Over the past two years, reporting on the Covid-19 pandemic has dominated media airwaves.

While that intense spotlight on Covid is starting to wane, a byproduct of this obsessive coverage is that one of the world’s most destructive (and insidious) pandemics has slipped out of focus: diabetes.

Now might be a good time for investors to re-focus. One company, GlucoTrack Inc. (NSDQ:GCTK), is seeking to revolutionize the treatment of Type 2 diabetes. More on this later.

In the United States alone, the CDC has estimated there are roughly 37.3 million Americans with diabetes (2021 data), 11.3% of the total population.

Globally, the WHO estimated there were 422 million people with diabetes as of 2020.

Worse still, this number has quadrupled since 1980. This reflects the rise in poor diets/lifestyle habits, and in particular, the increasing prevalence of obesity.

Of these numbers, approximately 90% of these patients have Type 2 diabetes (not requiring regular insulin injections).

Living with diabetes means constantly testing one’s self to monitor the disease. And here is the huge problem in treating Type 2 diabetes.

Huge patient populations, poor testing compliance

Diabetes is a killer. According to the WHO, it is the 9th leading cause of death globally (2019 data). Even for those who don’t have a terminal outcome, Type 2 diabetes is associated with a long list of serious complications.

  1. Heart disease
  2. Stroke
  3. Kidney disease
  4. High blood pressure
  5. Eye damage

Even more alarming given the huge populations suffering from this affliction, is the dismal data on patient compliance with the (crucial) blood sugar testing required to monitor diabetes.

One study, published by the National Library of Medicine reported that only 57.6% of patients demonstrated “good compliance”.

The same study found that this low rate of compliance was roughly equal across all demographics. Young or old, male or female, rich or poor; proper compliance is a major issue in successfully managing (treating) diabetes.

Eliminating the pain and blood from Type 2 diabetes testing

Why is compliance with this necessary and important testing so inconsistent?

Jab your finger with a needle tip, with enough force to draw blood.

Since the beginning of diabetes treatment, that has been the process of doing these necessary blood sugar measurements. Blood on a strip.

It’s not pleasant, whether you’re averse to pain, averse to blood, or both. It explains why compliance with Type 2 diabetes testing is so abysmal.

Consequently, pioneering a Type 2 diabetes test that can avoid the pain and the blood (while achieving consistent results) has been a “Holy Grail” in medical device research for many years.

It’s a challenge that has already been met with Type 1 diabetes.

DexCom Inc. has developed its “continuous glucose monitoring” for Type 1 diabetes. Even after the bloodbath in biotech stocks, DexCom sits with a $34.1 billion market cap.

This is despite the fact that DexCom is a one-product company. But with the combination of revolutionary technology and very high adoption rates, DexCom generated 2021 revenues of nearly $2.5 billion.

For reasons only a scientist could properly explain, achieving the same testing consistency – calibrated to the unique biology of each individual patient – has been a much more elusive goal with Type 2 diabetes.

Enter NASDAQ-listed GlucoTrack Inc., with revolutionary diabetes-testing technology for Type 2 diabetes that has the potential for very robust adoption rates.

GlucoTrack is not the first biotech company to pursue this quest for a patient-friendly solution for Type 2 diabetes testing. But it may very well be the first to do it right.

GlucoTrack adds some heavy-hitters to its team

How promising is GlucoTrack’s R&D for its no blood/no pain, portable and nearly instant Type 2 diabetes blood sugar test?

Promising enough to lure not one but two executives who played prominent roles at Dexcom.

Front and center among these recruits is GlucoTrack’s CEO and President, Paul Goode. Goode rose to the position of Director of Engineering at DexCom during his tenure with that company.

While there, Goode was already doing some personal sleuthing. He was looking for the next DexCom: the company that could solve the Type 2 diabetes testing conundrum.

That search led Paul Goode to GlucoTrack, at that time Israel-based Integrity Applications. Now with a head office in New Jersey and a NASDAQ listing, GlucoTrack is transitioning to U.S.-based biotech.

The Market Herald sat down for a chat with CEO Goode. At the top of our list of questions: how and why did he make the transition to Integrity Applications (now GlucoTrack, Inc)?

“As someone with deep expertise in the medical device market, it’s a rarity to find a company that is uniquely positioned to solve a problem in a way that addresses patient’s pain points so flawlessly, not forcing people to choose between their health and their lifestyle.

Knowing the R&D at GlucoTrack has such a novel solution within reach has been the driving force in the team and I joining Integrity Applications as we aim to disrupt the diabetes device market.”

Joining Goode at GlucoTrack from DexCom is Dr. James P. Thrower, who has assumed the role of Vice President of Engineering, together with Paul Goode, authored dozens of DexCom’s patents.  

Paul Goode hinted to The Market Herald that investors should be looking for further additions from that original Dexcom team in the near future.

Very promising results in early testing

While GlucoTrack may have changed its name and base of operations, there has been no loss of continuity or stumbles in its R&D. On June 22, 2022, the Company released an update on its “Gen 2 Non-Invasive Glucose Monitor”.

Perhaps the most notable excerpt:

The completion of bench testing and analyses of the Gen 2 clinical prototype system was followed by simulated use testing. During this in-house testing, the Company achieved better than expected accuracy and performance.

Initial data collected indicates that the Gen 2 system may achieve an accuracy comparable to invasive Continuous Glucose Monitors (CGM’s) currently available in the market when conducting the upcoming first-in-human clinical study. [emphasis mine]

Officially, GlucoTrack will only be able to declare “mission accomplished” once it goes through the FDA’s formal approval process for medical devices. This will include at least one in-depth clinical trial.

