E!9477 - OCWHD VERNEX -Development of wound healing device with biologically active salmon roe extract-SP
|RISE RESEARCH INSTITUTES OF SWEDEN AB - SP Kemi, material och ytor, Stockholm
|Funding from Vinnova
|SEK 1 991 345
|March 2015 - December 2017
Purpose and goal
The aim of the project was to develop a safe and efficient MedTech product for wound healing based on a biologically extract from unfertilized salmon eggs (VERNEX, patented by Regenics). RISE have successfully developed and tested a range of different gel formulations for VERNEX within the project frame. The ambition was to submit a technical file for EU CE marking within the time-frame of the project. This has been delayed due to regulatory challenges but is in progress.
Expected results and effects
The project has developed a range of different prototype formulations with VERNEX that have been optimized for different types of wounds. A clinical study has been performed within the project showing that VERNEX formulated in lipid-based gel formulation is safe to use on intact skin. The project has significantly increased the knowledge about VERNEX role in wound healing and which different formulation approaches are of special interest. Overall the project has taken Regenics a big step closer to commercialization of products for wound healing.
Planned approach and implementation
RISE have taken responsibility for formulation development and characterization of VERNEX in both polymer-based and lipid-based matrixes and developed several product prototypes based on properties such as rheology, phase behavior and stability for further testing in both pre-clinical and clinical tests, in collaboration with Regenics. Regenics have been responsible for all regulatory aspects and other preparatory steps in advance to commercialization.