It was baseball that first drew Will Rosellini to the field of neurotechnology.
Rosellini, a retired professional minor-league pitcher, could not stop thinking about the role the nervous system played in the game.
“I was fascinated with the idea that some pitchers when they were practicing could throw 80 miles an hour, but when you put them in front of lights and people their body could deliver the pitch 15 miles an hour faster, based purely on having adrenaline in the nervous system,” he said. “That set me off on a quest to understand the nervous system.”
That quest led Rosellini to acquire six graduate degrees— including an M.B.A., master's degrees in neurobiology and neurosciences, and a juris doctor degree—and start five companies over the past 15 years.
Today, he is the Chairman and Chief Executive Officer of Nexeon MedSystems, a bioelectronics company which has developed a deep brain stimulation technology poised to make a significant impact for patients with nervous system disorders like Parkinson’s disease.
Nexeon’s platform technology is a thin implantable pulse generator (IPG), which provides two connectors for electrode leads with up to eight contacts each. The IPG includes a custom chip designed to deliver current in multiple contacts independently and simultaneously for selective electrical stimulation. The chip also incorporates a recording system that can monitor stimulation and patient response, providing neurologists with key tools for symptom management.
In an exclusive interview with R&D Magazine, Rosellini explains deep brain stimulation technology, its benefits, and the future of bioelectronics for the treatment of disease.
R&D Magazine: How did you first get involved in the bioelectronic space?
Rosellini: One of the companies I started, but left in 2012 due to thyroid cancer, is Microtransponder. They are developing an implantable vagus nervous stimulator. The idea is to apply a brief burst of electricity to each of the vagus nerves and in doing so, set off a chemical cascade that is similar to the ‘flight-or-fight’ response. The brain goes into learning mode, where you are paying attention. What we’ve found with learning is that you can’t pay attention to everything. Therefore, what you want to do is enhance the brain’s ability to pay attention to the right things. In a series of animal and clinical studies, published in some top journals, we have shown that by pairing vagus nervous stimulation with rehabilitation you can improve a stroke survivor’s upper limb function, which is a critical component to them regaining control of their lives. They are going to run a pivotal study that just got approval to begin this month and they will be taking that product to the U.S. in about two years.
My second company, which I am currently the CEO of, is Nexeon MedSystems. With Nexeon, I bought a company that was about 10 years old and took it public. It was a group of neuro-engineers that spent 10 years and millions of dollars developing a platform device. What is unique about this platform device is not only can it stimulate the nervous system with electricity, but it can also record nervous system signals. Our first product is going to be a deep brain stimulator that stimulates and records. What this enables us to do in the longer term is create a closed loop neuro-stimulation system for the deep brain. That would be important to patients that have movement disorders related to Parkinson’s. This has been developed, CE marked, and implanted in patients, and we expect to launch the device commercially in Europe next year. Then we will start our pivotal study in the U.S. next year as well.
R&D Magazine: How does the deep brain stimulator work?
Rosellini: If you imagine the pace maker controller, known as the implantable pulse generator, in that little can is the battery, circuitry, and wires that extend up and in to the brain. That device can be rechargeable battery or traditional battery. The circuitry allows you to control each of the electrode contact points and the wire. Parkinson’s is the death of dopaminergic neurons in one of two parts of the brain. The patients took drugs for as long as they could, but eventually the drugs stopped working. What a clinician is trying to do is open up the brain, push the electrodes through to a grape-size area in either globus pallidus or substantia nigra, and put something about the size of pencil, but thinner, up about 4 centimeters into the brain. What they are trying to accomplish is to fill that area up with electrical current. When you that, you regulate those dying neurons to have consistent electrical output.
R&D Magazine: What sort of impact has this technology had for patients thus far?
Rosellini: Right now there has been almost 135,000 patients implanted with a device like this, but not ours. It is a very safe, well-tolerated procedure. Patients regain almost the level of function they had before their disease. The challenge now is— how do we make the procedure easier for the neurologist to maintain the patient in the therapeutic window? The question really is not will it work, the question it is how do we make it better so we can get more patients implanted.
R&D Magazine: What challenges are you hoping to tackle with your device specifically?
Rosellini: The biggest challenge is that it takes a long time to reprogram the device once it is implanted. Imagine you have to sit with an 85-year old Parkinson’s patient, they have to get off their medication, which is hard, so they are uncomfortable all day, and they go to their neurologist’s office and sit there while their neurologist plays with combinations of electrodes. It takes over 20 hours to get the device programed and the neurologist is kind of doing it from a subjective approach, by trying something and seeing if the patient improves and then trying something else. This is what distinguishes our device; we are actually going to give the neurologist the recording data to enable them to reprogram very quickly, and reprogram very efficiently to keep the patient in the therapeutic window. Ideally, we could make an adaptive system so that the patient never has to go into the neurologist at all.
We know that the symptoms of Parkinson’s show up in frequency bands in the brain so we could record a symptom, essentially a quantitative biomarker of the symptom, and adjust the stimulation parameters without having to look at the patient at all.
R&D Magazine: Does this technology have applications outside of Parkinson’s disease?
Rosellini: One of the things that I say to people is that we are in the first hour of the first day of applying this technology to diseases. There are 600 diseases of the nervous system. There are four diseases that are currently approved and reimbursed by Medicare to treat with this type of device. One is brain stimulation for Parkinson’s, another is spinal cord stimulation for chronic back pain, a third is vagus nerve stimulation for the treatment of epilepsy, and the fourth is sacral nerve stimulation for the treatment of overactive bladder.
We have funded research programs to develop our device for the treatment of dysphagia, asthma, COPD, overactive bladder, and atrial fibrillation. We have a very big pipeline, mostly funded through NIH grants.
R&D Magazine: Do you see the role of bioelectronics for the treatment of disease continuing to grow in the future?
Rosellini: There are at least 30 companies developing this kind of battery, wire, electrode, nerve stimulation technology, so over the next 10 years we will see an explosion of approved devices utilizing electrode energy to treat disease.
I think what the drug companies are seeing is that the ability to give a pill to treat some of these disorders has failed. There has been an abysmal effort with this for central nervous system disorders. What a lot of the drug companies are saying now— at least GSK who is probably the biggest supporter of bioelectronics— is that they have an understanding of how these disorders work, and the mechanism of the disease, so they should take that knowledge and apply it to treating with an electronic device. This can be implanted, used locally, and made precise, and it eliminates a lot of the systemic toxicities associated with drug testing, and it’s cheaper. They are trying to make devices that are super small. I think over the next 10 years the hardware is going to be important, but understanding the neuroscience and developing the software is going to be the big race.
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Source Article: RDMag.com