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

Galaxy Therapeutics Completes Cohort Enrollment in Pivotal SEAL IT Trial

Galaxy Therapeutics, a clinical-stage medical device company based in Milpitas, California, has made a significant stride in its clinical journey by announcing the completion of patient enrollment for the primary cohort of its pivotal SEAL IT IDE trial. This trial is pivotal in assessing the efficacy of the SEAL device, particularly designed for treating wide-neck bifurcation aneurysms, which represents a challenging anatomical issue in neurointerventional procedures.

The primary arm of the trial, the WNBA subgroup focusing on Wide Neck Bifurcation Aneurysms with widths ranging from 2.0 mm to 19.0 mm, has successfully enrolled 163 patients from various prestigious neurointerventional centers across the United States. Conducted under the FDA Investigational Device Exemption (IDE), this trial is a crucial step toward obtaining Premarket Approval (PMA) for the device.

Dr. David Altschul, the Principal Investigator of the SEAL IT trial and Chief of Neurointerventional Surgery at Montefiore Medical Center, expressed pride in reaching this milestone. He emphasized that the SEAL IT trial is notable as it represents the first prospective multicenter study in the U.S. that evaluates the SEAL device specifically for the treatment of wide-neck bifurcation aneurysms.

Joining Dr. Altschul in highlighting the device's potential, Dr. Brian Jankowitz, another Principal Investigator and Chief of Neurosurgery at the Hackensack Meridian Neuroscience Institute, noted the device's ease of use and the positive outcomes observed in both ruptured and unruptured aneurysms. The trial aims to establish robust clinical evidence supporting the device's usage in various aneurysm conditions.

The SEAL IT trial will further continue to enroll patients in two additional cohorts focused on sidewall and ruptured aneurysms, with plans to enroll 52 patients in both subgroups. These efforts are built upon the foundation already established, whereby the SEAL device has been used in over 300 patients in global clinical studies sponsored by Galaxy Therapeutics.

The SEAL implant itself is an innovative, self-expanding intrasaccular device designed to enable successful aneurysm occlusion, negating the need for additional adjunctive devices. Previous studies, including the Pre-SEAL IT trial, have shown encouraging safety and effectiveness results, thus paving the way for its broader application.

About Galaxy Therapeutics

Founded by four practicing neurointerventional physicians, Galaxy Therapeutics is committed to innovation in medical technology. As a private, clinical-stage company, it has dedicated its resources to developing solutions that address critical needs in the treatment of brain aneurysms, holding multiple patents across significant global markets. With its headquarters in Milpitas, the company is diligently advancing its clinical programs worldwide and remains dedicated to delivering effective, evidence-based therapies to both healthcare professionals and patients.

For additional information on Galaxy Therapeutics, please visit www.galaxytherapeutics.com or follow the company on LinkedIn.