Breathe Biologics, Inc. Announces IND Amendment for IND Transfer in eCTD Format

Oceanside, CA / April 03, 2026 / 

Breathe Biologics Inc. is pleased to announce its amendment to Investigational New Drug Application (IND) #19757 to formally document the transfer of sponsorship from Therapeutic Solutions International, Inc. (TSOI) to Breathe Biologics Inc.

This submission was provided in eCTD format in accordance with FDA guidance for commercial stage INDs and reflects the Agency’s request to ensure proper documentation of sponsor transition within the official regulatory record.

Summary of Submission

• IND Number: 19757.27
• Product: JadiCell™ (umbilical cord-derived mesenchymal-like stem cells)
• Indication: Acute Respiratory Distress Syndrome (ARDS)
• Previous Sponsor: Therapeutic Solutions International, Inc.
• New Sponsor: Breathe Biologics Inc.

This amendment includes the following documents:

• Form FDA 1571 (updated to reflect Breathe Biologics Inc. as Sponsor)
• Sponsor Transfer Letter (TSOI to Breathe Biologics Inc.)
• Letter of Acceptance of Sponsorship by Breathe Biologics Inc.
• Updated Contact Information for the Sponsor
• Any additional administrative documentation supporting the transfer

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.”