Insulet (Nasdaq:PODD) announced today that it commenced the full market launch for its next-generation Omnipod 5 system.
The Omnipod 5 automated insulin delivery (AID) system has now been made fully available through U.S. retail pharmacy channels for individuals aged six years and older with type 1 diabetes.
Acton, Massachusetts-based Insulet received FDA clearance for Omnipod 5, the latest iteration of its wearable insulin pump, in January. The company designed its Omnipod 5 as a tubeless pod with SmartAdjust technology, the Dexcom G6 CGM and the Omnipod 5 mobile app with an integrated SmartBolus calculator.
Users can download the app onto a compatible smartphone or use the Omnipod 5 controller, provided free with the first prescription. The device provides a Dexcom CGM value and trend to the SmartAdjust technology every 5 minutes. It then predicts where glucose will be 60 minutes into the future before increasing, decreasing or pausing insulin delivery, using the wearer’s desired and customized glucose target to protect against highs and lows.
Insulet said in a news release that Omnipod 5 represents the first tubeless AID system that integrates with Dexcom’s G6 and the only one that offers the option of using the compatible smartphone or Omnipod 5 controller. The company added that it is working to expand its list of compatible smartphones to reach a wider population.
Omnipod 5 has shown strong performances in multiple studies, including one that demonstrated significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use. Further data showed HbA1c improvements (1.3%) and time in range improvements (4.6 hours per day) over an eight-week study of adults between 18 and 75 years old.
“With the significant demand for our tubeless AID system and impressive clinical outcomes, we continue to expand access to Omnipod 5 and provide a best-in-class experience to more people with type 1 diabetes,” Insulet Chief Commercial Officer Bret Christensen said in a news release. “Through our team’s learnings from the limited market release, we have met our timeframe and goals. We are thrilled to announce that Omnipod 5 is now fully available through retail, specialty, and mail-order pharmacies to anyone with a prescription and coverage.”
Insulet added that its Omnipod 5 and previous-generation Omnipod Dash are the only insulin pumps available through the pharmacy channel, eliminating upfront cost and four-year lock-in periods that are typical with the traditional durable medical equipment channel.
The company is also looking to widen awareness of Omnipod 5 through direct-to-consumer television advertising on top of its ongoing digital and social campaigns.
“Omnipod 5 has been such a life-changing technology. My patients and I have seen significant improvement of their time in range with no overnight lows and much less work required,” said Dr. Anita Swamy, assistant professor of pediatrics, Northwestern Feinberg School of Medicine, associate clinician, pediatric endocrinology, Ann and Robert H. Lurie Children’s Hospital of Chicago and medical director, Chicago Children’s Diabetes Center. “It has given parents and other caregivers more peace of mind, especially overnight, and that’s priceless.”
BTIG analyst Marie Thibault wrote in a report that the limited market release for Omnipod 5 was expected to last “anywhere from 3-9 months” from a starting point of Feb. 23. Falling within that range is a positive sign, the analyst said, with the company still considered a “Buy” option.
“We think this indicates successful user experiences and logistical capacity during the LMR, which allowed physicians to write prescriptions through a limited distribution network of specialty and mail order pharmacies,” Thibault wrote.