Galaxy’s Pivotal Trial of SEAL Device for Brain Aneurysms Completes Enrollment 

December 31, 2025—Galaxy Therapeutics announced it has completed enrollment in the SEAL IT pivotal trial evaluating the company’s saccular endovascular aneurysm lattice (SEAL) device.

According to Galaxy Therapeutics, the multicenter, prospective SEAL IT trial, conducted in the United States under an FDA investigational device exemption, was conducted at 50 sites and enrolled 279 patients across three key aneurysm cohorts: wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, and ruptured aneurysms.

The company noted the following in the press release:

• The WNBA subgroup builds upon the framework of the WEB-IT trial, which evaluated Terumo Neuro’s Web aneurysm embolization system, and extends the indication to a broader size range.
• The Sidewall cohort addresses single-vessel, nonbifurcation aneurysms.
• 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.

The Principal Investigators of the SEAL IT trial are David Altschul, MD, and Brian Jankowitz, MD. Dr. Altschul is Chief of Neurointerventional Surgery at Montefiore Medical Center in New York, New York. Dr. Jankowitz is Chief of Neurosurgery at Hackensack Meridian Neuroscience Institute in Hackensack, New Jersey.

“SEAL IT represents an important step in advancing clinical research for complex aneurysms such as wide-neck bifurcations,” commented Dr. Altschul in the company’s press release. “The design of the study reflects a broad real-world population, and I’m grateful to all participating centers and colleagues.”

Dr. Jankowitz added, “SEAL IT is one of the first prospective United States 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 United States, a testament to the engagement of investigators across the country.”