Modular Medical, Inc. provided an update on its insulin pump product. The Company has successfully completed the majority of the tests and documentation required for its 510(k) submission with the U.S. Food and Drug Administration ("FDA") of its MODD1 insulin pump product. However, in one of its qualification tests, the Company experienced a materials/sterilization process compatibility issue, which has delayed the submission to the FDA.

Tests are underway to identify a solution, and, if the product needs to undergo qualification for a new sterilization method, the submission timeline will experience further delays. The Company now expects to make its submission to the FDA between December 2022 and June 2023 and intends to provide further updates after the required additional testing has been completed. Progress on developing production manufacturing capability has been promising.

The Company is in the process of transferring production to a tier 1 contract manufacturer located in North America as part of its efforts to shorten and onshore its supply chain. Currently, this project is both ahead of schedule and initial cost estimates are in line with or better than the Company's initial internal estimates. Key initiatives on manufacturability, parts list reduction, and materials cost reductions are in process.