In December 2025, Galaxy Therapeutics completed enrollment in its pivotal SEAL IT IDE trial, enrolling 279 patients across 50 U.S. sites in three cohorts: wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, and ruptured aneurysms. On April 27, 2026, the company submitted the final module of its Premarket Approval (PMA) application to the U.S. FDA for the SEAL device in the WNBA indication, supported by data from 163 patients. In July 2025, the company opened a new 9,200-square-foot manufacturing facility in Milpitas, California, featuring two ISO Class 7 Controlled Environment Rooms, to support commercial reADINess and global distribution.
Company Profile (Updated April 2026)
Galaxy Therapeutics, Inc. is a privately held, clinical-stage medical device company headquartered in Milpitas, California, USA. The company was founded by four practicing neurointerventional physicians and is dedicated to advancing innovative implant technology for the treatment of brain (intracranial) aneurysms. Galaxy Therapeutics has developed the proprietary SEAL (Saccular Endovascular Aneurysm Lattice) Embolization System, a self-expanding intrasaccular flow diverter designed to promote durAble aneurysm occlusion without the need for adjunctive devices such as stents or coils.
Development History:
- Founded: Established by four neurointerventional physicians with a mission to develop physician-designed solutions for complex aneurysms
- Pre-SEAL IT Trial: Enrolled 33 patients across multiple international sites, successfully demonstrating proof of concept, clinical safety, efficacy, and durability
- May 2025: Completed enrollment of the Primary WNBA cohort (163 patients) in the SEAL IT IDE trial
- June 2025: Appointed Dr. Michael Alexander as Chief Medical Officer to lead global clinical development
- July 2025: Opened a new 9,200-square-foot manufacturing and R＆D facility in Milpitas, CA, including two ISO Class 7 cleanrooms
- December 2025: Completed full enrollment (279 patients) in the SEAL IT IDE trial across 50 U.S. centers
- April 2026: Submitted the final module of the Modular PMA application to the U.S. FDA for the WNBA indication
Core Mission: To deliver effective, evidence-based neurovascular solutions that transform the treatment of brain aneurysms, improving patient outcomes through innovative intrasaccular flow diversion technology.
2026 Breakthrough: FDA PMA Submission
Final PMA Module Submission (April 27, 2026)
Regulatory Milestone:
- On April 27, 2026, Galaxy Therapeutics submitted the final module of its Modular Premarket Approval (PMA) application to the U.S. FDA for the SEAL device
- Indication: Treatment of wide-neck bifurcation aneurysms (WNBA)
- Clinical Support: Data from the WNBA cohort of the SEAL IT IDE trial, which enrolled 163 patients across leading U.S. neurointerventional centers
- Study Design: The trial was designed to evaluate the SEAL device in a real-world patient population, including a broad range of aneurysm sizes and anatomical complexities
- Scope: This submission includes the WNBA cohort only
- Next Steps: The company will continue to collaborate with the FDA during the PMA review process while supporting ongoing global clinical programs
Core Product: SEAL Embolization System
SEAL Device Technology
- Design: A novel 3D spatial design with dual-layer architecture combining nitinol and platinum
- Mechanism: Intrasaccular flow diverter that disrupts blood flow into the aneurysm, promoting thrombosis and healing while preserving parent vessel patency
- Size Range: Treats aneurysms ranging from 2mm to 19mm in width with just 7 device sizes
- Configurations: Two unique shapes to fit a broad range of aneurysm morphologies, including bifurcation and sidewall configurations
- Atraumatic Leading Tip: No lead-in marker band for soft entry into the aneurysm and fast, easy placement
- Conformability: Ultra-soft design allows confident oversizing for ultimate conformability to irregular aneurysm shapes
- Visibility: Fully visible under fluoroscopy for quick, easy placement
- Deployment: Simple push-out or unsheath technique versatility
Clinical Evidence
- Pre-SEAL IT: 33-patient multicenter study demonstrated safety, efficacy, and durability across all enrolled patients
- SEAL IT IDE Trial: One of the most comprehensive prospective U.S. studies in intracranial aneurysms
- WNBA Cohort: 163 patients; builds upon the prior WEB-IT trial framework and extends the indication to a broader size range
- Sidewall Cohort: 52 patients planned; addresses single-vessel, non-bifurcation aneurysms
- Ruptured Cohort: 52 patients planned; one of the first prospective U.S. IDE trials to include a ruptured aneurysm cohort, treating patients in the acute phase of subarACHnoid hemorrhage
- Total Enrollment: 279 patients across 50 U.S. sites
