Precise Bio, Inc. reported that the first patient has undergone a successful treatment with its 3D-bio-printed corneal implant as part of an ongoing phase 1 clinical trial.
Interesting … but first, tell me about Precise Bio.
Operating out of Shoham, Israel, and Greensboro, North Carolina, the regenerative medicine company is developing and commercializing 4D-bio-fabricated functional tissues and organs.
Its purpose: To make transplantable tissues / organs scalable, repeatable, and reproducible—in lieu of relying solely on donor tissues.
How it’s doing this: Via a core platform that integrates 3D printing, tissue engineering, cell expansion, biomaterials, and bioengineering to produce scalable and repeatable bio-fabricated organs from patients’ own cells.
- Among its target therapeutic areas: Cardiology, dermatology, orthopedics, and ophthalmology
Focus on this ophthalmology sector.
In this therapeutic area, Precise Bio has focused its attention on such indications as:
- A corneal graft for cornea transplants (our focus)
- A retinal patch for treating age-related macular degeneration (AMD)
- Vision correction lenticules to solve refractive errors
- Targeting ocular surface disease disorders involving damaged cornea surface or limbal stem cell deficiency
Zero in on this corneal graft.
As the company’s lead ophthalmic program, its 3D-printed cornea graft—dubbed the Precise Cornea—is designed to replace donor corneas.
How: By using cells to form a fully functional bio-fabricated, corneal implant to achieve “superior quality, cell density, transparency, and mechanical properties.”
- Its potential: To resolve corneal blindness for millions of patients awaiting corneal transplants across the globe.
And what do we know about this corneal implant?
PB-001 is Precise Bio’s 3D-bio-printed corneal implant made from corneal endothelial cells.
How it’s manufactured: Via the company’s robotic 3D-bio-fabrication system, in which Precise Bio "isolates, cultivates, and prints corneal cells into a precisely layered structure that integrates with the patient’s own tissue.”
- To note: This is done within its Israel-based Good Manufacturing Practice (GMP) facility.
Talk design.
- The implant is provided pre-loaded on standard delivery devices during implantation, assuming a natural corneal shape.
- It also combines descemet stripping automated endothelial keratoplasty (DSAEK) with the optical precision of descemet membrane endothelial keratoplasty (DMEK).
And with those capabilities, it’s intended to deliver:
- Improved visual outcomes
- Lower complication rates
- Consistently quality
The potential: To enable long-term cryopreservation for “streamlined logistics and a sustainable solution” for that aforementioned global shortage of corneal tissue.
So how does PB-001 compare to traditional grafts?
The obvious difference: The implant is manufactured entirely in the lab from cultured human corneal cells (rather than direct donor tissue).
Plus: It’s also engineered to replicate the optical clarity and biomechanical properties of a human (native) cornea—without reliance on what the company referred to as “limited” human donors.
And how was it used in this phase 1 trial?
The bio-implant was implanted in a legally blind patient on Oct. 29, marking the procedure as the “first transplant of a cell-based, functional 3D-bio-printed cornea.”
As for the ongoing study, here’s what we know about it:
- Its design: A single-arm trial evaluating the safety and tolerability of PB-001 implanted in legally blind patients
- The participants: 10 to 15 patients diagnosed with corneal edema caused by endothelial dysfunction
- The measured outcomes: Early efficacy outcomes at 6 months
Do we know how the patient responded to this implant?
Aside from the transplant being referred to as “successfully implanted,” no other specific details were provided.
Big-picture-wise: As Precise Bio co-founder noted, “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,” he added.
Any other details shared … like when we can expect data?
No other info on the study itself. However, the company plans on releasing topline data in the second half (H2) of 2026.