NeuroOnes’s Innovative Electrode Brain Monitoring Seeks To Provide Insights Into Neurological Disorders
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March 28, 2024 08:15 AM Eastern Daylight Time
by Meg Flippin, Benzinga
When it comes to diseases of the brain, epilepsy is among the more common ones, affecting roughly 50 million people globally. This condition arises from various factors that disrupt normal brain activity, such as strokes, brain tumors, traumatic brain injuries, and infections of the central nervous system, with the annual cost of managing epilepsy approximately $28 billion.
Current treatments, despite the availability of over 20 antiepileptic drugs (AEDs), fall short of effectively managing the condition for all patients. Approximately 36% of individuals with epilepsy experience uncontrolled seizures, which could have a significant impact on their quality of life and mortality. For many, the only solution is surgery.
Better Outcomes With Electrodes
NeuroOne Medical Technologies Corp. (NASDAQ: NMTC) is hoping to achieve better outcomes for patients suffering from neurological disorders with its high-definition, minimally invasive thin film electrodes used for intracranial monitoring. The electrodes are implanted inside the skull to record brain activity and the company says they may someday be able to treat diseases like epilepsy.
NeuroOne’s Evo® Cortical Electrode portfolio consists of various configurations of strips and grid electrodes made with polyimide thin film, which reduce trauma to the brain. They are a less invasive implant because the material is flexible, thin and light. They can monitor brain activity for less than 30 days. NeuroOne’s Evo® sEEG Electrode technology enables the recording and monitoring of brain activity for less than 30 days. With the technology, the company says doctors can identify the right foci zones to determine the best treatment for patients.
The company has said its technology provides new options for surgical placement and potentially smaller incisions, as well as for lower inflammation compared to the bulky electrodes currently on the market, while also enabling the pairing of diagnostic and therapeutics in one offering. With proven placement accuracy and enhanced signal quality, physicians can capture the vital data they need to support more confident diagnoses, according to NeuroOne.
Thanks to NeuroOne’s partnership with Zimmer Biomet Holdings Inc. (NYSE: ZBH), the company’s technology is already being used in the marketplace. Zimmer Biomet, which is the exclusive worldwide distribution partner for the NeuroOne Evo Cortical and sEEG electrode product lines, uses it for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. That segment of the business is growing, and the company expects its revenue to increase with the addition of new accounts by Zimmer Biomet.
Making Strides With Regulators
More recently, NeuroOne received U.S. Food and Drug Administration 510(k) clearance to market its OneRF™ Ablation System, a stereoelectroencephalogram (sEEG)-guided tool that surgeons can use to record electrical activity and ablate nervous tissue under temperature-controlled environments. That, along with the electrodes, has the potential to revolutionize diagnoses and treatment of brain diseases, NueroOne says.
Following 510(k) clearance, NeuroOne just announced that it has initiated a limited commercial launch of its OneRF™ Ablation System, which has FDA 510(k) clearance for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.
"The FDA clearance of NeuroOne's OneRF system will provide neurosurgeons with an important new tool in the surgical management of epilepsy, with the ability to provide ablative therapy using already implanted depth electrodes used for diagnosing the epileptic focus as part of stereoEEG,” Robert E. Gross, MD, PhD, chair of the Department of Neurosurgery at New Jersey Medical School and Robert Wood Johnson Medical School, said in a press release. “This may lead to improved outcomes for patients with potential for fewer interventions and an improved therapeutic window."
In another recent press release, NeuroOne CEO Dave Rosa commented that the company expects “to start shipping systems this week to centers participating in our limited launch with cases already scheduled starting in April. We believe physicians and patients will benefit from our technology given it may reduce hospital stays, number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety. Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.”
Pinpointing Where Seizures Occur
The company’s electrodes may help pinpoint the exact location in the brain where seizures originate, which today proves difficult to do. Epileptic seizures are caused by excessive electrical discharges in a group of brain cells. Since different parts of the brain can be the site of such discharges, getting them under control is hard. After all, seizures can vary from the briefest lapses of attention or muscle jerks to severe and prolonged convulsions. They can also vary in frequency from less than one per year to several a day.
Armed with more precise information from NeuroOne’s technology, medical professionals can provide patients with more accurate diagnoses and determine the best course of treatment for patients with epilepsy, according to the company. That will be welcome news to sufferers around the world. As it stands, the risk of premature death among epilepsy patients is up to three times higher than non-suffers.
Currently, NeuroOne is focused on improving epilepsy diagnoses, but in the future, the focus could shift to treating seizures. For example, the company says its electrodes could be used to deliver electrical stimulation to suppress seizure activity. If they are able to achieve this, it could be game-changing for patients. It is important to note that further clinical trials are needed to determine if its electrodes can be used in the treatment of epilepsy.
Epilepsy affects millions of people, costing billions of dollars annually. As it stands, more than one-third of sufferers don’t get the relief they so desperately need. NeuroOne is determined to revolutionize the landscape of neurological disorders and is making strides thanks to its unwavering dedication to developing groundbreaking products for the medical community.
Featured photo by Natasha Connell on Unsplash
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