Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump.
The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study.
Embecta describes the pump as convenient and discreet, featuring a 300-unit insulin reservoir. Embecta designed it to lighten the burden of managing diabetes while improving user outcomes. Colleen Riley, the company’s CTO, said the pump design is informed by “the unique needs” of people with type 2 diabetes and their healthcare providers.
Henry Anhalt, chief medical officer, says nine out of 10 people with diabetes live with type 2 diabetes. However, Anhalt says the majority of automated insulin delivery systems cater to those with type 1 diabetes. Embecta aims to offer more options and tools to the broader diabetes care community, he says.
“Since we became an independent company in April 2022, our team has been working diligently on our priorities, which include investing for growth — notably in the development of a patch pump,” Kurdikar said. “The 510(k) submission of our patch pump to the FDA is an important step in the advancement of our strategic priorities, and we look forward to working with the FDA to seek clearance for a product that we believe has the potential to positively impact type 2 diabetes management for many people.”