San Diego-based Modular Medical can now conduct an in-house feasibility study for its next-generation Pivot insulin delivery system. The company plans for the study of the new pump to use sterile saline.
Modular Medical unveiled Pivot, its next-generation insulin patch pump technology aimed at simplifying diabetes care, earlier this month.
Its new pump designed for “almost-pumpers” targets adults with a user-friendly, affordable design. Modular Medical’s current pump, the MODD1, won FDA clearance nearly a year ago. It has microfluidics technology that allow for the low-cost pumping of insulin. The company announced last month that it began converting its manufacturing line to prepare for production of Pivot.
Now, with IRB approval, the company can conduct its study that simulates real-world conditions. The company plans to deliver sterile saline to adult participants for up to 90 days. It expects to gather critical data on device usability, extended wear performance and user feedback.
Key objectives include assessing usability and identifying challenges in prolonged wear scenarios. The company also plans to collect participant feedback to optimize the design for everyday diabetes management.
Modular Medical plans to use findings to refine its pump ahead of its planned FDA 510(k) submission in October.
“This IRB approval marks another significant milestone in advancing our tubeless insulin pump technology toward market readiness,” said Jeb Besser, CEO. “By testing extended wear in real-world simulations, we expect to gather invaluable data to make our Pivot pump more intuitive and reliable for adults with diabetes. Once FDA clearance is achieved, we believe our Pivot pump will be well positioned to achieve rapid adoption in the growing wearable diabetes technology sector. This progress underscores our commitment to innovation, as we look to achieve long-term growth in the expanding diabetes care landscape and bring value to the Company’s shareholders.”
