Modular Medical’s current pump, the MODD1, won FDA clearance nearly a year ago. It has microfluidics technology that allows for the low-cost pumping of insulin.
The company announced earlier this year that it began converting its manufacturing line to prepare for production of Pivot, its next-generation insulin patch pump technology.
Pivot aims to simplify diabetes care, the company says. Modular Medical designed its new pump for “almost-pumpers,” targeting adults with a user-friendly, affordable design. The two-part tubeless patch pump features a 3 mL removable reservoir. It needs no battery recharge, can detach easily for activities like showering and it requires no controller for bolus doses.
Modular Medical said in a news release that the recent U.S. government shutdown delayed its submission. However, upon the government’s reopening, the company completed its filing, adding to its quest for CE mark as well. It also recently received Institutional Review Board (IRB) approval to conduct an in-house study of Pivot. The study will simulate real-world conditions by delivering insulin to adult participants to gather critical data on device function and usability and obtain user feedback.
The San Diego-based company anticipates approval, followed by a launch in the first quarter of 2026.
“The Pivot submission is an exciting milestone in our mission to deliver a differentiated tubeless patch pump experience to those who want a simple pump to manage the treatment of diabetes,” said Jeb Besser, CEO of Modular Medical. “Our Pivot patch pump offers a 3 ml reservoir, the flexibility of removing the pump and the ability to bolus without a separate controller, all without sacrificing the accuracy, communications and clinical reporting advantages of a true electronic pump.
“Convincing a person who requires daily insulin to adopt a pump, instead of multiple daily injections, can improve the patient and clinical experience, while potentially reducing healthcare costs and improving long-term patient outcomes. We believe our two-part Pivot patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated user experience and represents a unique approach to this market.”
