Modular Medical Receives IRB Approval for Pivot Insulin Delivery System Feasibility Study

Modular Medical has received IRB approval to conduct a feasibility study of its Pivot insulin delivery system, which aims to evaluate usability and extended wear for its next-generation tubeless patch pump. The study will simulate real-world conditions by delivering sterile saline to adult participants for up to 90 days, gathering critical data on device usability, extended wear performance, and user feedback. The insights derived from the study will be used to refine the Pivot pump ahead of its 510(k) submission to the FDA.

Modular Medical (NASDAQ: MODD) has received Institutional Review Board (IRB) approval to conduct a feasibility study for its next-generation Pivot insulin delivery system. The study aims to evaluate the device's usability and extended wear performance by delivering sterile saline to adult participants for up to 90 days. The findings from this study will be instrumental in refining the Pivot pump before its anticipated 510(k) submission to the FDA in October 2025.

The Pivot pump builds upon Modular Medical's FDA-cleared first-generation MODD1 patch pump, targeting the $3 billion adult "almost-pumpers" diabetes market. This market segment includes patients who are currently using multiple daily injections but could benefit from pump therapy. The company plans to use insights gathered from the study to address key areas such as usability, wear challenges, and participant feedback, thereby optimizing the design for everyday diabetes management.

The IRB approval represents a significant regulatory milestone in Modular Medical's development pathway. The feasibility study will gather critical 90-day extended wear data using sterile saline, simulating real-world conditions. This data will be crucial for the company's 510(k) submission, which is designed to demonstrate the Pivot pump's substantial equivalence to predicate devices while offering improvements. This approach typically offers a more predictable regulatory timeline compared to more stringent approval pathways.

Modular Medical's focus on the "almost-pumpers" market segment highlights their strategic approach to targeting an underserved population. This market segment represents a significant opportunity, and the company's efforts to refine their technology to meet the needs of this group could positively influence the FDA's view of the product's public health significance during the review process.

The study design demonstrates regulatory savvy by focusing on three critical areas: usability assessment, prolonged wear performance, and user feedback. These elements directly address key FDA concerns for wearable insulin delivery systems, particularly regarding safety and effectiveness in extended use scenarios. The IRB approval indicates that the study protocol meets ethical and scientific standards required for human subject research.

Modular Medical's IRB approval for the Pivot pump feasibility study marks critical regulatory progress toward their October 2025 FDA submission. The company's commitment to innovation and user-friendly, affordable patch pumps positions them well to achieve long-term growth in the expanding diabetes care landscape and bring value to shareholders.

References
Modular Medical Receives IRB Approval for Pivot Insulin Delivery System Feasibility Study^[1] https://www.stocktitan.net/news/MODD/modular-medical-receives-irb-approval-for-pivot-insulin-delivery-1p37en90jy6x.html
Modular Medical Announces Completion of Clinical Study of MODD1 Pump^[2] https://www.stocktitan.net/news/MODD/modular-medical-announces-completion-of-clinical-study-of-modd1-rv929eyrl7k2.html