Business
Modular Medical Provides Update on FDA Submission Strategy
SAN DIEGO, CA / ACCESSWIRE / January 25, 2023 / Modular Medical, Inc. (the "Company" or "Modular Medical") (NASDAQ:MODD), a development stage insulin delivery
About this update from Modular Medical, Inc.
[{"type":"text","content":"SAN 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 StatementsThis press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, the risk that the Company is unable to make the FDA submission in a timely manner or at all; the Company's expected resolution of its materials/sterilization compatibility issue; the Company's ability to develop production manufacturing capability; whether the Company can successfully develop its proprietary technologies and whether the market will accept the Company's products and services, as well as other risk factors and business considerations described in the public filings the Company makes with the Securities and Exchange Commission, including its annual report on Form 10-K. Any forward-looking statements in this press release should be evaluated in light...