Greensboro, North Carolina — November 19, 2025 — Leads & Copy — Precise Bio, Inc., a clinical-stage regenerative medicine company, has announced the successful first human implantation of its 3D-bio-printed corneal implant, PB-001. The procedure, part of an ongoing Phase 1 clinical trial, was performed at Rambam Medical Center in Haifa, Israel on October 29, 2025. The recipient, a patient who was legally blind prior to the treatment, received the bio-implant in one eye.
The transplant marks a significant milestone as the world’s first cell-based, functional 3D-bio-printed cornea. The company hopes this breakthrough will transform ophthalmology and regenerative medicine.
Aryeh Batt, Co-Founder and Chief Executive Officer of Precise Bio, stated that the achievement signifies a turning point for regenerative ophthalmology. It offers hope for millions with corneal blindness. Batt envisions a future where a single donor cornea can produce hundreds of lab-grown implants, addressing the current scarcity of donor tissue.
PB-001 is engineered to mimic the optical clarity and biomechanical properties of a natural cornea. It is manufactured at Precise Bio’s GMP facility within Sheba Medical Center, utilizing the company’s robotic 3D-bio-fabrication system. The process involves isolating, cultivating, and printing corneal cells into a precisely layered structure designed to integrate with the patient’s tissue. This approach aims to enhance visual outcomes, reduce complication rates, and ensure consistent quality.
Anthony Atala, M.D., Co-Founder of Precise Bio, noted that PB-001 has the potential to offer a standardized solution for corneal replacement and reshape transplant medicine. Professor Michael Mimouni, who performed the transplant procedure, described the event as an unforgettable moment, offering a glimpse into a future where donor tissue shortages are no longer a barrier to restoring sight.
Ori Hadomi, Chairman of the Board of Precise Bio, highlighted the significance of this milestone, calling it the culmination of vision, persistence, and world-class science. He emphasized the company’s role in creating a new category in ophthalmology, where tissue scarcity no longer limits patient access.
The Phase 1 clinical trial is a single-arm study designed to assess the safety and tolerability of PB-001 in patients with corneal edema caused by endothelial dysfunction. The study will also evaluate early efficacy outcomes at six months. Precise Bio anticipates announcing topline results in the second half of 2026.
PB-001, or the PVEK corneal implant, is a 3D-printed tissue made from Corneal Endothelial Cells. It is designed to unroll and assume a natural corneal shape when implanted using standard delivery devices, combining the handling benefits of DSAEK with the optical precision of DMEK.
Precise Bio integrates cell biology and biomaterials to produce clinical-grade human tissues under GMP conditions. PB-001 is the first bio-printed corneal implant to enter human clinical trials.
Investor Contact:
Leigh Salvo
New Street Investor Relations
leigh@newstreetir.com
Media Contact:
Jason Braco, PhD
LifeSci Communications
jbraco@lifescicomms.com
Source: Precise Bio
