Precise Bio Achieves World’s First 3D-Bio-Printed Corneal Implant
Successful first human implantation marks a transformational moment in ophthalmology and regenerative medicine
Breakthrough marks key clinical milestone for Precise Bio’s proprietary 3D-bio-fabrication platform and lead candidate PB-001
GREENSBORO, N.C., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Precise Bio, Inc. (“Precise Bio” or the “Company”), a clinical-stage regenerative medicine company pioneering bio-printed tissues and organs with an initial focus on ophthalmology, today announced the first patient has been successfully treated with PB-001, the Company’s 3D-bio-printed corneal implant, at Rambam Medical Center in Haifa, Israel as part of its ongoing Phase 1 clinical trial. The procedure was performed on October 29, 2025, 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-bio-printed 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-bio-fabrication 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 affecting more than 13 million patients awaiting corneal tissue.
“This is a defining moment for the future of regenerative medicine,” said Anthony Atala, M.D., 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.”
Professor Michael Mimouni, Director of the Cornea Unit at Rambam Medical Center, who performed the procedure, commented, “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.”
Ori Hadomi, Chairman of the Board of Precise Bio, commented:
“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.”
About the Phase 1 Clinical Trial
The ongoing Phase 1, single-arm trial at Rambam Medical Center is designed to evaluate the safety and tolerability of PB-001 in 10–15 patients with corneal edema caused by endothelial dysfunction. The study will also explore early efficacy outcomes at six months. Precise Bio expects to announce topline results from the study in 2H 2026.
PB-001 - also referred to as the PVEK corneal implant - is a first-in-class 3D printed tissue, made from Corneal Endothelial Cells and designed to unroll and is provided pre-loaded on standard delivery devices during implantation and assume a natural corneal shape, combining the handling advantages of DSAEK with the optical precision of DMEK.
About Precise Bio
Precise Bio is a clinical-stage regenerative medicine company pioneering a proprietary 3D-bio-fabrication platform that integrates cell biology, and biomaterials to produce clinical-grade human tissues under GMP conditions. Its lead program, PB-001, is the world’s first bio-printed corneal implant to enter human clinical trials, with additional ophthalmology and advanced tissue programs in development. For more information, visit www.precise-bio.com.
Investor Contact
Leigh Salvo
New Street Investor Relations
leigh@newstreetir.com
Media Contact
Jason Braco, PhD
LifeSci Communications
jbraco@lifescicomms.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
