Moroxite AB granted Breakthrough Device Designation by U.S. FDA

We’re thrilled to announce that Moroxite AB has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for our innovative material, Xerafuse—developed for use in spinal fusion.

This designation means we will now have direct contact with the FDA, enjoy higher priority in regulatory processes, and gain the opportunity for early reimbursement approval from U.S. insurers upon market authorization.

“We’ve done this before—and this time the material is just as exciting,” says Fredrik Lindberg, newly appointed CEO of Moroxite AB.

Fredrik brings extensive experience from Bonesupport, where he led the company through multiple FDA designations. Now, he’s leading Moroxite on its journey toward U.S. market approval, with the ambition of establishing Xerafuse as a new standard in spinal fusion procedures—a market valued at over $2 billion.

Read more: https://rapidus.se/2025/05/07/flygande-start-for-lindberg-pa-moroxite/