Published On: June 27, 2023

CraniUS becomes the first company with a smart, refillable, and fully embedded medical device that effectively bypasses the blood-brain barrier and achieves long-term, convection-enhanced medicine delivery.

BALTIMORE, Md., June 27, 2023 /PRNewswire/ — CraniUS LLC, an R&D company focused on building groundbreaking diagnostics and treatments for patients with chronic brain diseases, announces the scientific findings of successful convection-enhanced delivery in their pre-clinical study investigating the company’s patented NeuroPASS device.

The study proves the ability to achieve convection (meaningful flow and distribution of medicine beyond the catheter pathway) by delivering gadolinium through catheters with NeuroPASS, which is implanted in the skull space, invisible under the scalp. This is the first time a device has been successfully placed into the skull space allowing direct access to the brain to achieve successful convection and validates the potential for CraniUS to bring disruptive innovation to the Neuroscience and Neurosurgery markets.

When evaluating the MRI images from the devices tested by the company, the CraniUS NeuroPass device is on the way to achieving its goal of convection and that gadolinium was spreading within the white matter of the brain,” said Martin Pomper, M.D., Ph. D., Professor of Radiology at Johns Hopkins University (Baltimore, MD).

NeuroPASS provides a potentially safe alternative to systemic drug delivery for brain disease at a lower dosage with easy access for refilling. Systemic drug delivery has been shown to create adverse effects on other organs due to the larger doses required to get through the blood brain barrier.

“What CraniUS has built, and now tested successfully, in their large animal study is without question a quantum leap forward for our field. It has the immense potential to be a major disruptor in terms of how we, as neurosurgeons, approach and treat brain disease moving forward,” says Henry Brem, MD and board member at CraniUS.

The success of this study allows CraniUS to advance forward towards an FDA pre-clinical study as part of the FDA approval process and is looking to obtain IND approval for a first-in-human study by the end of 2024.

About CraniUS:

CraniUS’ stated mission is to invent and engineer world-class technology to define the future of diagnostics and treatments for patients with chronic brain disease. Its flagship device, known as the NeuroPASS, is being specifically developed to bypass the challenges presented by the blood-brain barrier, which has rendered traditional therapeutic treatments of brain disease ineffective. CraniUS utilizes a novel pump design, refillable reservoir, and wireless charging technology to enable long-term and direct medicine administration via CED (convection-enhanced delivery), an effective method of medicine delivery first introduced by the National Institute of Health (NIH). CraniUS began in May 2021 in Baltimore, MD, as a byproduct of the emerging field known as “Neuroplastic and Reconstructive Surgery”, through the vision, insight, and pioneering work of Dr. Chad Gordon.

As several other companies proceed within the brain-computer interface (BCI) space and battle for market share in treating brain pathologies needing electrical neuromodulation, CraniUS has focused on leading a new frontier known as the brain-medicine interface (BMI). This creates an expansive new platform in neurological medicines that can be delivered directly to the brain to treat multiple diseases.

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