Modular Medical Provides Update on FDA Submission Strategy
News provided byACCESSWIRE
Jan 25, 2023, 9:00 AM ET
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.
This 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 of these important risk factors. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company assumes no obligation to update these forward-looking statements, except as required by law.
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. More information is available at https://modular-medical.com.
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Modular Medical, Inc.
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SOURCE: Modular Medical, Inc.