Periodic Reporting for period 4 - GoSafe (Restoring complete sensory ability for natural walking of amputees)
Reporting period: 2023-05-01 to 2024-04-30
In EU 3.18 million people have an amputated lower limb, and each year 295,000 undergo lower-limb amputation. Commercially available leg prostheses do not give any sensory feedback to the user (i.e. they do not give any information about the movement of the prosthesis itself or about the interaction with the ground). As a consequence, (1) prosthetic leg users risk falls and lose trust in the device, (2) overuse the healthy leg, developing an asymmetric gait, (3) which results in low mobility and fatigue. Finally, since there is not a physiological connection between the extremity and the brain, the amputated nerves send unphysiological signals to the brain, which interpret that as phantom limb pain. Amputees need a prosthesis that restores natural sensations from their missing leg.
SensArs Neuroprosthetics, one of the industrial partners of the consortium, has developed the solution to amputees’ problems. In 2017, the company developed and tested (in collaboration with Ossur, the other industrial partner of the consortium) on 3 transfemoral amputees the first worldwide neuroprosthesis restoring sensory feedback by the electrical stimulation of the sciatic nerve through electrodes implanted transversally in it. SensArs’s product - consisting in A) a sensorized insole to place under the foot of a commercial prosthesis provided by Ossur and B) an implantable stimulating system injecting current in the sciatic nerve of the user, driven by the instructions of the insole – was added to the commercial prosthesis provided by Ossur. In all the subjects the intraneural stimulation elicited tactile and muscular contraction sensations over the whole phantom foot and lower leg. Also, SensArs showed that the subjects, using the prosthesis restoring sensory feedback, (1) fell less on surfaces with obstacles and were faster on stairs, (2) had fatigue reduction, (3) reported pain relief.
The main aim of the GoSafe project is to optimize SensArs’ solutions, to manufacture it in certified facilities (e.g. ISO standards), with the purpose to prepare the regulatory pathway to gather CE mark which will allow its penetration into the European market (and after the USA one). To realize this disruptive goal, two industrial and two non-industrial partners with multidisciplinary expertise (SensArs: neuroprosthetics, Ossur: prosthetics, UCSC and CHAR: clinical and surgical aspects) have created the GoSafe consortium, through 7 Work Packages (WPs).
SensArs Neuroprosthetics, one of the industrial partners of the consortium, has developed the solution to amputees’ problems. In 2017, the company developed and tested (in collaboration with Ossur, the other industrial partner of the consortium) on 3 transfemoral amputees the first worldwide neuroprosthesis restoring sensory feedback by the electrical stimulation of the sciatic nerve through electrodes implanted transversally in it. SensArs’s product - consisting in A) a sensorized insole to place under the foot of a commercial prosthesis provided by Ossur and B) an implantable stimulating system injecting current in the sciatic nerve of the user, driven by the instructions of the insole – was added to the commercial prosthesis provided by Ossur. In all the subjects the intraneural stimulation elicited tactile and muscular contraction sensations over the whole phantom foot and lower leg. Also, SensArs showed that the subjects, using the prosthesis restoring sensory feedback, (1) fell less on surfaces with obstacles and were faster on stairs, (2) had fatigue reduction, (3) reported pain relief.
The main aim of the GoSafe project is to optimize SensArs’ solutions, to manufacture it in certified facilities (e.g. ISO standards), with the purpose to prepare the regulatory pathway to gather CE mark which will allow its penetration into the European market (and after the USA one). To realize this disruptive goal, two industrial and two non-industrial partners with multidisciplinary expertise (SensArs: neuroprosthetics, Ossur: prosthetics, UCSC and CHAR: clinical and surgical aspects) have created the GoSafe consortium, through 7 Work Packages (WPs).
WP1
SensArs has completed the design, development and preliminary tests of novel intraneural electrode, implantable stimulator, wearable sensors and sensorized insole (including firmware and software). Compliance with standards has been shown.
