Milpitas, California, August 4, 2026
Galaxy Therapeutics has announced that its SEAL™ Embolization System has received CE Mark certification under the European Medical Device Regulation (EU MDR 2017/745), enabling the commercial launch of the innovative neurovascular device across the European Economic Area (EEA). The certification, granted following a successful conformity assessment by DQS Medizinprodukte GmbH, confirms that the SEAL™ Embolization System meets the European Union’s stringent requirements for quality management, clinical safety, performance and regulatory compliance. The regulatory milestone marks a significant step in Galaxy Therapeutics’ global commercialization strategy while expanding access to a next-generation treatment option for patients with ruptured and unruptured wide-neck intracranial aneurysms. The approval also builds upon years of product development, engineering innovation and clinical research, including the company’s international clinical studies and the SEAL IT U.S. Investigational Device Exemption (IDE) trial, one of the fastest-enrolling neurovascular IDE studies conducted in the United States.
CE Mark Accelerates European Commercial Expansion
The newly awarded CE Mark enables Galaxy Therapeutics to begin phased commercialization of the SEAL™ Embolization System across selected European markets while supporting future expansion into additional international territories recognizing European regulatory standards. The device was specifically designed for the endovascular treatment of wide-neck intracranial aneurysms, offering physicians a novel intrasaccular embolization approach intended to simplify complex aneurysm procedures while accommodating a broad range of aneurysm anatomies. Developed by experienced neurointerventional physicians, the system is engineered to improve procedural flexibility and provide clinicians with an advanced treatment option for aneurysms ranging from 2 mm to 19 mm, addressing limitations associated with existing intrasaccular technologies. Company leadership noted that achieving CE certification validates the strength of the organization’s engineering, manufacturing, quality management systems and clinical evidence while establishing the operational foundation required to support long-term international commercial growth.
Innovative Neurovascular Technology Advances Aneurysm Treatment
The SEAL™ Embolization System represents Galaxy Therapeutics’ commitment to advancing minimally invasive neurovascular therapies through clinically driven innovation. Designed to treat both ruptured and unruptured intracranial aneurysms, the device utilizes a unique intrasaccular embolization technology that supports effective aneurysm occlusion while simplifying treatment of complex vascular anatomies. The CE approval follows extensive product development supported by international clinical investigations and the company’s pivotal SEAL IT IDE trial in the United States, which demonstrated strong investigator interest and rapid patient enrollment. Galaxy Therapeutics continues generating additional clinical evidence to further evaluate long-term safety and effectiveness while supporting broader physician adoption. The company believes the technology will expand treatment options for neurointerventional specialists seeking innovative solutions capable of improving patient outcomes in one of the most challenging areas of cerebrovascular disease management.
Advertisement
Global Regulatory Strategy Supports Future Market Growth
With CE Mark certification now secured, Galaxy Therapeutics is preparing a phased commercial launch across Europe while continuing to advance additional regulatory initiatives worldwide. The company is actively supporting the Premarket Approval (PMA) review process for the SEAL™ Embolization System by the U.S. Food and Drug Administration (FDA), reflecting its broader strategy of establishing the technology across major international healthcare markets. Founded by four practicing neurointerventional physicians, Galaxy Therapeutics remains focused on developing innovative medical devices that address significant unmet clinical needs in the treatment of brain aneurysms. By combining physician-driven product design, rigorous clinical evaluation and internationally recognized manufacturing quality systems, the company continues strengthening its position within the rapidly evolving neurovascular medical device market. The CE Mark achievement represents a major milestone in Galaxy’s mission to improve patient access to advanced aneurysm therapies while supporting the continued evolution of minimally invasive endovascular treatment worldwide.
Source: Galaxy Therapeutics press release
