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A California startup is aiming to “redefine continuous glucose monitoring” for people with diabetes by introducing a next-generation, intelligent CGM that promises to be smaller, less-invasive, more reliable and lower cost than anything on the market now.

The new system, from San Diego-based Biolinq, will use a sensor just the size of a nickel, that will be inserted in the form of a quick press-on skin patch. It will use microarray technology for best-in-class accuracy, and house a microchip inside that will handle the measurements and connectivity.

Though it's a few years out from hitting market at best, functionality and accuracy seen in early human clinical studies are impressive, we’re told. And many folks “in the know" in the diabetes tech industry have described it as some of the most promising technology on the horizon.

Earlier in 2019, the JDRF T1D Fund led an investment round of $4.75 million into Biolinq.

John Sjolund

Because the system is still under development, there’s a lot the company cannot say publicly yet. But Biolinq VP of Product Strategy John Sjölund tells us: "This technology is unbelievable… when we've shown it to companies who know CGM very well, they cannot believe their eyes! It's kinda crazy, the product we're working on here. It's totally different."

Normally that kind of gushing from a company exec brings on eye-rolling. But Sjölund certainly has some serious diabetes street cred. He’s lived with type 1 diabetes himself for decades, and many may recognize his name as inventor of the Timesulin insulin pen cap dose tracker back in 2011. That product was eventually sold to Bigfoot Biomedical in 2017, where Sjölund worked until joining Biolinq in September 2019. He tells us the company caught his eye based on the industry-insider buzz about what they’re developing.

 

A new kind of CGM sensor

Here's what we know so far about the Biolinq system under development:

  • The sensor is small hexagon about the size of a nickel, that would be thinner than existing CGM tech. It will be applied like a band-aid, with a small adhesive patch on the back that is expected to last at least 7 days, or longer (which may depend on FDA).
  • Each sensor has its own built-in rechargeable battery as well as an enclosure housing all the other tech.
The in-development Biolinq CGM sensor
  • The sensors will not require an insertion device like existing CGMs do, but would instead use a press-on sensor patch device that’s ready-to-go right out of the box. "You don't feel it going in, you just feel your finger pressing on the skin," Sjölund says.
  • The company hopes one big benefit will be that Biolinq could be worn on other parts of the body that a traditional CGM can't, because of certain skin fat underneath, especially for very young children where sites may be more limited. "It opens up more real estate on the body," Sjölund notes.
  • It monitors glucose fluctuations “differently in almost every way” from existing products. Using microarray technology, an array of mini sensors monitor interstitial fluid in the dermis (just below the skin about a fraction of millimeter), rather than somewhat deeper below the skin with a tiny wire, like existing CGMs.
  • Rather than requiring a separate transmitter attached on top of the sensor (like Dexcom, Medtronic, Senseonics, and even the upcoming non-invasive SugarBEAT CGM) the Biolinq product would have all the parts assembled into one.
  • There is a microchip inside that does the thinking and glucose monitoring and transmits data via Bluetooth to a smartphone app, and potentially other devices,.
  • Functioning as a platform, this sensor will be able to go beyond just glucose monitoring to also tackle other biomarkers for other health aspects and applications.

The whole system is built on a foundation of data science and predictive analytics, otherwise known as Artificial Intelligence, according to Sjölund.

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Conceptual design for the Biolinq CGM sensor, still in the pre-FDA development stages.

“I am tasked with building a new way of interacting with technology and diabetes. Contextual, smarter, more automated — to free up brain space and let (patients) focus on things other than (their) diabetes," he explained in a recent Medium post in which he explains his choice to join the company.

 

Aiming for widespread CGM use

"We're looking to redefine CGM," says Dr. Jared Tangney, Biolinq's Co-founder and Chief Executive Officer. "It's an approach very different from what's out on the market. I think our vision is to ask how we can simplify and improve the user experience for CGM, and how we can make it more accessible for people with diabetes. How can we lower the barriers so there's really no excuse to not use (CGM)? Once you try it and see the benefits, it'll show that this is really such a helpful technology."

Indeed, one of Biolinq’s key goals -- which mirrors the broader industry push led by Dexcom and Abbott Libre, in particular -- is making CGM accessible for a far broader swath of patients.

With less than a third of type 1s currently using the technology worldwide, many believe that lower cost and ease-of-use are critical factors in raising awareness and adoption of CGM for better diabetes management. The hope is that CGM will become standard care for almost all PWDs.

 

The Biolinq story

This small startup with roughly 23 people isn't exactly new, as it was first formed in 2012. But initially, it had a different name and had its sights on sweat-monitoring biosensors for athletes rather than glucose monitoring for PWDs.

Founders Jared Tangney and Josh Windmiller are both Ph.D. grads from UC San Diego and began with the name Electrozyme, building printed electrochemical sensors that detected biomarkers in sweat for the wearable fitness market. Notably, that outfit raised $1 million in seed funding from Dallas Mavericks’ owner and Shark Tank star Mark Cuban, as well as $2.6 million in grants from the National Institutes of Health. But while that led to initial R&D, it didn't last and in 2015 the company renamed itself Biolinq with a new focus on continuous glucose monitoring for PWDs.

Since then the small outfit has been largely in stealth fundraising mode while quietly moving forward. The company completed its first clinical study in 2018.

Now, they’ve received the $4.75 million from JDRF, in addition to $10 M in Series A venture financing raised a few years back.

CEO Tangney said in a statement: “This funding round validates our strong clinical results and will continue to advance our technology platform towards commercial feasibility.” 

Katie Ellias, Managing Director at the JDRF T1D Fund, also issued a statement saying:

“We are impressed with the initial clinical results Biolinq has achieved with their very promising technology…

“We believe the company is well-positioned to set new standards for minimally invasive CGMs and are excited to support Biolinq during this critical phase as they work towards bringing next-gen solutions to market and explore future applications for people living with type 1 diabetes.”

Biolinq has also added some big names from the D-tech industry to their ranks, including Tom Peyser, an early exec at Dexcom and successful medtech consultant who now serves as SVP of Scientific, Clinical and Regulatory Affairs for Biolinq.

For Sjölund’s part, he says this is the “next evolution” of his diabetes tech career that began about a decade ago with creating Timesulin, which Bigfoot Biomedical is now using as a foundation for their connected smart insulin pen closed loop system in the works.

He’s clearly thrilled about the prospects, not just for his career, but for what this new tech can do for those of us who struggle with this disease every day.

"When you can solve for all of those (barriers) in one product, I believe you can make CGM more accessible. When you can make it more accurate, easier-to-use, with no pain and less expense... you start crossing those items off the list. I believe we're uniquely qualified to do that, and that’s what makes this so powerful!"

We’re certainly intrigued by what Biolinq's working on, and look forward to seeing more product details and clinical data once that's available.