Most people think of brain health in terms of MRI and CT scans, but QuantalX is marrying transcranial magnetic stimulation with EEG such that clinicians can now measure individual brain function against QuantalX’s database of healthy brains and monitor changes over time. Both neurologists and psychiatrists can benefit from the device and associated software as a medical device, said Dr. Iftach Dolev, CEO of the company, in the MedCity Pivot Podcast. The company’s Delphi-MD device recently won a de novo FDA clearance.
This episode is sponsored By Claritev. Claritev’s healthcare technology solutions and data-driven insights improve affordability, transparency, and quality across the healthcare ecosystem.
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Here’s an AI -created transcript of our conversation:
Arundhati Parmar: Hello, and welcome to MEC City’s Pivot podcast. I’m your host Arundhati Parmar. Lay people have always thought of brain health in terms of MRI, CT and EEG, but Quantal X is a startup that wants to measure and benchmark individual brain functions against QuantalX’S database of healthy brains and monitor changes over time.
This can all be done under an hour and at the point of care. The company’s Delphi MD system combines transcranial magnetic stimulation with EEG. To actively stimulate brain networks and measure their response. The device just received FDA clearance as a de novo tool, and Penn Medicine UCSF and other organizations are using it.
In this episode, I’m speaking with QuantalX’s co-founder and CEO [00:01:00] if talk. This episode is sponsored Bylar Clarity’s Healthcare Technology Solutions and Data-Driven Insights improve affordability, transparency, and quality across the healthcare ecosystem.
Arundhati Parmar: Welcome Iftach to our Med City Pivot podcast.
Dr. Iftach Dolev: Thank you very much. Thank you for having me here.
Arundhati Parmar: Um, so let’s talk a little bit about Delphi md. Um, I understand obviously brain imaging, uh, tools that are out there. I understand EEGs, but you guys are doing something completely different, right?
Uh, you’re trying to understand how the brain actually functions as opposed to looking at structural themes. Um, so tell me a little bit about Delphi md and then we’ll go into details of your com competition and all of that.
Dr. Iftach Dolev: Yeah, sure. So maybe just to put things into perspective and un understand what Del is all about.
Maybe we’ll start from the beginning. Okay. How we started. So, uh, in my background, I’m a neuroscientist, uh, and during my PhD studies, uh, as most neuroscientists I think, or the, I use the most common tool used in neuroscience and specifically in physiology, which is electrophysiology. Has been around for at least four decades.
Uh, basically just to explain, for those who don’t know what electrophysiology is, electrophysiology is basically the idea of I, uh, putting an electrode inside either a, a neuron cell slice, brain, uh, uh, a behaving, uh, brain, stimulating the brain and measuring the evoked potential, what’s called the tap or the what’s called evoked.
Uh, response, uh, looks a bit like a wave, like an EKG. So in, in a way you can call it measuring the EKG of the brain. And we’ll get to this actually in a second as well, because it’s really relevant for what Delphi does. Mm-hmm. So this is what I did in most of my PhD studies, and measuring this evoked potential response actually gives you a lot of information, almost all the needed information to understand brain function.
Uh, and understanding brain function. You can actually understand whether the brain functions normally to his age group. What is the age of the brain, whether it functions normally, whether it is any kind of. Functional and structural, but any kind of abnormality and understanding this, you can, uh, use this platform of [00:04:00] electrophysiology to understand any kind of effect, uh, the effects of any kind of intervention, whether it’s a drug rehabilitation, damage to the brain.
Um, so this is basically electrophysiology. Mm-hmm. Mm-hmm. During PhD, I also worked as a paramedic. Okay. So, and the, the, the huge gap that exists and I think that in neurology or brain science, in, in general, brain health in general, there, there is a huge gap between our knowledge in neuroscience and what actually exists or doesn’t exist.
When it comes to clinical care mm-hmm. When it comes to clinical care, as, as obviously, you know, there aren’t many tools. So when somebody goes to the physician with complaints of, I feel like I lose my memory, I have a cognitive decline, I feel depressed. If you think about it, the brain may, might be the only organ that we never actually see.
