Moria Surgical is reported to have received FDA 510(k) clearance for its corneal storage solution—dubbed XTRA4—for corneal transplantation.
First, Moria.
The French medical equipment manufacturing company specializes in designing precision instrumentation and equipment for ophthalmic surgery, including:
- Reusable and single-use surgical instruments
- Keratoplasty and corneal graft surgery
- Refractive surgery and laser-assisted in situ keratomileusis (LASIK) equipment
- Vitreoretinal surgery
To note: Moria’s U.S. headquarters (Moria, Inc.) are based in Doylestown, Pennsylvania.
Now to the FDA clearance.
Essentially, a 510(k) clearance from the FDA is a premarket submission demonstrating that a device can be marketed as safe and effective—and can be considered “substantially equivalent” to a predicate (a similarly legally marketed device) already in use.
In other words: A device with this clearance has permission to be sold for commercial use around the United States.
And in this case?
Moria’s XTRA4 is trademarked and designed as a corneal stage solution that preserves human donor corneas for up to 14 days (under refrigeration at 2–8 °C [35.6–46.4°F]).
Its purpose: To improve both tissue quality and human donor cornea availability for patients in need of a transplant by maintaining key structural and cellular properties over a longer period.
- Why availability is crucial: There’s currently a global shortage of donated corneal tissue—due in large part to limited healthcare access as well as cultural and social barriers deterring donations.
Explain to me why 14 days is the magic number for storage.
That’s according to FDA guidelines, which mandate a “maximum 14-day period from recovery to transplant” for corneal transplants.
Interestingly: Despite this, clinical research has reported that U.S. ophthalmic surgeons have largely avoided using corneas preserved for more than 7 days—as longer preservation times have been associated with a lower success rate for transplants.
Got it. So tell me more about XTRA4.
Through its key structural and cellular property maintenance, XTRA4 aims to streamline logistics for tissue distribution while also reducing the risk for complications (such as graft detachment).
- To note: Graft detachments involve the partial or complete peeling of a transplanted corneal tissue (the graft) from a patient’s cornea following transplant.
… how, exactly?
Jana D’Amato Tothova, PhD, Moria’s group research & development director, highlighted three key mechanisms that make the technology “a major breakthrough for transplant centers and eye banks.”
These include:
- Stromal thickness preservation
- Endothelial integrity maintenance
- Edema prevention, including in:
- Epithelium-free corneas
- Precut lamellar Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) grafts for 14 days
And how does this preservation compare to standard global practice?
In the U.S.: The FDA dictates that corneas must be preserved in a solution formulated with chondroitin sulfate, additional antioxidants, energy sources, and nutritive substrates.
Around the world: A cornea can be preserved via organ culture, hypothermia, or cryopreservation to guarantee the corneal epithelium’s viability for the transplant.
Which of these methods does XTRA4 utilize?
That would be the hypothermia approach. A couple of notes:
- Hypothermia is the most commonly applied storage method in the United States, as dictated by the FDA for that aforementioned maximum duration of 14 days
- Organ culture—keeping the cornea at 28–37°C—extends the cornea’s storage time to 4 weeks (and is commonly used in European eye banks)
- Only cryopreservation offers the possibility of an unlimited storage time for the cornea (though its potential for damage and complexity of the process mean it’s seldom used)
Lastly, when might this be available for commercial use?
According to reports: later this year (so, at the very latest, December 2025).
Reach out to Moria with any questions.