TURKU, Finland--(BUSINESS WIRE)--Medicortex Finland today announced that the Ethics Committee approved an additional site in the second clinical trial of ProbTBI™, a diagnostic kit for mild Traumatic Brain Injury (TBI) detection. Accelerated recruitment of patients will be performed in the central hospitals of Turku, Pori and Vaasa in Finland during the next few months.
The clinical trial is being conducted in Finland at three central hospital sites with first level emergency departments and high expertise in the TBI management. Patients with suspected mild TBI or concussion will be studied with respect to their specific biomarker signature in their bodily fluids and they will be compared to control patients with orthopedic injury and to healthy controls. Among the first target of 60 subjects, all healthy controls and more than half of the injured patients have been recruited until now. In the second stage the number of patients is extendable to 160. The study is posted in a public database where the status and progression are kept updated (www.ClinicalTrials.gov, NCT03306563).
"ProbTBI™ will be a highly innovative novel diagnostic kit for rapid detection of TBI and concussion. It is now further developed and evidenced in the ongoing clinical trial" said Dr. Adrian Harel, CEO of Medicortex. “Involvement of the third hospital will speed up the recruitment of patients and it will guarantee us adequate population for the next extended stage as we are now covering the entire Western Finland” Dr. Harel adds.
Dr. Mårten Kvist, Medical Director of Medicortex says: "A diagnostic tool for rapid detection of TBI is truly awaited and it will satisfy an urgent need to considerably improve the detection of brain injury in patients who are suffering a head injury without self-evident symptoms of brain damage.” and he adds that “By including sufficient number of patients in the clinical study Medicortex will justify the scientific and statistic strength of its biomarker detection assay.”
Medicortex Finland Oy is engaged in the development of first-of-its-kind diagnostic kit for rapid detection of concussion and mild TBI. The Company has the technology to capture biomarkers from noninvasive body fluid samples and to develop them into an affordable diagnostic tool. The patent portfolio held by Medicortex grants safety to develop the products. More information about TBI and its detection is available on Company's website at www.medicortex.fi
Medicortex Finland Oy is a biotechnology company dedicated to improving the diagnostics and treatment of Traumatic Brain Injury (TBI). Its current focus is on developing biomarker diagnostics to detect the presence and severity of a head injury. Once the company completes the kit development, its next goal will be to develop an innovative drug to halt the progression of brain injury.
Key words: brain injury, head injury, concussion, diagnostics, TBI, early detection, trauma, clinical trial