Modular Medical Submits Pivot Tubeless Insulin Patch Pump for FDA 510(k) Clearance

-Targets $3 Billion "Almost-Pumper" Market with First Simplified and Removable/Replaceable Insulin Patch Pump

- Aims to Improve Patient and Clinician Experience for the Care of Diabetes

SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company") today announced the 510(k) premarket submission of its next generation Pivot tubeless patch pump to the U.S. Food and Drug Administration (the "FDA"). The Company expects to commence the commercial launch of its Pivot pump in Q1 2026.

Key Investment Highlights

Feature	Impact
First 2-part tubeless patch pump	3 milliliter ("ml") removable reservoir; no battery recharge; detachable for showering/physical activity, no controller needed to bolus
Targets $3B "almost-pumper" market	~70% of insulin-dependent adults still rely on multiple daily injection; Pivot pump aims to solve the "3 Cs:" complex, cumbersome, costly
Manufacturing on track	Validated production line conversion on track; Q1 2026 launch-ready upon clearance from FDA
FDA timeline	Submission delayed by U.S. government shutdown; initial FDA questions expected during Q4 2025

"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," commented 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.