Modular Medical Provides Update on FDA Submission Strategy

Rhea-AI Summary

Modular Medical, Inc. (NASDAQ:MODD) has updated its progress on the MODD-1 insulin pump, transitioning to a full commercial version designed with a tier-1 medical product manufacturer. This new version aims to resolve prior material compatibility issues, enhance cost-effectiveness, and streamline usability. The company anticipates submitting the device for FDA approval in the quarter ending December 31, 2023, following the arrival of key production equipment and subsequent testing. The initiative seeks to make insulin delivery technology more accessible and user-friendly for diabetes patients.

Positive

• Progress made on the full commercial version of the MODD-1 insulin pump.
• Partnership with a tier-1 medical product manufacturer enhances product reliability.
• Improved cost of goods and usability expected with the new version.
• Submission for FDA approval anticipated in Q4 2023.

Negative

• Risks associated with timely FDA submission.
• Potential unresolved materials/sterilization compatibility issues.

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 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 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.

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.

View source version on accesswire.com:
https://www.accesswire.com/736657/Modular-Medical-Provides-Update-on-FDA-Submission-Strategy

FAQ

What is the latest update on Modular Medical's MODD-1 insulin pump?

Modular Medical announced significant progress on the MODD-1 insulin pump, moving towards a full commercial version designed in partnership with a tier-1 manufacturer, with an FDA submission planned for Q4 2023.

When does Modular Medical expect to submit the MODD-1 insulin pump for FDA approval?

The company expects to submit the MODD-1 insulin pump for FDA approval during the quarter ending December 31, 2023.

What improvements does the new MODD-1 version offer?

The new version aims to resolve prior material compatibility issues, enhance usability, and reduce costs.

Who has Modular Medical partnered with for the MODD-1 insulin pump?

Modular Medical has partnered with a tier-1 medical product manufacturer for the development of the MODD-1 insulin pump.