Modular Medical receives IRB approval for Pivot system feasability study

Modular Medical (MODD) announced Institutional Review Board approval to conduct an in-house feasibility study of its next-generation Pivot insulin delivery system using sterile saline. Pursuant to U.S. Food and Drug Administration regulations, an IRB is a group that has been formally designated to review and monitor biomedical research involving human subjects. The Study will simulate real-world conditions by delivering sterile saline to adult participants for up to 90 days to gather critical data on device usability, extended wear performance and user feedback. Modular Medical’s second-generation tubeless platform, its Pivot pump, builds on the Company’s FDA-cleared first-generation patch pump, the MODD1, and aims to continue to enhance accessibility for underserved patients with diabetes and drive market expansion. The insights derived from the Study will be used to refine the Pivot pump ahead of its 510(k) submission to the FDA, which is anticipated in October 2025. Key objectives and potential impacts of the Study include: Assess usability and identify challenges in prolonged wear scenarios; Collect participant feedback to optimize design for everyday diabetes management; and Support regulatory pathways, potentially unlocking new markets and revenue streams.