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25/01/2023 15:00
Modular Medical Provides Update on FDA Submission StrategySAN DIEGO, CA / ACCESSWIRE / January 25, 2023 / 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. In the process of assessing and optimizing materials and sterilization processes for its MODD-1 insulin pump (the "MODD-1"), 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 ("FDA") during the quarter ended December 31, 2023. Forward-Looking Statements About Modular Medical, Inc. 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. More information is available at https://modular-medical.com. All trademarks mentioned herein are the property of their respective owners. CONTACT: SOURCE: Modular Medical, Inc. View source version on accesswire.com: https://www.accesswire.com/736657/Modular-Medical-Provides-Update-on-FDA-Submission-Strategy Source : Webdisclosure.com |
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