Fortis Medical

Key highlights:

• Freeze of Gait (FoG) leads to an increased risk of falls, a loss of mobility, an increase in co-morbidities due to inactivity and a significant reduction in quality of life. Adult falls in the US cost the Healthcare System $50 (EUR45.5) Billion per year. 
• cueStim has been shown to be over 72% effective in reduction of FoG duration and 52% in reduction of FoG events in a Peer Reviewed, Independently Assessed and Published Study
• Fortis' cueStim is a Class II De Novo medical device which was designated as a Breakthrough Technology device by the FDA in 2023 and was included in the FDA's highly selective Total Product Life Cycle Advisory Program ("TAP") in 2024. Fewer than 106 devices have ever received this distinction as of the end of 2026 
• As a member of TAP, the FDA has assigned a regulatory team to work with the company to safely speed cueStim to market
• To date over EUR4.5 Million in grants and other funding has been invested to bring the cueStim technology to its current pre-production state of readiness. 
• Neurological disorders are now the leading source of disability globally, and the fastest growing neurological disorder in the world, on a percentage growth basis, is Parkinson's disease
• The company's IP is patent protected (12 issued patents between 2016 and 2025)
• Company is projecting annual revenues of more than EUR20 in its first-year post market launch in Q4'2027. 
• The founder/management team is high calibre mix of medical device/scientific PhD expertise, decades of commercial experience, US market credibility and a track record which includes 20 M&A transactions and two IPOs.