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Modular Medical Provides Product Update
Modular Medical Inc. (the "Company" or "Modular Medical") (NASDAQ:MODD), a development stage, insulin delivery technology company seeking to launch the next generation of easy to use and affordable insulin pump technology, today 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.
In addition, the Company announced that its chief executive officer, Jeb Besser, will be attending the Benchmark Company and Piper Jaffrey investor conferences in New York City during the week of November 28, 2022. The Company will provide more information on presentation times and one-on-one availability at a later date.
About Modular Medical, Inc.
Modular Medical, Inc. (NASDAQ:MODD) is a development-stage medical device company that intends to launch the next generation of insulin delivery technology. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Our mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond "superusers" and providing "diabetes care for the rest of us."
Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding MODD, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump.
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