TETmedical Receives FDA Breakthrough DeviceDesignation for NSE-FAST®, the First Rapid Test
Designed to Aid in the Diagnosis of Acute Ischemic Stroke

Fair Haven, NJ, Ithaca, NY, June 22, 2026 — TETmedical, Inc., a clinical stage medical
diagnostics company developing rapid tools for diagnosing acute neurological injury based on
its patented Tethered Enzyme Technology (TET), today announced that the U.S. Food and
Drug Administration (FDA) has granted Breakthrough Device Designation to its NSE-FAST®
(Neuron Specific Enolase — Functional Activity Stroke Test), a rapid in vitro diagnostic assay
intended to aid in the diagnosis of acute ischemic stroke.
The designation was issued by the FDA’s Center for Devices and Radiological Health (CDRH),
Division of Immunology and Hematology Devices.
Stroke remains one of the leading causes of death and a major cause of long-term disability in
the United States. Each year, approximately 840,000 Americans suffer an acute stroke, of which
roughly 87 percent are ischemic, resulting from obstruction of blood flow to the brain.
An estimated 2.3 million patients present annually to emergency departments with neurological
symptoms suggestive of stroke. While CT scans are highly effective at identifying hemorrhagic
strokes, they frequently fail to detect acute ischemic strokes. A recent published study1
reported that stroke is the number one clinical condition associated with serious misdiagnosis-
related harms with an average of 17 percent of strokes missed.
NSE-FAST® is a rapid, enzyme-based luminescence assay that measures the functional
enzymatic activity of Neuron Specific Enolase (NSE) in a patient’s blood plasma. The test is
intended for use with other available clinical information to aid in the diagnosis of acute ischemic
stroke in adult patients. The NSE-FAST® utilizes TETmedical’s patented Tethered Enzyme
Technology to rapidly measure NSE functional activity as a biomarker for acute ischemic stroke.
The FDA Breakthrough Devices Program is intended to accelerate the development and review
of medical devices that may provide for more effective diagnosis or treatment of life-threatening
or irreversibly debilitating diseases or conditions where no approved alternatives exist. The
designation provides TETmedical with prioritized access to FDA experts, enhanced
opportunities for interactions with the agency, and the potential to efficiently align with clinical
and regulatory requirements throughout the development process.