Modular Medical Announces Product Test Update
SAN DIEGO, CA / ACCESSWIRE / November 28, 2022 / Modular Medical, Inc. (the “Company” or “Modular Medical”) (NASDAQ:MODD), a development-stage insulin delivery technology company aiming to introduce the next generation of easy-to-use and affordable insulin pump technology, today announced an update in development its first insulin pump product.
The Company has made further progress on the testing required for 510(k) submission of its MODD1 insulin pump product to the US Food and Drug Administration (“FDA”). The company identified certain material in the pump assembly that was incompatible with the sterilization process used. As previously announced, this compatibility issue has delayed the company’s 510(k) filing schedule. The company has identified substitute materials that are being qualified for use in the product. With the anticipated resolution of the compatibility issue, the Company now expects to file its submission with the FDA during the quarter ended June 30, 2023.
This press release contains forward-looking statements 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 differ materially from those in the forward-looking statement. These factors include, among others, the risk that the Company may not be able to file the FDA filing on a timely basis or at all; the company’s anticipated solution for material/sterilization compatibility; the Company’s ability to develop manufacturing capabilities; whether the company can successfully develop the company’s proprietary technologies and whether the market will accept the company’s products and services, and other risk factors and business considerations described in the company’s SEC filings, including the annual report on Form…