Mm-hmm. And we can only detect abnormalities when they already occur. Right. In like 99.9% of the cases. You can only identify problems, and of course it can be relevant for degenerative disorders like dementia, for example, Alzheimer’s, Parkinson’s, stroke, psychiatric disorders. We can only detect them when they are already seen as behavioral or structural or mobility abnormalities.
Right? When obviously it’s well understood today that these abnormalities start years, at least five to 10, maybe more years. Before they actually have a phenotype, they can actually be seen in behavioral or cognitive changes. Right. These changes are physiological, functional, mm-hmm. Changes. Mm-hmm. That can be measured using electrophysiology.
This is exactly what we had in mind, or I had in mind at that point to bridge this gap. Bringing the ability to measure electrophysiological measures in clinical practice. I see. And that’s what Delta is all about now, just to explain what is the vision behind it? Just going back for a second to cardiology.
Mm-hmm. Now [00:06:00] think about your brain health or your annual health assessment. Mm-hmm. Getting your cardio assessment. So you get an EKG, again, going back to EKG, you do your EKG, maybe on a treadmill measuring what’s called the stress test. And for most cardiac abnormality, you can actually identify them.
Mm-hmm. When it comes to the brain, you don’t have anything like this. So just serving me for a, for, for a second, the vision of Delphi md, the Delphi will come exactly this executive cardiology for EKG for cardiology. Mm-hmm. Delphi will become. The Brain health assessment, annual brain Health assessment to understand whether your brain functions normally or there is any kind of early abnormality that can be treated or can be in between or can be prevented maybe.
Arundhati Parmar: Okay. But then your company also uses this term trans. Cranial magnetic stimulation. Right, right. So that is the, but then it marries it to an e, EG. Is that what sort of the differentiation is between your company’s products and maybe some competitors?
Dr. Iftach Dolev: Yeah, so, so the, the, so let me explain for a second for a second how we, how, how the system works.
Fair enough. So the system is a, is a combination of two technologies that has been around for a long time. Of course, TMS, as you mentioned, transcranial magnetic stimulation and EEG. Mm-hmm. Mm-hmm. Both used, approved. EG of course used clinically in some cases, like sleep disorders, epilepsy, mostly right.
But is not really used in routine neurological or psychiatric clinical care. Mm-hmm. Uh, for identifying early changes in brain function. Right, and we’ll explain exactly in a second why. TMS is used more for, in the psychiatric world, for treatment of depression, OCD, things like this. Mm-hmm. While being a very powerful tool to stimulate the brain you can actually use.
And that was the concept of what we did. The same principle of magnetic stimulation, but minimize it, do it in a very, very high resolution, focused, minimal, minimize this device and the design and EEG, which is specifically designed. To work with magnetic fields in the proximity of a TMS device. Put the both of them together in one small device, a bedside tool, and Delphi is a bedside tool.
Okay. Very accessible. Used in any clinical setting. Okay. Both T and EEG devices are in, in the same device. It is controlled by the Delphi software. And that’s the idea. Maybe I’ll, I’ll just explain that. TMS and EEG by themself or the combination has been around for a long time. Mm-hmm. In research, because combining the two.
For clinical use, I would say up to now, up to Delphi, was almost impossible. Very hard to combine them. Mm-hmm. You have to be an engineer, uh, in order to actually put them together in the same room. Uh, on a patient’s head to run a study, but it also afterwards analyze the data very complex, and that was the idea to deliver this very significant, very powerful technology to clinician in any point of care without really the need to understand how the technology works.
It’s a software that controls the, the, the whole process from the beginning. Mm-hmm. Until the report is generated in real time.
Arundhati Parmar: And who is going to use it? Is it a neurologist? Like if there’s a referral for a, you know, a person from their primary care physician, you don’t expect the primary care physician to use it, do you?
