February 13, 2026

TAP selection builds on September’s FDA Breakthrough Device Designation and formalises the next phase of regulatory collaboration as Sentante prepares for first-in-human remote stroke trials.

Sentante has been accepted into the U.S. Food and Drug Administration ( FDA ) Total Product Life Cycle (TAP) Advisory Program for its SENTANTE™ Stroke System.

The TAP Program provides selected medical device developers with early, frequent and strategic engagement with the FDA and its partner agencies across the full product lifecycle – from clinical development and regulatory strategy through to market entry and post-market evidence generation.

Acceptance into the TAP Program follows the Breakthrough Device Designation granted to the SENTANTE™ Stroke System by the FDA in September 2025 – Sentante is the only endovascular robotic system with breakthrough designation and FDA’s recognition of the technology’s potential to address a critical unmet need in stroke care.

While thousands of devices are cleared by the FDA (more than 20,000 standard FDA submissions each year), only a small fraction qualify for Breakthrough Device Designation (less than 200 per year), and an even smaller, elite group is selected for the TAP Pilot.

“Acceptance into the FDA’s TAP Program provides strong validation of both the urgency and the credibility of what we are building,” said Edvardas Satkauskas, CEO of Sentante. “Breakthrough Device Designation recognised the game changing nature of this technology and provided a “VIP pass” for regulatory related communication with FDA. TAP is about strategic support – we will be working hand-in-hand with the FDA to navigate external hurdles like insurance (reimbursement) and faster doctor adoption helping us to derisk and accelerate the pathway to commercial success.”

Accelerating access to gold-standard stroke care:

Stroke remains a leading cause of death and long-term disability worldwide. For acute ischaemic stroke, every minute without treatment results in the loss of approximately two million neurons. Mechanical thrombectomy has become the gold-standard treatment for large-vessel occlusion, yet access remains severely limited: more than 60% of the U.S. population – and far more globally – does not have timely access to a thrombectomy-capable center. “Geography should never determine whether someone survives a stroke or lives with permanent disability,” added Satkauskas

Sentante’s multi-domain, device-agnostic endovascular platform is designed to overcome this gap by enabling expert neurointerventionalists to perform thrombectomy procedures remotely, with full tactile feedback, using standard off the shelf catheters and guidewires. The specialist comes to the patient over a secure network, eliminating delays associated with long-distance transfers and limited specialist availability.

From world-first demonstrations to clinical readiness:

Over the past year, Sentante has rapidly advanced its platform through a series of major milestones, including a world-first transatlantic remote stroke thrombectomy performed on perfused human cadaver models, a multi-day GLP live-subject study involving 24 remote thrombectomy procedures conducted from three continents, and FDA Breakthrough Device Designation for the SENTANTE™ Stroke System.

“Our recent live-subject GLP studies demonstrated that the system can safely and precisely operate in complex, living biological environments,” said Dr. Tomas Baltrunas, Co-founder and Chief Medical Officer of Sentante. “TAP allows us to build directly on that evidence with early regulatory input, helping ensure that our clinical strategy is robust, efficient and focused on patient safety.”

US regulatory approvals – next steps with the FDA:

Through the TAP Program, Sentante will work closely with the FDA to align on clinical trial design, endpoints, risk mitigation strategies and evidence requirements ahead of first-in-human studies.

Initial engagement under TAP will focus on defining the pathway toward an Investigational Device Exemption (IDE) for remote stroke thrombectomy clinical studies. In parallel, Sentante continues to advance regulatory clearance for its peripheral vascular indication, making it a unique multi utility robotic platform technology.

About Sentante:

Sentante is a medical robotics company founded in 2017 building a haptic, device-agnostic endovascular platform that enables clinicians to perform complex vascular procedures remotely with full tactile feedback. Designed to integrate with existing cath-lab infrastructure, Sentante aims to expand access, improve clinician safety, and elevate procedural consistency across peripheral vascular, neurovascular and cardiovascular applications.