CraniUS Therapeutics, a Baltimore, Maryland-based neurotechnology company founded in 2021, announced on September 9, 2026 that the FDA granted 510(k) clearance for the CraniUS® Plate, designated NeuroPASS 1, on July 29, 2026. CEO Michael Maglin said: “This clearance is an inflection point for the company and a defining milestone for the people who did the work to get here. It moves us from development to a cleared product we can put in surgeons’ hands.”
A Patient-Specific Implant for Cranial Defects
The CraniUS Plate is a Class II preformed alterable cranioplasty plate, cleared under FDA submission K261058, used to repair cranial defects resulting from trauma, tumor resection, decompressive craniectomy, and other causes. Unlike off-the-shelf options, each implant is individually designed and manufactured to match a patient’s specific anatomy; the release doesn’t detail the manufacturing or imaging process behind that customization, or say when the plate will be commercially available or which surgeons or hospitals will use it first. Founder, Executive Chairman, and Chief Medical Officer Dr. Chad Gordon framed the clearance as a shift in how the field treats the problem: “Cranial reconstruction has been treated as a purely structural problem for decades, when the space beneath the plate is some of the most valuable real estate in the body. A cleared, patient-specific plate is the foundation of our long-term vision for what a cranial implant could one day do for patients.”
The First Piece of a Larger Platform
CraniUS positions the Plate as the initial cleared component of its broader NeuroPASS platform, which the company envisions eventually supporting brain access, integrated diagnostics, and drug delivery systems designed to bypass the blood-brain barrier; those additional capabilities remain investigational and are not yet FDA-authorized. Chief Operating Officer and Chief Technology Officer Mark Wladkowski said: “NeuroPASS 1 is the foundation of the platform we set out to build. It gives surgeons a patient-specific implant today, and it gives our team a cleared, manufacturable base that the rest of the platform is designed to build on. The architecture is configurable by intent, so brain access, diagnostics, and drug delivery can be added to the same base as each of those programs matures and is authorized on its own.” The clearance follows a $20 million Series B round CraniUS closed earlier this year in January to advance the NeuroPASS platform toward commercialization.
About CraniUS Therapeutics
CraniUS Therapeutics is a Baltimore-based neurotechnology company founded in 2021, developing the CraniUS Plate and investigational NeuroPASS platform addressing neurological conditions.
The NeuroPASS platform is a configurable implant architecture being developed to add durable access to the brain, integrated sensing and diagnostics, and fully implantable systems designed to bypass the blood-brain barrier through long-term, targeted drug delivery from within the cranial space. These investigational programs are being developed with the aim of addressing debilitating neurological conditions across multiple disease types. CraniUS Therapeutics collaborates with clinical and research partners globally.
