Safety Study Of Final Product Has Started And Is Proceeding Well
As a final product testing step before conducting human clinical trials, safety studies have now been initiated. Those safety studies are supervised by the Clinical Research Organization (CRO) – NAMSA.
NAMSA is one of the most prestigious CRO’s in wound care and has performed an estimated 40 – 50% of all trials on new wound care products in Europe. As our product consist of animal derived material and is applied for longer than 28 days the most stringent safety trials are applied including long term studies. The already obtained results are all positive.
“To enter these safety studies is a major milestone for Biovotec in many aspects, as we are testing a product as it will be sold afterwards – this means that we have completed the build up of a commercial supply chain. In addition; this is the last step before applying to the ethics committee in the UK to enter human trials in the spring of 2017.” - Ralf Schmidt, Co founder Biovotec AS
The trials will also include studies on pig skin which is very similar to human skin.