Precise Bio, Inc. announced the first patient has been successfully treated with PB-001, the company’s 3D-bio-printed corneal implant, at Rambam Medical Center in Haifa, Israel, as part of its ongoing phase 1 clinical trial.
The procedure was performed on October 29, 2025, on a patient who was legally blind at the time of treatment and received the bio-implant in 1 eye. This procedure marks the world’s first transplant of a cell based, functional 3D-bio-printed cornea, the company said in a press release.
Unlike traditional grafts that rely on limited human donors, PB-001 is engineered to replicate the optical clarity and biomechanical properties of the native cornea, the company said. The implant is manufactured at Precise Bio’s GMP facility located in Sheba Medical Center, using the company’s robotic 3D-bio-fabrication system. Within the facility, Precise Bio isolates, cultivates, and prints corneal cells into a precisely layered structure that integrates with the patient’s own tissue. The design aims to deliver improved visual outcomes, lower complication rates, and consistent quality, while also enabling long-term cryopreservation for streamlined logistics and a sustainable solution, the company said in the press release.
Professor Michael Mimouni, director of the Cornea Unit at Rambam Medical Center, who performed the procedure, commented, “For the first time in history, we’ve witnessed a cornea created in the lab, from living human cells, bring sight back to a human being. It was an unforgettable moment—a glimpse into a future where no one will have to live in darkness because of a shortage of donor tissue. This is a game changer.”
According to Precise Bio, the ongoing single-arm trial at Rambam Medical Center is designed to evaluate the safety and tolerability of PB-001 in 10 to 15 patients with corneal edema caused by endothelial dysfunction. The study will also explore early efficacy outcomes at 6 months. Precise Bio said it expects to announce topline results from the study in the second half of 2026.