Medicortex International (MEDFIN) investor relations material

TBI diagnostic need

• TBI affects 69M people worldwide annually; ~90% of injuries are mild, and Europe records 2.5M cases yearly.

• Mild TBI criteria include <30 minutes unconsciousness, Glasgow Coma Score 13–15 and <24 hours of post-traumatic amnesia.

• Neurological exams depend on patient responses; CT and MRI can miss mild injury, while blood protein tests typically require hospital and laboratory settings and are invasive.

ProbTBI product

• ProbTBI is in development as a rapid, non-invasive point-of-injury test using urine or saliva, with a bedside or sideline result in minutes and a simple positive/negative readout.

• Proprietary glycan biomarkers are released into body fluids after brain cell damage; biomarkers were identified in TBI patients across three studies.

• The urine-based handheld lateral-flow prototype is designed to detect TBI-associated glycan biomarkers; development received U.S. Department of Defense support.

• A saliva-based test using the same biomarker platform is in development, with self-testing as a potential application; it also received U.S. Department of Defense support.

• The planned test emphasizes speed, portability, ease of use, patient friendliness, affordability and no radiation or contrast-agent exposure; ProbTBI is trademarked and the portfolio includes 7 patents.

Development and market opportunity

• Timeline targets prototype optimization and assembly, multicenter clinical validation and regulatory activity in 2027–2028, then manufacturing and commercialization in 2029; milestones are subject to financing.

• Near-patient testing without self-testing falls under Class B of the IVD Regulation 2017/746; funding and manufacturing and distribution partnerships are identified as requirements.

• The global TBI biomarkers market is projected to reach $4.7B by 2033, with an 18.8% CAGR for 2025–2033; cited growth drivers include aging populations, road use, active lifestyles and improved detection.

• Target channels include emergency care, hospitals, paramedics, schools, nursing facilities, military and defense, insurers, pharmaceutical firms, sports organizations, pharmacies and e-commerce.

• The presentation positions ProbTBI around ease of use and non-invasiveness against blood- and saliva-based alternatives; the exit strategy targets Roche, Abbott, Danaher and Siemens through partnerships or M&A after multicenter trials or regulatory approval.