That formal approval process will include testing similar to what GlucoTrack has already completed with its in-house testing. Savvy investors may connect the dots with these preliminary results and conclude that GlucoTrack is a strong bet to make it to the finish line here.

Not included in the 2022 release was another of GlucoTrack’s important goals with this device.

The Company is targeting a price level that would make this blood sugar testing cost-competitive with the conventional blood-on-a-strip testing used by Type 2 diabetes patients.  At such a price level, sky-high adoption rates for the Gen 2 would seem to be a lock.

“At risk” Type 2 diabetics need better testing now

Crunch the overall numbers for diabetes, and it works out to roughly 378 million people globally and 33.5 million in the U.S. alone with Type 2 diabetes. All are potential customers for GlucoTrack’s next-generation Type 2 diabetes tester.

However, we can crunch the numbers further.

Factor in the 42.4% of Type 2 diabetics with poor compliance in their testing, and we come up with an “at risk” population with an especially critical need for non-invasive (and accurate) diabetes testing.

More than 14 million Americans are so averse to blood-on-a-strip that they are jeopardizing their health through being in poor compliance. These are patients who can be expected to immediately embrace no pain/no blood sugar testing.

That’s a compelling market opportunity for investors.

Pocket-sized, portable, and nearly instant results

The GlucoTrack “Gen 2” is small enough to be carried by diabetics in their pocket (or purse). Battery-operated, the device is portable, with readings from the test delivered wirelessly to the user’s smartphone.

With a clip that is painlessly attached to the patient’s ear, Gen 2 can produce its test results in mere seconds.

For patients, the Gen 2 checks every box on their wish list for an ideal Type 2 diabetes tester. For physicians, the ultimate determinant will be patient treatment outcomes.

If GlucoTrack can duplicate its preliminary results through the formal approval process and if patient compliance rates soar as a result, doctors can also be expected to be enthusiastic in adopting this revolutionary testing for Type 2 diabetes.

Gen 2 will need to go through the formal “clinical trials” process, about which many investors are already familiar with respect to drugs. However, the process for device testing is quite different and somewhat more streamlined.

This means that taking a medical device through this process tends to be both faster and cheaper than piloting a pharmaceutical through clinical trials, which presents a unique opportunity for early investors.

In speaking with The Market Herald, CEO Goode indicated that if GlucoTrack’s preparatory testing of Gen 2 is thorough enough (and satisfies the FDA) that it may only require a single, large-scale (formal) trial to obtain regulatory approval, creating a direct pathway to bring the device to market.

Is the acute need for Gen 2 actually much greater?

In explaining Type 2 diabetes testing to The Market Herald, Paul Goode revealed an interesting insight on the Type 2 diabetes patients officially regarded as being in good compliance.

To be “officially” in good compliance requires the Type 2 diabetes patient to check their blood sugar only twice per day.

For patients whose condition is especially stable, two tests per day is generally sufficient. Hence the low bar set for “good compliance”.

What about Type 2 diabetes patients whose conditions are less stable? As Goode observed, for these patients (only) twice-a-day measurements provide little more than “random numbers”.

Over 40% of Type 2 diabetes patients already can’t even meet the threshold of twice-a-day testing due to aversion to the pain and blood. How many of the high-risk Type 2 patients fail to do the (at least) 3 – 4 tests per day necessary to provide reliable monitoring?

Logic suggests it’s another significant percentage. And likely a lot more Type 2 diabetes patients desperately in need of Gen 2 becoming available.

It’s part of what motivates Dr. Paul Goode in his professional quest to bring an accurate and pain-free Type 2 diabetes tester to market which patients will actually use.

Another heavy-hitter joins GlucoTrack

GlucoTrack Inc.’s promising solution for Type 2 diabetes testing has caught the attention of biotech executives outside of its much larger peer, DexCom. On June 22, 2021, the Company announced the addition of Luis J. Malavé to the Board of Directors.

Malavé boasts his own impressive biotech credentials: more than 30 years of “leadership experience” in the MedTech industry.

Much of that experience (~25 years) is also connected to diabetes management devices. This includes his prior roles at $100 billion+ NYSE-listed Medtronic and with NASDAQ-listed Insulet, an $18 billion company in its own right, where he served as Chief Operating Officer

We wanted to ask Luis Malavé a similar question to what we posed to Paul Goode: what lured someone with deep experience with major device developers to a junior biotech company like GlucoTrack?

“It has always been abundantly clear that a non-invasive glucose monitor would be a game changer for the industry. After understanding the science and methodology behind GlucoTrack, I believe that it can be a pioneer in the space, similar to what Medtronic and Insulet did for the insulin pump market and Dexcom did for the continuous glucose space.”

A potential Type 2 diabetes solution is generating a lot of excitement

The need for better (more patient-friendly) Type 2 diabetes testing is as obvious as it is important. For this reason, biotech companies have been pursuing such a solution for many years.

This is more than pure altruism.

The global diabetes devices market was valued at US$26.7 billion in 2021, according to a 2022 research report from Grandview Research. And Grandview is estimating a very robust CAGR of 8.2% for this market from 2022 through 2030.

An extremely urgent need. A huge prize for success.

Nothing new there regarding Type 2 diabetes testing. What is new is that a junior biotech Company with (at present) a very lean market cap of only $34 million has gotten some senior industry executives very excited with its R&D.

Thanks to Covid hogging the spotlight across the entire healthcare spectrum for the past two years, GlucoTrack Inc has been flying under the radar of investors even as they are positioned to bring a game-changing product to this immense and underserved market.

Given the millions of people in urgent need of better Type 2 diabetes testing and the billions of revenue dollars on the table for a strong solution, it’s likely that investors are going to zero-in on this biotech opportunity sooner rather than later.

FULL DISCLOSURE: This is a paid article by The Market Herald.

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