Modular Medical provides update on FDA submission strategy

Modular Medical provided an update on its insulin pump product. The company said, "In the process of assessing and optimizing materials and sterilization processes for its MODD-1 insulin pump, the Company has made sufficient progress on the full commercial version of the product that it now believes that the use of this commercial version for pre-submission validation testing constitutes its best and most cost-effective path forward. The full commercial version was designed in partnership with a tier-1, medical product manufacturer, and the Company believes that this new version will address all prior material compatibility issues, improve cost of goods and usability, and reduce redundant testing of different versions of the MODD-1. Given the expected arrival time of key production equipment and the resulting timing of tests of both the equipment and the product itself, the Company now expects to make its submission to the U.S. Food and Drug Administration during the quarter ended December 31, 2023."