World’s First Smart, Refillable and Fully Implantable Medical Device Delivers Medicine Directly to the Brain

Made up of specialized endothelial cells, tight junctions, and astrocytes, this barrier effectively blocks over 95% of drugs delivered through the bloodstream or in pill form, making it hard to treat a range of brain-related conditions. Now, an implantable drug delivery device capable of circumventing the blood-brain barrier could revolutionize brain treatment.

CraniUS LLC’s (Baltimore, MD, USA) NeuroPASS device is a groundbreaking solution that aims to overcome the obstacles created by the blood-brain barrier. It is the world’s first fully implantable, wireless medical device that enables chronic and direct medicine delivery to the brain. It is easily refillable, rechargeable from a distance, and can remain unnoticed under the skin in the skull. The device employs catheters driven by a pump that go into the brain tissue, allowing for controlled infusion of medications. NeuroPASS uses a technique called convection-enhanced delivery (CED), which utilizes pressure differences to accurately spread medications throughout the targeted brain area, surpassing the limitations of passive diffusion. The device is versatile, with applications for a variety of brain-related conditions including neurodegenerative diseases and brain tumors.

A preliminary study has validated the device's capability to achieve meaningful medication flow and distribution beyond the initial catheter pathway by delivering gadolinium through catheters with NeuroPASS. This marks the first time that a device has been successfully implanted in the skull area to allow direct brain access for successful convection. This achievement clears the way for CraniUS to proceed to an FDA pre-clinical study, and the company aims to secure IND approval for initial human trials by the close of 2024.

"I could not be any prouder of our talented team and the findings of this recent breakthrough study,” said Mike Maglin, CEO of CraniUS. “Being able to show that our patented device is both safe and effective in achieving convection in large animals with similar brains to humans represents a tremendous culmination of hard work and determination by our team."

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