Spryte Medical Advances Neuro Imaging Program With First INSYTE Trial Participants

Spryte Medical, a company specializing in intravascular neuroimaging technologies, has announced the successful enrollment of the first participants in the INSYTE clinical trial at Baptist Health Jacksonville. The milestone marks an important step in the clinical development of the Company's neuro-optical coherence tomography (nOCT) Imaging System, an investigational technology designed to provide high-resolution intravascular imaging during the treatment and follow-up of patients with intracranial aneurysms.

The INSYTE Trial, short for *Intravascular Neuro OCT Imaging System for AneurYsm Treatment Evaluation*, is being conducted under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA). The study is designed to evaluate the safety and effectiveness of Spryte Medical's nOCT Imaging System and determine its ability to generate detailed intravascular images that can support diagnostic assessment during endovascular aneurysm treatment procedures and subsequent follow-up evaluations.

The first participants in the study were enrolled at Baptist Health Jacksonville by the neurointerventional team led by Ricardo Hanel, M.D., Ph.D., a neurosurgeon who serves as Co-Principal Investigator of the INSYTE Trial. According to Dr. Hanel, although endovascular therapies for intracranial aneurysms have advanced considerably, clinicians continue to face limitations in visualizing the vessel wall and understanding the interaction between implanted devices and surrounding tissue during procedures. He stated that the INSYTE trial has the potential to significantly improve knowledge of brain vessel wall diseases while providing real-time imaging that could enhance diagnostic decision-making during complex neurovascular interventions.

The INSYTE study is the first FDA-approved clinical trial to evaluate an intravascular optical imaging system developed specifically for use in the neurovasculature. As the study progresses, additional clinical sites across the United States are expected to begin enrolling participants, expanding the evaluation of the technology across a broader patient population.

Demetrius Lopes, M.D., a neurosurgeon at Advocate Health and Co-Principal Investigator of the INSYTE Trial, said the initiation of patient enrollment represents an important milestone for both Spryte Medical and the neurointerventional community. He noted that the nOCT Imaging System has the potential to provide unprecedented image resolution inside the brain's blood vessels, allowing researchers to thoroughly assess its safety, imaging performance, and potential clinical value throughout the trial.

David W. Kolstad, Chief Executive Officer of Spryte Medical, said reaching the first patient enrollment reflects years of collaboration among physicians, engineers, clinical researchers, and regulatory authorities. He explained that the Company's goal is to provide clinicians with a new level of intravascular visualization that could ultimately improve clinical decision-making, increase procedural precision, and enhance patient outcomes during the treatment of intracranial aneurysms.

Spryte Medical emphasized that the nOCT Imaging System remains an investigational medical device and has not yet been approved or cleared by the U.S. Food and Drug Administration. Its safety and effectiveness are currently being evaluated through the INSYTE clinical trial, and the technology is not yet available for commercial clinical use.