Biotechnology company Medicortex Finland has launched the Phase II clinical trial of ProbTBI diagnostic kit for Traumatic Brain Injury (TBI) detection following the enrolment of the first patient.
The company will carry out additional enrolments for the trial in the central hospitals of Turku and Pori in Finland during the next few months.
Medicortex CEO Dr Adrian Harel said: “ProbTBI is a highly innovative and advanced diagnostic kit for rapid detection of TBI, and now it is further developed in this second trial.”
The trial is expected to enrol up to 160 study subjects, a majority of which will be healthy control patients suffering from head injury or with bone fractures.
The patient population will be divided into three subgroups to receive the best study results.
Under this study, Medicortex intends to determine the biomarker levels in the study groups.
Medicortex medical director Dr Mårten Kvist said: “Medicortex plans to quickly advance its second clinical trial to confirm the promising findings of its previous proof-of-concept study.
“Such a diagnostic tool is truly awaited and it will considerably improve the possibilities to detect a traumatic brain injury in patients who are suffering from symptoms caused by a hit to the head.”
The progression of the study can be followed at the clinical trials database in which the trial is posted.
Medicortex Finland is engaged in the development of a diagnostic kit for rapid detection of concussion and mild TBI.