Paul Goode, President & CEO, GlucoTrack, was recently a guest on Benzinga's All-Access.
GlucoTrack is a medical technology company whose two-year implantable Continuous Blood Glucose Monitoring (CBGM) technology provides discreet, accurate, real-time glucose readings. The company's vision is to create a future where diabetes management is automatic and inconspicuous, empowering people to live boldly and unapologetically.
GlucoTrack is a medical technology company whose two-year implantable Continuous Blood Glucose Monitoring (CBGM) technology provides discreet, accurate, real-time glucose readings. The company's vision is to create a future where diabetes management is automatic and inconspicuous, empowering people to live boldly and unapologetically.
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NewsTranscript
00:00Hey, Zingers, and welcome in to All Access.
00:02I've got a fantastic guest for you today.
00:03It's Paul Good, the President and CEO of Glucotrack.
00:06That NASDAQ ticker is GCTK.
00:10He's joining us for an exclusive talk today.
00:12All Access starts right now.
00:15And it is my pleasure to welcome in the President and CEO of Glucotrack, Paul Good.
00:28Wonderful to be with you today, Paul.
00:30Good to be with you, too, Dan.
00:32Hey, the pleasure and honor is all mine.
00:34Let's start off here.
00:35Give everyone an overview of Glucotrack, if you could.
00:40Yeah, so we at Glucotrack, we tend to think of ourselves as medical technology innovators.
00:46We're trying to increase or improve the lives of patients with diabetes by developing really
00:53people-centric solutions to make their management of their disease less burdensome.
00:58So our flagship product is what we call the CBGM, or the Continuous Blood Glucose Monitoring
01:04System.
01:05And it's a very unique system.
01:06It provides benefits that are above and beyond what current CGM systems do.
01:12In particular, we're targeting to be the very first and only multi-year CGM system that
01:19has no wearable component for the body.
01:21And it measures the glucose directly from the blood, as opposed to from under the skin
01:27in the interstitial space.
01:28So you're getting blood glucose real time, which is the gold standard.
01:31Now, that's phenomenal stuff.
01:33And, you know, let's talk about the CBGM.
01:35Why is your CBGM technology competitive?
01:38Help us understand what makes it different from the traditional CGM's, quote, unobtrusive
01:42integration, end quote, works.
01:46Yeah, so the traditional CGM's, you know, you've probably seen these, they're devices
01:52that are typically worn on the back of the arm.
01:54They're very nice.
01:55They're, you know, they are small.
01:57They've done a lot of good to help people with managing their disease.
02:02Unfortunately, you know, even though there's 10 million lives in the U.S. that are covered
02:08by insurers that can be using CGM technology, little over half of them are using it.
02:15So that leaves almost, you know, half the market segment that is not using the technology
02:20when they could be.
02:22And when you, you know, when you want to understand what the reason is, it really boils down to
02:28two things, wearability and accuracy.
02:31There's a collection of reasons on the wearability front, you know, the adhesive itches the skin,
02:36it hurts going in, oh, I don't want people to see me wearing this, you know, or it snags
02:41on the furniture.
02:42So, you know, all those types of wearability issues are an aggregate one type of a problem.
02:48The other type of a problem is accuracy.
02:50Now, these sensors are indeed very accurate, the typical CGMs, but they do have a time
02:56lag from blood glucose, which is about 10 to 15 minutes.
02:59And that time lag is typically not a problem.
03:02However, when you have rapid rates of change, such as when you're exercising or when you're
03:07eating, or even, believe it or not, when patients with diabetes are stressed or when
03:11they're sick, their blood sugars can go up and down rather quickly.
03:14And that's when that 10 to 15 minutes is very important.
03:18So we believe we address both these issues, both the wearability and the accuracy by having
03:23a fully implantable system with no one body wearable, measuring directly in the blood.
03:29That's absolutely fascinating stuff.
03:31Oh, God.
03:32I'm sorry.
03:33Go ahead.
03:34Yeah.
03:36I was going to say, this is exciting too, Paul, you recently completed your first human
03:39clinical study.
03:40Can you walk us through those key findings and what this means for your development timeline?
03:45Yeah.
03:46Yeah.
03:47So we're excited.
03:49We just finished that first human study.
03:51Now, the first human study, when you think about our technology, effectively, we've got
03:55to prove five things, right?
03:57We've got to prove that the device is safe to place in the patient, prove that it's safe
04:01while it's in the patient, that it functions while it's in the patient.
04:04Fourthly, that it lasts for as long as, you know, we're talking three years here.
04:09And fifthly, that it's safe to remove or replace.
04:13And so what we did was a small acute study where we could address four of those five
04:20things.
04:21The fifth one, of course, is the longevity.
04:23That'll be proven in a subsequent study.
04:26But we did a small study in Sao Paulo, Brazil at Incor Hospital, which is one of the, actually
04:32the leading cardiology and cardiovascular surgery hospital in all of Latin America.
04:39And you may wonder, you know, why are you going into a cardiology or cardiovascular
04:44surgery hospital?
04:45The reason is that our device leverages a lot of the technologies from cardiology devices,
04:52such as implantable Holter monitors or implantable pacemakers.
04:57So the same types of techniques used to build those and to implant those are the same techniques
05:04that we use.
05:05So an interventional cardiologist is the perfect physician to do the implants.
05:11And the implant takes about 20 minutes.
05:14It's an outpatient procedure, very small skin incision, about a half an inch, and local
05:19anesthesia only.
05:21So we did this small study down in Sao Paulo, and we found that, you know, we met our primary
05:27endpoint.
05:28Our primary endpoint was safety.
05:30We wanted to confirm that there was no device or procedure related serious adverse events.
