A New Era of Neurosurgery

A New Era of Neurosurgery

Dave Rosa, president and CEO, NeuroOne

Dave Rosa, president and CEO, NeuroOne

1. What, in your perspective, are some of the predominant challenges in the neurotechnology space, and how can they be addressed?

First, the COVID-19 pandemic has clearly slowed down the number of procedures being done in neurosurgery because many of them are still considered elective procedures. There are a number of centers that have begun to ramp back up again but caseloads are still not where they were pre-COVID-19.

Second, in neurotechnology or neurosurgery, there has clearly been a drive to go from invasive procedures to less invasive procedures, and in some cases devices that are used on the scalp that are non-invasive. These non-invasive technologies still have not yet demonstrated appropriate efficacy where they've been accepted as mainstream solutions for indications like epilepsy, Parkinson's disease and spinal cord stimulation, and no one knows how long it will take or if it's ever going to be possible to use something that's external.

There's still a drive to perform less invasive craniotomies. The need to remove the top part of the skull in a number of these procedures, with the exception of brain tumors, has been a huge hurdle for patients --especially because about half of the patients treated for epilepsy are pediatric patients. For this age group, as well as adults, there is a psychological effect of having epilepsy surgery via craniotomy, with visible deformity as the patient ages.

This has spurred the advent of using SEEG electrodes. This requires that tiny holes be drilled into the skull, which is considered to be less invasive than removing the top part of the skull. But it's still a challenge because you are drilling into the brain matter with limited access.

It reminds me of heart surgery. Many people opt for coronary stents over having bypass surgery because they don’t want their chest cracked, even though surgeons believe this is the best way to access the heart. It’s the same with the brain because patients clearly prefer having tiny holes drilled into their skull versus having the top portion of their skull removed.

Continuing the comparison between neurosurgery and the cardiovascular field, many neurosurgeons feel they are 30-40 years behind where the cardiovascular field is now. It’s still a relatively immature space. The good news, however, is there is a great deal of room for growth.

2. In light of your vast experience, what are the latest trends in the industry, and how are they driving change?

Scalability is a big trend in which we're able to get better resolution, which allows us to obtain more information. The more we can learn about the brain the better, and this takes more advanced tools to help gather that information to more quickly learn how the brain functions.

The pandemic has accelerated the drive for remote monitoring. In the field of epilepsy, there are technologies that utilize wrist watches and arm bands to detect the onset of seizures. This can help prevent fatal car crashes for someone who is driving a car and unaware they are about to have a seizure.

Additionally, there’s more research and work being done on non-invasive ways of treating neurological conditions. For instance, there are skull caps with electrodes for a patient who suffers from severe migraines.

Also, many of the surgical procedures being done now are utilizing SEEG electrodes, or very tiny electrodes, which are less-invasive technology that is placed deeper into the brain.

3. Please discuss some of the interesting innovations in the manufacturing of thin film electrodes.

Polyimide films have been around for more than 30 years but none have been commercially approved for clinical use in the United States. Our proprietary process is different than many of the reported previous methods.

For years, the challenges within film technologies have been delamination of the film or fluid penetrating in between the layers of the film as well as lack of durability of the electrodes when stimulating and recording. There's been some proprietary advancements that have occurred in the last few years that have been put in place to address those issues, and more is being done.

Let’s just say that there’s a great deal of enthusiasm regarding NeuroOne’s new processes and the implications for devices intended to be placed permanently.

4. Could you give us more insights on thin film technology? How can it be used to advance neuroscience?

The material we use is less invasive on the brain based on testing performed at the Mayo Clinic. The resolution is better due to lower resistance providing better signal. This may potentially allow for more precision in identifying problematic brain tissue. The thin film nature can enable minimally, less invasive procedures. It is intended to be used for multiple applications, meaning diagnostic and therapeutic procedures may potentially no longer require multiple surgeries since this technology has the potential of eliminating one procedure. This may impact patient outcomes and reduce associated costs of surgeries.

For example, consider a patient that comes in for a diagnostic surgery. They go home and come back later for the therapeutic surgery. As a result, the surgeon must re-drill holes in the patient’s skull or again remove the top part of their skull. This raises the likelihood for complications. Another challenge is going back in and re-drilling holes and making sure the electrode is back in the identical spot as the first surgery. There is a further risk of destroying healthy tissue and perhaps not extracting all the diseased tissue that was initially identified.

Much of our story is about improved precision by making these contacts smaller.

Also, the likelihood of a positive outcome is greater if the devices could be left in place as opposed to taking them out and reinserting. 

What patient would want two surgeries when they could have one?

5. What can healthcare organizations do to effectively educate their staff and physicians about thin film electrodes?

Because the technology can be used for brain surgery as well as spinal cord surgical procedures, its benefits should be communicated to stakeholders in a variety of areas throughout the system. Numerous healthcare providers and organizations should take the opportunity to educate all providers on the value of this technology. Because this device may potentially perform multiple functions, there is clearly a chance to introduce a device might provide better patient care as well as save money.  It’s a win-win: better for the patient and clearly better for the payer.

6. Could you elaborate on some exciting projects/initiatives that you’re currently overseeing?

We're working on a device that can reduce two surgeries to one and is intended to perform both the diagnostic and therapeutic procedures. This means it can diagnose the problem area of the brain and then resect that tissue using radiofrequency energy.

We also have a similar project for spinal cord stimulation using one electrode instead of two, typically one electrode is placed for a seven-day trial period which is then replaced with a larger device. What we're aiming to do is utilize the larger device initially and, assuming the patient gets a benefit, leave that device in place.

Reducing two surgeries to one avoids losing the benefit or risking displacement of the device. The placement would be percutaneous, through the skin, eliminating the need to make an incision in the back for placement of any of the electrodes.

7. What would be your piece of advice for business decision-makers looking to venture into and thrive in this industry?

The neurology industry, as a whole, is ripe for new technology and technology improvements.  But it's still a relatively young and immature space. There are plenty of opportunities for growth, especially as we learn more about the brain and how the brain works.

8. What are some of the misconceptions when it comes to thin film electrodes in neurological applications? How do you advise peers accordingly?

I wouldn't characterize them as misconceptions but I would say they are concerns. Many thin film electrodes simply don't work, although many people have been trying unsuccessfully for a number of years to perfect the technology.  This has led to skepticism about the viability of this technology for clinical use.

What we're doing is different from what has been done in the past -- even though the materials are the same.  Stay tuned to our progress for future updates.

9. How do you see the industry evolving a few years from now with regard to disruptions and transformations?

I think you're going to see a lot more robotic procedures being performed.  This approach removes some of the human error factor. This is especially relevant when you're dealing in the brain, especially deep parts of the brain.

Using robots will potentially improve the safety and the precision of the procedures, and they’ll likely become a larger part of mainstream neurosurgery than what you see today. I know if I was a patient undergoing a procedure that required drilling into my brain, I would opt for it be performed robotically.

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