Matt Hoffman, Senior Editor for NeurologyLive, has covered medical news for MJH Life Sciences, NeurologyLive’s parent company, since 2017. He hosts the NeurologyLive Mind Moments podcast, as well as Second Opinion on Medical World News. Follow him on Twitter @byMattHoffman or email him at firstname.lastname@example.org
The CEO of INSIGHTEC offered insight into what challenges in the neurologic space the company plans to tackle in the coming years, and why 2020 marks the start of the “Century of the Brain.”
Maurice R. Ferre, MD
The crossroads of medicine and technology have allowed for drastic advancement in a number of fields of medicine, particularly in neurologic disorders. A number of devices have granted patients nonpharmacologic, noninvasive options in disease states such as migraine, epilepsy, and movement disorders, with many groups working toward continued expansion across neurology.
Maurice R. Ferré, MD, CEO and Chairman of the Board of Directors, INSIGHTEC, and colleagues are one of those groups. Ferré noted in a conversation with NeurologyLive that with more than 600 diseases identified in this space, many of which have limited options even pharmacologically, there is plenty of room to improve. This challenge is what INSIGHTEC and other groups are seeking to take on.
To discuss further why 2020 marks what has been referred to as the beginning of the “Century of the Brain” through increased investment in clinical research and innovative options, NeurologyLive probed Ferré on some of the work that must be done, and some that has been done so far.
Maurice R. Ferré, MD: I would kind of preface it as saying I think we are in this “Century of the Brain” for so many reasons that are well beyond the scope of what we do, as a company at INSIGHTEC. With all of the expanses, the exponential changes that are occurring, with computing with artificial intelligence with data mining. with big data, with gene therapy, with immunotherapy, sequencing—all these things are all coming together in a really interesting way. That's why I think that there's going to be so much advancement in understanding a lot of diseases in the brain that I think are going to have a lot of impact on some of these horrendous neurodegenerative diseases, in particular.
It has been cited that by the year 2035 that these are going to bankrupt our healthcare system by the year 2035 if we don't come up with a treatment. For Alzheimer, it's been billions of dollars and failed phase 3 trials, and there are so many people working on this and not enough money. If you look at just the NIH funding for just these types of diseases, we're far off the mark of what we did to solve other diseases, including AIDS. It's just kind of dumbfounding to me as to why we're not spending more money and energy as a society on solving these diseases.
What we bring to the equation and what's exciting about INSIGHTEC is that we have a very unique tool or mechanism that has 3 different types of modalities that we're just starting to have an appreciation for, with the way it works, and it's using energy. It's the use of energy inside the brain, not to do diagnostics, but actually these do some type of therapy. And we think that that form of energy, which is sound—ultrasound—it's nonionizing, which is key. It’s very different from radiation therapy, very different from proton beams, and at different frequencies, we can do different things with that type of energy. We've been able to demonstrate that both in labs, in animal studies, and in humans, that technology—that energy—has certain capabilities that allow us to do some important things. For example, first and foremost, what we're very excited about is the ability to use the energy at a high frequency to do lesioning or ablation.
Now, ablation in the brain has been around for many years. In fact, before deep brain stimulation for the treatment of things like Parkinson disease, lesioning was kind of the mode of choice, but that type of choice was radio frequency with a needle that would be placed. You'd have a craniotomy to place it and then all of a sudden you with a stereotactic frame you’d be able to kind of target the lesion, and the energy source would propagate externally, or it would go out from the center of the needle. What we've introduced is an electronic, steerable beam of energy, that kind of blasts from the outside in. It's a very tight, compact, submillimeter type of burst of lesion that we call printing lesions in the brain with high precision. What's different from 30 to 40 years ago with lesioning is that now we understand tractography, we understand mapping, we have high-resolution magnetic resonance. We can build this closed-loop technology with a steerable beam that has that is completely non-invasive, and is very focal, and it gives us a closed-loop enterprise. That allows us to tackle some of these diseases we've targeted where we have identified over 200 million lives that can be saved around 7 different diseases.
The one that is that right now that we're FDA approved for, where we've done most of the work, has been in movement disorders, and specifically around essential tremor, and tremor dominant Parkinson. In these diseases, we've now done up to 3000 patients. We started off with a pivotal study that was in about 4 or 5 years ago that was published in the New England Journal of Medicine, that was a double-blinded, randomized controlled trial. Those patients in that cohort, we've been able to now to track for 4 years with very, very significant positive results in treating their central tremor, which has led us to now doing, globally, 3000 patients and has also led us to get societies to endorse it, and us now to get reimbursement for it. We're confident by year’s end will have global we’ll have reimbursement of the United States in all 50 states. That's significant because what it does is it brings a new armamentarium to the neurosurgical suite. It doesn't replace DBS. There’s a cohort of patients out there that are ideally suited for this, this noninvasive incision, this type of lesioning that we call MR-guided focus ultrasound, which is the Exablate system.
We’re happy to say that we now have over 20 sites in the United States that are now kind of coming up to speed, and what started first in the academic centers, is now starting to propagate into other types of community-based centers, which I think is an exciting trend that's happening. That, first and foremost, is kind of our first tier of applications and procedures. We're in the end of a phase 3 trial on treating Parkinson, within a year, or a year and a half, I think we'll have an indication for that which hopefully, we plan to submit to the FDA. Then we're going to follow up with epilepsy, which we think is a very important disease that has a lot of potential with this whole concept of lesioning. Then from there, we also see, and we've seen some good studies going around neuropathic pain. These are all kinds of studies that are ongoing, globally, that we think are going to be able to add to this type of technology, to add new tools for the neurologists and the neurosurgeons in treating these types of neurodegenerative and movement disorder type diseases.
Transcript edited for clarity.