A Microscopic Revolution: New Trial Tests First In-Brain Imaging Tech

BEDFORD, Mass. – March 03, 2026 – Spryte Medical, a Massachusetts-based medical technology firm, today announced a significant step forward in neurovascular medicine with the enrollment of the first participants in its INSYTE clinical trial. The trial, initiated at Baptist Health Jacksonville, is the first of its kind approved by the U.S. Food and Drug Administration (FDA) to evaluate an intravascular optical imaging system designed specifically for the delicate arteries of the brain.

The INSYTE trial will assess the company's neuro-optical coherence tomography (nOCT) Imaging System, a device poised to give surgeons a real-time, microscopic view inside the brain's blood vessels during complex procedures. This technology aims to revolutionize the treatment of intracranial aneurysms, potentially offering a new level of precision and safety that could transform patient outcomes.

A New Frontier in Neurovascular Imaging

The trial marks a pivotal moment for a field that has long sought better ways to visualize its work. The INSYTE — Intravascular Neuro OCT Imaging System for AneurYsm Treatment Evaluation — trial operates under an FDA Investigational Device Exemption (IDE), allowing clinicians to gather crucial data on the safety and effectiveness of the novel system.

The initial procedures were performed by the neurointerventional team at Baptist Health Jacksonville, led by world-renowned neurosurgeon Dr. Ricardo Hanel, who also serves as Co-Principal Investigator for the trial. Dr. Hanel highlighted the existing limitations in the field, which this new technology seeks to overcome.

“Despite advances in endovascular therapy, our ability to visualize the vessel wall and device–tissue interaction during aneurysm treatment remains limited,” said Dr. Hanel. “INSYTE represents a landmark trial that will significantly increase our understanding of brain vessel wall pathologies. Intravascular neuro-OCT imaging will enhance real-time diagnostic insights during these complex procedures.”

This sentiment is shared by the trial's Co-Principal Investigator, Dr. Demetrius Lopes, a neurosurgeon at Advocate Health. “This technology has the potential to deliver unprecedented image resolution within the neurovasculature, and this trial will help thoroughly evaluate its safety, performance, and clinical utility,” he stated.

Seeing the Unseen: The Power of nOCT Technology

At the heart of the trial is Spryte Medical's nOCT Imaging System. The technology is a specialized application of Optical Coherence Tomography (OCT), an imaging technique analogous to ultrasound but using light instead of sound waves. It provides cross-sectional images of tissue at a near-histologic level, offering a resolution that is more than ten times greater than current standard imaging modalities.

For decades, neurosurgeons have relied on techniques like Digital Subtraction Angiography (DSA), Computed Tomography Angiography (CTA), and Magnetic Resonance Angiography (MRA). While indispensable, these methods primarily visualize the lumen—the channel through which blood flows—leaving the vessel wall itself largely unseen. They also come with drawbacks, including radiation exposure (CTA), procedural risks (DSA), and potential for artifacts from metallic implants like stents and coils.

Spryte Medical’s nOCT system promises to overcome these hurdles. It uses a miniaturized, flexible fiber-optic probe, with a diameter of just 0.39 mm, designed to navigate the brain's small and tortuous arteries—a feat that has prevented the use of larger, stiffer cardiology-based OCT systems in the past. Once inside the artery, the probe emits near-infrared light, capturing incredibly detailed images with a resolution approaching 10 microns.

This allows surgeons, for the first time, to see the intricate structure of the arterial wall, characterize plaque, identify small clots, and, crucially, assess how therapeutic devices like flow diverters are positioned against the tissue in real time. This artifact-free visualization of implants is a key advantage, providing clarity where other imaging methods fall short.

Addressing Critical Gaps in Aneurysm Treatment

The treatment of intracranial aneurysms—weak, bulging spots on brain arteries that can rupture with devastating consequences—is a high-stakes endeavor. Endovascular procedures, where surgeons thread catheters through blood vessels to place coils or stents to seal off the aneurysm, have become a standard of care. However, success often hinges on the surgeon's ability to make critical decisions with incomplete information.

Without a clear view of the vessel wall or the precise interaction between an implant and the tissue, surgeons face challenges in ensuring optimal device placement and complete aneurysm occlusion. The nOCT system is designed to fill this critical information gap. By providing an unprecedented intraprocedural view, it aims to enhance diagnostic assessment and empower clinicians to make more informed decisions during the procedure itself.

This could lead to more precise deployment of devices, a lower likelihood of complications like incomplete treatment or vessel injury, and a better understanding of the healing process over time. The ultimate goal, as articulated by Spryte Medical's CEO, David W. Kolstad, is to equip clinicians with a new level of insight that translates directly into better care.

“Reaching first participant enrollment in INSYTE reflects years of close collaboration between our clinical partners, engineers, physicians, and regulators,” said Kolstad. “Our goal with nOCT is to provide clinicians with a new level of intravascular insight that may ultimately improve decision-making, procedural precision, and patient outcomes in the treatment of intracranial aneurysms.”

The Path Forward: From Trial to Transformation

The INSYTE trial is a prospective, single-arm, multicenter study that will continue to enroll participants at additional clinical sites across the United States. Its primary focus is to establish the safety and imaging performance of the nOCT system. The data gathered will be foundational for Spryte Medical's future regulatory submissions to the FDA for market approval.

As an investigational device, the nOCT Imaging System is not yet available for commercial use, and its safety and effectiveness have not been formally established. However, its development as a platform that integrates advanced imaging with artificial intelligence underscores the company's broader strategy to not only improve treatment delivery but also accelerate the understanding of neurovascular diseases.

The initiation of this landmark trial represents a convergence of engineering innovation and clinical need. For the millions of people worldwide living with brain aneurysms, this microscopic view inside the artery could herald a future of safer, more effective treatments. As the INSYTE trial progresses, the neurointerventional community will be watching closely, hopeful for a new era of clarity and precision in the treatment of cerebrovascular disease.