#United States #Milpitas #Galaxy Therapeutics #brain aneurysms #SEAL IT

Galaxy Therapeutics Completes Enrollment in Pivotal SEAL IT IDE Trial

Galaxy Therapeutics, a clinical-stage medical device firm focused on innovative treatments for brain aneurysms, recently announced the successful completion of enrollment for its pivotal SEAL IT trial. This study, assessing the SEAL device's effectiveness in treating brain aneurysms, represents a significant advancement in neurointervention technology.

The SEAL IT trial involved a multicenter, prospective design and incorporated 50 sites across the United States, enrolling a total of 279 patients. These participants were categorized into three distinct cohorts: wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, and ruptured aneurysms. This diverse patient population ensures a comprehensive evaluation of the SEAL device across a range of challenging clinical scenarios.

The WNBA subgroup is particularly noteworthy, as it expands upon the foundation established by the previous WEB-IT trial, allowing for a broader range of aneurysm sizes. The Sidewall cohort specifically targets non-bifurcation aneurysms, while the Ruptured arm addresses cases treated during the acute phase of subarachnoid hemorrhage. Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics, emphasized the importance of this enrollment milestone: "Completing enrollment in SEAL IT is a major milestone—not only for Galaxy but for the field of neurointervention. This study is designed to reflect real-world aneurysm complexity, and we believe the resulting evidence will significantly enhance patient care."

The rapid progression of all three trial arms underscores the effective integration of the SEAL device into clinical practices by participating physicians. Dr. Michael Alexander, Chief Medical Officer at Galaxy Therapeutics, affirmed this sentiment, noting the ease of use of the device as a key factor. Dr. David Altschul, Principal Investigator and Chief of Neurointerventional Surgery at Montefiore Medical Center, praised the study’s design for its inclusion of a broad, real-world population. He stressed the significance of SEAL IT in advancing clinical research for complex aneurysms such as wide-neck bifurcations.

Moreover, SEAL IT stands out as one of the first prospective IDE trials in the U.S. to include a cohort of ruptured aneurysms, a demographic often overlooked in device studies. Dr. Brian Jankowitz, Principal Investigator and Chief of Neurosurgery at Hackensack Meridian Neuroscience Institute, highlighted the trial's rapid enrollment. He attributed this success to the exceptional engagement from investigators nationwide.

With the patient enrollment phase now complete, Galaxy Therapeutics is shifting its focus towards analyzing the collected data in preparation for premarket submission. Concurrently, the company remains dedicated to supporting its global clinical programs aimed at innovating treatments for brain aneurysms.

About Galaxy Therapeutics

Founded by four neurointerventional physicians, Galaxy Therapeutics is a privately held, U.S.-based clinical-stage medical device company dedicated to developing advanced solutions for brain aneurysms. The company holds several patents across key markets, including the U.S. and the EU, and is committed to delivering evidence-based treatments to healthcare professionals and patients alike. To learn more about Galaxy Therapeutics, visit www.galaxytherapeutics.com.

For updates and additional information, follow Galaxy Therapeutics on LinkedIn.