Modular Medical Announces Product Testing Update
Modular Medical (NASDAQ:MODD) has updated on the development of its insulin pump product, MODD1. The company is making progress on the testing needed for its 510(k) submission to the FDA. However, they encountered compatibility issues with certain materials used in the device, delaying the submission timeline. Replacement materials have been identified and are in the qualification process. Modular Medical now anticipates submitting to the FDA by June 30, 2023, pending resolution of these issues.
- Progress on testing for the FDA 510(k) submission for MODD1 insulin pump.
- Identified replacement materials for sterilization compatibility, potentially expediting the submission timeline.
- Compatibility issues with materials have delayed the FDA submission timeline.
SAN DIEGO, CA / ACCESSWIRE / November 28, 2022 / 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 announced an update on the development of its initial insulin pump product.
The Company has continued to make progress on the testing required for its 510(k) submission to the U.S. Food and Drug Administration ("FDA") of its MODD1 insulin pump product. The Company has identified certain material in the pump device that was incompatible with the sterilization process utilized. As previously announced, this compatibility issue has delayed the Company's 510(k) submission timeline. The Company has identified replacement materials, which are being qualified for use in the product. Given the expected resolution of the compatibility issue, the Company now expects to make its submission to the FDA during the quarter ended June 30, 2023.
Forward-Looking Statements
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 the Company's 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 Company's SEC filings, including the annual report on Form 10-K. Any forward-looking statements in this document 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.
All trademarks mentioned herein are the property of their respective owners.
CONTACT:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com
SOURCE: Modular Medical, Inc.
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