Periodic Reporting for period 2 - BFS (BIONIC FEEDBACK SYSTEM FOR AMPUTEES AND DIABETICS)
Reporting period: 2021-09-01 to 2022-08-31
Those who wear prostheses will love SAPHENUS. This claim stands for the company since we know what a positive influence sensory feedback has on amputees, whether it is pain or gait stability. This is the company's overriding objective. We are consistently changing the path of prosthetic fitting in the sense that the prosthesis adapts more and more to the body, resulting in embodiment. This principle can be applied not only to prosthesis wearers but also to the large group of polyneuropathy patients.
For these two target groups, wearer of prostheses and patients with the diagnosis polyneuropathy SAPHENUS has the breakthrough solution using the bionic principle. With the Bionic Feedback System (BFS) the affected persons get back the feeling of the lost or damaged foot, they feel authentic again, and the brain is provided with sensory information again. SURALIS and CUTANEUS, the two BFS-products of SAPHENUS are patented high-tech add-on devices that consist of (i) a sensor sole and (ii) a transmission part which is applied on the stump or leg. SURALIS and CUTANEUS represent a new medical product category supporting cost-efficient, affordable, optimised care for amputees and diabetics. SAPHENUS has a strong network in medical research as well as in health insurances and in distribution partners.
For these two target groups, wearer of prostheses and patients with the diagnosis polyneuropathy SAPHENUS has the breakthrough solution using the bionic principle. With the Bionic Feedback System (BFS) the affected persons get back the feeling of the lost or damaged foot, they feel authentic again, and the brain is provided with sensory information again. SURALIS and CUTANEUS, the two BFS-products of SAPHENUS are patented high-tech add-on devices that consist of (i) a sensor sole and (ii) a transmission part which is applied on the stump or leg. SURALIS and CUTANEUS represent a new medical product category supporting cost-efficient, affordable, optimised care for amputees and diabetics. SAPHENUS has a strong network in medical research as well as in health insurances and in distribution partners.
The first project year covers the period 01 Sep 2020 to 31 Aug 2021.
We can now make available the therapy to combat phantom pain worldwide for the first time in Europe (Austria, Germany and Italy - South Tyrol). For this purpose, SAPHENUS R&D Labs were founded, where medicine, medical technology and orthopedic technology work together in a strongly interdisciplinary approach to help patients on their way to a pain-free and more mobile life. In this context, SAPHENUS has expanded its cooperation with renowned research institutes, such as the BG clinics in Tübingen, the Ludwig Boltzmann Institute for Experimental Traumatology and the Austrian national health insurer, AUVA. Patentable inventions continue to be covered by defensive publications, and existing patents are also published in the most important target countries.
SAPHENUS has launched the 4-phase therapy concept in Germany and Austria with great media impact and has also disseminated it in the scientific community, for example the Chief Medical Officer Dr. Gardetto at the first phantom limb pain congress in Gothenburg.
In line with the SDGs, SAPHENUS has launched “second-leg” with its project partner Vitalone, where the re-use of prostheses and possible digital upcycling is being tested in the pilot region of Tunisia. Here, SAPHENUS is cooperating with the Ministry of Health in Tunis and local hospitals to provide prosthetic care that meets the conditions in a region where more than two-thirds of all amputees have no prosthetic care.
Promising results have been seen despite COVID restrictions via single case studies regarding reduction of phantom limb pain in amputees, where in almost all cases a drastic reduction in analgesics and a significant improvement in clinical gait parameters was observed.
A planned multicenter study has received its ethics vote, but due to COVID 19 restrictions still in place, the start of the intervention has been postponed until the fall of 2021. The corona-crisis also causes difficulties from critical suppliers of SAPHENUS to meet the planned delivery times for further series development.
The second project year covers the period 01 Sep 2021 to 31 Aug 2022.
