Junaid Kalia, MD:

There you go. Good morning, everyone, and thank you for joining the Signal and Symptoms podcast. As usual, I am here with my two besties, Harvey Castro and Edward Marx. These are our co hosts and we have an amazing lineup of guests today. I am so glad that our good friend Itay Segal from Unlock Healthcare is here. And Dr. John Claude is also going to be presenting. He, has a specialty in pain, and they have done a startup which is called Unlock Healthcare. Now, this is going to be Edward Marx, proper specialty.

Because what we are trying to do over here is what they have done is extremely important. This is X USA and we are going to help them and work through them to basically bring this to USA. What they have done is how to use cannabinoids in different, specialties, including pain, epilepsy, Parkinson's, and many other subspecialties.

So, again, Doctor, Dr. Jean Claude and Itay Segal, I'm extremely grateful that you came. This is an important topic. So feel free to introduce yourself, tell me about you, your background, your story, your startup, and then we'll actually have a discussion all casual and go from there. Perfect. So I'll take the lead here.

Itay Segal:

Coming out of Israel by personal background, I'm coming from a product, computer science. I've stumbled upon the problem in cannabinoids or cannabis. Following a personal story from my father having a motorcycle accident and left with chronic pain in his leg, being treated obviously with opioids as the standard for chronic pain.Coming out of Israel is, well, has been using medical cannabis, actually the first one after California, so it's kind of a already existing market. But still coming to the doctor with him, asking the doctor, okay, so how much should he be taking and what the answer was. It's kind of personal and there's an entourage effect and me coming from inputs and outputs and closing loops, it felt like, okay, something is off there. So this is what brought me into the cannabinoid space. Soon after meeting with Jean Claude, handing over to him.

Dr. Jean Claude:

Thanks Itay. So for me, you know, fairly standard in medicine. Specializing in pain.

And when I was doing the pain clinics, that's when it coincided with the regularization of, medical cannabinoids in Malta. I found it interesting and decided to, do a few clinics, privately, because obviously, you know, government hospitals there remain that tension, which made me more interested rather than less interested in cannabinoids because from the one end you're seeing potential and you're seeing huge interest in this, in this new, newly allowed, newly regularized medical space. And from the other end there's tension because there's lack of knowledge, there's a lack of, insights.

It was from those clinics though that I did notice that there are, a lot of gaps, not just in the information, but how we process the information. And then perfectly is when I met with Itai, because that was when I was looking around, for anyone who was interested to solve this problem at scale.

And yes, since then it's been a good few years of combining both my, medical path, but also with a startup, path in trying to solve, these problems at scale. An information problem at scale, but also I would say an execution problem, at scale.

Junaid Kalia:

Harvey, first question.

Harvey:

Well, first of all, thank you guys for coming. It's an honor to see you guys. Get to work, with you guys and a big picture for me, just going, looking at it from a patient point of view, what are some of the top things that you think this product gives to patients?

Itay Segal:

I guess our patients are the one with standard medication didn't necessarily work for them. And there is always that part of the statistics that yes, treatment Is not as effective as it can be. So we're starting off with kind of the desperate.

But what we believe that we are providing is actually back the reassurance of the treatment. Actually meeting with a physician which is not just there to license you. Yes, you can go ahead and try the treatment. But to have the physicians as knowledgeable as possible.

We are working with the American association of Endocannabinoid Physicians, which all of the doctors which are working with Unlock are going through their accreditation courses. So we do try to keep the bar as high as possible from the care perspective.

This is being at this point in time direct to consumer or direct to patient. This is eventually our one and only KPI making sure our patients are treated well, are satisfied. There is actually an improvement in, in progress of the treatment here.

Harvey Castro:

I just want to know better, like the product, can you explain it better to the, to everybody listening, is it, you know, is it helping the patients to help the doctors? It decrease in side effects?

Itay Segal:

Perfect. I'll take our recent launch in Peru. So we are currently working in Germany, several months back. So a patient would encounter us either through social or whatever channels, hearing about Unlock Healthcare. Through us, he's able to schedule an appointment with a physician. So this physician is working on a custom EHR more tailored into personalized treatment and cannabinoids. This doctor was treated, trained and actually took the courses in order to be qualified to.

