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BIONIC FEEDBACK SYSTEM FOR AMPUTEES AND DIABETICS

Periodic Reporting for period 1 - BFS (BIONIC FEEDBACK SYSTEM FOR AMPUTEES AND DIABETICS)

Reporting period: 2020-09-01 to 2021-08-31

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.
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.
It is therefore all the more surprising and gratifying for the company that the first reimbursements from health insurance companies have already been achieved. This was also due to the consistent implementation of the regulatory requirements of the medical device according to MDR. Here, there are initial precedent cases now in Germany and Austria. The R&D Labs, which were developed in the D-A-CH region for the bundling of the various expertise, could also be set up in Tunisia ahead of schedule, and the first supplies could already be made in the R&D Lab Tunis.
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.
Sensory feedback system SURALIS