GlucoTrack (NDAQ:GCTK) is an American medical device company focused on design, development and commercialization. The company is developing proprietary painless and non-invasive blood glucose monitoring devices for both Type 2 diabetes and prediabetes, a market almost expected to double in size by 2030 to US$61 billion.
Joining us today to learn a little more about the company’s plans as it looks to grow its presence in the diabetes treatment industry is GlucoTrack CEO, Paul Goode.
TMH: To start with, give us an overview of your company and what separates you from the competition in the diabetes testing market.
PG: GlucoTrack is a diabetes device technology company, and we’re presently working on two products, and both of them are in glucose sensing. One targets the insulin-dependent patient population, which is primarily type one patients and a subset of the type two population of diabetes. The other product is for non-insulin dependent patients, and it is primarily for type two and even pre-diabetes patients. Now, both of these market segments already have glucose-sensing technologies available to them. However, for one reason or another, there’s still a huge segment of the market that’s not being addressed. In the case of the non-insulin dependent patients, the technology that’s available to them, as most people are familiar with, is to stick the finger and take a drop of blood out and put it on a measurement strip and get a reading.
Quite frankly, many patients don’t do that. So, in fact, our device is a non-invasive measurement for blood glucose, and it takes the measurement rather quickly, so patients will be able to take the measurements without any pain or discomfort. On the insulin-dependent side of the product portfolio that we’re bringing to market or we hope to bring to market, an implantable continuous glucose sensor. Most of these patients are type one patients, and the subset, the type two’s, they’re using continuous glucose monitors, and most of those are wearable devices that go through the skin. There is one implantable on the market, but we will be differentiated from them by three main factors. Number one is that it still requires a wearable to power the device and get the data out. Ours does not require a wearable. Number two, its longevity is only six months, and we’re targeting several years, and number three, it still requires frequent calibration.
TMH: You mentioned Type 1 and the subset of Type 2 diabetes, but you announced this past fall that you were expanding your reach and getting into the Type 1 diabetes market for the first time, tell us about that.
PG: Yes, you’re absolutely right, and we’re super excited about it. We acquired technology late in the fall that is for implantable technology but in particular for multi-year longevity, which is what’s needed for an implantable to be successful in the market, and so we’re working on this doing a research phase at this point, validating the claims and verifying on the bench that we can hit those targets, and we expect that we can, and so we’re going to spend the better part of the first half of this year getting to that validation and then migrating into in vivo studies with animal studies and proving it working there. So quite excited about it, and as I mentioned earlier, one of the nice features we think with this technology, other than longevity, is the fact that it should only need a one-time calibration. Whereas the other implantable on the market today, the six-month version still requires regular calibration with finger sticks. We expect a calibration at the beginning of the device’s life after implant and hopefully none thereafter.
TMH: Getting back to your flagship device for a minute, how is the development of your GlucoTrack 2.0 prototype system going, and when do you anticipate human trials starting?
PG: Well, thank you. Actually, another fun project that we’re doing, a product that we’re developing, is an iteration on our first generation, our 1.0, and that product took about 60 seconds to take a measurement, it had multiple pieces, it was rather a dated technology, so this was a pretty big overhaul in terms of electronics firmware, mechanical, the basic engineering principles and we believe that we’ve seen very good results internally, we believe we’re going to have much better accuracy than the, than the 1.0 device and also our measurement time is going to dramatically reduce from 60 seconds down to less than two seconds. We’ve been able to achieve that as well, so we’re very excited. These things, though, of course, affect the use case scenario and how the subject or the patient actually uses the device.
And in so doing, there are some human factors and considerations that we’re working through that seem to be compromising the consistency of the accurate readings that we’re getting. So before we migrate into our clinical trial full force, we want to resolve some of those consistency issues and put those to bed, which we’re working on. We already have approval for a clinical study in Israel, and we could start when we’re ready likewise, we’re signing up for us to start a study here in the US as well and expect approval to do that study right around the end of Q1, beginning of Q2 and that is in line with when we anticipate to have the human factors issues resolved and be able to start the clinical trial.
