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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - IPS (INTELLIGENT PROSTHESIS SYSTEM)

Teaser

Summary

\"Phantom pain and the risk of falling are the two major unsolved problems of leg and foot amputees. The Austrian company Saphenus Medical Technology is developing a sensory feedback system (IPS) that solves these two problems. The novelty of IPS is the Â«feeling prosthesisÂ» for the leg: The authentic capturing of the gait image represents a breakthrough innovation which does not exist in the global market so far. The key market application of IPS is an add-on device for prostheses, which represents a new product category supporting cost-efficient, affordable, optimised care for amputees. The factor of pain in the form of phantom, neuroma or stump pain puts a majority of amputees under pressure and more than 2 million people throughout Europe are affected by a loss of their limbs. The potential market worldwide is around 40 to 60 million. Saphenus brings to market a patented, non-proprietary and non-invasive device prosthesis solution that reduces or makes disappear phantom pains and at cost savings of 50-85% to existing models. Social and health insurance institutions have recognised the socio-economic benefits of this breakthrough innovation of a direct cost saving of EUR 10.000 to 24,000 per year per pain-induced prosthesis wearers. In SME-1 of horizon 2020 , Saphenus has found reimbursement models with one of the major insurers in Austria and further negotiations with Germany and Italy are on the way. A couple of Competence Centers will be established 2019 for a new point of care for amputees with pain problems. They are subsumed with the preamble of a \"\"Competence Center for bionic prosthetics and paintherapy\"\".

The roll out will take place in several steps, beginning in dedicated centers of excellence (GER, AT, IT) followed by further Centers of Competence in Europe, and grow into points of sale in certified medical supply stores in Europe. Huge markets beyond the EU will be approached from 2022 onwards.

By the year 2021, a total of 20 additional employees will be hired for sales, research and development and marketing.\"

Work performed

\"
* Classification of Med Class I, Tests for approval of IPS as medical class I performed
* FDA 513 Statement drafted
* further manufacturing routes of the feedbacksystem detected, paths for further series with rapid prototyping and moulding technologies
* production Partners for the first series identified, collaboration started
* Quality Management System (QMS) was designed and established.
* Application for the international association of the economy for the common goof (ECG)
* Branch office in Graz StraÃŸgang built up to upscale the idea of competence Centers with gait labs with VR/AR technology (cooperation with FH St.PÃ¶lten)
* New CTO at Saphenus Aaron Pitschl, beginning with March 1st 2019

* IP Managment: in total 4 registered patents established,
* A strategy for fullfilling FTO, in cooperation with patent attorney Paul Rosenich/ Liechtenstein
* In cooperation with ARGOS Consult barriers and risks on the way to market are analysed
* Procedures for developing a cashflowplanning are developed.
* Investment plan is established, with one completion of convertible loan.
* Reimbursment with great Austrian insurer is acknowledged.
* Innovative price model solutions are elaborated in cooperation with IMC FH Krems
* Saphenus Competence Centers (SCC) are built up in GER and IT, a handbook with the process design of the SCC is written.
*The Austrian insurer AUVA could be won as a partner for further R&D activities.
*The Knowledge Transfer Group (KTG) of CERN could be won as a partner for further R&D projects
*A series of media contributions to \"\"feeling prosthesis\"\" were produced.

\"

Final results

Saphenus was able to develop a revolution at the point of care in the surgical method at an early stage.
It has managed to develop a method to find an amputation with simultaneous nerve reinnervation.
Also generally the method TSR (targeted sensory reinnervation) could be further perfected.The aim is in the future to perform the nerve reinnervation with planned amputation simultaneously. An authentic Feeling could then be realised.

With the sustainability partner SERI (sustainable europe reserach institite), a concept has been developed that transparently illustrates the resource flows of medical devices in general and our feedback system in particular.
Here, Saphenus wants to make an essential contribution through the United Nations Global Reporting Initiative (GRI).