BALTIMORE, June 29, 2026
CraniUS Therapeutics has received an initial $1.1 million award through the National Institutes of Health (NIH) Blueprint MedTech Optimizer Program, with the potential to receive up to $4 million in total funding to accelerate development of its NeuroPASS™ skull-embedded drug delivery platform. The funding will support engineering, manufacturing, regulatory, and preclinical activities required to prepare the innovative technology for a first-in-human clinical study in patients with recurrent glioblastoma (GBM). The award highlights growing interest in technologies designed to overcome the blood-brain barrier (BBB), one of the biggest challenges limiting effective treatment of neurological diseases and brain cancers. By enabling direct therapeutic delivery into brain tissue, NeuroPASS aims to improve drug concentrations at the disease site while reducing systemic exposure, potentially opening new treatment possibilities for patients with aggressive brain tumors.
NeuroPASS Designed to Overcome the Blood-Brain Barrier
The NeuroPASS™ platform is a refillable, skull-embedded implant engineered to deliver medicines directly into brain tissue while bypassing the protective blood-brain barrier that often prevents therapeutic agents from reaching effective concentrations. Unlike conventional treatment approaches, the device incorporates a concealed refill port intended to support repeated outpatient dosing without requiring repeated invasive surgeries. According to CraniUS Therapeutics, this technology has the potential to establish a new standard for long-term targeted drug delivery across multiple neurological diseases.
Founder and Executive Chairman Dr. Chad Gordon emphasized that overcoming the blood-brain barrier remains one of medicine’s greatest challenges, while CEO Michael Maglin noted that NIH support significantly strengthens the company’s path toward clinical evaluation and future strategic collaborations. The company believes the platform could eventually support delivery of biologics, gene therapies, cell therapies, precision medicines, and other advanced neurological treatments requiring reliable access to the brain.
NIH Blueprint MedTech Funding Accelerates Development
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The award was granted through the NIH Blueprint MedTech Program, an initiative funded by the National Institute of Neurological Disorders and Stroke (NINDS) and administered by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The program provides non-dilutive funding and expert development resources to accelerate promising medical device technologies addressing neurological disorders. CraniUS joins a select group of innovators supported by the program to advance cutting-edge neurotechnology solutions.
Chief Operations and Technology Officer Mark Wladkowski stated that the funding will accelerate critical engineering validation, manufacturing readiness, regulatory planning, and preclinical development needed before initiating first-in-human evaluation. While recurrent glioblastoma serves as the lead indication due to its urgent unmet medical need and poor prognosis, the company envisions broader applications across numerous central nervous system disorders where targeted drug delivery remains a major therapeutic limitation.
Platform Could Expand Beyond Brain Cancer
Although the initial clinical focus is recurrent glioblastoma, CraniUS believes the NeuroPASS™ platform has the potential to transform treatment across a wide range of central nervous system (CNS) diseases. The company is developing the technology as a long-term infrastructure capable of supporting repeated administration of emerging therapies that currently struggle to cross the blood-brain barrier.
Future applications may include neuro-oncology, neurodegenerative diseases, rare neurological disorders, gene therapy, cellular therapy, and precision biologics, where sustained and targeted brain delivery could improve therapeutic outcomes. With NIH support now in place, CraniUS plans to advance the platform through the remaining preclinical and regulatory milestones required for clinical testing, positioning NeuroPASS as a potentially transformative medical technology designed to redefine how therapies are delivered directly to the brain for patients with serious neurological diseases.
Source: CraniUS Therapeutics press release