Dr. Iftach Dolev: No, no. So the, the virus and also the indication for use, and of course, as you know, we have to be very strict here and very careful with indication for use. Yeah. The, the indication for use is for the use of a brain specialist. Okay, which means neurological psychiatrist can prescribe the treatment, okay?
Any, any technician can operate the system, any medical technician can operate the system. The one who interpret the results of the, the data or the report is of course a neurologist or psychiatrist.
Arundhati Parmar: Fair enough. Fair enough. So I find this really interesting. So you, you are able to monitor how the brain is responding to certain stimuli, right?
Right. And does this negate the need for something like an MRI?
Dr. Iftach Dolev: So in some cases, so generally saying it does not replace an MRI. Mm-hmm. I think today when we look at technologies. Uh, there are technologies that evaluate brain cognition, like cognitive tests, right? As you might know, MINIMAN moca test pen and paper test to evaluate cognition, of course, right?
Very subjective, can only detect very late stages of progression of cognitive abnormalities. And there are of course imaging like MRI, CT scan. That’s right. Very good. Of course, uh, uh, uh, methods, but of course, evaluate brain structure, not brain function. Mm-hmm. And again, the brain, like the heart is a functioning organ.
Right. So Phi adds, uh, a very significant, uh, or the missing [00:11:00] piece of the puzzle. Mm-hmm. Uh, which is very important of course. And that’s exactly what Delphi does. In some cases, of course, it’ll prevent an unnecessary MRI. In some cases, it’ll refer somebody who thinks. He’s completely healthy, but does have significant abnormality to the required CT scan or an MRI.
Mm-hmm. But it’s like that neurological psychiatric management system in a way.
Arundhati Parmar: So are you looking at this, I, I guess I’m trying to put a label on you guys. Are you looking at this as a, as a diagnostic tool, as a early prevention tool, as a monitoring tool for, to see if there’s further decline? How are you sort of positioning this?
Dr. Iftach Dolev: So, so I would say all of the above. Okay. So the device is a tool today, uh, is. So the indication, uh, we got from the FDA under the de novo, which is of course, means that that’s the first ever device right. That is in the market. Mm-hmm. Basically, it’s a very general indication, which is great for us. Okay.
Meaning any brain specialist can use the system to evaluate, determine, monitor, [00:12:00] brain function. Mm-hmm. Uh, which means it enables the, the, the, the physician a better vision and door into the brain. To improve the ability to have the right diagnosis, an improved way to give the right intervention and monitor the efficacy of any given intervention.
Drug rehabilitation process using the system, which is of course doesn’t include, include any radiation can be done in any clinical setting, even every day if the physician decides, uh, adds a very significant part of the diagnostic or the observation assessment, uh, way to assess the brain. In the front level, which is not available today, or wasn’t available up to now.
Arundhati Parmar: Let’s talk about the cost of healthcare, right? As you, as everyone knows it’s skyrocketing, um, there is a desire to, you know, this is, would be a capital expenditure, right? It’s a physical equipment that’s gonna be bought by the health system or specialist that you’re, you know, specialist practice, right?
So what is the. Economic argument, the value-based care argument, for lack of a better term. Yeah. To have a device like this in your practice.
Dr. Iftach Dolev: Yeah. So, so I think a, a very good example as we, we just discussed is the, the patient journey Today, somebody going to the clinic with complained, for example of a cognitive abnormality has to go through from the primary care point, has to go through an early uh, uh.
Diagnosis to a certain way, which the primary care and also a neurologist doesn’t have any tools in his office so they can, uh, have a cognitive assessment, which takes a long time, of course, costs a lot of money. Generally, I would say that the process to get a neurological diagnosis today in clinical practice takes an an average of six months.
Mm-hmm. Cost a lot of money over $4,000 in the US to get. Even in the early, the, the, the easiest or the most simple neuro diagnose di diagnosis. Mm-hmm. Uh, yet still, even when we look at the treatment, no matter how good a treatment might be, and it might be a drug intervention, cognitive assessment, whatever lifestyle changes, no matter how good a treatment can be, it’ll always be only as good as the ability to detect the disease early enough and accurately.
