FDA Grants XGal-3® Breakthrough Device Designation!

Published 2 days ago
To our valued Wefunder community,
Today marks a transformative milestone for Eliaz Therapeutics! I’m honored to share that the FDA has officially granted XGal-3® its coveted Breakthrough Device Designation.
What is Breakthrough Device Designation?
This prestigious recognition is reserved for innovative technologies addressing life-threatening conditions with no effective treatments. It signifies the FDA’s recognition of XGal-3®’s potential to fundamentally shift the course of sepsis treatment.
What this means for our development timeline:
- Accelerated review process, potentially reducing regulatory timelines by up to 30%
- Enhanced FDA collaboration with senior officials guiding our development
- Priority status for all regulatory submissions
- Powerful market validation of our approach and technology
For our early investors, this designation represents powerful external validation. For those considering joining our mission, our early-bird terms offer a unique opportunity as these validations continue to accumulate.
Thank you for joining us on this journey! Together, we are delivering hope where none existed before.
With profound gratitude,
Isaac Eliaz, MD, MS, LAc
Founder & CEO, Eliaz Therapeutics