WP2
Ossur has adapted their prosthetics to integrate it with the technology developed by Sensars in WP1
WP3
Acute and chronic animal studies have been executed at Shamir Health Corporation (Tel Aviv, Israel)
WP4
2 cadaver studies informed the completion of clinical protocol and informed consent
WP5
- The consortium has conducted a market entry study based on quality, regulatory and reimbursement aspects and Key Opinion Leaders interview
- SensArs has interviewed 25+ Key Opinion Leaders, published 4 articles acknowledging GoSafe, presented the GoSafe technology and business plan at 6 events
- SensArs’ patent (US10974043B2, EP3522773B1) has been granted in EU and USA
- 3 more provisional applications have been submitted by SensArs
- SensArs has closed a financing round of €1.1M
- Documentation for future clinical studies and CE mark submission has been prepared
- GoSafe website has been updated
WP6
- The consortium has organized periodic meetings to update on activities and agree on future actions
- SensArs and consortium have updated the data management plan
WP7
Ethics requirements from the EU have been fulfilled when applicable
SensArs has completed the design, development and preliminary tests of novel intraneural electrode, implantable stimulator, wearable sensors and sensorized insole (including firmware and software). Compliance with standards has been shown.
WP2
Ossur has adapted their prosthetics to integrate it with the technology developed by Sensars in WP1
WP3
Acute and chronic animal studies have been executed at Shamir Health Corporation (Tel Aviv, Israel)
WP4
2 cadaver studies informed the completion of clinical protocol and informed consent
WP5
- The consortium has conducted a market entry study based on quality, regulatory and reimbursement aspects and Key Opinion Leaders interview
- SensArs has interviewed 25+ Key Opinion Leaders, published 4 articles acknowledging GoSafe, presented the GoSafe technology and business plan at 6 events
- SensArs’ patent (US10974043B2, EP3522773B1) has been granted in EU and USA
- 3 more provisional applications have been submitted by SensArs
- SensArs has closed a financing round of €1.1M
- Documentation for future clinical studies and CE mark submission has been prepared
- GoSafe website has been updated
WP6
- The consortium has organized periodic meetings to update on activities and agree on future actions
- SensArs and consortium have updated the data management plan
WP7
Ethics requirements from the EU have been fulfilled when applicable
Since the GoSafe prosthesis will restore symmetric walking and standing of amputees (details in the next section), long-term use of the device will help prevent the occurrence of associated illnesses, such as osteoporosis, osteoarthritis and back pain. This further contributes to long-term health benefits and quality of life for amputees. The technology is expected to result in stronger prosthetic acceptance and thus more prosthetic use and social participation.
The long-term health benefits of GoSafe will be an important driver for reimbursement of GoSafe for insurers, in turn favouring the growth of the prosthetics market and companies providing such prosthetics (or elements thereof). Furthermore, since many limitations with currently available commercial devices will be reduced by the market launch of GoSafe, the phenomenon of prosthesis abandonment will be reduced and sales of prosthetic devices will be propelled.
The GoSafe technology (i.e. the neuroprosthesis) would represent a new product in the prosthetics market (which was already estimated at €1.4 billion in 2016) which would allow its further expansion. Also, it would create a new European actor in the global neuroprosthetic market (estimated value of €4.6 billion), being today of exclusive leadership of the USA.
The innovations from GoSafe and the innovation potential they bring will help to consolidate the leading position of European companies in this market, such as Össur. It also accelerates growth of SMEs such as Sensars, who greatly benefit from the collaboration with a big player as Össur. Sensars will augment the personnel, especially in high-tech production sites in Italy and Germany (again, with the creation of new working places) to manage the serial production of the sensory feedback restoration device and the sales activities.
The long-term health benefits of GoSafe will be an important driver for reimbursement of GoSafe for insurers, in turn favouring the growth of the prosthetics market and companies providing such prosthetics (or elements thereof). Furthermore, since many limitations with currently available commercial devices will be reduced by the market launch of GoSafe, the phenomenon of prosthesis abandonment will be reduced and sales of prosthetic devices will be propelled.
The GoSafe technology (i.e. the neuroprosthesis) would represent a new product in the prosthetics market (which was already estimated at €1.4 billion in 2016) which would allow its further expansion. Also, it would create a new European actor in the global neuroprosthetic market (estimated value of €4.6 billion), being today of exclusive leadership of the USA.
The innovations from GoSafe and the innovation potential they bring will help to consolidate the leading position of European companies in this market, such as Össur. It also accelerates growth of SMEs such as Sensars, who greatly benefit from the collaboration with a big player as Össur. Sensars will augment the personnel, especially in high-tech production sites in Italy and Germany (again, with the creation of new working places) to manage the serial production of the sensory feedback restoration device and the sales activities.