After the FDA voiced concerns about the device's software during an assessment, diabetes tracker manufacturer Dexcom is delaying the G7, the most recent generation of its continuous glucose monitor, for release in the United States.
The company now plans to redesign how the G7 and its smartphone apps transmit alerts to inform the user of material changes in their blood sugar, despite the fact that the wearable sensor was initially submitted to the agency in late last year, reports FierceBiotech.
“We discussed several options that we had, we decided the best option at this time was to revise the software and file it differently and we have added a few other features to it as well based on our discussions with them,” CEO Kevin Sayer said on the company’s second-quarter earnings call with investors, according to a Seeking Alpha transcript.
“We are in the middle of revising the software for that, and have to run it through the complete validation and verification process and resubmit,” Sayer said. The company has narrowed expectations for the device’s initial, limited release in the U.S. to the fourth quarter, after previously planning for the FDA’s go-ahead to come at some point in the year’s second half, and has slated a full commercial rollout for early 2023.
Comparing the latest version to its mainstay G6, Sayer went on to describe how the G7’s development had already brought on a complete revamp of the company’s processes. “We changed the algorithm. We changed the insertion techniques. We changed every manufacturing procedure that we have and completely rewrote the entire app and the software experience, which is a lot for [the FDA] to digest and a lot for us to submit,” he said. “If I look at learnings for us over time, I think we will probably do things a little more incrementally going forward, rather as big as this one was, and we can get things through faster.”
The disposable G7 offers a 30-minute warmup interval after application and is around 60% smaller than its predecessor, which made its debut in 2018. This past March, it was given the all-clear in Europe, and now it is making its way to users in the U.K. A larger continental rollout will begin before the end of the year.
Following the revelation, Dexcom's stock fell by nearly 17% in after-hours trading on Thursday. However, when the Nasdaq opened on Friday, the price started to rise once more, reaching about $80 per share, or about 7% less than its previous close.
Dexcom recorded second-quarter revenue of $696.2 million, or nearly 17% more than the same period the previous year, driven by 39% sales growth in international markets. This includes revenue from the introduction of its Dexcom One programs in Spain and the United Kingdom, which are based on a more affordable, less complex system. Dexcom One, the company's first attempt to market numerous products at various price points, shares the same 10-day sensor technology as the G6 but lacks the same set of software capabilities, automated warnings, and real-time data sharing as the G6 and G7.
Even though there were speculations of a potential merger with the manufacturer of wearable insulin pumps Insulet early this year, Sayer stated in an interview last month that significant acquisitions are not on the company's top of mind despite posting $2.75 billion in cash and untapped credit.
“We’ve been the organic growth story of the decade. No medical device company goes from $40 million to almost $3 billion organically — we’ve done that,” Sayer told Fierce Medtech in an interview during the American Diabetes Association’s annual meeting. “Where we see opportunities to get technologies or capabilities that enhance what we do or possibly enable us to differentiate in the future, we will consider that,” he added, perhaps coming from small startups outside its main product line that the company has already invested in, as well as from the purchase of existing distribution partners to help increase its geographic footprints.
