Dexcom Explained

DexCom, Inc.
Type:Public
Key People:Kevin Sayer (chairman, president & CEO)
Products:Medical devices
Revenue: (2023)
Operating Income: (2023)
Net Income: (2023)
Assets: (2023)
Equity: (2023)
Num Employees: (2023)
Footnotes:[1]

DexCom, Inc.[2] is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.

History

Dexcom was founded in 1999 by Scott Glenn, John Burd, Lauren Otsuki, Ellen Preston and Bret Megargel.[3] [4] In 2006, Dexcom received U.S. Food and Drug Administration (FDA) approval and launched the Dexcom STS Continuous Glucose Monitoring System, which is a three-day sensor that provides up to 288 glucose measurements for every 24 hours. Dexcom received approval of the second generation product, the Seven Continuous Glucose Monitoring System, in May 2007. This device improved on accuracy and extended use from three to seven days. In 2008, Dexcom announced two consumer development agreements with Insulet Corporation[5] and Animas Corporation[6] as well as a development agreement with Edwards Lifesciences for a continuous glucose monitor in the intensive care unit hospital environment.[7]

During February 2009, Dexcom received approval for the Seven Plus Continuous Glucose Monitor, its new continuous glucose monitoring system, from the FDA. This product received a CE mark in November 2009. In 2013, development work for integration with Insulet was discontinued. Dexcom entered a non-exclusive agreement with Tandem Diabetes Care, Inc. in 2015 to allow the integration of its forthcoming G5 and G6 continuous glucose monitoring systems into Tandem's insulin pumps.[8] The G5 was approved in 2016 by the FDA for use as a standalone device, while the G6 gained approval in 2018.[9]

Dexcom's first G-series CGM, the G4 Platinum, received a CE mark[10] and FDA approval in 2012 for adults ages 18 and over. This device improved hypoglycemic accuracy by 30%. It also offered a longer range of transmission between the sensor and receiver, as well as a color LCD.[11] The G4 Platinum was approved by the FDA for use in patients ages 2–17 in February 2014.[12] Dexcom received FDA approval in January 2015 for the G4 Platinum with Share, which enabled the sharing of CGM data with up to five other people using the "Share" and "Follow" smartphone apps.[13]

The Dexcom G5 was approved in August 2015 by the FDA for use as a standalone device,[14] the G5 has Bluetooth integrated into its transmitter, enabling it to send data to a mobile device.[15] This allows for use of the device without the standalone receiver. The Dexcom G5 received a CE mark in September 2015.[16]

The Dexcom G7 was approved in December 2022 by the FDA for use as a standalone device and is the most accurate currently approved CGM in the U.S.[17]

Partnerships

Venture Capital arm

In early 2021, Dexcom launched Dexcom Ventures, a venture capital arm focused on emerging continuous glucose monitoring technologies and devices measuring the levels of other types of substances and analytes. [29] In practice, Dexcom Ventures has also invested in cybersecurity platforms for the software used in medical devices. [30]

External links

NASDAQ:

Notes and References

  1. Web site: 2023 Annual Report (Form 10-K) . February 8, 2024 . U.S. Securities and Exchange Commission.
  2. DexCom Showcases Expanded CGM Portfolio at International ATTD Conference, Offering More Choice to People with Diabetes . 26 April 2022 .
  3. Web site: Dexcom adding 500 jobs in Mesa. www.bizjournals.com. September 19, 2019.
  4. Web site: Freedom Meditech raises $7 million. August 7, 2013. San Diego Union-Tribune. en-US. September 19, 2019.
  5. Web site: Insulet Corporation and DexCom Announce Development Agreement (NASDAQ:DXCM). Investor.shareholder.com. January 7, 2008. December 3, 2015. December 8, 2015. https://web.archive.org/web/20151208060344/http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=285480. dead.
  6. Web site: DexComâ„¢ Announces Joint Development Agreement with Animas Corporation. Investor.shareholder.com. June 10, 2008. April 4, 2016. March 18, 2016. https://web.archive.org/web/20160318123026/http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=286182. dead.
  7. Web site: Edwards Lifesciences and DexCom to Develop Continuous Glucose Monitoring Products for Hospital Market (NASDAQ:DXCM). Investor.shareholder.com. November 10, 2008. December 3, 2015. December 8, 2015. https://web.archive.org/web/20151208082139/http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=346852. dead.
  8. Web site: Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems. PR Newswire. July 30, 2015. December 3, 2015.
  9. FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices. March 27, 2018. FDA. March 27, 2018.
  10. Web site: 11 October 2012 . FDA Nod for Dexcom G4 Platinum - Analyst Blog . Nasdaq . Zacks.
  11. Web site: DexCom Stock History. 13 June 2018.
  12. Web site: FDA Approves Pediatric Use for Dexcom's G4 Platinum CGM. 19 February 2014.
  13. Web site: January 29, 2015 . Dexcom G4 Platinum With SHARE Gets FDA Approval . March 2, 2023 . DiabetesInControl.
  14. Web site: Dexcom wins FDA nod for G5 CGM. 25 August 2015.
  15. Web site: FDA approves Dexcom for Bluetooth-enabled CGM G5. 25 August 2015.
  16. Web site: Dexcom gets CE Mark for G5 continuous glucose monitor. 14 September 2015.
  17. Web site: Dexcom G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S.. 8 December 2022.
  18. Web site: Fierce Biotech . 2015-08-11 . fiercebiotech.com.
  19. Web site: Verily Life Sciences . 2017-02-15 . verily.com.
  20. Web site: Dexcom G7 CGM - Powerfully simple diabetes management . 2023-06-28 . Dexcom . en-US.
  21. Web site: FDA Approval of Tandem's t:slim with Integrated Dexcom G4 Platinum CGM Expected in 2015. 7 August 2015.
  22. Web site: FDA Approves New Insulin Pump-Continuous Sensor Combo.
  23. Web site: FDA approves new closed-loop insulin delivery system for people with Type 1 diabetes. 13 December 2019.
  24. Web site: June 7, 2019 . DexCom and Companion Medical Collaboration to Support CGM . March 2, 2023 . yahoo!finance.
  25. Web site: JPM20: Livongo strikes deal with Dexcom to integrate continuous glucose monitoring data. 14 January 2020 .
  26. Web site: Insulet Partners With Dexcom for Automated Insulin Delivery. February 24, 2020. Yahoo Finance.
  27. Web site: Insulet's Omnipod to integrate with Dexcom, Abbott CGMS for automated, smartphone-controlled dosing. 20 February 2020.
  28. Web site: Dexcom G6 integration enables insights from Welldoc BlueStar, Apple's rumored video workout app and more digital health news briefs. 12 March 2020.
  29. Web site: Freeman . Mike . 2021-02-13 . Dexcom unveils new corporate venture fund to invest in sensor, health monitoring startups . 2024-04-15 . San Diego Union-Tribune . en-US.
  30. Web site: MedCrypt . MedCrypt Extends Series B with Additional Investment from Dexcom Ventures . 2024-04-15 . www.prnewswire.com . en.