Modular Medical (Nasdaq:MODD) announced today that it submitted its next-generation MODD1 insulin pump to the FDA for 510(k) clearance.
San Diego-based Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump.
Modular Medical designed the 90-day MODD1 with new microfluidics technology to allow for the low-cost pumping of insulin. Its new intuitive design makes the product simple to use and easier to prescribe.
The pump 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.
In a news release, DiPerna stated that more than 75% of those who could benefit from an insulin pump choose not to wear one. He said the company believes its simplified design could encourage “almost-pumpers” to adopt the technology for their diabetes management. In turn, they could avoid the complexity and expense required by current solutions, he said.
CEO Jeb Besser said the company expects initial questions from the FDA during the quarter ending June 30, 2024. While it works with the FDA, the company plans to prepare applications to garner marketing approval in the UK. Operationally, Modular Medical plans to move its pilot production line to its manufacturing partner to prepare for commercial launch.
“Getting a person who requires daily insulin to adopt a pump instead of multiple daily injections can reduce healthcare costs and improve long-term patient outcomes,” Besser said. “Pump adoption has been impeded by the ‘three-Cs:’ they are too complex, cumbersome and costly. The MODD1 was designed to be simple and affordable with an attractive form factor. We believe our two-part patch pump design, easy-to-learn interface and scalable manufacturing will all contribute to a differentiated and lower-cost marketing approach.”