05:35We did that, procedure was safe, but we also wanted to look at, you know, device functionality
05:40and actually the surgical technique, you know, did we need some special tools or not?
05:45You know, we didn't need any special tools or anything different that was typically used
05:49for these types of devices or no special procedures.
05:53So we confirmed that.
05:54And we also had a very good sensor function, and we had very accurate readings.
06:00And we're going to be presenting, you know, the actual data on those at an upcoming diabetes
06:04conference in Amsterdam next week at ATTD conference.
06:09So we're ready for the next step, which is the long-term clinical study.
06:12Dr. Axelrod.
06:13And I know you got a new member of the team as well, Paul.
06:17Tell us about the appointment of Dr. Guillermo Umpierrez to your medical team.
06:22How does his expertise influence your technology development?
06:26Yeah, we're super excited to have Dr. Umpierrez, you know, from Emory University in Atlanta
06:32to be, you know, leading our medical advisory board and help us build it out.
06:38He's our first member, and he's got such extensive clinical research experience.
06:44He's been an investigator on so many major CGM studies in the past for, you know, for
06:49some of the commercial players that are out there.
06:52He's published over 500 scientific manuscripts and book chapters.
06:57He's also had like a ton of awards from so many national organizations like the American
07:02Diabetes Association, the American Association of Clinical Endocrinologists, the Endocrine
07:07Society, the American College of Physicians, and the Diabetes Technology Society.
07:12What's great about Dr. Umpierrez is, you know, he's really a patient advocate, and he understands
07:17our technology can bring value to patients.
07:20You know, not everybody will want an implant, but many do because they're frustrated with,
07:24you know, some of these issues that I mentioned before about wearability and accuracy.
07:28And so he will help us understand, you know, how to apply our technology, you know, for
07:34patients, you know, looking for better tools for their diabetes care.
07:37So we're really thrilled to be learning from him and collaborating with him.
07:42It's always great to have those top-level people, Paul, as you well know.
07:45And, you know, when it comes to what I know you guys are going to be doing, I know GlucoTrax
07:48can initiate a $3 million public offering.
07:52What do you plan on using that capital for?
07:56Yeah, so we did close that, and we're using, you know, of course, the bulk of that capital
08:01towards the study that I mentioned a little while ago, which is our long-term study.
08:07So as I mentioned with the first in human, we felt comfortable that we proved four of
08:12the five things.
08:13The fifth one being longevity.
08:14So we need to do a long-term study.
08:17So now we're going to have a fully implantable system.
08:20We're going to be kicking that off in later Q2, and it'll be done in Melbourne, Australia.
08:26There'll be two centers, up to 30 patients, and we're going to run the study for a minimum
08:31of a year.
08:32That's what patients are signing up for.
08:34And if things are still going good every year, which we expect, we will file to extend
08:40the trial for another year, and then yet another year, because we expect the device to function
08:44for three years.
08:46So that'll be kicking off again later Q2, and we're excited for those results to be
08:52rolling in soon.
08:54To look forward for a minute here, how do you see the diabetes monitoring market evolving?
09:00And what role will GlucoTrac play in reshaping?
09:04Here's Paul.
09:08Yeah.
09:09So the CGL market has really evolved and progressed to the point that it is standard of care.
09:16About 2017, there was a major inflection point, I would say, a couple of major inflection
09:23points in the technology, as well as in reimbursement, which really catapulted it into, you know,
09:29again, becoming standard of care and being used by so many patients, even though it's
09:33just a little over half.
09:35But if you go back and look at market research from patients back then, and you look at what
09:41the market research says now, it's relatively the same things that they're asking for.
09:46They want the sensor to last longer.
09:49They want more discreteness.
09:51They want it to be aware better.
09:53They want it to be more accurate.
09:56And those complaints from, say, the 2017-18 time frame are still there today.
10:03And again, there seems to be somewhat of a saturation, if you will, in the patient population.
10:07So we think that, you know, while the device manufacturers have actually made those improvements
10:14that the patients were asking for, and kudos to them for doing so, the patient voices are
10:18still there and they're louder.
10:19And so patients are still pushing for more improvements.
10:22And they're also pushing for, you know, maybe different technologies like what we're trying
10:25to do, which is something that is altogether new and completely redefined and new approach
10:30to glucose sensing.
10:32So we think we can bring that to the patients with diabetes, as well as a lot of these patients
10:38are suffering with a lot of comorbidities and, you know, from other multiple chronic
10:44conditions that you can think of, you know, high blood pressure, cardiovascular issues,
10:49and so forth, kidney issues.
10:52And sleep apnea.
10:53So we believe there's ways to potentially integrate our technology with some of those
10:57other technologies to treat those.
11:00So you can have a sort of one-stop shop to actually treat, you know, maybe more than
11:05one condition with a single device.
11:08So at the end, you know, we just, you know, we're really trying to change the shape of
11:12the future of CGM for patients to bring more innovation and less, you know, or more innovation,
11:20more convenience to the point where, you know, patients don't have to worry about,
11:23you know, constantly ordering and managing their supplies like they do now.
11:27They don't have to worry about, you know, having to replace the sensor every 10 to 15
11:30days like they do now, or maybe it fell off, you know, prematurely, or it's not working
11:35properly.
11:36It's really a set it and forget it, you know, one-time implant for three years, no on-body
11:41wearable, and it just communicates directly to the smartphone.
11:45So that's what we're hoping to provide.
11:46We're really excited to help these patients and bring this vision to them.
11:50I love it.
11:51Very exciting times for GlucoTrac.
11:53And Dean, it was an absolute pleasure talking with you today, Paul.
11:55Thank you so much for your time.
11:58Thank you, Dan.
11:59Really appreciate it and take care.
12:01Have a good week.