Galaxy Therapeutics Completes Enrollment of Primary Cohort in Pivotal SEAL IT IDE Trial
MILPITAS, Calif., May 30, 2025 /PRNewswire/ -- Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, today announced the completion of enrollment in the primary cohort of its SEAL IT IDE trial. The trial's primary arm, known as the WNBA subgroup (Wide Neck Bifurcation Aneurysms from 2,0mm to 19,0mm of width), has successfully enrolled 163 patients across leading U.S. neurointerventional centers. The study is being conducted under an FDA Investigational Device Exemption (IDE) and is a key step toward eventual Premarket Approval (PMA).
"We are proud to have reached this important milestone," said Dr. David Altschul, Principal Investigator of SEAL IT and Chief of Neurointerventional Surgery at Montefiore Medical Center. "This trial represents the first prospective multicenter U.S. study evaluating the SEAL device for wide-neck bifurcation aneurysms — one of the most challenging anatomical presentations in our field."
Dr. Brian Jankowitz, also Principal Investigator and Chief of Neurosurgery and Co-Chair of Stroke and Neurovascular Program at the Hackensack Meridian Neuroscience Institute at JFK University Medical Center in Edison, New Jersey, added: "The SEAL device has consistently demonstrated ease of use and promising early outcomes in the investigation, in both ruptured and unruptured aneurysms. Completing enrollment in the primary cohort is an important achievement as we continue generating high-quality clinical evidence to support its use."
The SEAL IT trial continues to enroll patients in two additional cohorts evaluating use of the device with sidewall and ruptured aneurysms, with 52 patients planned for enrollment in each subgroup. In total, the SEAL device has been used in more than 300 patients worldwide across Galaxy-sponsored clinical studies.
Developed by physicians for physicians, the SEAL implant is a proprietary, self-expanding intrasaccular device designed to promote durable aneurysm occlusion without the need for adjunctive devices. It has shown encouraging safety and efficacy in earlier clinical studies including Pre-SEAL IT, which enrolled 33 patients at multiple international sites.
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, China, 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, follow the company on Linkedin or please contact: Sergi López García, sergi@gtseal.com, contact@gtseal.com, +34690926013
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