Precise Bio completes procedure using PB-001, a 3D-bioprinted corneal implant

Precise Bio has successfully treated a patient with PB-001, the company’s 3D-bio-printed corneal implant, at Rambam Medical Center in Haifa, Israel. The procedure was conducted as part of the company’s ongoing phase 1 clinical trial.

PB-001 is a first-in-class 3D-printed tissue made from corneal endothelial cells. It is designed to unroll and is provided pre-loaded on standard delivery devices during implantation and assumes a natural corneal shape, combining the handling advantages of DSAEK with the optical precision of DMEK.

The company notes that this procedure marks the “world’s first transplant of a cell-based, functional 3D-bioprinted cornea.” Aryeh Batt, co-founder and CEO of Precise Bio, commented on the occasion.

"This achievement marks a turning point for regenerative ophthalmology—a moment of real hope for millions living with corneal blindness. For the first time, a corneal implant manufactured entirely in the lab from cultured human corneal cells, rather than direct donor tissue, has been successfully implanted in a patient. Imagine a world where a single donor cornea can give rise to hundreds of lab-grown implants, transforming scarcity into abundance.”

PB-001 is engineered to replicate the optical clarity and biomechanical properties of the native cornea using the company’s robotic 3D-bio-fabrication system, according to the company. The design of PB-001 aims to deliver “improved visual outcomes, lower complication rates, and consistent quality, while also enabling long-term cryopreservation for streamlined logistics.”

Michael Mimouni, MD, director of the Cornea Unit at Rambam Medical Center, performed the procedure and commented on it, saying, “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.”

The ongoing phase 1 trial is a single-arm trial at Rambam Medical Center designed to evaluate the safety and tolerability of PB-001 in 10–15 patients with corneal edema caused by endothelial dysfunction. Efficacy outcomes at 6 months will also be observed. The company expects results from the trial to be announced in the second half of 2026.

References:

1. Precise Bio Achieves World’s First 3D-Bio-Printed Corneal Implant. Published November 19, 2025. Accessed November 20, 2025. https://www.globenewswire.com/news-release/2025/11/19/3190933/0/en/Precise-Bio-Achieves-World-s-First-3D-Bio-Printed-Corneal-Implant.html