Hmm. Delphi does exactly this, actually, it accelerates the process going into the physician office with complaints of a cognitive abnormality. The physician can put a Delphi system over his head and understand whether there is any kind of abnormality. The device not only assesses the brain, but everything is compared, uh, streamlined compared.
To the age dependent of the client. Of the patient. Mm-hmm. Of course, all the population between the age of 50 to 75. So everything is benchmarked again against a normative database that was approved and it was established by the company. Mm-hmm. So given this, any physician can understand. What’s in front of him, [00:15:00] giving him her window into the brain, understanding whether this person should be admitted immediately to an MRI or ct.
Whether this person complains like many people, what? There is no actual abnormality. Let’s monitor him. Let’s tell him or her to come back next year to his annual brain health assessment. Mm-hmm. Maybe we can even with lifestyle changes. Uh, so the opportunity here is huge and it went. I mean, for me as a, as a, as a both entrepreneur, but also a brain scientist and neuroscientist.
Mm-hmm. It’s really exciting. I mean, we, we started this over 10 years ago, this project, uh, and you can actually see how 10 years ago, even physicians didn’t talk about brain health. Today, everybody, everyone does understand health. Yeah. Everybody wants to take care, everybody. Understands there is a need to take care to be involved in your brain health, take care of your brain, brain health, manage your brain health.
And Delphi is exactly the tool that is required and enables a very easy and accessible way to monitor and evaluate and assess your brain health in routine clinical care.
Arundhati Parmar: So let me ask you this. You said that even psychiatrists can use it. Um, my understanding is, and I have a very, you know, um. Basic understanding is that if someone is diagnosed with, you know, clinical depression, there are physiological chemical changes in the body.
Are there similar changes in brain activity is, of course.
Dr. Iftach Dolev: Yeah. Yeah, of course. So,
Arundhati Parmar: no, no, continue. Sorry. I’m sorry.
So I will stop you. And why is it that. Uh, you know, today when you diagnose someone with clinical depression, is it just a paper-based test that they do or do they actually monitor the brain and see patterns that are concerning?
Dr. Iftach Dolev: So, so actually that’s a very good question. Psychiatry even more, much more than neurology. Neurology does have [00:17:00] MRI CT scans. When it comes to psychiatry, these tools are not really relevant because you don’t see psychiatric disorders, right. Using an MRI or CT scan. So the need there is even mm-hmm. Much, much bigger the subject.
Subjectivity in the psychiatric world mm-hmm. Is enormous. Um, and even, even if you take somebody with depression, uh, um, and you have a few psychiatrists, they might not all agree of exactly the same type of depression, whether it’s depression, whether it’s OCD with a background of depression, very complicated, I would say a mess.
Uh, and that actually helps because it can differentiate whether the abnormality is related more to neurological abnormalities that the physician should regard to take into consideration, should follow up on, or, uh, the complaints of, for example. People come to the clinic, and we hear this, this all the time with complaints of depression.
Depression can be actually depression, and you can see it in specific physiological measures of imbalance of specific areas of the brain. Uh, but it’s a symptom of degenerative disorder, always a degenerative disorder like Parkinson’s Disease, dementia, Alzheimer’s disease. One of the symptoms is depression.
So is it really depression or it’s a symptom of degenerative disorder differently, which should be treated in a whole different way. Okay. Of course. That’s very interesting. So this is, um, I wanted to talk to you about your competitors. There are companies out there that are, you know, using various steps of devices too.
Arundhati Parmar: Look at the brain. How do you compare, say. And I don’t know if these are your competitors, but I did a quick search, uh, you know, companies like, um, I think Maxim was one that I came across. Um, and um, yeah, NeoSoft and Soter Medical. How do you look at these companies and how are you different, um, from them?
