Santa Rosa, CA, USA, June 11th, 2026, NewsDirect
FDA Breakthrough Device Designation Granted for XGal-3, an Investigational Apheresis Device Designed to Target Galectin-3 in Sepsis Patients
Eliaz Therapeutics, Inc., a clinical-stage medical device company developing a first-of-its-kind apheresis device for the treatment of sepsis, has launched a new Regulation Crowdfunding (Reg CF) investment round as the company prepares for GLP safety studies and first-in-human clinical trials of its lead device, XGal-3.
Sepsis is the leading cause of death in intensive care units, claiming 11 million lives annually worldwide, more than all cancers put together. The disease costs the U.S. healthcare system alone over $62 billion each year. Despite its severity, there are currently no FDA-approved treatments designed to directly address the process of sepsis itself or the immune and inflammatory dysregulation that drive it.
Galectin-3 is a protein implicated in the inflammatory and fibrotic processes associated with sepsis and organ dysfunction. Using equipment that is widely available, XGal-3 is designed to selectively remove Galectin-3 from the bloodstream, intervening early before the inflammatory cascade becomes irreversible.
"Thirty years ago, I lost my father to immune dysregulation," said Dr. Isaac Eliaz, Founder and CEO of Eliaz Therapeutics. "I have dedicated my career to understanding the role of Galectin-3. XGal-3 represents the culmination of that work, and this raise will help us to start our first-in-human trials. We are inviting investors to be part of that moment."
The company's progress to date includes:
- FDA Breakthrough Device Designation granted Q1 2025, a crucial step in accelerating the development and review of technologies intended to address serious unmet medical needs
- $1.9M NIH grants awarded to support large animal safety studies
- Formal collaboration with Terumo BCT, a global leader in apheresis technology, supplying core platforms and disposables for pre-clinical and clinical programs
- Published preclinical data featured as a journal cover article in a high-tier peer-reviewed medical journal, demonstrating improved survival and key inflammatory markers in controlled sepsis animal models
- 75+ patents across 30 countries protecting the antibody-based binding matrix, device architecture, and therapeutic applications of Galectin-3 removal
- Over 1,700 investors have committed to the mission, with $8M raised to date
With preclinical proof-of-concept established and FDA Breakthrough Device Designation secured, Eliaz Therapeutics is now focused on advancing XGal-3 through GLP safety studies and first-in-human clinical trials.
Beyond sepsis, Galectin-3 has been implicated in a range of serious conditions, including fibrotic diseases such as liver and lung fibrosis, chronic kidney disease, heart failure, and certain cancers. While XGal-3 is currently being developed for sepsis, the company believes its platform technology may have broader applications across multiple Galectin-3-associated conditions.
Eliaz Therapeutics' investment round is now open to the public. Learn more and invest at investcf.eliaztherapeutics.com.
Contact
Project ManagerWendy Bi
Eliaz Therapeutics
wendy@eliaztherapeutics.com