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Dexcom submits new glucose sensor to FDA, expects launch this summer

January 9, 2024 By Sean Whooley

Dexcom Stelo glucose monitor
The Stelo glucose monitor. [Image courtesy of Dexcom]
Dexcom (Nasdaq:DXCM) announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year.

The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It features a software experience tailored specifically for non-insulin users.

In early 2023, Dexcom Chair, President, and CEO Kevin Sayer hinted at potential new avenues when speaking to Drug Delivery Business News. He explained that the company wanted to broaden its focus, even revising its mission statement.

At the company’s June Investor Day event, it revealed its plans to bring the new product to market in the U.S. in 2024. According to Dexcom, the target population includes approximately 70% of Americans with diabetes.

The company expects to launch Stelo in the U.S. in the summer of 2024.

“Understanding glucose levels is key to unlocking our metabolic health, and Stelo will help users see first-hand how their health is affected by factors such as diet, exercise, sleep and stress,” said Jake Leach, Dexcom EVP and COO, during the company’s preliminary earnings announcement yesterday. “Through our expanding product portfolio, Dexcom is defining the future of sensing technology and empowering people to take control of health.”

Dexcom also released preliminary fourth-quarter results. It expects $1.03 billion in revenue for a 26% year-over-year increase. The company projects a full-year sales total of $3.62 billion, marking a 24% increase from 2022.

The company projects $4.15 billion to $4.35 billion in sales in 2024, representing 16% to 21% growth over 2023. Those numbers include the expected impact of the new Stelo sensor.

“Dexcom had an incredible year in 2023 with the largest expansion of coverage in our company’s history, a successful rollout of Dexcom G7 in the U.S. and expansion of G7 to more than 15 international markets, and an acceleration in our revenue growth,” Sayer said. “We plan to continue this momentum in 2024 and further expand our addressable market with the expected launch of our first product for people who do not use insulin.”

Dexcom stock was up more than 4% to $129.63 apiece by the close of trading yesterday. MassDevice‘s Medtech 100 Index was up more than 1%.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Dexcom, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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