Hunterbrook Media launched a brief report on diabetes-focused DexCom Inc. DXCM, citing that the corporate offered the “adulterated” system.
Benzinga reached out to DexCom for feedback and is but to listen to from them.
A shock FDA inspection discovered Dexcom made an unauthorized design change to the G7 glucose monitoring system, with inside checks displaying worse accuracy throughout the board.
Regardless of this, the corporate offered the system, drawing FDA scrutiny. Executives have since departed as affected person complaints climbed, rivals gained share, insiders offered inventory, and accounting practices got here beneath query.
Additionally Learn: Goldman Sachs Bullish On Dexcom And Insulet As Diabetes Tech Surges
Many sufferers are reverting to the G6 or shifting to rivals, suggesting Dexcom’s challenges run deeper than anticipated.
Stories collected by Hunterbrook embody accounts of sufferers struggling extreme penalties from inaccurate G7 readings.
A legislation agency investigating the system mentioned no less than 60 folks have been hospitalized, with a number of deaths alleged. A Fb group devoted to G7 points surged previous 58,000 members in little over a yr.
Former workers describe a tradition that positioned earnings above affected person security.
Some mentioned the G7 was rushed to market to compete with Abbott Laboratories ABT.
The brief report alleges the management of the group behind a part flagged by the FDA reportedly lacked the right experience.
The report added that one former senior director of producing admitted, “Dexcom undoubtedly dropped the ball,” and “the conceitedness of Dexcom is de facto what wanted to be reset.”
Others claimed the corporate compromised security to guard revenue margins.
Endocrinologists interviewed famous higher-than-usual sensor inaccuracies, frequent system failures, and adhesive issues. A number of mentioned they not prescribe the G7, and a few described Dexcom’s responses to complaints as dismissive or deceptive.
Inner paperwork present that in December 2023, Dexcom altered a crucial sensor coating with out regulatory clearance. FDA inspectors later cited the corporate for promoting “adulterated” units after its personal research confirmed accuracy points. Complaints spiked after the fabric swap, in line with Hunterbrook’s evaluation of FDA information.
Regardless of advertising and marketing the G7 because the “most correct CGM,” together with in a 2023 Tremendous Bowl advert that includes Nick Jonas, Dexcom has obtained extra FDA accuracy complaints than Abbott’s competing Libre 3.
Financially, Dexcom has come beneath scrutiny for accounting ways that boosted current earnings. Citing analysts, the report warns the corporate may face one other draw back shock much like 2024, when disappointing outcomes triggered a pointy inventory decline.
In the meantime, Dexcom has been hit by govt departures, together with the abrupt exit of longtime CEO Kevin Sayer, and rising aggressive threats from Abbott and the rise of GLP-1 medication that would gradual diabetes development charges.
DXCM Value Motion: DexCom shares have been down 4.54% at $72.97 on the time of publication on Thursday. The inventory is buying and selling inside its 52-week vary of $57.52 to $93.25, in line with Benzinga Professional information.
Learn Subsequent:
Picture: Picture Nature Journey / Shutterstock.com