Dr. Iftach Dolev: So generally, uh, so let’s say, let’s start for example with Maxim. Maxim is a TMS company. Uh, so they develop TMS devices focused on mostly treatment of psychiatric disorders following the other TMS companies that are focused depression mainly, and then OCD and. The rest of the psychiatric world, uh, device, basically TMS DI device, uh, TMS devices.
They do not go into the diagnostic world. They don’t have. A combination of the technologies that we have and our device by itself. Also, the TMS component is completely different than what they do. They have, uh, if you have seen a device of a magazine or those companies, they are specifically for the treatment.
So the coils there, the device is quite big. Mm-hmm. Very expensive. Are. TMS components is very small. All the device is small. The core itself is in a size and a weight of an iPhone attached to the cap, uh, on the head. But the device itself also, the indication for you is completely okay, completely different specifically for Meg Steam and the other, uh, components or the other companies in the world of TMS.
We are [00:20:00] not really competitors. Um, there are companies that I would say that generally, like in Usoft, Terex, those companies. Are mostly focused on either neuromodulation with other tools like T-D-C-S-D-A-C-S, esoteric, for example. Uh, high definition TDCS, which is a powerful tool, but they are all in the world of mm-hmm.
Treatment in different ways, different modalities. It’s not a magnetic stimulation here, it’s, uh, transcranial current stimulation, which might be effective. But all of these are compatible, let’s say, uh, compatible devices or complementary devices to what we do. But in the treatment side, uh, in the diagnostic side, we are still.
Uh, I won’t say alone, but we are quite this FDA approval, uh, clearance. Mm-hmm. Under the de novo. Mm-hmm. Uh, I would say generally the technologies are going in two ways today. There are companies that try to take what’s available today in [00:21:00] the diagnostic world, like MRI scans, CT scans, and try to miniaturize them to put them in the clinical office, like in the primary care office.
Uh, right. A lot of potential, but still. It’s an MRI, it’s a CT scan, uh, uh, miniaturized, you can put it. But still the technology itself is limited, uh, by the performance of a structural imaging of the brain. Um, other companies, uh, are focused on in the diagnostic world or using ai. Ways, more lifestyle to monitor the way that you, uh, perform in your daily life through for your iPhone, your, uh, apple watch or things like this to monitor behavior and then to detect early changes in behavior that can be correlated to specific degenerative disorders.
Right. But this is where most of the company companies are focused. Okay. I think where we are, which is a straightforward medical device. Mm-hmm. Software device, a software and medical device. Uh, clinical use. Uh, we are, uh, I won’t say alone, but far ahead [00:22:00] than any other company.
Arundhati Parmar: So, uh, I understand that the device is already being used in, uh, you know, used at, you know, Penn Medicine, uh, university of Texas, right.
Um, and UCSF. What are the different sort of applications that you are seeing in the marketplace today?
Dr. Iftach Dolev: With the use of the device?
Arundhati Parmar: Yes. Yes. How, how are these hospitals or health systems using your, your device?
Dr. Iftach Dolev: Yeah, so, so. First of all, the, the, the, uh, as, as I mentioned before, one of the advantages is that the indication for use is quite wide.
And this is exactly what we want to do today to enable a widespread adoption of the system by any neurologist, psychiatrist, uh, brain specialist that understand the value of evaluating brain function monitoring. Mm-hmm. So there are centers for rehabilitation, for example, that’s focus on rehabilitation, UCSF, for example.
Uh, focus using the device on evaluating and monitoring chronic pain in [00:23:00] the study they run. Okay. Uh, in the Center for Brain Health in Dallas, Texas, run by, uh, managed by, uh, uh, Sandy Chapman, which is one of the leading, uh, uh, uh, brain health, uh, uh, key opinion leaders in the world. Uh, they’re using it to monitor, uh, aging, brain aging, healthy aging compared to abnormal aging and try to improve.
Uh, uh, brain health and monitor it using the device, whether there are any kind of physiological improvements in brain performance. Uh, so every center, uh, UIC for example, use it for evaluating the, uh, uh, uh, evaluating acute stroke. And what is the potential to rehabilitate for related following an acute stroke cases.
