December 6, 2023

CraniUS, a medtech firm based mostly in Baltimore, has developed the NeuroPASS drug supply system. The know-how is designed to ship medicine to the mind, and it could possibly bypass the blood-brain barrier. This layer of specialised endothelium considerably restricts which drug molecules can enter the mind, usually vastly limiting remedy choices for sufferers with brain-based illness.

The NeuroPASS gadget is implanted into the cranium, the place it sits below the scalp. The gadget inserts catheters into the mind tissue which permit for managed infusions of drug when required. The implant might be simply refilled from outdoors, permitting for long-term, minimally invasive drug remedy. It’s also wi-fi and may even be charged wirelessly.

Right here’s a fast video introducing the know-how:

Medgadget had the chance to debate the know-how with Mike Maglin, CEO at CraniUS.

Conn Hastings, Medgadget: Please give us an summary of the blood-brain barrier, and the way it impacts remedy for a wide range of brain-based situations.

Mike Maglin, CraniUS: The blood-brain barrier serves as a formidable protection mechanism, defending the mind from potential dangerous substances whereas permitting important vitamins to go by. This selective barrier, composed of specialised endothelial cells, tight junctions, and astrocytes, prevents many therapeutic brokers (medication delivered systemically by tablet kind or through the bloodstream) from reaching the mind, posing a major problem for treating varied brain-based situations.  Over 95% of therapeutic medicine’ effectiveness is blocked by the blood mind barrier.

Medgadget: What current strategies are used to bypass this barrier? How are they suboptimal?

Mike Maglin: There are a number of current strategies which have been employed to bypass the blood-brain barrier however typically face limitations that hinder their efficacy (I might chorus from calling out different firms right here). These limitations embody the next:

  • In-hospital administration by exterior catheters that may trigger an infection over time.  As well as, it isn’t sustainable to have sufferers in-hospital for months at a time in search of this kind of remedy.
  • Incapability to chronically ship medication by “one and accomplished” supply mechanisms
  • Incapability to simply refill medication for some implanted gadgets
  • Incapability to vary circulate charges and monitor affected person care remotely
  • Not MRI protected or suitable. The NeuroPass gadget resides in essential actual property within the cranium house with shut proximity and entry to the mind

Medgadget: What impressed you to develop a drug supply gadget that might circumvent the blood-brain barrier? 

Mike Maglin: The motivation to develop a drug supply gadget able to circumventing the blood-brain barrier stems from the urgency to revolutionize mind remedy. Witnessing thousands and thousands of sufferers combating restricted remedy choices and recognizing the potential of modern medical know-how compelled Dr. Gordon and our group to embark on this endeavor. The NeuroPass gadget serves as a platform that has the potential to be drug agnostic and deal with a number of persistent mind illnesses.

Medgadget: Please give us an summary of the NeuroPASS gadget, how it’s used and what situations it’s appropriate for.

Mike Maglin: The NeuroPASS gadget is a groundbreaking answer designed to navigate the challenges posed by the blood-brain barrier. It’s the first absolutely implantable, wi-fi medical gadget that permits persistent and direct supply of drugs to the mind.  It’s simply refillable, rechargeable from a distance, and sits invisible below the pores and skin within the cranium house.

It’s a minimally invasive implantable gadget that makes use of convection-enhanced supply (CED) to exactly administer therapeutic brokers to the mind. NeuroPASS is appropriate for a spectrum of brain-based situations, starting from neurodegenerative illnesses to mind tumors.

Medgadget: How does the gadget work? What’s convection-enhanced supply?

Mike Maglin: The gadget operates by inserting catheters into the mind tissue pushed by a pump, permitting for the managed infusion of therapeutic brokers. Convection-enhanced supply leverages stress gradients to distribute these brokers all through the affected area with unparalleled precision, overcoming the constraints of passive diffusion.

Medgadget: What are the subsequent steps for the know-how, and the way do you intend to realize them?

Mike Maglin: CraniUS not too long ago accomplished a breakthrough pre-clinical research efficiently demonstrating convection enhanced supply in a swine mannequin. Our roadmap for advancing this know-how entails rigorous testing, refinement, and collaboration with consultants in neurology, neurosurgery, and medical engineering. We intention to optimize the gadget’s design for enhanced security, reliability, and affected person consolation and are concentrating on FDA IND submission and approval in late 2024 to conduct a Section I first-in-human research in 2025.

The NeuroPASS gadget represents a major leap ahead in addressing the challenges posed by the blood-brain barrier. By harnessing the facility of convection-enhanced supply, we aspire to remodel the panorama of mind remedy and supply hope to numerous people and their households who’ve lengthy awaited simpler therapeutic choices.

CAUTION – The NeuroPASS gadget is an investigational gadget restricted by Federal (or United States) legislation to investigational use and isn’t accessible for business distribution

Hyperlink: CraniUS homepage…