TBI - A Global Problem and Unmet Need for Immediate Diagnosis

Head injuries constitute a global epidemic with more than 69 million cases each year worldwide. The total number is as high as the incidence of Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis combined. Unfortunately, there are no reliable diagnostic tests to assess the presence or severity of brain injury. Undiagnosed concussions have led to a number of life-changing conditions that could have been avoided.

Each year, there are approximately 69 million new cases of traumatic brain injury (TBI) globally. Of these, 2.8 million are confirmed in the US, 2.5 million in Europe, 0.6 million in Australia, and 0.5 million in Canada. Notably, around 90 % of all TBI cases are mild. Mild TBI (mTBI), also known as concussion, may externally look innocent but can still lead to chronic diseases or debilitating conditions, such as Chronic Traumatic Encephalopathy (CTE). Unfortunately, mTBI goes often undiagnosed since current detection methods that are based on head imaging by CT or MRI cannot reliably detect mild cases. TBI is currently recognized as a “silent epidemic”. Improved diagnostic methods are required to increase awareness of TBI and to tackle the predisposition to long-term neurological issues.

Medicortex Finland is currently developing a biomarker-based diagnostic test for detection of mTBI. The hand-held test is rapid, can be used at the point-of-injury, and does not require medical personnel or equipment. In parallel, Medicortex is proposing to develop an electrochemical test device that can quantitatively detect mTBI. This new product will be co-developed with Fepod Oy Ltd, a Finnish company that has patented the aforementioned technology for blood sample analysis. The co-developed product will use urine samples for mTBI detection.

Medicortex's products are addressing TBI diagnostic global market that is expected to grow at an annual rate of about 8% and reach the size of $3.3 billion in 2029. The North American market alone is expected to yield $1 billion and the
European market $0.9 billion (Cognitive Market Research 2021 & 2023).