And this is a very important one because people usually hear cannabis and thinking of flowers.

We're not using flowers, we are not using different strains. It's all around different cannabinoids. They are already available as APIs in the pharmacies. So a prescription can be that much CBD, that much CBN, that much CBD. Of course, according to available research, which is not necessarily as full, but to provide the physician with all of the information needed according to the patient demographics, background, clinical information, and then a prescription.

The prescription is being compounded by a pharmacy which sends it directly to the patient. And this is actually where the poison journey starts the loop. Because what we're doing is actually connecting to the patients and gathering as much data as possible on the treatment outcome.

This eventually what feeds back the physician in order to play their tailored the treatment for that patient needs of course keeping in mind that patients do change throughout time and their symptoms does change.

Jean Claude:

Yeah, if I can add something to that. Harvey. I think we are providing the infrastructure to allowing a proper consultation involving cannabinoids.

Consultations involving cannabinoids are long winded things. There's a lot of working with the patient, understanding where the patient is at and understanding patient outcome as well. And to add to that, even when you're done translating that information to a pharmacist.

They have to know the different cannabinoids and the different ratios and they have to understand what's going through your head when you prescribe this, not that.

And then when the patient is coming in two weeks later with a different prescription because his reactions have changed. And all this complexity basically requires infrastructure. And that is what we're providing the patient. We're providing the infrastructure for all this to happen, for the doctor to know what to prescribe the first time for the doctor to know how to follow up that prescription and for this complex prescription to be made and delivered to the patient by a pharmacist who's understanding and supporting the process.

Junaid Kalia:

Thank you. Awesome. Actually just start with what you suggested, Dr. John Claude, that there are different strains, different ratios and different dosages and that requires essentially the infrastructure.

And your intelligence is important that how you built into your product and then goes from there. Can you give us the audience to understand that, why different strains are there? but give them a little bit more idea behind what different cannaboids exist, why the ratios of collecting them and mixing them together is important and how dosage and more importantly with your digital platform, which is amazing by the way, and you can show it if you want or at least talk about it, that continuous monitoring leads to doses adjustment.

Jean Claude:

So now the first thing to understand is when we talk about the cannabis plant, that cannabis plant, more than one. So there are hundreds of cannabinoids. Right? Over 120 that we know about, probably hundreds more that we don't know about.

Junaid Kalia, MD

Exactly.

Jean Claude:

Every cannabis plant is really a, has a fingerprint of cannabinoids and other substances that give it.

And there's so much anecdotal evidence about that isn't any singular cannabinoid, that is a group of cannabinoids altogether, which is it's only true for that one plant because a sister plant, another plant growing somewhere else will have a similar group of those cannabinoid molecules, but in a different either ratio or some new ones will be there or some other ones won't be there.

So it makes it a similar but yet different medicine. And what we have observed as a, as a civilization anecdotally over the past years is that different strains, people have tried different plants and said, hey, you know, I tried this plant and it helped me with this.

And someone else said, well, I've tried this one, it helped me with that. And realistically, thousands upon thousands of these anecdotal evidence is really the biggest amount of evidence that we have.

So that as a basis, is why there is this complexity and why you need, infrastructure. Because essentially this is a data problem. There's a lot of data which is different to the kind of data we're used to in pharmaceutical.

And in pharma it's all about that one molecule. You're identifying one molecule, and that is a billion dollar molecule With cannabinoids, it doesn't work that way because you can identify one molecule, and people have identified cbd, which, makes people feel better, people have identified thc, which, makes people feel better, also makes people feel fun.

But essentially none of those in isolation is your $20 billion medicine. Right?

Juanid Kalia, MD

Now if you're going to onboard me as a physician, as a neurologist, how do you teach me using your software to onboard me as a. Because, let's just be honest, I have an education. I'm telling you right now on video live that I have an education. Now how would you do? Go ahead and fix my education problem so I can help the patients.

