MILPITAS, Calif., Aug. 4, 2026 /PRNewswire/ — Galaxy Therapeutics, a privately held medical device company dedicated to advancing the treatment of intracranial aneurysms, today announced that it has received CE Mark under the European Medical Device Regulation (EU MDR 2017/745) for the SEAL™ Embolization System, following successful assessment by Notified Body DQS Medizinprodukte GmbH.
The CE Mark enables commercialization of the SEAL Embolization System across the European Economic Area and recognizes compliance with the European Union’s rigorous requirements for quality management, safety, performance, and clinical evidence.
The SEAL™ Embolization System is designed for the endovascular treatment of ruptured and unruptured wide-neck intracranial aneurysms. Developed by physicians for physicians, the device offers a novel intrasaccular approach intended to simplify aneurysm treatment while addressing a broad range of complex anatomies.
The approval builds upon several years of product development, engineering, manufacturing, and clinical investigation, including Galaxy’s international clinical programs and the pivotal U.S. SEAL IT IDE trial, one of the fastest-enrolling neurovascular IDE studies conducted in the United States.
“Receiving CE Mark represents one of the most significant milestones in Galaxy’s history,” said Dr. Sam Zaidat, President and Chief Executive Officer of Galaxy Therapeutics. “This achievement reflects years of dedication from our entire team and validates the strength of the clinical evidence, engineering innovation, and quality systems behind SEAL. Most importantly, it allows us to bring this technology to physicians and patients across Europe who are seeking new treatment options for complex brain aneurysms.”
“SEAL was developed to address the challenges physicians face when treating complex intracranial aneurysms,” said Dr. Michael Alexander, Chief Medical Officer of Galaxy Therapeutics. “CE Mark brings a clinically driven technology to European physicians and expands the treatment options available for patients with ruptured and unruptured wide-neck aneurysms for a wider range of aneurysm sizes (2-19 mm) than other current intrasaccular technologies offer. We look forward to supporting its thoughtful adoption and continuing to build the clinical evidence around SEAL.”
“Achieving CE certification required exceptional collaboration across every function of the company—from engineering and manufacturing to quality, regulatory, and clinical operations,” said Jim Twitchell, Chief Operating Officer of Galaxy Therapeutics. “This approval demonstrates the maturity of our organization and establishes the operational foundation needed to support commercial expansion throughout Europe and beyond.”
“This approval is much more than a regulatory milestone—it marks the beginning of a new chapter for Galaxy,” said Sergi López García, Global Director of Commercial, Marketing & Clinical. “Over the past several years, we have worked closely with physicians worldwide to generate robust clinical evidence while simultaneously preparing the commercial infrastructure required for launch. We are excited to partner with clinicians across Europe to ensure patients gain access to this important new treatment option.”
Galaxy Therapeutics is now preparing the phased commercial introduction of the SEAL™ Embolization System across selected European markets while continuing to advance global regulatory initiatives, including review of its Premarket Approval (PMA) application by the U.S. Food and Drug Administration.
About Galaxy Therapeutics
Galaxy Therapeutics is a privately held U.S.-based medical device company founded by four practicing neurointerventional physicians. The company develops innovative technologies for the treatment of intracranial aneurysms and is committed to improving outcomes through clinically driven innovation. Headquartered in Milpitas, California, Galaxy Therapeutics is advancing global commercialization of the SEAL™ Embolization System while continuing to expand its clinical evidence worldwide.
For more information, visit www.galaxytherapeutics.com or follow the company on LinkedIn.
SOURCE Galaxy Therapeutics
