Business UpdateJun 29, 2026, 05:27 PM
Modular Medical Launches Pivot Insulin Pump; Receives FDA Clearance
AI Summary
Modular Medical, Inc. announced the commercial availability and initial shipments of its Pivot insulin delivery system in the United States in June 2026, following FDA clearance in April 2026. The company also received FDA clearance for its MODD1 pump in September 2024 but does not intend to commercialize it, focusing instead on the Pivot. Modular Medical aims to expand commercial activities across metropolitan markets by late 2026 and expects to obtain CE mark clearance for Pivot by Q2 2027. The company also effected a 1-for-30 reverse stock split on March 31, 2026.
Key Highlights
- Commercial availability and initial shipments of Pivot insulin delivery system commenced in June 2026.
- Received FDA clearance to market and sell Pivot pump in April 2026.
- Received FDA clearance for MODD1 pump in September 2024, but will not commercialize it.
- Expects to expand commercial activities for Pivot across metropolitan markets by late 2026.
- Anticipates obtaining CE mark clearance for Pivot by Q2 2027 for European markets.
- Effected a 1-for-30 reverse stock split on March 31, 2026.
- Pivot pump holds 3 mL of insulin, 50% more than Insulet's Omnipod's 2 mL reservoir.
- Estimated total addressable market of approximately $3 billion for Modular Medical.
Price Impact
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