September 18, 2025

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SENTANTE™ Stroke System for the remote delivery and manipulation of endovascular devices for the removal of thrombus from intracranial vessels in patients with acute ischemic
stroke who are in remote hospitals without access to local manual thrombectomy or timely transfer to a thrombectomy-capable center. It is intended to be used by trained neurointerventional physicians to remotely perform mechanical neurothrombectomy procedures using compatible endovascular devices.

Stroke remains a leading cause of death and long-term disability worldwide, with ischemic stroke requiring rapid restoration of blood flow to prevent irreversible damage. Every minute without treatment results in the loss of approximately 2 million neurons. While mechanical
thrombectomy has become the gold standard of care, significantly reducing mortality, severe disability, and the need for palliative care, over 60% of the U.S. population lacks timely access to thrombectomy-capable centers.

The SENTANTE™ Stroke System is designed to overcome these barriers by enabling expert neurointerventionalists to perform life-saving thrombectomy procedures remotely, eliminating the need for patient transfers to specialized centers. This innovation will expand access to care,
reduce disparities, and improve outcomes for patients suffering from acute ischemic stroke, regardless of their geographic location.

“Receiving Breakthrough Device Designation for the SENTANTE™ Stroke System is a major milestone in our mission to transform stroke care,” said Edvardas Satkauskas, CEO of Sentante.
“This recognition from the FDA highlights the potential of our technology to address a critical healthcare challenge and bring hope to millions of stroke patients.”

Tomas Baltrūnas, Chief Medical Officer of Sentante, added, “This technology could redefine access to stroke care, ensuring that geography is no longer a determinant of outcomes for patients suffering from acute ischemic stroke. We are committed to making timely, life-saving
interventions available to all who need them.”