Persista Bio has been awarded two grants from the US National Institutes of Health (NIH) to support development of its O2Line oxygenated cell therapy platform. The funding includes a $2.1 million Direct-to-Phase 2 SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), aimed at advancing large-animal studies and clinical-grade manufacturing for Type 1 diabetes (T1D) applications, while laying groundwork for broader chronic disease therapies.

The O2Line system was designed to address two long-standing challenges in cell therapy: insufficient oxygen supply to implanted cells and fibrosis that limits long-term function. It combines an implantable electrochemical oxygen generator with a core-shell nanofibrous encapsulation capsule, providing continuous, controllable oxygenation, high-capacity cell loading, protection against fibrosis, and the ability to be placed and retrieved subcutaneously. Preclinical studies demonstrated sustained diabetes correction in immunocompetent rats using densely packed allogeneic islets, suggesting potential for long-term, immunosuppression-free therapy.

“These NIH awards directly fund several de-risking steps we must take to move this technology toward the clinic: demonstrating scale-up and function in large-animal models, developing the fully implantable system, and producing the cell capsules at clinical grade under GMP standards,” Linda Tempelman, chief executive officer of Persista Bio, said. “The O2Line system is more than a device, it’s a platform for cell therapy. Our first program is in diabetes, but we see broad potential across diseases where cells can replace or augment lost physiological function.”

The Direct-to-Phase 2 SBIR grant will support scaling the O2Line system to minipig size, demonstrating long-term survival of allogeneic islets in immunocompetent animals, and validating diabetes correction in a large-animal model. A separate Phase 1 award will focus on manufacturing readiness, including transferring the encapsulation capsule to a GMP-qualified partner and executing pilot runs to finalise process specifications.

Persista Bio is positioning O2Line as a flexible platform for multiple indications. While T1D is the initial focus, the company is exploring applications in inflammation, pain, obesity, enzyme deficiencies, and metabolic disorders. The company is also raising a $3.5 million seed round to support large-animal milestones and the development of a human-system prototype.