CraniUS Therapeutics Secures Second FDA 510(k) Clearance in Six Weeks and Earns U.S. Patent for NeuroPASS™ 3 Cranial Drug Delivery System

Newly cleared CraniUS® Plate configuration, designated NeuroPASS 2, adds an opening designed to accommodate an implantable intracranial pressure sensor; issued patent protects the integrated drug delivery architecture at the heart of NeuroPASS 3.

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."

The FDA issued its substantial equivalence determination on September 11, 2026, under submission number K262874, finding the new configuration substantially equivalent to the CraniUS Plate cleared on July 29, 2026 (K261058), designated NeuroPASS 1. The device is regulated as a Class II preformed alterable cranioplasty plate under 21 CFR 882.5320 (product code GWO) and was reviewed by the Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices within FDA's Center for Devices and Radiological Health. The CraniUS Plate is indicated to fill bony voids or defect areas in the cranial skeleton and is cleared for prescription use in adults 22 years of age and older.

NeuroPASS 2 shares the indications for use, patient-specific PEEK construction and core technology of its predicate, and adds a surgeon-requested opening, a defined pattern of holes, designed to accommodate an implantable intracranial pressure sensor. The submission was supported by biocompatibility assessment, sterilization validation, bacterial endotoxin testing and third-party mechanical verification testing, and the implant is labeled MR Safe. Implantable sensors and reservoirs are not part of the cleared device.

"For more than a century, cranial reconstruction has meant one thing: close the skull and restore the bony anatomy. We founded CraniUS Therapeutics on the belief that the neuroplastic reconstruction itself can become something far more," said Dr. Chad Gordon, Founder, Executive Chairman and Chief Medical Officer. "With a second clearance in hand and a patent protecting the much-anticipated cranial drug delivery system that comes next within a PEEK cranial plate, we are building a new interface with the brain with the goal of helping patients with serious neurological conditions. We believe this is the beginning of an entirely new category within neuroplastic surgery, one that strategically uses the temporal region of the skull."

NeuroPASS™ 3: Protecting a New Approach to Drug Delivery from Within the Skull

The blood-brain barrier prevents most systemically administered, large-molecule drugs from reaching brain tissue at therapeutic levels. Existing intracranial delivery options rely on small subcutaneous reservoirs that require frequent injections, on external catheters that pass through the scalp, or on pumps implanted in the torso and connected to the brain through long lengths of catheter.

The newly issued patent, granted to CraniUS LLC from Application No. 19/346,681 (filed October 1, 2025), covers a different approach: 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.

NeuroPASS 3 is being developed as a drug-led combination product and is investigational. It has not been cleared or approved by the FDA and is not available for sale. CraniUS Therapeutics is completing its nonclinical data package and preclinical studies and is targeting a first-in-human study in the second quarter of 2027.

"We are not building isolated devices; we are building a sequential architecture on a common, FDA-cleared cranial plate encased within PEEK," said Mark Wladkowski, Chief Operating Officer and Chief Technology Officer. "NeuroPASS 2 creates the physical interface for future sensing technologies, and the NeuroPASS 3 patent secures the integrated drug delivery system our team is now carrying into bench testing and first-in-human planning."

Important Regulatory Information

FDA clearance of K262874 is a substantial equivalence determination under section 510(k) of the Federal Food, Drug, and Cosmetic Act and applies to the CraniUS Plate cranial implant only, for the indications stated above. FDA has not cleared or approved any implantable sensor, reservoir, intracranial pressure monitoring function, drug delivery function or other investigational technology described in this release. Issuance of a patent is a USPTO determination of patentability, not an FDA finding of safety or effectiveness. The CraniUS Plate is a prescription device; refer to the product labeling for indications, contraindications, warnings and precautions.

About CraniUS Therapeutics

CraniUS Therapeutics is a Baltimore-based neurotechnology company founded in 2021 by Dr. Chad Gordon, the pioneer behind the burgeoning field of neuroplastic surgery. The company holds two FDA 510(k) clearances for its patient-specific CraniUS® Plate, designated NeuroPASS 1 and NeuroPASS 2, which serve as the foundation of its investigational NeuroPASS™ platform.

The NeuroPASS platform is a configurable cranial 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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development of the NeuroPASS platform and NeuroPASS 3, planned capabilities for sensing, brain access and drug delivery, and the timing of a first-in-human study. Such statements reflect current plans and expectations, involve risks and uncertainties, including those related to product development, nonclinical and clinical testing, regulatory review and the scope of intellectual property protection, and are not guarantees of future performance or regulatory outcomes.

Investigational products and programs described in this release have not been cleared or approved by the FDA, and no claim is made regarding their safety or effectiveness. There is no assurance that any product or program in development will be completed, will perform as intended, or will receive regulatory authorization.

Media Contact
Elizabeth A. Dale | External Relations
[email protected] (m) 215-620-4482
https://craniustherapeutics.com

SOURCE CraniUS Therapeutics