Modular Medical confirmed that the manufacturing line for its Pivot insulin delivery system has been validated for human‑use production, a key step toward the company’s expected Q1 2026 market launch.
The Pivot is a two‑part, tubeless patch pump that uses a removable 3 mL cartridge, offering a larger reservoir than competitors and a lightweight, user‑friendly design aimed at the $3 billion adult “almost‑pumper” market.
Validation of the production line reduces the risk of supply‑chain or regulatory delays and positions Modular Medical to begin commercial manufacturing in the first quarter of 2026. The milestone follows the company’s recent Stage 1 ISO 13485:2016 audit, with a Stage 2 audit scheduled for early 2026.
The company has not yet received U.S. FDA clearance for the Pivot, and CE Mark approval remains pending. The company’s previous product, the MODD1, received FDA clearance in September 2024, but the Pivot must still complete regulatory submissions.
Modular Medical is a development‑stage, pre‑revenue company that has incurred significant net losses and acknowledges substantial doubt about its ability to continue as a going concern. The company plans to raise additional capital to support commercialization and regulatory activities.
Founder Paul DiPerna, who previously founded Tandem Diabetes Care and designed its t:slim insulin pump, leads the company’s strategy to expand the insulin‑pump market by making the technology more accessible and affordable.
The Pivot’s validation is a critical step that de‑risks the company’s path to commercialization and positions it to capture market share in a competitive landscape that includes Medtronic, Tandem, and Insulet.
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