First Removable 2-Part Design Targets $3 Billion "Almost-Pumper" Market with Expected Q2 2026 initial deployment.

Key Milestones & Investment Highlights:

FDA 510(k) Clearance Achieved: Pivot™ pump now cleared for commercial sale in the U.S. - major de-risking event unlocking revenue path.

First-in-Class Removable Tubeless Patch Pump: 3 mL detachable reservoir; no battery recharging required; removable for showering, sports or discretion; quick bolus button without a separate controller.

Targets Massive Underserved Market: ~70% of insulin-dependent adults remain on multiple daily injections (MDI) due to complexity, cumbersomeness and cost - Pivot addresses the "3 Cs" for "almost-pumpers" with its 2-part reusable pump.

Manufacturing Readiness: Production validation lots well underway; initial capacity supports ~6,000 users with scalable low-cost platform enabling a rapid production ramp-up.

Commercial Timeline: Initial customers expected by end of Q2 2026; software enhancements (e.g., variable bolus, improved alarms, ACE/AID compatibility) in development; CE Mark targeted Q4 2026/Q1 2027.

SAN DIEGO, CA / ACCESS Newswire / April 9, 2026 / Modular Medical, Inc. ("Modular Medical" or the "Company") (NASDAQ:MODD), a leader in innovative, patient-centric insulin delivery, today announced U.S. Food and Drug Administration ("FDA") 510(k) clearance for its next-generation Pivot tubeless insulin patch pump. This milestone clears the path for commercial availability, with initial customer shipments planned by the end of Q2 2026.

The Pivot is the first two-part tubeless patch pump featuring a removable 3 mL reservoir, disposable battery, smartphone connectivity for bolus and monitoring, and true electronic accuracy without tubes or constant wear. Designed specifically for "almost-pumpers" - adults with type 1 or type 2 diabetes hesitant about traditional pumps - Pivot offers simplicity, affordability, and flexibility to improve adoption and long-term outcomes while potentially reducing healthcare costs.