The Next Frontier in Neurological Diagnostics and Therapeutics

The Next Frontier in Neurological Diagnostics and Therapeutics

May 29, 2024PAO-05-24-CL-02

NeuroOne Medical Technologies Corporation is at the forefront of revolutionizing neurological and neuropsychological treatment through their advanced thin-film electrode technology. Designed to be less invasive while enhancing diagnostic and therapeutic accuracy, their dual-function technology can perform diagnostics and therapeutic interventions, such as radiofrequency ablation, within the same surgical session, improving surgical efficiency, reducing the need for multiple procedures, and reducing patient recovery times. Expanding beyond brain applications, NeuroOne is actively developing solutions for spinal conditions, promising significant advancements in the treatment of chronic pain through innovative, less invasive spinal stimulation techniques. With FDA approvals for multiple applications and strategic partnerships in progress, NeuroOne is poised to broaden its impact on various neurological disorders and pain management, offering new hope to patients with historically challenging conditions. In this Q&A with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D., NeuroOne’s President and Chief Executive Officer Dave Rosa discuss the core technology, its current applications, and future possibilities on the horizon.

David Alvaro (DA): Could you share the origins of your company, focusing on whether it was the technology or a vision that led to its inception?

Dave Rosa (DR): NeuroOne originated from the conception of two former sales representatives experienced in electrode technologies. Collaborating closely with the Mayo Clinic and the University of Wisconsin, they nurtured the idea of thin-film, high-definition electrode technology, which had been in development for nearly two decades. I joined in 2016, after a period of retirement, drawn in by the potential I saw in the technology that extended beyond the initial market vision. Despite early fundraising challenges, I was convinced that the technology had far-reaching applications, leading me to step in as CEO to realize its full potential.

DA: Could you explain the traditional silicone electrode grids and how your thin-film technology differs and improves upon that?

DR: Traditional brain surgery involves silicone electrode grids, which are bulky and manufactured by hand. These thick grids, used for recording brain activity during procedures like craniotomies, were state of the art about a decade ago. However, they necessitate invasive surgery and lengthy hospital stays. Our thin-film technology transforms this approach. Unlike the older silicone grids that only diagnose, our electrodes can diagnose and treat by ablation or stimulation, streamlining the surgical process. With the use of photolithography, our production is automated, yielding consistent, high-quality electrodes that offer clearer signals and less resistance than traditional grids. This innovation leads to less invasive surgeries, fewer complications, quicker recoveries, and overall cost savings for the healthcare system.

DA: How does the ability to use the same device interface for both diagnostics and radiofrequency ablation (RFA) benefit the surgical process?

DR: Our technology is a game changer in surgical efficiency. Traditional methods require removing the initial diagnostic electrodes, sending the patient home, then bringing them back for a separate laser surgery, which necessitates drilling new holes in the skull. This not only doubles the invasiveness but also lacks diagnostic feedback, post-ablation. Our electrodes stay in place for both diagnosis and treatment, which means after ablation a surgeon can immediately reconnect the electrodes to diagnostic tools to verify the success of the procedure. And — since the electrodes are still in place — any necessary touch-up work can be performed right there and then. This could potentially eliminate the need for additional surgeries, reduce patient risk, and ensure a more precise outcome.

DA: Can you provide some background on RFA and its applications, particularly in relation to your device?

DR: Radiofrequency ablation is a well-established procedure that’s been applied to various parts of the body, not just the brain. It involves using RF energy to disrupt nerve function, thereby alleviating pain or dysfunctional electrical activity. Cosman Medical, for example, successfully pioneered RF ablation throughout the body: brain, face, and spine. The recent acquisition of Relievant Medsystems by Boston Scientific, with their spine-focused RF ablation technology, underscores the significant market potential.

Our strategy at NeuroOne is to extend the utility of our hardware to other body areas, adapting the electrodes as necessary. The FDA has already approved our RF generators for ablating nervous tissue anywhere in the body. We’re positioned to explore a vast range of applications, from treating spinal conditions to potentially larger ablations, which could be revolutionary for pain management and neurological treatments.

DA: In the context of various neurological disorders, can you discuss how breaking or disrupting “bad circuits” can effectively treat these conditions?

