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Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump
First Removable 2-Part Design Targets $3 Billion "Almost-Pumper" Market with Expected Q2 2026 initial deployment.Key Milestones & Investment Highlights:FDA
About this update from Modular Medical, Inc.
[{"type":"text","content":"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.Jeb Besser, CEO of Modular Medical, said: \"FDA clearance for Pivot represents years of focused innovation to deliver a truly differentiated tubeless patch pump. By addressing the key barriers - complexity, bulkiness, and high cost - we believe we are positioned to convert millions still on injections to pump therapy. With manufacturing...