CraniUS Therapeutics Secures FDA Clearance and Patent for NeuroPASS 2

BALTIMORE, Oct. 7, 2026 /CourierPR/ -- CraniUS Therapeutics, a neurotechnology company founded in 2021 by Dr. Chad Gordon, has achieved significant milestones in its quest to revolutionize cranial reconstruction and drug delivery. The company has secured its second FDA 510(k) clearance in just six weeks, with the new configuration, designated NeuroPASS 2, being granted clearance on September 11, 2026, under submission number K262874. This clearance comes ahead of the company’s anticipated timeline and follows the clearance of the original NeuroPASS 1 configuration on July 29, 2026 (K261058).

The newly cleared CraniUS® Plate, known as NeuroPASS 2, adds an opening designed to accommodate an implantable intracranial pressure sensor. This feature enhances the device’s capabilities, making it more versatile for future sensing technologies. The device is regulated as a Class II preformed alterable cranioplasty plate under 21 CFR 882.5320 (product code GWO) and is cleared for prescription use in adults 22 years of age and older.

In parallel, the U.S. Patent and Trademark Office (USPTO) 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. This patent covers a patient-specific reconstructive implant for the temporal region of the skull that houses a refillable reservoir, a pump that maintains a regulated infusion flow rate, and catheters that deliver therapeutic fluid directly to a target site in the brain. Claims also cover a PEEK housing plate configured to minimize MRI artifact, and a MEMS-manufactured flow regulator configured to maintain a constant flow rate across a defined pressure range.

CraniUS Therapeutics aims to develop the NeuroPASS 3 as a drug-led combination product, targeting the challenge of bypassing the blood-brain barrier. The company is completing its nonclinical data package and preclinical studies and is targeting a first-in-human study in the second quarter of 2027. The NeuroPASS 3 platform is being developed to add durable access to the brain, integrated sensing and diagnostics, and fully implantable systems designed to deliver long-term, targeted drug delivery from within the cranial space.

Dr. Chad Gordon, Founder, Executive Chairman, and Chief Medical Officer of CraniUS Therapeutics, expressed optimism about the company’s progress.

CraniUS Therapeutics continues to advance its innovative approach to neuroplastic surgery, aiming to address debilitating neurological conditions through its unique platform. The company’s commitment to developing new technologies that can improve patient outcomes is a significant step forward in the field of neurotechnology.