Medicortex Finland Oy Announces the Advancement in Clinical Trial for Detection of Mild Traumatic Brain Injury in Children

Medicortex Finland Oy on saavuttanut puolivälin lasten ja nuorten tapaturmaisten aivovammojen diagnostiikkaan liittyvässä kliinisessä tutkimuksessa. Yrityksen kolmas kliininen tutkimus toteutetaan Satasairaalassa Porissa. Tavoitemäärään nähden noin 50% aivotärähdyspotilaista ja terveistä verrokeista on jo saatu tämän vuoden maaliskuussa alkaneeseen tutkimukseen.

The onset of the corona pandemic somewhat retarded the rate of patient enrolment in the early phase of the study as the hospital was put on standby to nurse infected patients, and the number of eligible head injury patients went down because of suspension of several everyday goings and leisure activities. Since the late spring the situation has gradually normalized and we are receiving near regular number of patients in the hospital and enrolling patients at a steady rate in the study, said Dr. Sari Malmi, the Principal Investigator of the study and the Head of Pediatric Surgery Department.

“A diagnostic kit for rapid detection of mild TBI in children is important. It will satisfy the pressing 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 ProbTBI, currently being developed by Medicortex, will help to diagnose brain injury especially in patients who do not show visible symptoms of brain damage which is frequently the case in concussion and mild injury.

Satasairaala hospital in Pori is the main hospital in Satakunta province with the first level pediatric emergency department and expertise in the TBI management. Body fluid samples are being collected from 30 young patients (0 - 17 years) with suspected mild TBI and from 30 age-matched healthy volunteers. The samples will be studied with respect to a specific biomarker signature following a head injury.

"ProbTBI™ 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 an 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 is a challenge, but we have a committed and skilled clinical team working with us in the hospital” Dr. Harel adds.

In this clinical trial, Medicortex intends to collect a sufficient number of pediatric samples in order to test the applicability of the brain injury test in children, an expected continuation for previously proven clinical performance in adults. The clinical trial is posted at the public database ClinicalTrials.gov with identifierNCT04288167.

Medicortex Finland Oy is engaged in the development of a 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. More information about TBI and its detection is available on the Company's website at www.medicortex.fi