The lots include the next-generation Pivot pump’s disposable cartridge and infusion set. With the milestone, the San Diego-based company said it remains on track for a commercial launch in the first quarter of 2026, subject to FDA 510(k) clearance.
Modular Medical introduced Pivot in September 2025, later beginning the process of converting its manufacturing line to prepare for production. Pivot targets underserved “almost-pumpers,” or adults with diabetes hesitant to move from multiple daily injections (MDI) due to cost and complexity. Modular Medical submitted it to the FDA
The company designed its patch pump for affordability with a user-friendly design. It features a full, 3mL removable cartridge and pump with a simple interface. It expects Pivot to expand access for millions managing diabetes with MDI by providing significant clinical therapy improvement. The company aims to address barriers that prevent many patients from adopting traditional pumps.
Modular Medical said the production lot commencement confirms readiness for high-volume demand once it receives clearance for Pivot.
“We are excited to hit this pivotal manufacturing validation on schedule, bringing us closer to delivering our Pivot pump’s game-changing simplicity to patients underserved by current options,” said CEO Jeb Besser. “This further derisks our expected path to Q1 2026 commercialization, which is subject to FDA response to our current 510(k) application, and would put us in position to drive market disruption.”
