Nipro : Announcement of Spryte Medical, a US Affiliate of NIPRO, First Participants Enrolled in the “INSYTE” US Pivotal Trial evaluating the nOCT Imaging System during Brain Aneurysm Treatment

NIPRO CORPORATION

March 18, 2026

NIPRO CORPORATION (Head office: Settsu, Osaka; President: Tsuyoshi Yamazaki) is pleased to announce that Spryte Medical (Head office: Massachusetts, USA; hereinafter "Spryte "), a consolidated subsidiary of NIPRO, has enrolled the first participants in the "INSYTE" US Pivotal Trial evaluating the nOCT Imaging System during brain aneurysm treatment.

Spryte issued a press release as follows.

Bedford, MA - March 3,2026 - Spryte Medical, a pioneer in intravascular neuro imaging, today announced the successful enrollment of the first participants in the INSYTE Trial, at Baptist Health Jacksonville which marks a major milestone in the clinical development of its neuro-optical coherence tomography (nOCT) imaging system. The study will assess the system's ability to provide high-quality intravascular images to support diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up procedures.

"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 study 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 provide unprecedented image resolution within the neurovasculature, and this study will help rigorously evaluate its safety, performance, and clinical utility."

"Reaching first participant enrollment in INSYTE reflects years of close collaboration between our clinical parters, engineers, physicians, and regulators," said David W. Kolstad, Chief Executive Officer of Spryte Medical. "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 nOCT Imaging System is an investigational product and has not been approved or cleared by the U.S. Food and Drug Administration. Its safety and effectiveness have not yet been established.

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 focuses on safety and imaging performance to support diagnostic assessment in the neurovasculature. Details of the study are available on ClinicalTrials.gov.

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