Itay Segal:

I guess starting off with physicians and obviously Dr. Jean Claude had mentioned it, the RCTs and the fact that it's still non existent in such a way that the pharmaceutical company would approach a doctor and say this is the research, this is the prescription, this is the outcome and potentially it's better than the previous medication that was prescribed there.

The difference here is that we need to start with the doctors who actually want to be educated. Yes, it's always starting off with the group of doctors who actually want that because the rest of the group, which unfortunately is very big at the moment, are working according to the existing standards, which is perfectly fair of our cities and we need our CTs in order to do that.

And you as a physician would actually take the decision of what needs to be prescribed. We're still not in a position that would able to say this is actually the best practice for 65 year old men suffering from mild Parkinson symptoms. We are hoping to have this in the future but at the moment it's more on the data gathering and making sure that the physician, and this is the second loop that would love to work with more physicians is actually on conducting research because assuming we already have a patient which is medication is much more tuned than I'm consuming cannabis.

Junaid Kalia, MD:

We're discussing here in specific molecules.

Junaid Kalia, MD:

Now, Harvey, I feel personally right now that I am losing control. It was very easy. Aspirin, 81 or 325 milligrams, or Keppra Dosage, 1500, et cetera.

But I knew the molecule in Keppra is Livertracetam. And then I can have this dosage adjustment. Only now you're telling me that with this one, that actually the formulation is not under my control. Now, how would physician react to it, or you personally would react to it?

And I can tell my opinion, and then we can talk to them about how they actually manage physician expectations.

Itay Segal:

Maybe just. And, And sorry, just the physician is actually in control because the compounding is done by cannabinoid and not by formulations.

So he's able to tweak, as Jean Claude had mentioned, the different cannabinoids and terpenes according to his vision and clinical vision and not just working out of the standard one.

Harvey Castro:

Yeah, I'm probably the, odd doctor in a way because I, really think we need to be doing personalized medicine.

I truly think if there's one drug and there's a bell curve and there's only two doses, what about the extremes? What about those weird situations? So I'm biased when I say I think this is the future of Medicine, this is where we should be headed. And because we have A., because we can find out what my genetic makeup looks like, who I am and create that molecule or that personalization instead of those two doses, I think that is magic.

Edward Marx:

But yeah, that's exactly what I'm saying. We're seeing it now with GLP and Peptides. It's all personalization. Simran's practice is becoming more and more about this because of the personalization. No one wants to get one size fits all, especially with medicine. So yeah, I think we're onto something here.

Junaid Kalia, MD:

Now let me ask you a little different problem. So if I do a clinical trial, which I've done that as a co sponsor, you have multiple problems.

One is no therapy, then multiple different therapies in terms of dosages. Then on top of that your complexity is multiple different formulations. So how do you design this clinical trial?

Itay Segal:

Obviously the challenge now is not necessarily around finding the right dosage, the right formulation for, for one symptom. It's kind of how we can make a system that dials in different patients, also taking into account patients and symptoms to change throughout time. So this is one aspect to that. So it's really the RCT to prove personalization is potentially better than a standard dosage.

I guess the challenge here and relate maybe to even the company name Unlock Healthcare is how you engage with the patients in such a way that propels something which I feel that should be different. You have discussed in one of your last podcast on payers and providers alignment and I think there is a true opportunity now Unlocking because of Perplexity just released, you know, a working app which connects to all of the wearables, connect to the EHRs, connect to whatever and the patient has this data.

Jean Claude:

I agree. One thing I'll add as well, I think the outcome is everything here. So the outcome of a trial of any experiment that we do, it needs to look at the patient journey or the outcomes of the patient using not just cannabinoids, any medicine, in the current way, in the best, best current, best current practice versus using it with this data infrastructure.

But we need And we have the data nowadays and we also have the technology to process a lot of data. But what we are missing is the infrastructure to put all that in, and actually execute. So when I started I said it's an information problem and an execution problem.

But how to actually put them into a patient journey, how to improve patient outcomes using these, these advancements in technology.

