CraniUS
Revolutionizing Brain Disease Treatment: CraniUS Unveils NeuroPASS, a Breakthrough in Brain-Medicine Interface Technology

The blood-brain barrier has long been a subject of medical research, serving as a natural defense mechanism against harmful substances but hindering drug delivery. Invasive methods, like catheters and external pumps, have attempted to overcome it, but the outcomes have not always been optimum. Less than one percent of therapeutic medications can breach this barrier, posing challenges in treating diseases like glioblastoma, Alzheimer’s, and Parkinson’s.

The struggle of millions of patients with limited treatment options has motivated Dr. Chad Gordon, co-founder and chief medical officer of CraniUS, and his dedicated team to engineer a revolutionary solution: NeuroPASS. This pioneering concept marks a watershed moment in the field of medical technology by enabling direct drug delivery to the brain, effectively bypassing the blood-brain barrier.

The NeuroPASS device is a groundbreaking solution designed to navigate the challenges posed by the blood-brain barrier. Unlike anything seen before, NeuroPASS is the first fully implantable, wireless medical device designed to facilitate direct drug delivery to the brain.

This remarkable device is equipped with a patented wireless charging platform to optimize patient experience, allowing it to be easily refillable and rechargeable from a distance. Nestled in the skull space along the temporal region, NeuroPASS is a minimally invasive implantable device that utilizes novel pump and catheter elements to precisely administer therapeutic agents to the brain. NeuroPASS is suitable for a spectrum of brain-based conditions, ranging from neurodegenerative diseases to brain tumors.

“Unlike companies in the brain-computer interface (BCI) space, which primarily focus on electrical neuromodulation, CraniUS pioneers the brain-medicine interface (BMI),” says Michael Maglin, CEO of CraniUS.

With NeuroPASS, CraniUS has not only overcome a formidable scientific challenge but has also opened new doors for patients, offering them a chance at a better quality of life.

Overcoming the Limitations of Passive Diffusion

NeuroPass does not breach or break through the blood-brain barrier. It instead, utilizes electro-osmotic pump technology to provide delivery and bulk, pressure-driven flow of medicine directly to the brain, bypassing the blood-brain barrier. CraniUS’s NeuroPASS operates by inserting catheters into the brain tissue driven by a pump, allowing for the controlled infusion of therapeutic agents.

The novel pump and catheter technology delivery system distributes these agents throughout the affected region with unparalleled precision, overcoming the limitations of passive diffusion.

Unlike conventional approaches to systemic drug delivery, the CraniUS device seamlessly integrates with the body’s natural processes. The pump offers precise medicine administration directly to the brain, eliminating the need for systemic circulation and enhancing drug efficacy. This innovative approach not only optimizes treatment outcomes but also minimizes the risk of collateral damage to patients.

CraniUS’s device incorporates intelligent design, featuring Bluetooth connectivity and Wi-Fi capabilities. This smart technology seamlessly integrates into a patient’s life, offering sustained treatment over an extended period.

“As opposed to other organs, the brain’s protective shield, around its blood vessels, impedes the delivery of large molecules and drugs through the bloodstream. With the assurance of direct medicine delivery, we can reduce the dosage and concentrations of active ingredients used in treatments, minimizing the risk of collateral damage to patients,” says Dr. Gordon.

Commitment to Patient Welfare

“Our success hinges on collaboration. We see ourselves as the bridge connecting pharmaceutical and biotechnology companies with patients. Our device opens doors for these companies to develop targeted therapies for neurological diseases,” says Jack Kent, VP of strategy and operations at CraniUS.

CraniUS has achieved significant milestones, with compelling evidence of its device’s efficacy in preclinical studies. An exceptional team stands behind this remarkable journey. Maglin, with two decades of corporate management experience, infuses a clear vision and structure. The company houses a multidisciplinary engineering team of chemical, electrical, mechanical design, manufacturing, testing, and quality experts. Their collective expertise fuels the rapid advancement of NeuroPASS.

The journey is far from over. Over the next 18-24 months, the company aims to finalize its device, undergo necessary FDA testing, and initiate a phase one clinical study, scheduled for early 2025. The team’s focus lies on a robust preclinical testing regimen to generate scientific evidence for future IND approval. This is an important and necessary step towards a first-in-human, Phase I clinical study – a pivotal milestone on the road to broader commercial approval via the 505b2 pathway for its drug-led, combination, Class 3 Device.

Additionally, CraniUS possesses a robust intellectual property portfolio, with issued patients and ongoing applications, promising future innovations and applications in the neuro space and beyond.

CraniUS stands at the forefront of medical innovation, redefining the landscape of neurological treatments. With their NeuroPASS device, they offer not just hope, but tangible progress for patients and the medical community alike. As they continue to pioneer advancements in drug delivery technology, CraniUS exemplifies the power of innovation, collaboration, and unwavering dedication to transforming lives.

CAUTION – The NeuroPass device is currently in the pre-clinical development stage and is not yet commercially available. It is on the pathway to clinical studies, and any information provided is subject to change as research progresses.