July 30, 2020
Author Dave Rosa, President and CEO, NeuroOne Medical Technologies
Innovative thin film electrode technology is expected to reach the market soon, prompting medical specialists, healthcare executives and investors to take note of its potential benefits over current technology. This technology has the potential to reduce patient complications during neurosurgery procedures, provide better signal clarity in recording brain activity and lower the cost of care if the device allows for shorter patient stays in the hospital.
High-definition thin film electrodes are being designed for the diagnosis and treatment of various neurological conditions, including epilepsy, Parkinson’s disease (PD) and chronic pain due to failed back surgeries. The intention for this platform electrode technology is that it can be implanted to record and identify the problematic brain tissue, monitor brain activity, and provide stimulation to the targeted area. Thin film electrodes also show promise for improving patient comfort during and after surgical procedures due to the product’s lightweight feature.
Thin film electrodes use technological advances to generate high-density electrode arrays that may be customizable per physician request. The flexible design should also allow a less invasive placement onto the brain compared to the large craniotomy method used for currently available electrodes. Furthermore, the potential to significantly increase the resolution of brain recordings may enable the usage of powerful computing techniques, such as machine learning and artificial intelligence for more complex patient conditions.
Evo™ Cortical Electrodes
NeuroOne is currently preparing the launch of Evo™ Cortical Electrodes (Evo)[1], the first FDA-510(k) cleared thin film flexible electrode for recording, monitoring and stimulation of brain tissue for up to 30 days of use. Solidifying its distribution strategy, NeuroOne recently announced the signing of a long-term licensing agreement for exclusive distribution of its Evo electrode technology with Zimmer Biomet.
Evo cortical electrodes are designed to be less invasive, improve the surgical experience and enhance mapping capabilities for people suffering from neurological disorders.
In pre-clinical studies conducted by the Mayo Clinic, Evo has demonstrated a reduction in the brain’s immunological response, which should increase patient comfort and reduce signal artifacts associated with the brain electrode interface. This technology is expected to generate significant interest from neurologists and neurosurgeons managing patients with epilepsy and brain tumors.
Limitations of Current Technology
Cortical electrode technology with thin film properties may enable minimally invasive delivery. This capability is a significant improvement over current, commercially available silicone electrodes, which are heavier and thicker than the new thin film electrodes.
In fact, current commercially available silicone electrodes are typically handmade, making them costly and time-consuming to manufacture. In addition, these silicone electrodes do not optimally conform to the brain unlike thin film electrodes. What’s more, the silicone electrode is limited in its ability to increase the recording resolution due to technology limitations as opposed to new thin film technologies which may provide higher resolution recording for more advanced clinical applications.
While most companies are generally focused on software and hardware advancements for these procedures, NeuroOne believes it is also important for advancements in electrode technology. NeuroOne’s technology is intended to improve recording resolution, making it easier to assess problematic tissue. In addition, thin film electrodes are thinner, lighter and have fewer electrode tails exiting the brain—thereby potentially reducing the risk of infection.
The manufacturing process for thin film electrodes also utilizes advanced automated processes which are more efficient than known current commercially available technologies and may also improve product availability for these procedures.
Potentially Important Future Advances for Epilepsy Market
According to the World Health Organization’s (“WHO”) report on epilepsy in 2017, nearly 50 million people have been diagnosed with the disorder around the word. In the U.S., approximately 3.4 million people suffer from epilepsy, and an additional 150,000 people are diagnosed every year. The CDC estimates that epilepsy costs the U.S. $15.5 billion per year. Approximately 30% (720,000) of people with epilepsy in the U.S. are not receptive to pharmaceutical treatment, making them appropriate candidates for surgical treatment.
Currently, a person with epilepsy is typically treated with medications. If the pharmacological therapy is not successful, the patient may then undergo an invasive surgical procedure to help identify the areas of the brain that are causing the seizures. This procedure, referred to as intracranial electroencephalography (iEEG), is the practice of recording electroencephalographic signals via cortical or depth electrodes. After the diagnostic procedure, a second therapeutic surgical procedure is performed to treat the seizure onset location. The success rate of seizure freedom after surgery ranges between 30% to 70% depending on the seizure location and surgical treatment.
Because of the invasiveness of a craniotomy, neurosurgeons that perform epilepsy surgery predominantly use sEEG depth electrodes since they can be placed less invasively through a stereotactic procedure. There are clinical scenarios where implanting cortical and sEEG depth electrodes would potentially provide a more complete map of the brain by obtaining recordings from the surface and deep structures of the cortex. Physicians also recognize the potential of thin film electrodes for applications with Parkinson’s disease, dystonia, essential tremors, and pain management for failed back surgery syndrome.
The Future of Neurosurgery
Leveraging thin film technology could be a defining moment in the world of medicine by allowing the patient to receive “optimal mapping” of the brain. This enables the evaluation of activity both deep in the brain and from the surface by utilizing both cortical and depth electrodes simultaneously.
Thin film strip, grid and sEEG depth electrodes made with lithographic polymer film technology are an effective way to increase mechanical flexibility and reduce mass. This is better for the brain because they weigh less than traditional silicone electrodes and conform more the brain for more direct contact. Furthermore, this technology’s high-definition recording may enable the clinician to be more precise in identifying the problematic tissue.
Equally important, the introduction of thin film electrodes enhances the value provided to physicians and their patients. NeuroOne has collaborated with leading clinicians and researchers to further its commitment to identifying the best technologies and solutions to deliver high quality, cost-effective patient care.
[1] Rx only