A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor.
The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented new data highlighting the accuracy the G7 in children at last month’s Advanced Technologies & Treatments for Diabetes (ATTD) conference.
Dexcom Chief Technology Officer Jake Leach recently told Drug Delivery Business News that while the excitement around G7 remains, the San Diego-based company has more to offer.
“We are producing a portfolio of products,” Leach said. “We’re differentiating our portfolio. We have our G6 product that is soon to be replaced by our G7, and we’re really excited about that G7 product. We also have another product in the portfolio that’s new, which is called Dexcom One. The idea behind that product is it’s got a differentiated set of features that helps expand the use of Dexcom CGM to a broader marketplace beyond where G6 and G7 are in terms of positioning for different customers. We’re really excited about that.”
Dexcom designed the Dexcom One system as an easy-to-use, real-time CGM (rt-CGM) that it aims to make more affordable and accessible for people with diabetes in the United Kingdom. Dexcom One is comprised of a wearable sensor and transmitter that continuously monitors glucose levels and sends real-time values wirelessly to a compatible smart device via the Dexcom One mobile app.
The company already launched the platform at the end of last year in a handful of European countries: Bulgaria, Latvia, Estonia and Lithuania. Dexcom One uses the G6 hardware platform with a different software experience, marking the company’s first leap into a differentiated product portfolio.
Leach said the introduction of G7 and Dexcom One — the latter of which was launched in the U.K. last month — allows the company to reach a larger segment of the diabetes patient population around the world.
With Dexcom One playing a major role, Leach said the company increased global access to its products by over one million individuals in 2021. That reach will continue to grow, as CEO Kevin Sayer said in January that the company is excited for a year that will consist of “more activity than we’ve ever seen.”
Analysts remain positive on Dexcom with all of its upcoming offerings. BTIG’s Marie Thiabult wrote that the company is experiencing strong adoption trends as the introduction of G7 in the U.K. is “going well.”
“Underlying business indicators are stable,” Thibault said. “We remain bullish on long-term, broad-based growth for CGM adoption.”
Said Leach: “We’re market leaders in the United States, and we really want to expand our business outside of the United States and really get to customers who can benefit from Dexcom CGM. It’s about having the right products for the right customers, and Dexcom One opens us up to a large population of customers who have diabetes but didn’t have access to G6 or G7.”
Awaiting a G7 launch in the U.S.
Although the expansion of Dexcom One highlights a foray into a diverse portfolio, the countdown to G7’s U.S. launch is at the forefront of the company’s efforts. Leach echoed previous statements from Sayer, saying that the process never moves as fast as they’d like and it’s hard to predict when the FDA 510(k) clearance will come, but back-and-forth with the FDA is ongoing.
G7 features a 60% size reduction from the previous generation G6, a 30-minute warmup (down from two hours for glucose readings to begin in the past), more information in one place with personalized insights, extended-wear design and more.
Sayer has previously pointed to the simplicity of the wear experience, with the process consisting of unscrewing a cap, putting the sensor on your body and pushing a button. The device is turned on and can be paired with a smartphone
Leach said Dexcom is providing the FDA with all information it may need, calling it “a great collaborative review process,” with the “meaningful launch” of G7 in the U.S. still slated for this year. Dexcom will be ready when that regulatory nod finally comes, he said.
Seeing Dexcom’s growth and the evolution of its technology over his 18 years at the company, Leach said the scale of where the company was when it first started launching products compared to today, with millions of customers around the world, is remarkable. However, it still takes time to ensure the products get into the different channels, he noted.
G7’s launch in Europe got started within weeks of securing the CE mark, highlighting how quickly Dexcom can move on the commercial front. Leach said manufacturing lines are already ramping up for when that U.S. approval finally comes.
“We’re really looking forward to continue to expand access to CGM around the globe,” Leach said. “There’s hundreds of millions of people that have diabetes and only half of them are actually diagnosed, so we believe that CGM is a tool that can really help people improve their health, whether they’re taking insulin or medications, oral medications or even just lifestyle choices like diet and exercise.
“We just feel like CGM is a wonderful tool to help people live a healthier life.”