BALTIMORE, Oct. 7, 2026 /PRNewswire/ — CraniUS Therapeutics today announced a one-two advance for its NeuroPASS™ platform. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a new configuration of the CraniUS® Plate, designated NeuroPASS 2, the company’s second FDA clearance in about six weeks and a decision that arrived ahead of the fourth-quarter timeline the company had anticipated. In parallel, the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent No. 12,752,051 “Cranial Drug Delivery System,” protecting the integrated implant architecture at the core of the company’s investigational NeuroPASS 3 program.
“Two clearances in six weeks, ahead of our own timeline, is what execution looks like,” said Michael Maglin, Chief Executive Officer of CraniUS Therapeutics. “NeuroPASS 1 established our regulatory foundation. NeuroPASS 2 begins expanding what that foundation can support, and the NeuroPASS 3 patent protects where the platform is going. We are moving from cranial reconstruction toward cranial infrastructure for future therapeutic access.”