Saturday, April 4, 2020
Breaking Medical Device Industry News

Clinical Trial for Detection of Mild Traumatic Brain Injury in Children Commences

Medicortex Finland Oy Reports Third Clinical Trial to Focus on Children and Adolescents Recruitment of Patients will Take Place at Satasairaala Hospital in Finland During the Next Few Months

Saturday, April 4, 2020

“A diagnostic kit for rapid detection of mild TBI in children is truly important. It will satisfy the urgent need to improve the detection of brain injury in children who suffered a head injury” said Dr. Mårten Kvist, Medical Director of Medicortex Finland Oy. The rapid diagnostic kit ProbTBITM, currently being developed by Medicortex, helps to diagnose brain injury especially in patients who don’t show visible symptoms of brain damage – which is frequently the case with a concussion and mild injury.

The clinical trial will be conducted at Satasairaala hospital in Pori – the main hospital in Satakunta region with the first level pediatric emergency department and expertise in the TBI management. Body fluid samples will be collected from young patients (0 – 17 years) with suspected mild TBI, and the samples will be studied with respect to a specific biomarker signature following a head injury. The Principal Investigator, Dr. Sari Malmi, Head of the Department of Pediatric Surgery, says that a new test for improving the diagnosis of traumatic brain injury is highly needed. It will improve the examination of young patients with a traumatic brain injury and thus improve the quality of their treatment.

“ProbTBITM will be a highly innovative diagnostic kit for rapid detection of concussion. Children, in particular, will benefit from it since they can be refrained from radiation or sedation which are needed for the CT scan of the head, as well as from exposure to other sick patients in the hospital” said Dr. Adrian Harel, CEO of Medicortex. “Participation of the young patients shortly after a head injury will be a challenge, but we have a committed and skilled clinical team working for us in the hospital” Dr. Harel adds.

In this clinical trial, Medicortex seeks to collect a sufficient number of pediatric samples in order to prove the applicability of the brain injury test in children, as a natural continuation for previously proven clinical performance in adults. The clinical trial is posted at the public database ClinicalTrials.gov with identifier NCT04288167.

Medicortex Finland Oy is engaged in the development of first-of-its-kind diagnostic kit for rapid detection of concussion and mild TBI from non-invasive body fluid samples. The Company has the technology to capture biomarkers from urine and saliva and to develop them into an affordable diagnostic tool. The patent portfolio held by Medicortex secures exclusivity to develop the product.

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