Precise Bio, a clinical-stage regenerative medicine company pioneering bio-printed tissues and organs with an initial focus on ophthalmology, has successfully treated the first patient with PB-001, the company’s 3D bioprinted corneal implant, at Rambam Medical Center in Haifa, Israel, as part of its ongoing Phase 1 clinical trial.
The procedure was performed on a patient who was legally blind at the time of treatment and received the bio-implant in one eye. This procedure marks the world’s first transplant of a cell-based, functional 3D bioprinted cornea, establishing a pivotal milestone for ophthalmology, regenerative medicine, and the future of tissue engineering.
“This achievement marks a turning point for regenerative ophthalmology – a moment of real hope for millions living with corneal blindness,” said Aryeh Batt, Co-founder and Chief Executive Officer of Precise Bio. “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. This milestone reflects over a decade of multidisciplinary innovation in cell biology, biomaterials, and 3D bioprinting, and demonstrates the potential of our platform to make corneal transplantation scalable and accessible worldwide. We look forward to advancing the clinical evaluation of PB-001 in our ongoing Phase 1 trial.”
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 implant is manufactured at Precise Bio’s GMP facility located in Sheba Medical Center, using the company’s robotic 3D biofabrication 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 to the global shortage reportedly affecting more than 13 million patients awaiting corneal tissue.
“This is a defining moment for the future of regenerative medicine,” said Anthony Atala, Co-founder of Precise Bio, and G. Link Professor and Director of the Wake Forest Institute for 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 ability to produce patient-ready tissue on demand could lead the way towards reshaping transplant medicine as we know it.”
“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,” said Professor Michael Mimouni, Director of the Cornea Unit at Rambam Medical Center, who performed the procedure.
“This milestone is the culmination of vision, persistence, and world-class science. We are witnessing the birth of a new category in ophthalmology – one where tissue scarcity no longer defines patient access. I am deeply proud of the team’s courage and precision in translating years of innovation into a first-in-human success,” said Ori Hadomi, Chairman of the Board of Precise Bio.
