Spryte Medical Announces First Participants Enrolled In The INSYTE Trial At Baptist Health Jacksonville

The INSYTE Trial - I ntravascular N euro OCT Imaging S ystem for Aneur Y sm T reatment E valuation - is a U.S. Food and Drug Administration (FDA)–approved Investigational Device Exemption (IDE) trial designed to evaluate the safety and effectiveness of Spryte Medical's nOCT Imaging System.

Initial enrollments were completed with the neurointerventional team at Baptist Health Jacksonville, led by Ricardo Hanel, MD, PhD, neurosurgeon, who serves as Co-Principal Investigator of the INSYTE Trial.

“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.”

The INSYTE trial is the first FDA-approved clinical trial of an intravascular optical imaging system designed specifically for the neurovasculature. Additional clinical sites are expected to initiate enrollment as the trial progresses.

“Initiating enrollment in the INSYTE Trial is a significant milestone for Spryte Medical and for the neurointerventional community,” said Demetrius Lopes, MD, Co-Principal Investigator of the INSYTE Trial and neurosurgeon, 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.”

David W. Kolstad

The nOCT Imaging System is an investigational device and has not been approved or cleared by the U.S. Food and Drug Administration. Its safety and effectiveness have not yet been established.

About the INSYTE Trial

The INSYTE Trial is a prospective, single-arm, unblinded, multicenter trial evaluating the Spryte Medical nOCT Imaging System for use during endovascular treatment and follow-up of intracranial aneurysms. The trial emphasizes safety and imaging performance to support diagnostic assessment in the neurovasculature. Details of the trial are available on ClinicalTrials.

About Spryte Medical

Spryte Medical is an intravascular imaging, AI, and data company headquartered in Bedford, MA. The company's unique imaging and data platform is purpose-built to accelerate understanding of target diseases, facilitate the development of novel therapies, and provide information for optimal treatment delivery to benefit patients worldwide.

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