NeuroOne, a medtech company based in Minnesota, has developed the Evo Cortical Electrode and the sEEG electrode, both of which are thin film electrodes for neural recording and stimulation. The small profile and flexible nature of the electrodes allows for less invasive insertion, and the low resistance they offer delivers improved signal quality.
The devices can combine both diagnostic and therapeutic functions, which could potentially reduce the number of procedures a patient has to undergo, as diagnosis and treatment can occur during the same procedure.
The company has also conducted simulations of long-term neural stimulation, and found evidence that the technology could provide stimulation for extended periods, which could make it useful for applications such as treating chronic back pain in patients who have undergone multiple failed surgeries.
Medgadget had the opportunity to speak with Dave Rosa, CEO of NeuroOne, about the technology.
Conn Hastings, Medgadget: Please give us an overview of neurostimulation/neuromodulation and how the technology has progressed to date.
Dave Rosa, NeuroOne: In the early 1960’s neuromodulation started with deep brain stimulation and then in the late 1960’s was followed by spinal cord stimulation. Sacral stimulation for urinary incontinence was developed in the early 1980’s finally receiving FDA clearance in 1997. The first single channel neurostimulator reportedly was implanted by in 1961 into two deaf patients but the first FDA cleared single channel device wasn’t released until 1984. Neuromodulation interacts with the nervous system using electrical stimulation to regulate, inhibit or modify neural activity. Today, the most common indications are for conditions such as: epilepsy, Parkinson’s disease, chronic back pain due to previously failed back surgeries, urinary incontinence, blindness, and peripheral pain. A colleague of mine told me a few years ago that while today we take medication to treat a variety of ailments, one day we would use electrical stimulation to treat the same conditions. I thought he was joking but it truly seems like this therapy has the potential to treat a plethora of conditions. Today with the public spotlight on mental health conditions, stimulation is being investigated as a potential solution to treat depression, OCD, short term memory loss and other neurocognitive disorders. One of the largest potential opportunities discussed is Alzheimer’s. There are promising diagnostic technologies such as SYNAPS Dx that are making progress in early identification of Alzheimer’s while deep brain stimulation is being investigated to treat the major inflow and output pathways in the brain that are reported to be impacted by Alzheimer’s.
In addition to new indications, there are a number of areas with respect to the technology that have made great progress.
While these procedures have generally been very invasive, required separate surgeries for diagnosis and treatment, and also relied on pre-determined stimulation settings that require the patients return to the doctor’s office to have adjustments, there are many advancements that have been made or that we are likely to see in the future. New minimally invasive or less invasive procedures now dominate the industry, wireless systems are in development to eliminate bulk and external wiring, closed loop systems now exist which make patient stimulation adjustments automatically, drug coated devices and multi-purpose devices that can perform both diagnostic and therapeutic functions are all advancing.
Medgadget: What inspired NeuroOne to develop the Evo Cortical Electrode?
Dave Rosa: NeuroOne initially set out to develop a thin film, high-definition electrode technology that had the capability to perform multiple diagnostic and therapeutic functions while utilizing advanced automated manufacturing procedures. While most companies race to get a single device or therapy to the finish line, we saw the opportunity to develop a platform of products but knew we had to start somewhere. We decided that the easiest development and manufacturing path would be to focus on a cortical electrode for recording and stimulating brain activity for less than 30 days. These devices were the gold standard for years for identifying the location of the brain that was causing irregular activity during a patient’s seizure. Doctors at the Mayo Clinic in Rochester Minnesota also partnered with us and provided essential feedback during the development phase. We are now working on the more popular sEEG electrode technology that require tiny holes to be drilled into the brain to perform a similar function as cortical electrodes but much less invasively. We expect to submit this product family to the FDA for 510(k) clearance in August 2022.
Medgadget: Please give us an overview of the electrode features, and its advantages compared with conventional electrodes.
Dave Rosa: The materials used for both our cortical and sEEG electrodes are very similar so both product families share similar features. In general, NeuroOne’s Evo cortical and sEEG electrodes are thin film devices. Given the thinness and flexibility of the devices, they are designed to enable less invasive insertion. They are also lighter weight, generally speaking, due to their thinness. These electrodes also have low resistance levels which help improve the signal quality for physicians. All our products utilize photolithography to manufacture the electrodes which provides a highly reproducible product versus most current commercially available electrodes that rely primarily on manual labor.
Medgadget: How is the electrode intended to be used? Does it have diagnostic and therapeutic applications?
Dave Rosa: The Evo cortical and sEEG electrodes are both designed for diagnostic purposes. However, one of the advantages of the technology is that it has the potential to be used for therapeutic purposes as well. Ultimately, we expect the devices to have the capability to monitor, ablate and stimulate targeted tissue all using the same device. We have devices in development for these multiple functions and will need to submit them for FDA clearance when development is completed.
Medgadget: Can the technology be used for long-term stimulation? What types of disease state would this be useful for?
Dave Rosa: We recently announced that we had successfully tested the devices in a bench top model to stimulate over a 5-year accelerated period. We also performed accelerated 5-year testing on the devices for recording. These tests suggest that the electrodes will function over a 5-year period.
The devices could be used for a variety of different conditions that have reported benefits from electrical stimulation. Parkinson’s disease, epilepsy, chronic back pain due to failed back surgeries, peripheral pain, incontinence, hypertension, and mental health disorders are either being used today to treat these conditions or are under investigation. We also will need to submit to FDA to receive clearance to market the devices for these functions.
Medgadget: Do you have any plans for other technologies in the future? Where do you see the company in five years?
Dave Rosa: We currently have a device under development that is intended to perform both a diagnostic and therapeutic function. It has the capability to record electrical activity in the brain in an effort to determine the problematic area(s) as well as ablate the problematic tissue. Today this is usually done with multiple surgeries and hospitalizations whereas our technology would intend to perform both functions in one hospitalization and surgery.
In addition, we have a separate program for spinal cord stimulation to treat chronic back pain due to multiple failed back surgeries. Given the properties of our thin film technology, we believe our electrodes have the potential to be placed less invasively along with providing additional benefits due to its uniqueness. In the future, I also expect these devices to help enable artificial intelligence to treat a variety of neurological conditions in addition to drug coated devices much like we have seen in the cardiovascular arena over the years. The neurovascular space reminds me of where interventional cardiology was 30 years ago and I believe it has similar exciting potential for future growth.
Link: NeuroOne home page…
