Precise Bio has reported the first successful human implantation of its 3D-printed cornea implant, constructed of functional human eye cells cultured in a laboratory.
The company described the procedure as the world’s first—and a major milestone toward its goal of alleviating the long wait times for people seeking transplants and faced with a lack of available donor tissue.
According to North Carolina-based Precise Bio, its robotic bio-fabrication approach could potentially turn a single donated cornea into hundreds of lab-grown grafts. It estimates that there is currently only one available cornea for every 70 patients who need one to see.
“This achievement marks a turning point for regenerative ophthalmology—a moment of real hope for millions living with corneal blindness,” Aryeh …
Precise Bio has reported the first successful human implantation of its 3D-printed cornea implant, constructed of functional human eye cells cultured in a laboratory.
The company described the procedure as the world’s first—and a major milestone toward its goal of alleviating the long wait times for people seeking transplants and faced with a lack of available donor tissue.
According to North Carolina-based Precise Bio, its robotic bio-fabrication approach could potentially turn a single donated cornea into hundreds of lab-grown grafts. It estimates that there is currently only one available cornea for every 70 patients who need one to see.
“This achievement marks a turning point for regenerative ophthalmology—a moment of real hope for millions living with corneal blindness,” Aryeh Batt, Precise Bio’s co-founder and CEO, said in a statement.
“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,” Batt added. “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.”
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The company said the transplant was performed Oct. 29 in one eye of a patient who was considered legally blind.
“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,” said Michael Mimouni, M.D., director of the cornea unit at Rambam Medical Center in Haifa, Israel, who performed the procedure. “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.”
Dubbed PB-001, the implant is designed to match the optical clarity, transparency and biomechanical properties of a native cornea. Previously tested in animal models, the company said its graft is capable of integrating with a patient’s own tissue.
The outer layer of the eye, covering the iris and pupil, can end up clouding a person’s vision following injuries, infections, scarring and other conditions. PB-001 is currently being tested in a single-arm phase 1 trial in Israel, which aims to enroll between 10 and 15 participants with excess fluid buildups in the cornea due to dysfunction within its inner cell layers.
Precise Bio said it plans to announce top-line results from the study in the second half of 2026, tracking six-month efficacy outcomes.
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PB-001 is also designed to be compatible with current ophthalmic surgery hardware and workflows. Shipped under long-term cryopreservation, it is provided preloaded on standard delivery devices and unrolls during implantation to form a natural corneal shape.
“This is a defining moment for the future of regenerative medicine,” said Anthony Atala, M.D., co-founder of Precise Bio 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.”