Jokke Maki, GlucoModicum - Wearable Needle-Free Precise Glucose Monitoring Solution | LSI Europe '24

Jokke Maki 00:02
Hello, everyone. My name is Jokke Maki. I'm GlucoModicum's CEO. The company started in 2017 when a University of Helsinki research program discovered a new method to transport molecules into the human body and out of the human body without the use of needles. That was quite unique and interesting, and that technology has now been productized into a small-sized, medical-grade device, which is wearable and enables needle-free glucose monitoring. There are quite a few people globally who need to monitor their glucose values; their glucose values are way too high. First, there is a risk group, then prediabetes, and then different phases of type 2 diabetes, and then type 1 diabetes. The annual cost of diabetes-related health costs is roughly 1 trillion, and instead of taking care of the last stages of diabetes-related complications, I think there is increasing focus on doing earlier glucose monitoring and proactive glucose monitoring.

All of us have seen the existing CGMs. They're mainly only used by insulin patients, and then they're making a push towards the larger groups of people, but they are too heavy tools. Wearing a two-week CGM for patients who are not critically ill is overkill, and having the finger prick or A1C is not an optimal user experience either. So there's a massive need for a glucose monitoring solution, which could be and should be used periodically. That's what we've been doing. We've done productization over seven years of hardcore science. We've created multiple different prototypes in Finland, and then we sought the best possible partner in the US. I guess you know stuff like this needs to be done in the US. So we found a really good CDMO. They have 50 years of experience in making FDA-approved devices and extensive experience with CGMs as well. They did 10 months of due diligence before they agreed to work with us. Now we've been working well together. We've productized this technology into a small-sized wearable, which you see there. It's the actual device, so we have optimized the usability, human factors, cost, and manufacturability.

Interestingly, this US-based player flew in a film crew to Helsinki last year. They created a video of us, and that was the first time they created a video like that outside of the USA. That's kind of interesting, isn't it? Then this is the actual product. It is a durable device that the user can use for two years, and then you can charge it overnight. There is a plug-and-play consumable biosensor that you put in the device, and there's adhesive you put on your arm. The product that we are selling here is a one-day glucose monitoring time in range, and then it needs to be accurate, small in size, affordable, and needle-free.

Then how is it possible? With MHD technology, we can extract interstitial fluid to the surface of the skin, the glucose molecules in interstitial fluid. The biosensor reacts to the glucose molecules. It creates a signal that goes to electronics for analysis, and then we get a value. We use existing technologies, which have seen a significant performance increase over the past years, but you see the number one over there, the MHD, that has been the missing link, and that was the reason why I joined this company a while ago. This is the first time there is something new, and we are the only company globally that has the right to use this technology. It has been peer-reviewed, with clinical performance 13 times better than the state of the art. This is the new state of the art.

Interestingly, clinical performance and accuracy are everything. We run broad clinical trials. The overall N with the existing product version is over 1,000. We see a strong correlation to blood glucose in multi-hour glucose tolerance tests. We don't use lab stuff. This is actually a device that is mass-manufacturable. To my understanding, no one has been able to create this earlier. Then, of course, low cost is key. We need to be able to manufacture this cost-efficiently. So actually, this is the device here. The first mass-manufacturable units are shipping as we speak. And I'm then concerned about the biosensor. We will enter into a master service agreement within two months. So we've been doing a lot of work in this field as well.

So fairly high volume is 20.1 million units in the first place. We've been looking at the pricing of Dexcom, and we know that we can go clearly below that, and that's key for us. Otherwise, this wouldn't be viable. Even though Dexcom's pricing went down a while ago, for those who don't know the existing CGMs, once you use it, you throw away everything: the battery, the microprocessor, the electronics, everything. Versus with us, you would dispose of the biosensor. This sets us in an interesting position.

Then we're actually doing this. With the product program, we are designing the packaging. You know how many sensors there will be, and this has been aligned. We are aligning this with the go-to-market partners and distributors. There's the medical-grade app, FDA grade. It's already in use on Android and iPhone. So this is trivial, but we need to make this right as well. We introduced, it was not us; it was one of the most recognized consulting firms on the planet. They introduced this product to 100 medical doctors, diabetes doctors in Italy and Germany. I was worried about what they would say about this. Is this interesting? But you see the text here, willingness to prescribe. I think the numbers are promising, particularly looking at the big user groups over here.

Then the roadmap. All good companies need to have roadmaps. We can miniaturize this even further, with a 50% size reduction and bringing in other analytes concerning the sensors. This is in the works, or actually the first versions do exist. Unique team. It's a busy slide. Don't look at it too detailed. We've done medical devices earlier. The team has IPOs and exits from different companies and runs multi-billion business operations. So I think we have a quite experienced and unique team of 50 persons from 17 nationalities. This is the simplified go-to-market blueprint. Seven years in R&D prioritization, multiple clinical trials, and intellectual property protected very broadly. All of the tech layers have been peer-reviewed and published by the global scientific community, looking at the manufacturing blueprint, go-to-market, and now we're heading towards pivotal clinical trials and launch in the EU. To date, we have used 18 million during the seven years of operation. That's just incredible. Many Americans don't understand this at all. Typically, it's 10 times what we've been using.

We have 13 million in the bank account, and we will be raising 20 to 25 million in Q4 this year. We have received substantial non-diluting funding, and we have a very narrow cap table. A few family offices are extremely knowledgeable about med tech. They have their own medical doctors and PhDs. We have also received the European Commission's Seal of Excellence, and we do have the EIB term sheet for 8 million. So we have the option to use that in the next funding round, or we can skip it.

Yeah, so this is the summary. I have introduced a lot of needle-free, affordable, reusable, small-sized CGM. Even introducing one of these, someone would call it a breakthrough. But, you know, combining all of this hasn't been exactly trivial, and this is interesting. So at LSI, I look forward to discussing with investors and partners who understand what this actually means and who have a shared vision of what we do. On this note, I say thank you for your attention.