finally, by sharing the results with the members of the NEBIAS consortium, we will train academia personnel to structure their research mind-set toward the resolution of problems tailored by the market needs. On the other hand we will favor the process of creating innovation in industry, offering job positions to people with a background in research, in case of success of our translational project.
Within the first month of SensAgain, SensArs showed the compliance of the actions with the ethical guidelines from EU commission. Then SensArs started the interview of stakeholders: patients, clinicians, manufacturers, reimbursement experts.
There are 1.4 million of lower limb amputees in USA and 148’000 new amputations are performed every year18. If these data were extrapolated for European Union, prevalence and incidence of amputation would be respectively 2.4 million and 232’000. The total number of lower limb prosthesis users is approximately 40% of the whole population of amputees. To give an idea of the value of the market, the healthcare sector of Ottobock, which is the leader providing both upper and lower limb prostheses, reported sales of those devices for €722 million (including sales of wheelchairs) in 2013, and a growth of 8.7% with respect to 2012. Ossur, competitor of Ottobock in the lower limb prostheses market, had sales for $509 million in 2014, and 5% growth with respect to 2013. According to patients’ surveys, the lack of sensory feedback from prosthesis is one of the biggest unmet needs, and should be fulfilled by the development of innovative technological solutions.
Regarding health systems, by avoiding asymmetry in amputees’ walking and balance, and therefore by avoiding the development of bone diseases, SENSY will save costs to the society.
From the viewpoint of normative regarding reimbursements, both in USA and Europe, DRG codes are available for the systems for peripheral nervous system stimulation (e.g. vagal stimulator), which can be suitable also for SENSY. Moreover, lower limb prostheses are reimbursed for up to 80000$ (e.g. Genium system in USA).
Nevertheless there is a clear need for such a neuroprosthetic system, to the best of our knowledge there are no companies commercializing a device similar to SENSY. That would enable potentially a disruptive placement of SENSY within the neuroprosthetic field. Overall, the potential customers with a real need are numerous, the market value is highly estimated, the reimbursement of devices for amputees is favourable, and the competition is low. These factors make the prosthesis market as a potentially remunerative one for the commercialization of SENSY.
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