Persista Bio Receives Positive FDA Feedback on Modular Cell Therapy System for Type 1 Diabetes
Persista Bio received positive feedback from the FDA during an INTERACT meeting regarding its modular approach to developing and testing its implantable cell therapy system. The company's O2Line™ platform, designed to address challenges in oxygenation and fibrosis protection of encapsulated cells, was viewed as reasonable by regulators. This milestone provides clarity for Persista Bio’s development path toward treating Type 1 diabetes without the need for immunosuppression. The feedback is expected to reduce regulatory uncertainty and allow the company to proceed with greater confidence. The O2Line™ system combines an electrochemical oxygen generator with a nanofibrous capsule, enabling long-term cell survival in subcutaneous implants. Preclinical studies have shown sustained diabetes correction in immunocompetent rats using allogeneic islets. Persista Bio plans to continue preclinical work and optimize manufacturing for its capsules while engaging potential partners across therapeutic areas.
Topics: biotech cell therapy regulatory feedback type 1 diabetes