Overview of results:
1. Evidence shown for reducing phantom pain – paper on four single case studies published in Clinical Medicine Journal (6 September 2021):
Targeted sensory reinnervation (TSR) reduces phantom pain and improves prosthetic rehabilitation: a case series of four patients with lower limb amputation.
2. Therapy Concept submitted. The therapy concept is the first in the world to reduce phantom pain in people with leg and foot amputations. It is based upon the BSF sensory feedback system that turns any prosthesis into a feeling prosthesis. The phantom pain decreases (up to complete elimination) because the constant transmission of sensory information leads to the brain perceiving this information as foot information.
Exploitation:
1. The launch of the strategy for reimbursers resulted in early success with precedents in DE-AT-IT.
2. Outside EU markets: negotiations with institutions of the medical / health sectors in the Arab-speaking world.
3. Establishment of SAPHENUS Research & Development Centres for further training, competence transfer.
Dissemination:
1. Presentations at the International Conference on Phantom Limb Pain, September 2, 2021, from 04:24:10.
2. SAPHENUS produced a variety of dissemination tools / channels (product folders, videos, user-generated content - interviews with users on social media)
3. SAPHENUS was awarded the title “Austria’s Born Global Champion” in September 2021 and was an official member of the Austrian delegation to EXPO 2021 in Dubai.
4. Presentation at International Exhibition and Conference for Printed Electronics, LOPEC.
5. Participation at World’s largest orthopedic fair, OT World Leipzig 2022.
6. Production of television footage and broadcast of SAPHENUS innovation and therapy concept in German public television channels.
We can now make available the therapy to combat phantom pain worldwide for the first time in Europe (Austria, Germany and Italy - South Tyrol). For this purpose, SAPHENUS R&D Labs were founded, where medicine, medical technology and orthopedic technology work together in a strongly interdisciplinary approach to help patients on their way to a pain-free and more mobile life. In this context, SAPHENUS has expanded its cooperation with renowned research institutes, such as the BG clinics in Tübingen, the Ludwig Boltzmann Institute for Experimental Traumatology and the Austrian national health insurer, AUVA. Patentable inventions continue to be covered by defensive publications, and existing patents are also published in the most important target countries.
SAPHENUS has launched the 4-phase therapy concept in Germany and Austria with great media impact and has also disseminated it in the scientific community, for example the Chief Medical Officer Dr. Gardetto at the first phantom limb pain congress in Gothenburg.
In line with the SDGs, SAPHENUS has launched “second-leg” with its project partner Vitalone, where the re-use of prostheses and possible digital upcycling is being tested in the pilot region of Tunisia. Here, SAPHENUS is cooperating with the Ministry of Health in Tunis and local hospitals to provide prosthetic care that meets the conditions in a region where more than two-thirds of all amputees have no prosthetic care.
Promising results have been seen despite COVID restrictions via single case studies regarding reduction of phantom limb pain in amputees, where in almost all cases a drastic reduction in analgesics and a significant improvement in clinical gait parameters was observed.
A planned multicenter study has received its ethics vote, but due to COVID 19 restrictions still in place, the start of the intervention has been postponed until the fall of 2021. The corona-crisis also causes difficulties from critical suppliers of SAPHENUS to meet the planned delivery times for further series development.
The second project year covers the period 01 Sep 2021 to 31 Aug 2022.
Overview of results:
1. Evidence shown for reducing phantom pain – paper on four single case studies published in Clinical Medicine Journal (6 September 2021):
Targeted sensory reinnervation (TSR) reduces phantom pain and improves prosthetic rehabilitation: a case series of four patients with lower limb amputation.
2. Therapy Concept submitted. The therapy concept is the first in the world to reduce phantom pain in people with leg and foot amputations. It is based upon the BSF sensory feedback system that turns any prosthesis into a feeling prosthesis. The phantom pain decreases (up to complete elimination) because the constant transmission of sensory information leads to the brain perceiving this information as foot information.
