Embecta (Nasdaq:EMBC) announced today that it received FDA 510(k) clearance for its proprietary disposable insulin delivery system.
The open-loop system is indicated for adults who require insulin to manage diabetes, including both type 1 and type 2 diabetes. It features a tubeless design with a 300-unit insulin reservoir, informed by feedback from people with type 2 diabetes and healthcare providers.
Clearance marks another regulatory milestone for patch pumps designed for the type 2 population, as Insulet received FDA clearance for its Omnipod 5 for type 2 last week.
Parsippany, New Jersey–based Embecta— one of the largest diabetes tech companies in the world — submitted its pump to the FDA in January. 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.
(CEO Dev Kurdikar spoke to Drug Delivery Business News last year about the opportunities ahead for Embecta. Read here.)
Embecta, the former BD Diabetes unit spinoff, said its system features a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, depending on the user’s needs. Its 300-unit reservoir specifically caters to the type 2 population, which typically requires higher daily insulin usage.
The system also has a locked-down controller with Bluetooth wireless technology and a color touchscreen for a simplified user experience.
“FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching Embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes,” said Kurdikar. “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. This platform is also serving as the basis for an automated insulin delivery system in development.”
Some questions still remain on Embecta after rumors of the company exploring a sale began circulating in July, though.
The analysts’ take on the latest development at Embecta
BTIG analysts Marie Thibault and Sam Eiber pointed to data presented by Embecta earlier this year that highlighted the need for larger insulin reservoirs in a significant percentage of adults with type 2 diabetes on multiple daily injections (MDI) transitioning to a patch pump.
That data, presented at ADA 2024, concluded that a 300-unit reservoir would meet the needs of 64% of adults with type 2 diabetes for 72-hour wear. Meanwhile, a 200-unit reservoir would meet the needs of just 38% of the same population.
The analysts say Embecta previously planned for a limited launch for the pump through one or two sales representatives. They say the company didn’t update on its commercial plans following the approval.
Additionally, the analysts point to continued progress on the closed-loop version, which Embecta intends to submit to the FDA in the future. They expect more details at the company’s December investor day and remain “Neutral” on Embecta.
