Red Bear Angels is proud to celebrate a landmark regulatory milestone for portfolio company TETmedical: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to NSE-FAST (Neuron Specific Enolase - Functional Activity Stroke Test), the first rapid blood test designed to aid in diagnosing acute ischemic stroke.
Stroke is the leading missed diagnosis in emergency medicine. Each year, approximately 840,000 Americans suffer an acute stroke - roughly 87% ischemic - and studies show that 17% of strokes are missed in emergency departments. TETmedical's NSE-FAST uses the company's patented Tethered Enzyme Technology to rapidly measure the functional enzymatic activity of Neuron Specific Enolase from a standard blood draw, delivering actionable information at the speed the emergency room demands.
The FDA Breakthrough Devices Program provides TETmedical with prioritized access to FDA experts, enhanced regulatory dialogue, and a clearer path toward marketing authorization. TETmedical plans to initiate a multi-center pivotal study in Q4 2026, with patient enrollment targeted for completion in H2 2027 and an FDA marketing application planned for Q4 2027.
