FDA Clears Moria Surgical’s XTRA4 Corneal Storage Solution

Moria Surgical announced that the FDA has granted 510(k) clearance for XTRA4, a corneal storage solution designed to preserve human donor corneas for up to 14 days under refrigeration (2–8 °C). The technology aims to improve tissue quality and availability for patients waiting for corneal transplantation.

“XTRA4 is the most advanced corneal storage medium we’ve ever developed,” said Jana D’Amato Tothova, PhD, Group R&D Director at Moria. “Its ability to preserve stromal thickness, maintain endothelial integrity, and prevent edema—even in epithelium-free corneas or precut lamellar DSAEK grafts for 14 days—represents a major breakthrough for transplant centers and eye banks.”

By maintaining key structural and cellular properties over a longer period, XTRA4 aims to streamline logistics for tissue distribution while reducing the risk of complications such as graft detachment. The product reflects years of research and close collaboration between Moria and leading eye banking professionals in Europe and the United States.

Mathew Feng, MD, of Price Vision Group, noted that “XTRA4 promises significant potential to preserve endothelium more consistently, not to mention prolong preservation. It will be a real asset to surgeons to reduce graft detachment following cornea surgery.”

According to Moria, with eye banks increasingly managing regional and international tissue distribution, demand is rising for storage solutions that maintain viability over longer timeframes. XTRA4’s 14-day refrigerated shelf life could ease logistical pressures and expand access to donor tissue for keratoplasty procedures.

Moria Surgical expects the US launch of XTRA4 later this year.