Breathe Biologics, Inc. Announces IND Amendment for RMAT Designation with FDA

Oceanside, CA / March 22, 2026 / 

We are pleased to provide an update on the continued advancement of our clinical development program at Breathe Biologics.

We have successfully submitted a formal request to the U.S. Food and Drug Administration (FDA) for Regenerative Medicine Advanced Therapy (RMAT) designation for JadiCell™ for the treatment of Acute Respiratory Distress Syndrome (ARDS) under IND 19757.

This submission follows recent important milestones, including the registration of our Phase III clinical study on ClinicalTrials.gov (NCT07479043) and the transition of our regulatory submissions into electronic Common Technical Document (eCTD) format, consistent with FDA requirements for commercial-stage programs.

ARDS remains a serious and life-threatening condition affecting approximately 200,000 patients annually in the United States, with mortality rates ranging from 30% to 45%. Current treatment approaches are largely supportive and do not directly address the underlying inflammatory lung injury.

JadiCell™ is an investigational, umbilical cord-derived cellular therapy designed to modulate immune responses and promote tissue repair in inflammatory lung disease. Preliminary clinical observations have demonstrated improvements in oxygenation, stabilization of respiratory function, and a favorable safety profile.

RMAT designation, if granted, is intended to facilitate the development and review of regenerative medicine therapies for serious conditions and may enable increased interaction with the FDA and potential for an accelerated regulatory pathway.

Our focus remains on the disciplined execution of our ARDS clinical program, with the goal of advancing JadiCell™ efficiently through clinical development.

About Breathe Biologics, Inc.:

Breathe Biologics, Inc. is a regenerative medicine company focused on lung diseases using licensed and patented umbilical cord derived multi-potent mesenchymal stem cell, termed “JadiCell.”