Opening a New Frontier in Drug Delivery to the Brain: Featuring CraniUS CEO, Michael Maglin
Michael Maglin, CEO of CraniUS, was interviewed by Kymanox CEO, Stephen M. Perry about their groundbreaking new drug delivery platform that seeks to open a brand new drug pathway to finally break through the blood-brain barrier.
Michael Maglin, CEO of CraniUS, was interviewed by Kymanox CEO, Stephen M. Perry about their groundbreaking new drug delivery platform that seeks to open a brand new drug pathway to finally break through the blood-brain barrier.
Today’s landscape of evolving technologies and medical advancements that are applying AI, automation, gene editing, and dozens of other innovations can be overwhelming. However, in the realm of these new medical innovations, certain ventures stand out, not just for their scientific merit, but for the impact that their mission will have on the field of medicine. CraniUS, under the leadership of Michael Maglin, is one such venture. Its story is not just about breaking new ground; it's about redefining what is possible for the treatment of neurological disorders.
CraniUS is a Baltimore-based neurotech company, one of many medtechs that are finding success in the Baltimore ecosystem. After a successful $20M Series A raise just over a year ago, the company is focused on taking their device towards FDA approval for a first-in-human clinical study.
In a recent interview moderated by Stephen Perry, CEO, Kymanox, a leading authority in the field of combination products and biopharmaceuticals, we explore the transformative work of CraniUS and their pioneering technology for drug delivery to the brain; a venture that promises to boldly go where no drug delivery device has gone before.
The Genesis of CraniUS: A Bold Leap Forward
The inception of CraniUS, founded in 2021, represents the culmination of a decade of pioneering research and prior inventions by founder, Dr. Chad Gordon, renowned director and pioneer of neuroplastic surgery. With CraniUS, Dr. Gordon set aim at overcoming one of the most daunting barriers in neuro medicine: the blood-brain barrier. Michael Maglin, stepping into the role of CEO with a background that spans across diverse industries, infused the company with the leadership that is now helping CraniUS to move closer to Dr. Gordan's original vision.
Maglin describes the mission with palpable fervor. “It’s not just about creating a new drug or device; it’s about charting a path previously uncharted, about reaching places in brain health that were unreachable before.” His words paint a picture of a journey fraught with challenges but driven by the promise of monumental rewards.
The team Maglin is assembling for this mission shares that same vision. “We look for people who love to solve really complex problems. We are truly flying to the moon for the first time and within our technology.”
As a leader, Maglin is characterized by an unyielding drive to innovate and a commitment to keeping patients at the forefront of their work; while pragmatically keeping the company and his team focused and meeting milestones. Under his guidance, CraniUS has not just advanced; it has pioneered, trailblazing a path into a new frontier for medicine.
Overcoming the Blood-Brain Barrier
At the heart of CraniUS's innovation is a groundbreaking approach to overcoming the blood-brain barrier. This natural defense mechanism of the brain, while vital for protection, has been a persistent obstacle in treating neurological conditions. Maglin explains, “What we’re developing at CraniUS isn’t just a new drug or device; it’s a completely new way to deliver treatment directly to the brain, bypassing the blood-brain barrier.”
The implications of this breakthrough are profound. Perry notes, “Your technology's ability to navigate this barrier could be the key we've been searching for in neurotherapeutic treatments.”
The novelty and complexity of this technology cannot be overstated. For decades, the blood-brain barrier has been the Achilles heel of neuropharmacology. The work being done by CraniUS is not just another step in the evolution of treatment; it’s a giant leap, opening up possibilities that could transform the entire field. If successful, CraniUS’ technology would open up a brand new field for therapeutics that can be developed on their platform to better target diseases that have been illusive for ages such as Alzheimer’s, Parkinson’s, and multiple sclerosis (MS).
The Journey Through the Regulatory Maze
Bringing such a revolutionary technology to market involves navigating a labyrinth of regulatory challenges, a journey that CraniUS has embarked on with determination and foresight. Maglin sheds light on this aspect, “Developing a technology that’s both a drug and a device places us in challenging regulatory waters. But it’s a challenge we embrace, for the potential impact it holds.”
As a combination product, CraniUS will have to seek approval as both a device and a biopharmaceutical; twice the hurdle that a traditional biopharmaceutical or medical device would have to face. That’s why choosing the right path and primary drug product is so important, and they have set their course with Topotecan, a drug for Glioblastoma Multiforme (GBM).
With a device as powerful and with as much potential as theirs, they also become very attractive and sought after by companies seeking to get their molecule approved. Maglin has committed CraniUS to staying focused on GBM as their lead product and top priority, and not getting distracted by all of the other possible therapeutics that have interest in their platform. As the CEO, he sees his job as keeping his team on track and making sure they are prepared to tackle the tasks at hand to achieve their first regulatory approval.
Perry, whose company has helped to develop and shepherd dozens of combination products through regulatory processes over the years, commended Maglin’s commitment to a focused approach. “We’ve seen a lot of CEOs that have the ownership and IP around a platform, start thinking about all the infinite possibilities and then start diluting their very finite resources. I've seen probably a dozen companies in the last 20 years self-destruct doing that, so it's really refreshing to hear your approach as a CEO, which is truly investment grade leadership.”
CraniUS’s commitment to not just meet but exceed the highest standards of safety and efficacy and their focused approach speaks to their commitment to a sound regulatory approach. The success in this endeavor will not just be a win for CraniUS, but a significant milestone for the entire field.
The Promise of a New Era in Brain Health
The significance of CraniUS's work can not be understated. “We’re not just developing a new treatment; we’re opening a new frontier in brain health,” Maglin states. This isn’t hyperbole. The impact of CraniUS’s work extends beyond the confines of laboratories and research papers; it holds the promise of a new era in the treatment of neurological disorders. If successful, they will open the door for many other companies to develop new therapies on their platform opening a new market and new possibilities as the blood-brain barrier no longer limits the potential of new medicines.
The story of CraniUS, is a testament to the power of a founder’s commitment to innovation, visionary leadership, and sound strategy. In their hands, the future of neuropharmacology is not just promising; it's exhilarating.
As CraniUS continues to forge ahead, breaking barriers and setting new standards, BioBuzz will be sure to continue to cover their milestones and advancements.