So another point I want to make is that we are not trying to be radical or change the system. Rather we are finding areas of potential which so far do not have the right attachments into the main system. So this is why you can't prescribe peptides and cannabinoids in the same way that maybe we're used to prescribing and we're used to working in the medical system per se.

Junaid Kalia, MD:

What do you think, Dr. Jean Claude, just looking at two big continents, U.S. and Europe, what do you think the projection of, regulation in general for digital health and monitoring solutions, and then specifically talk about cannabinoids. And of course Mr. Siegel can chime in.

DR. Jean Claude:

I think especially in Europe, both for cannabinoids and for digital health, we've seen an explosion in the last five years. So the way things have changed, is incredible. I think, regulators, although I guess we can imagine sometimes things to be slow, but when there is momentum, I think they pick up the pace very, very quickly when it comes to cannabinoids. It's been perhaps even more progress and even less time. And the fact they're happening at around the same time, you know, it's wonderful serendipity I think, and even more reason, to include cannabinoids, in this digital revolution, because if we do have the technology to do it, we should be doing it.

We need to own it and make sure we are driving that change and telling people how to use cannabinoids and how not to use cannabinoids. We need to be there. We need to be the ones who are first there and can drive that. Because if we're not, someone will find other applications which may not be as, beneficial or may indeed be harmful.

Junaid Kalia, MD:

So, so true. And I think what you were suggesting is very, very important for me to take a holistic care of the patient. We need to ensure that I, as a physician, or we, as a physician community, needs to understand that there is one more tool and it is our job to use it and improve it.

Perfectly said. Dr. John Claude.

Harvey Castro:

My. Begs the question for people that are out there. It's like, okay, when is it going to be here in the United States? I personally want to know when is it going to be in the United States? So can. Can you guys tell us what's that path? You know, is.

Itay Segal:

Is this going to be a medical device? You know, because technically, you know, it's at that line. It can, it cannot be, depending how you do it. So I'd love to see your thoughts. At this point in time, obviously us in the loophole of hemp versus cannabis. Some states are medical, some states are recreational, some states are still holding back. So there is definitely still accessibility of, I would say, the right products.

The services, as you rightfully said, also, are not reimbursed at the moment. So the entire mechanism is still not tuned towards that. We do believe that if and when Schedule 3 happened and President Trump Kind of alluded to that late last year that it's going to happen.

The question is literally on to when, because this is where a lot more research can be conducted, potentially reimbursement further down the line.

So just to conclude the sentence here, obviously this is a big decision. We are very, very attentive to the markets. We have started off in Germany, in Peru, for specific reasons now, and now over to Israel.

So the roadmap is definitely quite dispersed in terms of geography and obviously us is still a very big part of that.

Jean Claude:

100%. I think one of the things, Junaid, that you mentioned, just pounce upon. We said, oh, is it California? What we need ultimately. So this is, could you call it a medical device? I guess the closest thing would be. Right, a medical device.

And what we need is, is that medical layer of legislation. So you have legislation and our infrastructure sort of fits on top of that legislation and plugs into ideally medical infrastructure, which is utilizing cannabinoids.

So we are talking with, we are talking about pharma when working with pharmacies and hospitals prescribing.

So what we really need is for there to be more of a medical emphasis and for that to be really nationwide. And I think one of the biggest steps forward for us in terms of, you know, things that happened was the rescheduling, because we want cannabinoids to be on the mindset of doctors, pharmacists, and people who are on hospital boards who say, listen, cannabinoids are important and we want to be.

They will be very important and very probably lucrative in the future.

What we're doing is definitely medical. So we are looking for those medical institutions to maybe look away from the cannabis culture from, I guess, the stoner stereotype. That's not what we're talking about. We're talking about compounds which are coming from the same plant or a similar plant, let's put it that way, but which ultimately have a medical purpose and, a medical intention.

So that is really what is, what we, what we want to see and what we need to see in order to be able to take what we're doing into the United States States.

Junaid Kalia:

Now here's my take. Cannabinoids have multiple different priorities. Sorry, molecules that are different systems. We need to build an infrastructure which is different than our medication and that is where unlock healthcare comes in.