DR: Essentially, many neurological disorders could be conceptualized as “bad circuits” that can be disrupted to improve patient outcomes. The treatment, however, depends on the disorder’s specific physiology. Take Parkinson’s disease as an example: it’s tied to a dopamine deficit. Instead of ablation, the goal is to stimulate brain tissue in order to increase dopamine levels. Similarly, for severe depression or certain mood disorders, targeted stimulation of specific brain areas can mitigate symptoms.

For conditions like epilepsy, nerve ablation is more straightforward as it directly targets and disrupts the areas causing seizures. While this approach is primarily associated with the treatment of pain and epilepsy, research is expanding into other areas like short-term memory enhancement. It’s an evolving field, and the suitability of nerve ablation or stimulation varies significantly depending on the neurological condition and the underlying mechanisms at play.

DA: What kind of symptomatic relief can epileptic patients expect from brain ablation?

DR: Brain ablation offers substantial relief for epileptic patients. It’s currently the most effective treatment, especially when seizures originate from multiple brain regions or when the exact source can’t be identified. While brain stimulation is an alternative, it works differently by creating a background “noise” to prevent seizure occurrence, which isn’t as effective as ablation.

Sadly, many patients, about a third in the U.S., don’t respond to medications, and surgery becomes a necessity. Despite its effectiveness, ablation is underused primarily due to its invasive nature and the daunting prospect for parents of young patients. Delay in treatment can complicate epilepsy and increase the risk of injury from seizures. Early intervention is critical, and when done promptly, ablation can significantly reduce or even eliminate seizures, dramatically improving the quality of life for patients with epilepsy.

DA: What’s the strategy for exploring and developing the various applications of your technology?

DR: Our strategy is to advance on multiple fronts: ablation, stimulation, and drug delivery. For brain ablation, we’re in negotiations with Zimmer Biomet, who are firmly established in the diagnostic space and could be a strong strategic partner for this next step. For applications beyond the brain, like spinal ablations, we’re open to partnering with others or even going direct, as the market is concentrated and manageable.

In therapeutic stimulation, the significant market potential demands a considerable sales force or a partnership with an established strategic player. Our parallel approach — cultivating strategic partnerships while also being prepared to go direct — gives us flexibility and leverage in negotiations.

As for drug delivery, our wirelike electrodes could revolutionize gene therapy delivery in the brain, warranting partnerships beyond the device sector, possibly with pharmaceutical companies.

DA: From a regulatory standpoint, how do you navigate the pathways for ablation, stimulation, and drug delivery? Is each of these paths unique?

DR: Each of these areas has a distinct regulatory path. For diagnostics, the 510(k) clearance is the shortest and most straightforward, requiring evidence that your device is as safe and effective as an already FDA-approved device. If your device is in essence equivalent to an approved indication, the pathway is relatively short. We’ve leveraged this pathway to also gain approval for ablation, using additional data to extend the device’s clearance from purely diagnostic to therapeutic as well — thus giving it dual indications.

For therapeutic stimulation, where devices may be implanted for extended periods, clinical studies are necessary to demonstrate long-term functionality. Despite these challenges, we’re committed to pioneering these pathways, potentially starting with orphan diseases to establish proof of concept and exploring our unique capabilities for precise brain drug delivery and monitoring.

Drug delivery presents a more complex scenario since the FDA does not require clearance for devices used in clinical trials. Our drug delivery device must undergo biocompatibility testing, and any commercial use would necessitate FDA approval. The challenge here is creating a new category for direct brain drug delivery systems, as there are currently no such approved drugs. However, as gene therapies advance, we foresee an opportunity to gain approval for these innovative treatments.

DA: Regarding the first clinical use case at Emory University involving your device, can you clarify which application it addresses?

DR: The first clinical use of our stereoelectroencephalography (sEEG) wirelike electrode for diagnostic purposes took place prior to our partnership with Zimmer Biomet. Although we’ve performed ablation in an animal model, the first ablation in a human is pending. Recently, our device was placed in a patient at the Mayo Clinic. The usual practice is to insert about 15 electrodes and identify the precise problem areas within two to five days before proceeding with ablation. We anticipate the first human ablation to be completed imminently, marking a significant milestone, as we’ve only utilized the device for diagnostics to date.

DA: Are there any significant milestones for NeuroOne coming soon?