- Global Experience: The device has been used in more than 300 patients worldwide across Galaxy-sponsored clinical studies
- Principal Investigators: Dr. David Altschul (Chief of Neurointerventional Surgery, Montefiore Medical Center, New York) and Dr. Brian Jankowitz (Chief of Neurosurgery, Hackensack Meridian NeuroScience Institute, Edison, New Jersey)
Company Leadership and Team
Executive Team
Dr. Sam Zaidat - President ＆ CEO:
- Neurointerventional physician at Mercy Hospital, Toledo, Ohio, USA
- Co-founder of Galaxy Therapeutics
Jim Twitchell - Chief Operating Officer:
- Leads manufacturing, regulatory, and operational strategy
Ryan Chittaro - Chief Financial Officer:
- Oversees financial strategy and investor relations
Dr. Michael Alexander - Chief Medical Officer (appointed June 2025):
- Dual-trained cerebrovascular neurosurgeon and neurointerventionalist
- Professor and Vice Chair of Neurosurgery at Cedars-Sinai Medical Center, Los Angeles, USA
- Past President of the Society of NeuroInterventional Surgery (SNIS)
- Participated in more than 45 clinical trials; continuously funded NIH investigator for 18 years
- Co-author of two textbooks and over 160 peer-reviewed articles in neurovascular disease
Global Market Position and Competition
Market Landscape
Brain Aneurysm Burden:
- Brain aneurysms occur in up to 6% of the global population
- Up to half of brain aneurysms require treatment
- Represents a significant market opportunity in neurovascular intervention
Primary Competitors
- Terumo Neuro (WEB Device): Established intrasaccular flow diverter; the WEB-IT trial set the framework for WNBA indication
- Medtronic: Leading neurovascular portfolio including flow diverters and embolic coils
- Stryker (Neuroform, Wingspan): Stent-assisted coiling and intracranial stent platforms
- Penumbra: Neurovascular thrombectomy and embolization technologies
- MicroVention (Terumo): Flow diversion and intrasaccular devices
Competitive Advantages
- Dual-Layer Architecture: High surface area without compromising conformability enhances flow diversion for better early thrombosis
- Broad Indication: Designed to treat both bifurcation and sidewall aneurysms, as well as ruptured and unruptured cases, with one device platform
- Size Versatility: 7 sizes cover 2-19mm aneurysms, simplifying hospital inventory
- Physician-Founded: Developed by practicing neurointerventionalists with deep clinical insight
- Comprehensive Clinical Program: One of the first U.S. IDE trials to include a ruptured aneurysm cohort, reflecting real-world complexity
- Global IP Portfolio: Multiple patents across the U.S., EU, China, and other key markets
Manufacturing and Operations
Milpitas Facility (Opened July 2025)
- Size: 9,200 square feet (855 m²)
- Cleanrooms: Two ISO Class 7 Controlled Environment Rooms totaling 2,400 square feet (223 m²), with one room measuring 1,000 square feet (93 m²) and the other 1,400 square feet (130 m²)
- R＆D and Manufacturing Space: 1,500 square feet (139 m²)
- Logistics: Ground-level roll-up doors to streamline shipping and receiving
- Purpose: Supports transition toward commercial readiness, scaled production, and global distribution
2026 Outlook and Strategic Priorities
Regulatory and Commercial Roadmap
- U.S. Market: Collaborate with FDA during PMA review for WNBA indication; prepare for potential commercial launch upon approval
- Global Expansion: Continue supporting international clinical programs and regulatory submissions in the EU and other markets; device is not yet available for sale until CE marked
- Sidewall and Ruptured Cohorts: Continue follow-up and data analysis for the remaining SEAL IT trial cohorts to support future label expansion
- Manufacturing Scale-Up: Leverage the new Milpitas facility to meet anticipated commercial demand
Clinical and Scientific Expansion
- Expand clinical and scientific leadership team to support post-market studies and real-world evidence generation
- Continue physician education and training programs for neurointerventional specialists
- Pursue additional indications and next-generation device iterations
Contact Information
Headquarters
Address: Milpitas, California, USA
Website: www.galaxytherapeutics.com
LinkedIn: Follow the company on LinkedIn
Investor Relations
Status: Private company; funded through angel investors and SAFE instruments
Corporate Website: www.galaxytherapeutics.com
Keywords: Galaxy Therapeutics, SEAL, SEAL IT, SEAL-IT, brain aneurysm, intracranial aneurysm, intrasaccular flow diverter, wide-neck bifurcation aneurysm, WNBA, sidewall aneurysm, ruptured aneurysm, neurovascular, neurointervention, Dr. Sam Zaidat, Dr. Michael Alexander, Jim Twitchell, Ryan Chittaro, Milpitas, FDA, PMA, IDE trial, WEB device, flow disruption, endovascular embolization, dual-layer, nitinol, platinum, Pre-SEAL IT, David Altschul, Brian Jankowitz, Montefiore, Hackensack Meridian, Mercy Hospital, Toledo, Cedars-Sinai
