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(opens in new window).
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.