DR: In the immediate future, our first human ablation procedure will be a significant event. We’re also anticipating establishing a new strategic partnership for our ablation system. Within the next six months, we expect to announce collaborations with pharmaceutical companies for clinical studies using our devices. As a result, our revenue should see a considerable boost as we begin to capitalize on ablation procedures, adding to our existing diagnostic revenue. Additionally, we’re planning to submit for FDA approval new ablation applications in other parts of the body, which could further expand our revenue streams.

DA: What are your long-term visions for the scope of your technology and the partnerships you might establish?

DR: Looking ahead, the potential for our technology is unlimited. I envision it revolutionizing treatments for conditions like Alzheimer’s by improving short-term memory and offering new hope for those with severe depression, where current medications often fall short. The prospect of minimally invasive procedures that could alleviate symptoms or even cure diseases without the need for invasive open surgery is particularly exciting.

Looking even farther into the future, we may see advancements akin to what’s being developed at Neuralink, with a multitude of electrodes treating complex conditions. Gene therapy is also a particularly promising frontier, with the eventual possibility of a single electrode delivering the therapy and patients walking out post-procedure without the telltale signs of brain surgery. As gene therapy research progresses and new treatments gain approval, I believe our technology will be at the forefront, offering patients better options than ever before.

DA: For the conditions you’re addressing, is there already a comprehensive understanding of brain circuitry? Or is more research needed? Can your electrodes provide the necessary mapping?

DR: The mapping process is crucial because current noninvasive methods lack the specificity required to pinpoint problem areas in the brain accurately. We begin with noninvasive surface electrodes. These identify the general brain region of interest, and then we refine our focus using an MRI. But even the resolution of an MRI isn't fine enough for precise localization. That’s where our sub-millimeter electrodes come in — they provide the detailed mapping needed to identify the exact location of the issue.

DA: Is there anything that merits mention about NeuroOne’s financing or investors?

DR: From a financial viewpoint, since going public in 2017 and listing on Nasdaq in 2021, we’ve established a solid foundation. Our approach to financing has been traditional, relying on the public and institutional investors rather than venture capital. Since my arrival in 2016, we’ve been successful in raising funds.

Financially, we’re on sound footing, especially with ongoing revenue generation from our partnership with Zimmer Biomet. Looking ahead, we’re optimistic about potentially reaching a cash break-even point through strategic partnerships, which would alleviate the need for future fundraising. Maintaining this financial stability is a key goal.

It’s also noteworthy that the Mayo Clinic has been a long-term investor in our company and continues to support us. A point of pride is that our intellectual property portfolio is self-filed, with full ownership of all developments post the initial thin-film electrode device. This autonomy in intellectual property greatly strengthens our financial and strategic position in the marketplace.

DA: With the advent of artificial intelligence (AI) and machine learning (ML), do you see a role for these technologies in enhancing the diagnostic and therapeutic aspects of your company’s devices?

DR: Absolutely, there’s a significant role for AI and ML. While AI doesn’t necessarily aid in the initial diagnosis of the conditions we treat, its value becomes clear in the ongoing monitoring and precision treatment planning. For instance, AI can analyze data from a camera monitoring a patient to determine seizure types, durations, and brain regions involved. This advanced computational analysis, based on a vast repository of seizure data, provides insights far beyond traditional methods like patient diaries.

For therapeutic applications, AI’s potential is in interpreting brain activity to facilitate communication between the brain and external devices, which could bypass damaged neurological circuits. As we continue to collect high-resolution data from our devices, the intersection of this data with AI analysis shows promise in helping to evolve our understanding and treatment of neurological conditions at a complexity and resolution beyond what humans can handle.

DA: Before we conclude, is there any aspect of NeuroOne’s work we haven’t covered that you’d like to highlight?

DR: One area we haven’t discussed is our innovative back pain program. We’re developing a technique that could be a significant leap forward in treating chronic back pain. By rolling up our filmlike electrode and inserting it through a needle, we can implant a larger electrode directly onto the spine without major surgery. This approach has the potential to offer more extensive spinal stimulation than is possible with the thin wire devices typically used. It represents our commitment to advancing less invasive procedures while enhancing therapeutic outcomes for patients suffering from chronic pain.

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