Dive Brief:
- Embecta received 510(k) clearance from the Food and Drug Administration on Friday for its first insulin patch pump.
- The device can be used by people with Type 1 or Type 2 diabetes and worn for up to three days. It includes a 300-unit insulin reservoir so that people with higher daily insulin needs can wear it for all three days.
- Embecta said Tuesday it plans to develop a closed-loop version of the pump for automated insulin dosing that it will submit to the FDA in the future.
Dive Insight:
Embecta said its patch pump was designed with feedback from people with Type 2 diabetes. The company presented data in June finding that 200-unit reservoirs have enough capacity for only 38% of adults for 72-hour wear, while 300-unit reservoirs would have enough capacity for 64% of adults with Type 2 diabetes, assuming a mean daily insulin dose of 96 units. Embecta sponsored the study.
“As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes,” CEO Dev Kurdikar said in a statement. “This platform is also serving as the basis for an automated insulin delivery system in development.”
Embecta said in June that it had submitted an open-loop version of the patch pump to the FDA. In an open-loop system, the user manually controls insulin delivery. Embecta is still working on a closed-loop version of the device that would automatically dose insulin using a continuous glucose monitor and the Tidepool Loop algorithm.
In an August earnings call, Kurdikar declined to provide a 2025 sales forecast for the new pump.
Insulet brought the first patch pump to the U.S. market in 2005, introducing a device design that other diabetes technology companies are looking to replicate. Tandem Diabetes Care and Medtronic are both designing patch pumps.
Last week, Insulet received FDA clearance to offer its Omnipod 5 pump to people with Type 2 diabetes. Diabetes tech firms have focused on Type 2 in recent years as insurance coverage improves.