Modular Medical announced that it has received Institutional Review Board approval to conduct an in‑house study of its next‑generation Pivot patch insulin delivery system. The approval, disclosed on November 17, 2025, allows the company to test the device in people with diabetes and collect real‑world data on safety, efficacy, and user experience.
The study will involve a cohort of internal testers who will wear continuous glucose monitors while using the Pivot pump. By gathering objective data on insulin delivery accuracy, glucose control, and device usability, Modular Medical aims to generate the evidence needed to support future FDA clearance and reimbursement submissions. The IRB approval is a critical regulatory step that precedes the company’s planned 510(k) submission and eventual market launch.
Modular Medical submitted its 510(k) pre‑market application for the Pivot pump to the FDA on November 14, 2025. The company expects a commercial launch in the first quarter of 2026, contingent on clearance. CEO Jeb Besser emphasized that the IRB study “marks another important milestone in advancing our tubeless insulin pump technology toward market readiness” and that the data collected will strengthen the company’s regulatory dossier.
The Pivot pump is a tubeless, two‑part patch device featuring a 3 ml removable reservoir that delivers insulin without a separate controller or battery recharging. By targeting the $3 billion “Almost Pumper” market—diabetics who use multiple daily injections but are hesitant to adopt traditional pumps—Modular Medical seeks to offer a simpler, more affordable alternative that could accelerate adoption of pump therapy.
The IRB approval signals progress to investors and underscores the company’s strategy to capture a large, underserved segment of the diabetes market. By generating real‑world evidence now, Modular Medical positions itself to meet FDA and payer requirements more efficiently, potentially shortening the time to commercial launch and improving reimbursement prospects.
Additional context: Modular Medical’s first‑generation pump, the MODD1, received FDA clearance in September 2024 and was slated for shipment in Q3 2025. The company is also advancing toward CE Mark certification in the European Union, with a Stage 2 audit planned for early 2026. These parallel regulatory efforts reinforce Modular Medical’s commitment to a global rollout of the Pivot pump.
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