NIH Awards Up to $4 Million to CraniUS Therapeutics to Advance Skull-Embedded Platform Designed to Bypass the Blood-Brain Barrier

Blueprint MedTech award supports development of new treatment approaches for recurrent glioblastoma

BALTIMORE, June 29, 2026 /PRNewswire/ -- CraniUS Therapeutics, a neurotechnology company developing a skull-embedded drug delivery platform designed to bypass the blood-brain barrier, today announced it has received an initial $1.1 million award through the NIH Blueprint MedTech Optimizer Program, with the opportunity to secure up to $4 million in total funding. The award will support advancing the NeuroPASS™ platform toward a first-in-human study in recurrent glioblastoma (GBM).

Glioblastoma is the most common malignant primary brain tumor in adults. The blood-brain barrier prevents therapies from reaching effective concentrations in brain tissue, a central contributor to the unmet need in neuro-oncology. When glioblastoma recurs, median overall survival is approximately six to nine months. ¹

"The blood-brain barrier remains one of the greatest challenges in medicine," said Dr. Chad Gordon, Founder and Executive Chairman of CraniUS Therapeutics and Director of Neuroplastic and Reconstructive Surgery at Johns Hopkins. "Our vision is to create a practical, repeatable way to deliver therapies directly to the brain."

NeuroPASS is a refillable implant placed within the skull. It is designed to deliver therapy directly into brain tissue while reducing systemic exposure, with a concealed refill port intended to support outpatient dosing and repeated administration over time.

"NIH Blueprint MedTech support provides critical resources that will help accelerate NeuroPASS toward clinical evaluation and positions CraniUS to engage strategic partners," said Michael Maglin, Chief Executive Officer. "It reflects the importance of solving therapeutic access to the brain, and it strengthens our momentum at a pivotal stage of development."

The NIH Blueprint MedTech program, funded by the National Institute of Neurological Disorders and Stroke (NINDS) and administered by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), is an incubator that supports innovators by accelerating the development of cutting-edge medical devices for diagnosing and treating disorders of the nervous system. The program provides non-dilutive funding and access to essential resources, seeking to enhance patient access to safe and effective medical devices. CraniUS Therapeutics joins a competitive cohort of innovators supported by the program.

While the initial clinical focus is recurrent glioblastoma, NeuroPASS is designed to deliver a broad range of therapeutics across neuro-oncology and other CNS disorders. By combining long-term implantation, repeat dosing, and direct delivery beyond the blood-brain barrier, the platform aims to establish a new category of chronic brain access technology, one intended to support emerging biologics, gene therapies, cellular therapies, and other precision treatments that require reliable access to the brain.

"This award enables us to accelerate critical engineering, manufacturing, preclinical, and regulatory activities needed to prepare NeuroPASS for first-in-human evaluation," said Mark Wladkowski, Chief Operations/Technology Officer. "While glioblastoma is our lead indication, our long-term vision is for NeuroPASS to become the standard infrastructure for delivering therapeutics across CNS disease states."

This award is supported by the National Institutes of Health (NIH) Blueprint for Neuroscience Research and by the following NIH institutes: the National Institute of Neurological Disorders and Stroke and the National Institute of Biomedical Imaging and Bioengineering through grant 3U54EB033650-04S8.

About CraniUS Therapeutics

CraniUS Therapeutics is a neurotechnology company developing a fully implantable platform designed to bypass the blood-brain barrier for long-term, targeted drug delivery. Its flagship platform, NeuroPASS™, is designed to address debilitating neurological conditions across multiple disease types by leveraging the temporal skull space. Founded in 2021 and headquartered in Baltimore, Maryland, CraniUS Therapeutics collaborates globally.

Media Contact: Elizabeth A. Dale | External Relations
[email protected] | www.craniusmed.com

¹ Bernstock JD, et al. Recurrent Glioblastoma: Molecular Underpinnings and Evolving Treatment Paradigms. Int J Mol Sci. 2024;25(12):6733. PMID: 38928445. PMCID: PMC11203521.

Investigational device. NeuroPASS is an investigational device and has not been approved or cleared by the U.S. Food and Drug Administration. Its safety and effectiveness have not been established.

NeuroPASS™ is a trademark of CraniUS, LLC. The content is solely the responsibility of CraniUS Therapeutics and does not necessarily represent the official views of the National Institutes of Health. This release contains forward-looking statements regarding development plans and clinical timelines that involve risks and uncertainties, and actual results may differ.

SOURCE CraniUS Therapeutics