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Modular Medical updates test progress, submission timeline
The Fly

Modular Medical updates test progress, submission timeline

Modular Medical provided an update on its ongoing pre-submission testing and timeline for submission of its MODD-1 insulin pump to the U.S. Food and Drug Administration. The Company has made substantial progress on completing many of the tests required for submission and now has results back from some of the longest lead time tests, including insulin stability and potency. Modular Medical believes the test results received from multiple third-party laboratory tests are sufficient for submission of the MODD1 to the FDA for clearance, subject to the completion of other ongoing tests and reports. Jeb Besser, CEO of Modular Medical, commented, “The Modular Medical team has continued to make rapid progress towards our 510(k) submission to the FDA, since the completion of our pilot manufacturing line in August. While there is still additional testing to be done, we are starting to gain better visibility on our submission timeline, and we currently expect to make our FDA submission around year end 2023. We remain excited about our opportunity to bring access to better insulin delivery to underserved segments of the market.”

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