Spryte Medical has announced the completion of subject enrolment in the INSYTE trial, noting that this represents a key milestone in the clinical development of its proprietary neuro optical coherence tomography (nOCT) imaging system. The company is now advancing toward a US Food and Drug Administration (FDA) submission relating to an indication for use of the system during endovascular treatment of intracranial aneurysms.
“I have observed firsthand the unique insights that intravascular nOCT imaging can provide into vascular disease, vessel wall and device-tissue interface,” said INSYTE co-principal investigator (PI) Ricardo Hanel (Baptist Health, Jacksonville, USA), who shared this update at the ongoing Society of NeuroInterventional Surgery (SNIS) annual meeting (20–24 July, Seattle, USA) and also enrolled the first participants in the trial in March this year. “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.”
The investigational device exemption (IDE) INSYTE trial is designed to determine the nOCT system’s ability to safely and effectively generate high-resolution intravascular images during aneurysm treatment procedures, and subsequent follow-up evaluation. The study represents the first US FDA-approved clinical trial evaluating an intravascular optical imaging platform developed specifically for use within the neurovasculature, Spryte claims in a press release, having gained an IDE from the US regulator in November 2025.
In the trial, 65 subjects were enrolled in five months by 16 investigators at eight centres across three countries. According to Spryte, this participation “reflects a strong commitment by the neurointerventional teams to complete this pioneering evaluation of intravascular imaging in the treatment of brain aneurysms”.
“Completing enrolment in the INSYTE trial is a major achievement for Spryte Medical and reflects years of collaboration among physicians, clinical partners, engineers, and regulatory stakeholders,” commented David Kolstad, chief executive officer (CEO) of Spryte. “We are excited to take the next step toward an FDA submission and ultimately bring this technology to neurointerventional teams across the USA.”
With enrolment finalised, the company will now focus on trial completion activities, and preparation of its initial US FDA submission. Spryte says that, if marketing authorisation is received, the nOCT imaging system would provide neurointerventionists in the USA with access to real-time intravascular imaging capabilities designed to significantly improve visualisation of vessel anatomy, device-tissue interactions, and brain vessel wall pathology.
“This first phase was remarkable in so many ways,” added INSYTE co-PI Demetrius Lopes (Advocate Health, Chicago, USA). “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.”
