Published On: November 7, 2023

[BALTIMORE, MD, -November 7, 2023] CraniUS LLC, an R&D company focused on groundbreaking diagnostics and treatments for patients with chronic brain diseases, has been honored as Company of the Year – Top MedTech Startup 2023 by MedTech Outlook. The company’s patented NeuroPASS device is the first smart, refillable, and fully embedded medical device that effectively bypasses the blood-brain barrier and achieves long-term, convection-enhanced medicine delivery.

NeuroPASS provides a safe alternative to systemic drug delivery methods like oral ingestion or intravenous injection for treating brain disease by allowing 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.

A recently published study is advancing CraniUS towards an FDA pre-clinical study as part of the FDA approval process and the company is looking to obtain IND approval for a first-in-human study early 2025.

Mike Maglin, CEO of CraniUS, stated, “Being recognized among these exceptional innovators by Medtech Outlook is a great honor. Bypassing the blood-brain barrier is a technological advancement that has the potential to significantly improve patient care.”

About CraniUS

CraniUS’ 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, 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, MRI-lucent components, and wireless charging technology to enable long-term and direct medicine administration. CraniUS was founded 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 is pioneering a new frontier:  the brain-medicine interface (BMI), creating an expansive new platform in neurological medicines that can be delivered directly to the brain to treat multiple diseases.

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.