Persista Bio Receives Positive Feedback on Modular Approach from FDA INTERACT

—Increased confidence on cell therapy system approach for Type 1 diabetes

ITHACA, N.Y., Sept. 23, 2026 /PRNewswire/ -- Through a recent INTERACT meeting with the Food and Drug Administration Center for Biologics Evaluation and Research (CBER), Persista Bio, Inc. received positive feedback on its implantable cell therapy system; the FDA viewed Persista Bio's modular approach to hardware/cellular development and testing as reasonable. The company also was able to share its proposed sequence of preclinical studies during this INTERACT meeting (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs.) This early, targeted regulatory guidance on the development of the Persista Bio O2Line^™ system is an important milestone in the development program as the company pursues its first indication, Type 1 diabetes.)

"The meeting and feedback we received is an important step in reducing regulatory uncertainty as we advance our development program," said CEO Linda Tempelman. "We now have additional clarity on our development and testing program that allows us to move forward with greater confidence."

"Today's cell therapies show tremendous promise to cure disease but there are still roadblocks to using these cures—their current use requires immunosuppression, which most patients can't tolerate. When cells are encapsulated to give immune protection, the cells need oxygen to thrive in the compact implants and be long lasting in the body. Persista Bio is solving both of these challenges and is working on its first treatment for Type 1 diabetes." The cell implant system has the flexibility to be used with other cell types to treat additional chronic diseases and conditions such as inflammation, obesity, or pain control.

The Persista Bio O2Line™ system was created to address the challenges that have constrained cell-based therapies from broad adoption: the need for patients to take immunosuppression drugs, insufficient oxygen supply to implanted cells and fibrosis that limits long-term function. By combining an implantable electrochemical oxygen generator (iEOG) with a core-shell nanofibrous capsule, Persista Bio's O2Line™ provides continuous oxygenation, compact design, fibrosis protection, and the ability for subcutaneous placement and retrieval. In preclinical studies, the system achieved sustained diabetes correction in immunocompetent rats using densely packed allogeneic islets. See Nature Communications article, DOI: 10.1038/s41467-025-62271-2.

The company is pursuing additional preclinical work in a large animal (porcine) model, optimizing the design for manufacturing along with developing commercial manufacturing capacity for its cell capsules. They are also having discussions with potential cell partners in diabetes and other therapeutic areas.

"We look forward to future meetings with the FDA as we continue our preclinical studies and product development," said Tempelman. "Thanks to ProPharma for guidance and Breakthrough T1D for funding that brings us to this important milestone."

About Persista Bio

Persista Bio®, Inc. is a pre-clinical biotherapeutics company based in Ithaca, NY, developing technology designed to revolutionize cell encapsulation. With the O2Line™ Oxygenated Cell Therapy Platform, Persista Bio aims to enable long-term, immunosuppression-free cell therapy, starting with Type 1 diabetes. The company licenses technology from Cornell University and Giner, Inc. For more information, visit persistabio.com and follow us on LinkedIn.

Media Contact: Kathleen Rowe, 781-455-9050, [email protected]

SOURCE Persista Bio, Inc.