Periodic Reporting for period 1 - Medicortex (Launching the First Non-Invasive Point of Care Diagnostic Test for Traumatic Brain Injury)
Période du rapport: 2018-11-01 au 2019-02-28
Medicortex Finland Oy is a Finnish biotechnology company developing a rapid diagnostic kit for detection of concussion and mild traumatic brain injury (mild TBI). The kit is based on novel biomarkers that the company has discovered in urine and saliva following a brain injury. Generally, TBI is the leading cause of central nervous system impairment. Mild cases and concussions represent more than 90% of traumatic brain injuries but are the most difficult to accurately diagnose. Standard TBI diagnostic tools are based on CT scans, MRI scans or neurological examination which are not sufficient to diagnose mild cases, putting the patient at risks of long-term consequences of untreated TBI such as headache, dizziness, irritability, anxiety and depression and premature development of chronic neurodegenerative conditions such as Alzheimer’s or Parkinson’s diseases. TBI has become a silent epidemic. In Europe the incidence rate is 235 per 100,000 population and the global incidence is estimated to be more than 50 million cases each year. The overall objective of this feasibility study was to explore the strategies and to create a roadmap business plan for the commercialization of the ProbTBITM diagnostic kit for rapid brain injury detection.
The feasibility study comprised of setting up and engaging suppliers for further development and production of the ProbTBITM diagnostic kit as well as documenting the certification roadmap required for different user segments and regions. With help of engaged suppliers and consultants, we built the go-to-market strategy and simulated the pricing models for various sales schemes. The IP-plan to was updated to give us wider coverage and ensure the maximum freedom to operate.
We engaged the suppliers and first distributors for the development and commercialization of the first-generation ProbTBITM to facilitate smooth launch of the product in a reasonable time. Upon documenting the certification pathways, the product development and validation studies will be carried out according to the required quality standards. Based on the market analysis and pricing models we have realistic expectations of the revenues, and we recognized new opportunities in the IP-strategy, too. As a conclusion of action, we will continue the project to further develop and commercialize the ProbTBITM diagnostic kit to give healthcare personnel and people a tool for rapid and cost-effective detection of brain injury.