After another successful quarter, diabetes tech players look ahead to key product launches – MedTech Dive

Continuous glucose monitor and insulin pump makers continued their 2021 success last quarter while other medtechs were forced to manage through a pandemic spike that dragged third-quarter results.

Dexcom, Tandem Diabetes Care and Insulet grew users and revenues or sales amid the ongoing jump in use of wearables and digital health services. The success for diabetes tech comes as the space still has highly anticipated product launches on the horizon, including Dexcom’s G7 CGM system and Insulet’s Omnipod 5 insulin pump.

Dexcom CEO Kevin Sayer told investors that the G7 system is still on track for a 2021 CE mark clearance in Europe, setting the company up for a fourth-quarter launch. The CEO added that the company expects to submit its 510(k) application with the FDA in the next few weeks for the G7 hardware and software for both Android and iPhone systems.

“G7 is on schedule, and it’s coming,” Sayer said during an Oct. 28 earnings call. “All of the efforts related to G7 are moving at a frenetic pace around here.” 

J.P. Morgan analysts wrote that the system’s FDA application will be submitted as an integrated CGM 510(k), meaning the product “will be reviewed under the 90-day decision policy, which points to a US launch likely in late 1Q/early 2Q” of 2022.

Investors seemed impressed with Dexcom’s results and G7 update, sending shares up by nearly 9% between Oct. 28 and Wednesday.

MedTech Dive/Ricky Zipp

 

Insulet CEO Shacey Petrovic told investors the company is still working with the FDA on review of the upcoming Omnipod 5 pump. After submitting additional information in September that was requested by the agency, Petrovic said Insulet is now in the final stage of the review.

Omnipod 5 can connect with a CGM and automatically deliver insulin doses to patients based on blood sugar readings. The product will directly challenge Tandem’s Control IQ technology and Medtronic’s MiniMed automated pump systems.

Analysts have hyped the latest Omnipod product as a potential market leader because it will be a wireless patch, is expected to come in at a lower price and be available to patients through the pharmacy rather than a durable medical equipment channel.

Insulet originally expected an Omnipod 5 launch in the first half of 2021, and Petrovic said in May that the company was in the final stages of the process. However, a backlog created by the pandemic and the prioritization of COVID-19 work slowed the review, as did the agency’s request for more data.

Due to an approval expected later in the fourth quarter, Omnipod 5 will have a limited release this year before expanding in 2022. Although the limited launch is planned to be longer term.

“Omnipod 5 will be in a limited market release for some …….

Source: https://www.medtechdive.com/news/diabetes-tech-successful-q3-dexcom-insulet-tandem/609834/