Enrollment Completed in INSYTE Trial of Spryte’s nOCT Imaging System

July 23, 2026—Spryte Medical announced the completion of patient enrollment of the INSYTE trial of the company’s investigational neuro OCT (nOCT) imaging system. Sixteen study investigators enrolled 65 patients in 5 months across eight centers in three countries.

According to the company, INSYTE is an FDA-approved investigational device exemption trial of the intravascular nOCT imaging system for aneurysm treatment evaluation.

With enrollment now complete, Spryte Medical will focus on trial completion activities and preparation of its initial submission for FDA approval for an indication for use of the system during endovascular treatment of intracranial aneurysms, noted the press release.

Spryte Medical stated that the prospective, single-arm, unblinded, multicenter INSYTE trial is designed to determine the system’s ability to safely and effectively generate high-resolution intravascular images during aneurysm treatment procedures and subsequent follow-up evaluation. The trial focuses on safety and imaging performance to support diagnostic assessment in the neurovasculature.

The company advised that the nOCT imaging system is intended to provide access to real-time intravascular imaging capabilities that improve visualization of vessel anatomy, device–tissue interactions, and brain-vessel wall pathology.

Ricardo Hanel, MD, and Demetrius Lopes, MD, serve as Coprincipal Investigators of the INSYTE trial.

“I have observed firsthand the unique insights that intravascular neuro-OCT imaging can provide into vascular disease, vessel wall and device–tissue interface,” commented Dr. Hanel in the Spryte Medical press release. “I am excited about the higher levels of precision and confidence this will provide us, helping us to deliver the best possible treatment for our patients.”

Dr. Lopes stated, “This first phase was remarkable in so many ways. I am just as excited as we enter the second phase of the INSYTE trial, performing nOCT imaging of these patients in their follow-up sessions. For the first time, we will have a detailed longitudinal view of aneurysm treatment, therapeutic device response, and healing. I am confident this next phase will further expand our understanding of neurovascular disease healing across a range of device and antiplatelet regimens.”