Company Profile
Galaxy Therapeutics, Inc. is a US-based clinical-stage manufacturer of neurovascular implant devices for brain aneurysm treatment, headquartered in Milpitas, California. Founded in 2020 by four practicing neurointerventional physicians — Dr. Osama "Sam" Zaidat (President ＆ CEO), Dr. Thomas Wolfe (Vice President), Dr. Aamir Badruddin, and Dr. Edgard Pereira — the privately held company has raised USD 13.3 million in total funding. The company is led by COO Jim Twitchell and CMO Dr. Michael Alexander, and holds 3 patents (1 granted) across the US, EU, China, and other key markets.
Core Products ＆ Technologies
SEAL™ Intrasaccular Aneurysm Embolization System
• SEAL™ Arc: Ovoid upper loop with base bridging component configuration for wide-neck bifurcation and complex aneurysm morphologies
• SEAL™ Base: Base-only configuration for sidewall and select shallow aneurysms
• Dual-Layer Architecture: Self-expanding nitinol and platinum wire mesh design providing high surface area for flow diversion while maintaining conformability; approximated dual layer at the neck enhances thrombosis
• Atraumatic Leading Tip: No lead-in marker band design enabling soft entry and safe deployment within the aneurysm sac
• Deployment Versatility: Push-out or unsheath techniques allowing physician-preferred approach with smooth recapture and repositioning
Clinical Development Portfolio
• Pre-SEAL IT Early Feasibility Study: 33-patient international study establishing initial safety and effectiveness; first case report published 2023 demonstrating 1-year durable occlusion in ruptured trilobed MCA aneurysm
• SEAL IT IDE Pivotal Trial: Multicenter, prospective US study at 50 sites enrolling 279 patients across three cohorts: wide-neck bifurcation aneurysms (WNBA, 163 patients), sidewall aneurysms, and ruptured aneurysms; completed enrollment December 2025
• Principal Investigators: David Altschul, MD (Montefiore Medical Center) and Brian Jankowitz, MD (Hackensack Meridian Neuroscience Institute)
Market Position ＆ Certifications
Galaxy Therapeutics holds a development-stage position in the intrasaccular aneurysm treatment market, competing with MicroVention (WEB Device), Medtronic, Stryker (Contour Neurovascular System), and Balt. Key strengths include:
• Physician-founded innovation: Device developed by practicing neurointerventionalists for real-world clinical needs
• Comprehensive clinical program: SEAL IT IDE trial represents one of the most comprehensive prospective US studies in intracranial aneurysms, including wide-neck bifurcation, sidewall, and ruptured cohorts
• Regulatory progress: FDA PMA final module submitted April 2026 for wide-neck bifurcation aneurysms (WNBA); approved for marketing in New Zealand
• Unique dual-layer design: Combines flow diversion and coiling characteristics for durable occlusion without adjunctive devices
• Pre-market readiness: New controlled-environment manufacturing facility supporting commercial-scale production
Corporate Timeline
2020 — Founded in Milpitas, California by four practicing neurointerventional physicians
2023 — First peer-reviewed case report published demonstrating SEAL device safety and 1-year durability in ruptured trilobed aneurysm
2024 — Presented 6-month follow-up data at PAIRS Neuro MEA meeting in Dubai; independent core lab adjudication verified outcomes
2025 — Completed enrollment of primary WNBA cohort (163 patients) in SEAL IT IDE trial; appointed Dr. Michael Alexander as Chief Medical Officer; completed full SEAL IT enrollment of 279 patients across 50 US sites including sidewall and ruptured cohorts
2026 — Submitted final module of PMA application to FDA for SEAL device in wide-neck bifurcation aneurysms (April 27)
Target Markets ＆ Applications
• Wide-Neck Bifurcation Aneurysms (WNBA): Primary indication for SEAL device; addresses complex bifurcation aneurysms requiring durable intrasaccular occlusion
• Sidewall Aneurysms: Single-vessel, non-bifurcation aneurysm treatment via SEAL Base configuration
• Ruptured Aneurysms: Acute-phase subarachnoid hemorrhage treatment without need for dual antiplatelet therapy (DAPT)
• Shallow ＆ Irregular Aneurysms: Complex morphologies not amenable to traditional intrasaccular devices such as WEB
• Global Neurovascular Centers: Tertiary hospitals and specialized neurointerventional surgery departments worldwide
Contact Information
Global Headquarters
Address: 799 Ames Avenue, Milpitas, California 95035, USA
Website: www.galaxytherapeutics.com
