Company aims to detect undiagnosed head injuries

More than 50 million people worldwide suffer traumatic brain injuries (TBIs) ever year, often caused by falls, being struck by or against an object, traffic accidents and sports.

While 90% of cases are mild injuries, TBI is a major cause of death and severe disability, and can worsen rapidly without treatment. Diagnosis, however, can be problematic with conventional diagnostic tests – including head CT and MRI – often failing to detect mild concussions in the hours following injury.

Inspired by the BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies), a $300 million program launched by the Obama administration in the US in 2013 to drive global brain research, veteran neurobiologist Dr. Adrian Harel set out to improve the diagnostics and treatment of TBI.

Harel, who earned his PhD in Neurobiology at the Weizmann Institute of Science and was a postdoctoral fellow at Washington University, utilized financial assistance for research and development – offered by the Finnish government and the bio-incubator at the University of Turku – to establish Medicortex Finland Oy, a company developing a biomarker diagnostics kit that can rapidly detect TBI and concussions.

“I took all the available money that I had in Israel, and that was matched by the Finnish government,” Harel, Medicortex’s CEO, told The Jerusalem Post. “This is the money that I used to start running the company. The first thing was to try to prove my hypothesis that, following brain injury, there is a specific biomarker that is released and can be found in the bodily fluids.”

Although several American companies have focused on targeting proteins in the blood to identify TBI, Medicortex’s ProbTBI kit focuses instead on saliva and urine, which can be obtained without professional expertise.

The company targets glycans and cellular enzyme products, which are exposed to each other as a result of cell damage caused by TBI. Medicortex’s first clinical trial, completed in March 2017 with 24 patients, showed statistically significant differences between injured and healthy subjects based on glycan profiling. The results of a second clinical trial, conducted with 69 patients at three Finnish hospitals, are expected later this year.

“CT and MRI are not always capable of showing mild concussion in the first hours, unless there is active bleeding, deformation of the brain or intracranial pressure,” said Harel. “Our kit will detect those cases that are considered undetectable or overlooked by the medical team. Currently, the idea is to have a urine test for adults, similar to a pregnancy test, which will change the color of the kit. For children, we thought to focus on a lollipop-like kit that a child can put in his mouth and saliva will trigger the same reaction.”

Recognizing the importance of rapidly and accurately identifying trauma on the battlefield, Medicortex announced the award of a $1.1m. grant from the US Defense Department earlier this month. The grant was awarded by the US Army Medical Research and Material Command through the Combat Casualty Care Research Program, which supports the development of diagnostics with the potential to have a strong impact on patient care.

Medicortex, the only Finnish company in the last 12 years to receive a Defense Department grant, will use the funds to develop a prototype, hand-held kit that can be used by military personnel, first responders and health-care professionals.

Whether on the battlefield or any emergency setting, identifying TBI is especially critical when caring for a patient with multiple injuries, Harel said, as medication or treatment for other problems can lead to a severe deterioration in the brain injury.

The successful development of Medicortex’s diagnostic tool, he added, will also assist the company’s next ambitious project: advancing a drug for brain injury. “As of today, there is no real treatment for brain injury,” he said. “Without an objective test, how can you develop a drug?

“These projects are related. It is cheaper, easier and quicker to develop a diagnostic tool than a drug, but we will get there.”