Galaxy Therapeutics Submits Final Module of PMA to U.S. FDA for SEAL™ Device in Wide-Neck Bifurcation Aneurysms

MILPITAS, Calif., April 27, 2026 /PRNewswire/ -- Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, today announced the submission of its final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEAL™ device for the treatment of wide-neck bifurcation aneurysms (WNBA).

This Modular PMA submission is supported by data from the WNBA cohort of the SEAL IT IDE trial, which enrolled 163 patients across leading U.S. neurointerventional centers. The submission includes the WNBA cohort only. The study was designed to evaluate the SEAL device in a real-world patient population, including a broad range of aneurysm sizes and anatomical complexities.

The SEAL IT IDE trial represents one of the most comprehensive prospective U.S. studies in intracranial aneurysms, with dedicated cohorts evaluating wide-neck bifurcation, sidewall, and ruptured aneurysms.

"Submitting the final PMA module for SEAL marks a major milestone in our journey toward bringing this technology to patients," said Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics. "This achievement reflects the strength of our clinical program and our commitment to advancing the treatment of complex brain aneurysms."

"This submission is the result of strong execution across clinical, manufacturing, and regulatory functions," said Jim Twitchell, Chief Operating Officer of Galaxy Therapeutics. "We have built the operational foundation required to support the next phase of growth and future commercialization."

Galaxy Therapeutics will continue to collaborate with the FDA during the PMA review process.

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 to address 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. 

𝘊𝘈𝘜𝘛𝘐𝘖𝘕: 𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦. 𝘓𝘪𝘮𝘪𝘵𝘦𝘥 𝘣𝘺 𝘍𝘦𝘥𝘦𝘳𝘢𝘭 (𝘜.𝘚.) 𝘭𝘢𝘸 𝘵𝘰 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘶𝘴𝘦 𝘰𝘯𝘭𝘺.
𝘊𝘈𝘜𝘛𝘐𝘖𝘕: 𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘶𝘴𝘦 𝘰𝘯𝘭𝘺. 𝘕𝘰𝘵 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘧𝘰𝘳 𝘴𝘢𝘭𝘦 𝘶𝘯𝘵𝘪𝘭 𝘊𝘌 𝘮𝘢𝘳𝘬𝘦𝘥.

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SOURCE Galaxy Therapeutics