Precise Bio Achieves World's First 3D-Bioprinted Corneal Implant in Human Patient
Key Insights
Precise Bio (search) successfully implanted PB-001, the world's first 3D-bioprinted corneal implant, in a legally blind patient at Rambam Medical Center (search) in Israel on October 29, 2025.
The breakthrough implant is manufactured entirely from cultured human corneal cells using proprietary 3D-bio-fabrication technology, potentially transforming corneal transplantation from donor-dependent to lab-grown solutions.
The Phase 1 clinical trial will evaluate safety and tolerability in 10-15 patients with corneal edema (search), with topline results expected in the second half of 2026.
Precise Bio (search) has achieved a groundbreaking milestone in regenerative medicine with the successful implantation of PB-001, the world's first 3D-bioprinted corneal implant, in a human patient. The procedure was performed on October 29, 2025, at Rambam Medical Center (search) in Haifa, Israel, on a patient who was legally blind at the time of treatment, marking the first transplant of a cell-based, functional 3D-bioprinted cornea in medical history.
Revolutionary Technology Platform
Unlike traditional corneal grafts that rely on limited human donors, PB-001 is manufactured entirely from cultured human corneal cells using Precise Bio (search)'s proprietary robotic 3D-bio-fabrication system. The implant is produced at the company's GMP facility located in Sheba Medical Center, where corneal cells are isolated, cultivated, and printed into a precisely layered structure designed to integrate with the patient's own tissue.
"This achievement marks a turning point for regenerative ophthalmology—a moment of real hope for millions living with corneal blindness (search)," said Aryeh Batt, Co-Founder and Chief Executive Officer of Precise Bio (search). "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."
Addressing Global Corneal Shortage
The breakthrough addresses a critical medical need, as more than 13 million patients worldwide are currently awaiting corneal tissue. PB-001 is engineered to replicate the optical clarity and biomechanical properties of the native cornea, with the design aiming to deliver improved visual outcomes, lower complication rates, and consistent quality. The technology also enables long-term cryopreservation for streamlined logistics.
"Imagine a world where a single donor cornea can give rise to hundreds of lab-grown implants, transforming scarcity into abundance," Batt explained, highlighting the scalability potential of the platform.
Clinical Innovation and Design
PB-001, also referred to as the PVEK corneal implant (search), is a first-in-class 3D-printed tissue made from corneal endothelial cells (search). The implant is designed to unroll and comes pre-loaded on standard delivery devices during implantation, assuming a natural corneal shape that combines the handling advantages of DSAEK with the optical precision of DMEK.
Professor Michael Mimouni, Director of the Cornea Unit at Rambam Medical Center (search), who performed the procedure, described the moment: "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."
Phase 1 Clinical Trial
The successful implantation is part of Precise Bio (search)'s ongoing Phase 1, single-arm clinical trial at Rambam Medical Center (search). The study is designed to evaluate the safety and tolerability of PB-001 in 10-15 patients with corneal edema (search) caused by endothelial dysfunction (search). The trial will also explore early efficacy outcomes at six months, with Precise Bio expecting to announce topline results in the second half of 2026.
Anthony Atala, M.D., Co-Founder of Precise Bio (search) and G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine (search), emphasized the broader implications: "This is a defining moment for the future of regenerative medicine. PB-001 has the potential to offer a new, standardized solution to one of ophthalmology's most urgent needs - reliable, safe, and effective corneal replacement."
The successful first-in-human implantation represents over a decade of multidisciplinary innovation in cell biology, biomaterials, and 3D bioprinting, potentially reshaping the landscape of transplant medicine and offering new hope for patients with corneal blindness (search) worldwide.