The newly cleared NeuroPASS 2 configuration builds on the foundation established by the company’s first plate, approved in late July. This iteration introduces a specific opening designed to accommodate intracranial pressure sensors, a feature requested by surgeons to enhance monitoring capabilities during and after cranial reconstruction. The device remains classified as a Class II preformed alterable cranioplasty plate, intended for adult patients requiring the repair of bony defects.
CraniUS Therapeutics Secures FDA Clearance and Patent for NeuroPASS Platform
Baltimore-based CraniUS Therapeutics has cleared a significant regulatory hurdle, securing its second FDA 510(k) approval in six weeks. The company also received a U.S. patent for its NeuroPASS 3 system, marking a strategic shift toward developing implantable cranial infrastructure for advanced neurological drug delivery.
Simultaneously, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,752,051, which protects the architecture behind the investigational NeuroPASS 3. Unlike traditional delivery methods that rely on external catheters or pumps implanted in the torso, this technology utilizes a patient-specific PEEK implant in the temporal region to house a refillable reservoir and a MEMS-manufactured flow regulator. By integrating these components directly into the skull, the company aims to bypass the blood-brain barrier to treat serious neurological conditions. While the NeuroPASS 3 remains an investigational product, the company is finalizing preclinical studies with the goal of launching first-in-human trials by the second quarter of 2027.
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