Modular Medical Announces Institutional Review Board Approval To Conduct In-House Feasibility Study Of Next-Gen Pivot Insulin Delivery System Using Sterile Saline

Author: Benzinga Newsdesk | September 15, 2025 07:15am

-Study to Evaluate Usability and Extended Wear for Next-Generation Tubeless Patch Pump

SAN DIEGO, CA / ACCESS Newswire / September 15, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery technology targeting the $3 billion adult "almost-pumpers" diabetes market with user-friendly, affordable patch pumps, today announced Institutional Review Board ("IRB") approval to conduct an in-house feasibility study of its next-generation Pivot insulin delivery system using sterile saline (the "Study"). Pursuant to U.S. Food and Drug Administration ("FDA") 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.

The Pivot insulin delivery system is not currently cleared for sale by the FDA.

Posted In: MODD