Periodic Reporting for period 1 - IPS (INTELLIGENT PROSTHESIS SYSTEM)
Période du rapport: 2018-08-01 au 2019-01-31
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."
* 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 Straßgang built up to upscale the idea of competence Centers with gait labs with VR/AR technology (cooperation with FH St.Pölten)
* 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.
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).