Galaxy Therapeutics Completes Enrollment in Pivotal SEAL IT IDE Trial

MILPITAS, Calif., Dec. 23, 2025 /PRNewswire/ -- Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, today announced it has successfully completed enrollment in SEAL IT, its U.S. IDE trial evaluating the SEAL device for brain aneurysms. The multicenter, prospective study brought together 50 sites and enrolled 279 patients across three key aneurysm cohorts: wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, and ruptured aneurysms.

The WNBA subgroup builds upon the prior WEB-IT trial framework and extends the indication to a broader size range. The Sidewall cohort addresses single-vessel, non-bifurcation aneurysms, while the Ruptured arm includes patients treated in the acute phase of subarachnoid hemorrhage. Together, these subgroups represent a comprehensive evaluation of the SEAL device across a wide spectrum of clinical scenarios.

"Completing enrollment in SEAL IT is a major milestone—not only for Galaxy but for the field of neurointervention," said Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics. "We designed this study to reflect real-world aneurysm complexity and believe the evidence generated will meaningfully advance the care of these patients."

"It is impressive that all three arms of the trial progressed so rapidly. It's a testament to our enrolling physicians' ability to integrate a new device into their practices and the ease of use of the device itself", said Dr. Michael Alexander, Galaxy Therapeutics CMO.

"SEAL IT represents an important step in advancing clinical research for complex aneurysms such as wide-neck bifurcations. The design of the study reflects a broad real-world population, and I'm grateful to all participating centers and colleagues," said Dr. David Altschul, Principal Investigator and Chief of Neurointerventional Surgery at Montefiore Medical Center.

"SEAL IT is one of the first prospective U.S. IDE trials to include a ruptured aneurysm cohort, a critical and underrepresented population in device studies. To our knowledge, it is also among the fastest-enrolling aneurysm studies in the U.S., a testament to the engagement of investigators across the country," added Dr. Brian Jankowitz, Principal Investigator and Chief of Neurosurgery at Hackensack Meridian Neuroscience Institute.

Galaxy Therapeutics will now focus on data analysis and preparation for premarket submission, while continuing to support its global clinical programs.

About Galaxy Therapeutics

Galaxy Therapeutics is a private, U.S.-based clinical-stage medical device company founded by four practicing neurointerventional physicians. The company has developed a novel implant technology for the treatment of brain aneurysms and holds multiple patents across the U.S., EU, and other key markets. Headquartered in Milpitas, California, Galaxy Therapeutics is advancing multiple clinical programs globally and is committed to delivering effective, evidence-based solutions to physicians and patients.

For more information, visit www.galaxytherapeutics.com, or follow the company on LinkedIn

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SOURCE Galaxy Therapeutics