Deep (Brain) Thoughts with Medtronic’s Neuromodulation President

Headlines have increasingly presented disturbing news with regard to pharmaceutical solutions for addressing medical concerns including chronic pain, mental health, and other healthcare issues. Addiction, increasing costs, and even death have all been tied to some medications intended to address problems rather than create new ones. As such, patients, doctors, and caregivers are seeking alternative solutions.

Medtech may have an answer in the form of neuromodulation technologies. These devices utilize different approaches to enhance the treatment options available to healthcare professionals without the aforementioned negative aspects. In some cases, they can replace the pharmaceutical solution, while for others, they work in tandem to increase efficacy.

Taking time to share how Medtronic views this area of healthcare, as well as share the company’s focus and future aspirations, is Nnamdi Njoku, president of Neuromodulation at the organization. In the following Q&A, he provides insights into this device sector, it’s impact, and where it’s headed.

Sean Fenske: There may be a portion of our audience that’s unfamiliar with the concept of neuromodulation. Can you explain what exactly we’re talking about?

Nnamdi Njoku: Broadly speaking, neuromodulation is using electrical stimulation of the nervous system to restore proper function. That can include disrupting abnormal signals like we do for chronic pain—one of the diseases we treat. It could also include exciting or up-titrating activity, where the disease state the patient has, has inhibited normal function, so you need to, in a sense, excite it with neuromodulation. It’s called neuromodulation because you’re modulating the body’s function using electrical stimulation of the nervous system. Medtronic pioneered the field of neuromodulation 40 years ago.

Fenske: What are some of the disease states, some of the application areas, that can be addressed with neuromodulation?

Njoku: We have made significant investments in science and technology over the past four decades. Some of the conditions we currently treat include pain and movement disorders. We are also studying new indications.

First, we treat chronic pain. One way we accomplish that is with spinal cord stimulation. Spinal cord stimulation has multiple indications, including (most recently), diabetic peripheral neuropathy. Targeted drug delivery is also part of our platform. It’s not electrical stimulation, but is delivering a pharmaceutical in an intrathecal manner to treat chronic pain, cancer pain, and spasticity. Balloon kyphoplasty is an option for pain related to vertebral compression fractures, and we also have ablation therapies indicated for bone tumors and nerves.

In the category of movement disorders, we’re treating diseases like Parkinson’s, essential tremor, and epilepsy with deep brain stimulation [DBS]. We also have what we call interventional therapies, which include things like ablation.

Fenske: When it’s a drug delivery instead of an electrostim, is that a combination product or does that still fall under the category of neuromodulation?

Njoku: Intrathecal drug delivery is part of neuromodulation. If you were to go to a neuromodulation society meeting, for example, you will frequently see intrathecal drug delivery highlighted. But it’s also a drug-device combination, like you said. It’s an implanted device that delivers a drug in a unique delivery mechanism that requires much less drug in a much more targeted fashion. It can directly affect the mechanism that’s needed versus taking something orally that can have more of a whole-body effect.

Fenske: Something we’ve heard about so much during the pandemic is mental health. Is neuromodulation being used for things like depression and/or bipolar? Are there different mental health application areas?

Njoku: It’s an area of high research interest. We do not yet have an on-label indication for depression or for addiction; those are also mental health issues as well. Or Alzheimer’s, for example, but there is a lot of research taking place. Some of that research we’re participating in, some is happening through academic centers and grants, but it’s an area I expect to grow over time. I expect neuromodulation may be used for mental health increasingly over time.

Fenske: How fast is the neuromodulation space growing, and what are the primary drivers of that growth?

Njoku: It’s a fast-growing space. Some segments are growing faster than others, though the industry has been impacted by broader issues including supply chain challenges and has not bounced back to pre-COVID levels as quickly as we expected. There are two primary reasons for growth in this space. Fundamentally, the diseases we treat today are under penetrated, and our devices are not being utilized as fully as they could be, given their effectiveness and the evidence we have. We’re also pursuing new indications; new disease states that can be treated. So those two factors together really drive opportunity to bring meaningful therapies to more patients in this space.

Fenske: In the pharmaceutical industry, reps are face-to-face with the doctors and are constantly being made aware of new drugs and new solutions for conditions that neuromodulation can also address. Do you find there’s a challenge with exposure or access to these same doctors for device companies? Is that an area that needs to be improved or just more effort in that area to get them exposed to the technological alternatives?

Njoku: Awareness is a big opportunity for us. We’re working to increase awareness at the patient level and at the referring physician level, but awareness is only one of the big barriers today. Another opportunity (in some geographies, not in the U.S.) is payment—being able to ensure these devices are paid for by insurance and patients have access to that care. Even within the U.S., I think there are access barriers at times, especially as we look at new indications.

