Proof of concept studies in animal model and humans
Pre-clinical studies
Medicortex has performed preclinical research comparing fluid biopsies from normal and injured lab animals. The results showed some unique biomarkers released as biodegradation products after head injury. The data served as the basis and confirmation for patent applications to protect the novel biomarker idea.
Clinical development
The first clinical study demonstrated that the new biomarker can be used for clinical detection of brain injury. Samples from 12 TBI patients and 12 healthy volunteers were collected in Turku University Hospital (Tyks) and those were analyzed in state-of-the-art laboratories to evaluate the presence of the biomarker in the body fluids. The level of biomarker was significantly elevated in TBI patients compared to healthy controls. The result was a significant milestone for Medicortex.