CraniUS received FDA 510(k) clearance for the CraniUS Plate, a patient-specific cranial implant and its first commercial product. NeuroPASS 1 establishes the manufacturing foundation for the broader NeuroPASS platform, designed to improve brain access, diagnostics, and drug delivery over time.

CraniUS received an initial $1.1M award from the NIH Blueprint MedTech program, with the potential to increase to $4M. The Baltimore company builds NeuroPASS, a fully implantable, skull-embedded device designed to bypass the blood-brain barrier and deliver drugs directly into brain tissue. The funding supports engineering, manufacturing, and regulatory work toward a first-in-human study. The first application explored is recurrent glioblastoma, the most common malignant primary brain tumour in adults.