On October 29, 2025, a groundbreaking surgery that rewrites the history of regenerative ophthalmology was completed at the Rambam Medical Center in Haifa, Israel. The surgery involved the successful implantation of a 3D printed laboratory-cultured cornea, PB-001, developed by Precise Bio from North Carolina, USA, into the eye of a legally blind patient, helping them regain their sight.
This is the world’s first corneal transplant surgery using human corneal cells entirely cultivated in a laboratory, marking a significant breakthrough in addressing the global shortage of corneal donors.
Precise Bio’s core innovation lies in its robotic biomanufacturing technology. This technology can transform a single donated cornea into hundreds of laboratory-cultured transplant tissues, fundamentally changing the reliance on donations for corneal transplants. Data shows that currently, only 1 out of every 70 patients needing a corneal transplant can find a usable donated cornea, leaving countless patients at risk of permanent blindness due to long waiting times and donor shortages.
The corneal implant, named PB-001, closely matches the optical clarity, transparency, and biomechanical properties of a natural cornea. It is constructed from laboratory-cultured human corneal cells and has been validated through animal experiments to effectively integrate with the patient’s own tissue.
Moreover, PB-001 is compatible with existing ophthalmic surgical equipment and procedures. It can be transported through long-term low-temperature cryopreservation and is preloaded in standard delivery devices, allowing it to naturally unfold into a physiologically structured corneal shape during implantation without requiring changes to the surgeon’s routine operational procedures.
Dr. Michael Mimouni, head of the cornea department at Rambam Medical Center, who led the surgery, stated that this is a historic moment—witnessing laboratory-cultured living corneal cells restoring vision to humans for the first time. “This breakthrough allows us to glimpse the future: no one will have to live in darkness due to donor shortages, fundamentally changing the game.”
Currently, PB-001 is undergoing a single-arm Phase 1 clinical trial in Israel, planning to recruit 10 to 15 patients suffering from corneal edema due to dysfunction of the corneal endothelial cells. The study will track efficacy data over six months, with Precise Bio expected to announce the main results of the trial in the second half of 2026.
As clinical trials progress, this 3D bioprinting technology may extend beyond corneal transplants. Its core concepts of “donor amplification” and “customized tissue cultivation” are expected to expand into other organ transplant fields, opening new pathways to address the global organ donor shortage and bringing regenerative medicine into the broad realm of clinical applications.
Reference:Fierce Biotech