U-Pump announced on social media that it reached a new milestone in its development of an AI-powered, reusable insulin patch pump.
The company said on LinkedIn that it completed its minimum viable product (MVP) for the U-Pump system. It designed its patch pump to address affordability, precision and ease of use in insulin therapy.
Currently, Insulet leads the way in the patch pump space with its Omnipod platform of pumps. The market also has expected entries from Medtronic and Tandem Diabetes Care in the future. PharmaSens also submitted a patch pump to the FDA last year, while Luna Diabetes last year launched a pivotal trial for its automated patch pump system. Modular Medical offers its own patch pump that isn’t automated and Embecta won an FDA nod for its own open-loop patch pump, but discontinued the program not long after.
U-Pump says it designed its system to address affordability, precision and ease of use. It features OneMove technology, with a painless, one-step application, no tubes and no setup hassle. The company says on LinkedIn that its system also has “seamless CGM integration” and is “fully compatible” with leading Dexcom and Abbott systems.
Next steps include an FDA pre-submission application for 510(k) clearance for the patch pump “within three weeks,” the company said. It aims to prove that the device is similar to existing approved products, expediting the approval process. This pre-submission enables the company to receive preliminary recommendations from the FDA before submitting an official 510(k) application.
U-Pump says it has discussions underway with strategic partners and investors to scale operations and bring its pump to market.
More about the U-Pump system
U-Pump developed its system with a small, lightweight design that brings advanced AI technology to monitor glucose levels and automatically adjust insulin delivery in real-time. It features an intuitive interface operated by smartphone and smartwatch apps as well, the company’s website says. The company also touts a long-lasting battery and affordable, accessible pricing.
To use the pump, a person simply has to fill its reservoir and insert the reservoir into the pump. The pump automatically connects to the piston and measures the filled volume. Users then glue the reservoir sole to their desired installation location on the body and remove the OneMove system cap. Then, they separate the OneMove system from the reservoir after inserting a catheter.
The system’s standard two-week set includes seven reservoirs, with one reservoir lasting for 2-3 days of use. With each change, the pump is recharged for the full cycle of the new reservoir’s operation, eliminating the need for charging, batteries or refilling, the company says.
According to the company’s website, it aims to embark on a funding campaign this summer after its pre-FDA submission.
This video highlights some of the U-Pump’s features:
