FDA одобрила первый продукт CraniUS Therapeutics для рынка США

News provided by CraniUS Therapeutics Sep 09, 2026, 07:50 ET Clearance establishes the company's first product for the U.S. market and the foundation of its investigational NeuroPASS™ platform. BALTIMORE, Sept. 9, 2026 /PRNewswire/ -- CraniUS Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CraniUS Plate, a patient-specific cranioplasty implant intended for the repair of cranial defects. The clearance permits CraniUS Therapeutics to market the CraniUS Plate in the United States — the company's first commercially available product. The CraniUS Plate is designated NeuroPASS 1 and is the foundational configuration of the company's NeuroPASS platform. "This clearance is an inflection point for the company and a defining milestone for the people who did the work to get here," said Michael Maglin, Chief Executive Officer of CraniUS Therapeutics. "It moves us from development to a cleared product we can put in surgeons' hands." The FDA issued its substantial equivalence determination on July 29, 2026, under submission number K261058. The CraniUS Plate is regulated as a Class II preformed alterable cranioplasty plate under 21 CFR 882.5320 (product code GWO), and the submission was reviewed by the Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices within FDA's Center for Devices and Radiological Health. Each CraniUS Plate is designed and manufactured to match the individual patient's anatomy, giving neurosurgeons and craniofacial surgeons a patient-specific option for reconstructing cranial defects resulting from trauma, tumor resection, decompressive craniectomy, and other causes. That anatomy, the company believes, holds untapped potential. "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," said Dr. Chad Gordon, Founder, Executive Chairman and Chief Medical Officer of CraniUS Therapeutics. "A cleared, patient-specific plate is the foundation of our long-term vision for what a cranial implant could one day do for patients." NeuroPASS™ 1: The Foundation of a Configurable Cranial Implant Platform The cleared CraniUS Plate, designated NeuroPASS 1, establishes the structural and manufacturing foundation of the NeuroPASS platform. The platform is built on a patient-specific implant architecture that CraniUS is developing to support additional features for brain access, diagnostics, and drug delivery, subject to applicable regulatory requirements. Programs in development include durable access to the brain, integrated sensing and diagnostics, and a fully implantable system designed for long-term targeted delivery of therapeutics from within the cranial space, with the goal of bypassing the blood-brain barrier. These programs are investigational and are not part of the cleared device. "NeuroPASS 1 is the foundation of the platform we set out to build," said Mark Wladkowski, Chief Operating Officer and Chief Technology Officer of CraniUS Therapeutics. "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 CraniUS Plate is cleared only for the repair of cranial defects, consistent with its FDA-cleared indications for use. About CraniUS Therapeutics CraniUS Therapeutics is a Baltimore-based neurotechnology company founded in 2021. The company's cleared CraniUS® Plate, designated NeuroPASS 1, provides patient-specific cranial reconstruction and serves as the foundation of the company's investigational NeuroPASS™ platform. 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. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the development of the NeuroPASS platform, its planned capabilities for brain access, diagnostics, and drug delivery, and future products. Such statements reflect current plans and expectations, involve risks and uncertainties, 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] | https://craniustherapeutics.com SOURCE CraniUS Therapeutics