The company completed its MODD1 product cartridge production run, meaning it can now turn to production for its Pivot product. San Diego-based Modular Medical unveiled Pivot, its next-generation insulin patch pump technology aimed at simplifying diabetes care, earlier this month.
Its new pump designed for “almost-pumpers” targets adults with a user-friendly, affordable design. Modular Medical’s current pump, the MODD1, won FDA clearance nearly a year ago. It has microfluidics technology that allow for the low-cost pumping of insulin.
MODD1 system has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. The pump uses a provided, single-use, disposable battery.
Modular Medical announced recently that it validated its insulin pump cartridge line for human-use production in the U.S. Days later, it reported the first human use of the MODD1 pump. Now, it continues to move toward the debut of a next-gen pump, set for FDA submission in October.
According to the company, Pivot will be the first tubeless, removable three-milliliter patch available to consumers.
“I want to congratulate our operational team for the successful validation of our MODD1 manufacturing process and production of human use cartridges,” said Jeb Besser, CEO of Modular Medical. We will now begin converting our cartridge line to Pivot production, and we expect it to be ready to produce cartridges for our Pivot product upon receipt of clearance from the [FDA].”
“The ability to scale production is a key differentiator in the pump space, especially given the much higher volumes required for a patch pump. Modular Medical’s simple, low-cost platform was designed from the ground up for high volume manufacturing.”
