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Eliaz Therapeutics’ XGAL-3® Receives FDA Breakthrough Device Designation for the Treatment of Sepsis
March 17, 2025 – Santa Rosa, California – Eliaz Therapeutics, Inc. (ETI), a MedTech company dedicated to advancing innovative treatments for life-threatening inflammatory conditions, has been awarded Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its XGAL-3® device.
XGAL-3® is an advanced extracorporeal therapy designed to selectively remove Galectin-3 (Gal-3) from the bloodstream of ICU-admitted patients diagnosed with sepsis. By targeting Gal-3, a key regulator of immune dysfunction and inflammation, XGAL-3 aims to address a critical unmet need in sepsis care and acute kidney injury prevention.
To qualify for Breakthrough Device Designation, a technology must demonstrate the potential to significantly improve treatment outcomes for patients with serious and life-threatening conditions where few or no effective options exist. The Breakthrough Devices Program facilitates close collaboration with the FDA, providing a streamlined regulatory pathway that includes priority review, enhanced communication, and expedited assessment processes.
Advancing the Future of Sepsis Treatment
The recognition of XGAL-3 as a Breakthrough Device underscores its potential to transform the standard of care for sepsis, a condition responsible for millions of hospitalizations and deaths globally each year.
Unlike traditional pharmaceutical interventions, XGAL-3 operates outside the body to remove excess Gal-3, potentially reducing organ damage, immune dysfunction, and mortality risk in critically ill patients.
“Receiving this designation marks an important step forward in our mission to combat sepsis,” said Dr. Isaac Eliaz, CEO and Founder of Eliaz Therapeutics. “Sepsis remains one of the most pressing challenges in critical care, and this recognition from the FDA reinforces the potential impact of our technology. We look forward to working closely with the FDA to accelerate XGAL-3’s path toward clinical validation and approval.”