Exploitation:
1. The launch of the strategy for reimbursers resulted in early success with precedents in DE-AT-IT.
2. Outside EU markets: negotiations with institutions of the medical / health sectors in the Arab-speaking world.
3. Establishment of SAPHENUS Research & Development Centres for further training, competence transfer.
Dissemination:
1. Presentations at the International Conference on Phantom Limb Pain, September 2, 2021, from 04:24:10.
2. SAPHENUS produced a variety of dissemination tools / channels (product folders, videos, user-generated content - interviews with users on social media)
3. SAPHENUS was awarded the title “Austria’s Born Global Champion” in September 2021 and was an official member of the Austrian delegation to EXPO 2021 in Dubai.
4. Presentation at International Exhibition and Conference for Printed Electronics, LOPEC.
5. Participation at World’s largest orthopedic fair, OT World Leipzig 2022.
6. Production of television footage and broadcast of SAPHENUS innovation and therapy concept in German public television channels.
Due to the consistent implementation of the regulatory requirements of the medical device according to MDR the first reimbursements from health insurance companies have already been achieved.
In the R&D area, there was a further scaling through research partners to other medical groups, for example generally to people with neurological deficits and also to patients with incomplete paraplegia.
IMPACTS:
Socio-economic impact:
Economic Impact is tremendous in macro-economic terms (national health/social system). The calculation of KPIs on national economies shows huge saving potentials for the national health insurers depending on the degree of pain of amputees and the status of diabetics confronted with an amputation.
Wider societal impact:
The development of SAPHENUS’ technology and therapy concept is well in line with the 2021 Nobel Price Laureats of Medicine and Physiology who showed that sense of touch and feeling tackles the problem of neuropathic and phantom pain. The launch of the Therapy Concept will lead to comprehensive patient treatment in certified medical hospitals by qualified surgeons, orthopedic and rehabilitation specialists.
Improved Health & Well-being: (i) the enhanced participation of concerned people in social life – much less support is needed, dependency on other people is reduced, reduction of the overall health care system; (ii) the well-being factor and the overall quality of life is increased considerably.Impact on the full range of sustainability dimensions including environmental aspects SAPHENUS contributes to fulfil the targets of the sustainable development goals of the UN by its integrated QMS (quality management system) and SMS (sustainable management system). SAPHENUS detected a number of targets with the potential of improving both the economic performance and the impact on the environment and local communities. Significant increase of health financing and recruitment, education and retention of health professionals in developing countries, especially in least developed and small island developing states are important incorporated issues.
In the R&D area, there was a further scaling through research partners to other medical groups, for example generally to people with neurological deficits and also to patients with incomplete paraplegia.
IMPACTS:
Socio-economic impact:
Economic Impact is tremendous in macro-economic terms (national health/social system). The calculation of KPIs on national economies shows huge saving potentials for the national health insurers depending on the degree of pain of amputees and the status of diabetics confronted with an amputation.
Wider societal impact:
The development of SAPHENUS’ technology and therapy concept is well in line with the 2021 Nobel Price Laureats of Medicine and Physiology who showed that sense of touch and feeling tackles the problem of neuropathic and phantom pain. The launch of the Therapy Concept will lead to comprehensive patient treatment in certified medical hospitals by qualified surgeons, orthopedic and rehabilitation specialists.
Improved Health & Well-being: (i) the enhanced participation of concerned people in social life – much less support is needed, dependency on other people is reduced, reduction of the overall health care system; (ii) the well-being factor and the overall quality of life is increased considerably.Impact on the full range of sustainability dimensions including environmental aspects SAPHENUS contributes to fulfil the targets of the sustainable development goals of the UN by its integrated QMS (quality management system) and SMS (sustainable management system). SAPHENUS detected a number of targets with the potential of improving both the economic performance and the impact on the environment and local communities. Significant increase of health financing and recruitment, education and retention of health professionals in developing countries, especially in least developed and small island developing states are important incorporated issues.