Uh, so any, or almost all the sites that are.
Using the device, they use it a bit differently, but all of them get this.
Arundhati Parmar: So are they, are they actually deployed or is it mainly being used in like pilots or in research?
Dr. Iftach Dolev: So, so most of them started as research, of course, because, uh, before FDA clearance today sure they are converted. Commercial use, some of them still continue to do research.
Some of them are converted to commercial use. Mm-hmm. Some of them are new users are already, uh, on a commercial path deployed as commercial use. Uh, in, in the US of course, the majority of us also in Europe and, and in Israel. Yeah.
Arundhati Parmar: And then I’m assuming that there’s some kind of a. CPT code available because a lot of devices may be wonderful and, and great.
Yeah. But actual adoption depends very much on whether physicians get reimbursed for their use. Yeah. So I’m curious about, about this, um, are what kind of codes are available.
Dr. Iftach Dolev: Yeah. So, so. So I would say this is of course one of the most important things that we focus on now, getting and working with the payers.
Uh, for the reimbursement, the device or the procedure itself has its own dedicated reimbursement code. Okay. Uh, the device or the procedure got even prior to getting the FDA, uh, the Novo clearance, uh, in 24 already. Uh, uh, it’s a T code, so it’s. Still under development together with the payers, uh, to see exactly what is the, the coverage, who covers it, who, so it’s, it’s a process still, uh, but it can be billed today.
Uh, but, but of course specifically, uh, with negotiation, with discussion with the payers. But there is a specific code for the procedure.
Arundhati Parmar: I’m curious about it. I’ve, you know, heard this like, I don’t know. Five, maybe 10 years ago that the next phase of great innovation is happening in neurostimulation. And that was 10, 15 years ago.
And they were talking about how pharma companies are now going to get into this, you know, neurostimulation, uh, uh, market by buying companies. How do you look at the, how the, the market has evolved, uh, or even how the technologies have evolved?
Dr. Iftach Dolev: Yeah, so. I, I think maybe it, it, it, it brings us back to the beginning of the conversation.
Uh, when, when we started by saying that in science, the technologies are very much evolved. We really understand how to understand the brain, how to look at the brain, uh, and in neuroscientists, understands the brain. We understand how to evaluate brain. How to assess, how to monitor. Hmm. Most of these are still not translated into clinical care.
Because of the lack of, at the end, and, and I said this, and I think today specifically because of, let’s say the new anti Alzheimer drugs, anti-amyloid drug drugs, right? There are drugs, uh, effective in some cases, uh, do have a lot of controversy around them because of side effects, because of costs, things like this, right?
Mm-hmm. Uh, and again, I think this is very good example because things are happening. There are very good drugs today that are developed. For, for example, Alzheimer’s, Lewy body dementia. Mm-hmm. Normal pressure, hydrocephalus, other indications that we are all also very much involved in. And I think one of the things that was missing up to now is the actually ability to understand whether the drug is effective, whether the treatment is effective.
So all the pharma companies are running to develop drugs, but the missing link was still to understand. Who will benefit from the drug And whether this drug does something without a specific, uh, uh, a window into the brain that can actually visualize whether the brain function changes using these drugs.
You can’t really evaluate the efficacy of the drug. So the ability to. To, to move forward this, these technologies, these new drugs, will al or was always limited. Mm-hmm. This is where I think Delphi has a lot of advantage, a lot of potential, uh, for benefiting, for example, uh, pharma companies that develop new drugs, they can actually.
Determine who will benefit, who should be recruited to the study, who will benefit from the drug, who should prevent taking the drug because they are at high risk for suffering from severe side effects. So again, no matter how good a treatment or a drug can be, it’ll always determine of the on the ability to determine or to detect the disease early enough and accurately.
Mm-hmm. And this is exactly our vision with Delphi md.
Arundhati Parmar: Okay, perfect. Thank you so much for spending some time with us at Pivot Today.Dr. Iftach Dolev: Thank you very much. Thank you for having me.