Fenske: One of the major issues when we’re talking about pain management has been the opioid crisis. It creates a challenge. People are still in pain, and you don’t want that addiction threat. Are device-delivered technologies for pain management an opportunity for Medtronic?

Njoku: The opioid crisis is just devastating. You look at the number of fatalities and how that’s accelerating. It’s unfortunate. And then you look at drug overdose deaths, and roughly 70% of those come from opioids. You see a rising problem and the contributor behind it.

To help face the underlying problem of chronic pain, I’d say neuromodulation devices and procedural solutions, like balloon kyphoplasty and ablation, are very effective. Depending on the therapy, evidence is building, and we would certainly advocate for a device intervention.

Fenske: One of the more exciting areas of medical technologies in recent years has been the “smart functionality” we’re seeing in so many devices. How is Medtronic using AI, patient data, connectivity, and cloud within the neuromodulation space?

Njoku: This is a huge area of focus for us, and I see us continuing to invest and lead here over time. In order to use smart capabilities, you have to be able to sense the body’s signals to understand how the body is responding to the stimulation delivered. That’s difficult in neuromodulation because the signals we’re sensing are a million times smaller than the therapy. That’s where it starts, and we’re the first to create a sensing platform. It’s available now for deep brain stimulation.

Once you have a sensing capability, you can create smart algorithms that are continually adapting the therapy to adjust to the signals you’re sensing. That’s what we call closed loop. Then, if you think of artificial intelligence and machine learning and bringing in multiple sources of data and learnings from each patient, you can truly personalize and have smart, adaptive therapies unique to each patient. I’d call it the ultimate fulfillment of this promise and it starts with sensing, which is available today.

What we call closed loop is in clinical study right now We’re studying it in a formal clinical trial. Then, the ability to continually adapt therapy and use AI and other methods to make that therapy smarter is where we’re also researching for the future.

Fenske: I know Medtronic has clearance or approvals in the diabetes space—a closed-loop solution—where action is taken by the physician, as well as through the smart functionality. Ultimately, is that what you’re looking for, where stimulation and the therapy is, in part, driven by the smart functionality?

Njoku: Yes. Although I’ll add to it. There’s perhaps greater complexity, and I don’t want to simplify the diabetes example, but if we were to take a brain example and you were to take a Parkinson’s patient, you can measure brain state, for example during sleep, which is very different than during wakefulness. During sleep, you can detect when a patient is about to wake by a change in the brain state. Then, DBS stimulation adusts in a way that could ready that patient to get out of bed and perform their daily activities. As that change occurs—let’s say they’re walking up a flight of stairs or they have a yoga class, increased need for motor function—there can be further changes in brain state where you might need to either enhance signals or disrupt signals to keep that patient with the best motor control. There’s also a combination of the stimulation with the medication the patient is taking.

The point I’m trying to make is the complexity that comes with a disease state in the brain that you need to sense multiple signals and combine your therapy with pharmaceutical therapy, I think adds another layer to why it’s so important to be able to sense, as we can do today, and be able to adapt therapies accordingly.

Fenske: In your example, the idea of these things happening on the fly and with a changing environment—having a system in place that adjusts automatically for you based on what it’s sensing from the brain—is phenomenal. That’s fantastic.

Njoku: Exactly. That’s the promise we see. We’re really excited about it. We’ve been working with fantastic researchers across the world on this. We’re studying that capability to do the closed loop that can continually adapt to meet each patient’s needs.

Fenske: What’s ahead for Medtronic? What can we expect to see from Medtronic in the coming year and beyond?

Njoku: What’s in the future is closed-loop capabilities within both our pain and brain platforms. We’re also looking at new evidence. As an example, in the pain space, we’re looking at non-surgical refractory back pain. Typically, spinal cord stimulation is for patients following back surgery still having pain. But we’re learning more about patients that have never had back surgery. We’re also looking at shoulder and arm pain; what’s called upper limb pain. Those are the two big things on the near horizon: a platform for pain that also is closed loop and the ability to use that platform for new indications.

I’ll say the longer term continues to be exciting as we think about this whole paradigm that I just shared; think of it as using electrical stimulation to restore function and having it be closed loop. There are new diseases you can treat with it. And I can’t share those yet publicly, but there’s multiple new diseases we are looking at that we think are really opportune now as we’ll soon have this platform that can sense and be closed loop. This could represent an enormous leap to more personalized patient care, ensuring patients receive the right dose of stimulation at the right time to support their therapeutic needs. That could be game-changing.