Insulet (Nasdaq:PODD) announced today that it received FDA clearance for its Omnipod GO long-acting insulin delivery device.
Omnipod GO, which received clearance for people with type 2 diabetes aged 18 or older, covers the basal-only insulin population. The target population typically takes daily injections of long-acting insulin.
The first-of-its-kind, standalone, wearable insulin delivery system provides a fixed rate of continuous, rapid-acting insulin for 72 hours. It features a tubeless and waterproof pod offered in seven different pre-programmed daily rates. These rates range from 10 to 40 units per day, Insulet said in a news release.
Omnipod GO operates without the need for a handheld device to control the pod. Its clearance covers use with NovoLog, Fiasp, Humalog, Admelog and Lyumjev U-100 insulins.
Insulet said it developed the product to serve the type 2 diabetes population earlier in their treatment journey. This technology starts them on pod therapy — built on Insulet’s longstanding Omnipod platform — for insulin delivery, rather than daily injections. If a patient becomes insulin-intensive, Insulet offers a seamless transition to another Omnipod product that fits their needs.
The company plans to commercialize Omnipod GO in the U.S. in 2024.
“Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes,” said Jim Hollingshead, Insulet president and CEO. “Our goal is to help people with type 2 diabetes successfully shift to insulin therapy with a product that fundamentally changes how they feel about diabetes management. We’re excited to bring this new solution to market and deliver on our mission to simplify life for people with diabetes.”
Insulet’s regulatory nod marks the second major insulin pump advance in the past few days. On Friday, Medtronic picked up FDA approval for its next-generation MiniMed 780G insulin pump.
Strong year continues for Insulet
Since Insulet received FDA clearance for its next-generation Omnipod 5 in February 2022, the company has hit a series of milestones.
The company began its full market launch for Omnipod 5 in August 2022. Within a month, it received an expanded FDA indication for the system to include pediatric users with diabetes. All of this occurred in a time of significant change as Hollingshead took over for longtime CEO Shacey Petrovic in May of last year.
Insulet kicked off 2023 with significant purchases to improve its IP portfolio. The company acquired insulin pump patents from Bigfoot Biomedical, then bought assets from insulin delivery technology developer Automated Glucose Control.
Then, in March, S&P Dow Jones Indices announced that Insulet would replace Silicon Valley Bank in the S&P 500 index. That followed the March 10 news that the FDIC took the bank into receivership.
The change became effective prior to the opening of trading on Wednesday, March 15. It added Insulet to the index tracking 500 large companies listed on stock exchanges in the U.S.