TMH: If everything goes to plan, once complete, how do you anticipate the new system to change the way patients live with diabetes?
PG: Good question. So with that particular system and we see that the big challenge is that there are a lot of patients not measuring their glucose because of the hassle factor of carrying this toolkit around and taking a minute and a half, two minutes to do a measurement. We believe that we’re going to be bringing patients into the market, if you will, patients who have not been testing themselves regularly. So they will be testing themselves for the first time and learning how diet and exercise and other decisions, their medications and so forth affect their blood sugar levels. And also, of course, we expect that we’ll be pulling some patients from the segment of the market that is doing the finger sticks as they should, and they would migrate over because they would want something more convenient and less painful.
So we expect that those patients would probably be testing themselves more frequently because they’re the more motivated patient already. On the implantable side, we believe that by removing the wearable factor, we’re going to be targeting a very significant group of patients who have not continued using CGM technology or will not consider using CGM technology. Studies have demonstrated that once the cost issue is resolved that the biggest hurdle is, in one form or another, one of the wearability concerns, it itches on the skin, it hurts to go through the skin, it hurts when they lay on it. They don’t want somebody to see them with it. They don’t like replacing it once every 10 days or whatever they have to do for their device.
So by taking all of those factors away, we believe these patients will be primed for CGM, and some existing CGM patients may also wish to migrate over. As one very, very seasoned endocrinologist told me recently, he said, we don’t spend half of our time trying to figure out how to treat our patients. We spend half our time trying to figure out how to convince our patients to do the treatments we give them, and this product is beautiful in that it takes away the patient compliance issue altogether.
TMH: You touched on the wearability and some of the concerns people have with the devices and certainly the need for them in the United States, marketwise, is expanding beyond your current focus in the US on the horizon?
PG: Oh, absolutely. Yes. we’re presently modifying our quality management system to be compliant with the new European regulations, the MDR as it is called, and we anticipate filing for CE mark approval within the European Union, leveraging that as well as, of course, all of our engineering data and our clinical trial data from the US, and that will be a springboard to other geographies that accept either CE mark or FDA that we could migrate to after that. Still, the EU is our next big target.
TMH: It sounds like an exciting and eventful year ahead of you, is there anything else we maybe haven’t touched on that is important for our viewers and your investors to know?
PG: I’d say there’s an intangible that we have that is not product focused per se, but we have put together a team, a seasoned leadership team that has very, very strong experience in diabetes device technology, not just glucose sensing but also insulin delivery systems and drug-device combination systems and working at companies such as Medtronic and Dexcom and Insulate and the former MiniMed and so we think we have this team that while we may not be the brightest guys and gals in the room but we know where to step and when to step. We have the grey hair to prove that, and we’ve learned a lot through the years.
So we feel that we have a team that we can bring together multiple diabetes solutions to the market. We won’t just be a one-product solution company or two-product solution company but go after multiple verticals, glucose sensing, insulin delivery type one, type two, pre-diabetes, insulin-dependent, non-insulin-dependent and now I realize that the market may be skeptical of that because no one has created a multi-year implantable glucose sensor or a non-invasive glucose sensor, but we really believe we have the team in place, the leadership team in place to bring this forward where we have a lot of successful milestones lined up for 2023 that make us very excited for our shareholders and of course for our future patients, most of all.
Thanks for spending some time with us at The Market Herald today and sharing your insights with our Top Line audience and your investors.
We’ve been speaking with GlucoTrack chief executive Paul Goode.
The company trades on the Nasdaq Composite under the ticker symbol GCTK. You can visit them at glucotrack.com for more information.
Thanks for watching Top Line. In Vancouver, I’m Simon Druker. We’ll see you next time.
FULL DISCLOSURE: This is a paid article produced by The Market Herald.