Modular Medical Provides Product Update
Modular Medical Inc. (NASDAQ:MODD) has updated investors on its insulin pump product, the MODD1. The company is nearing completion of its 510(k) submission to the FDA but has encountered a materials compatibility issue that has delayed the submission timeline, now expected between December 2022 and June 2023. Meanwhile, progress in establishing production capabilities is ahead of schedule and cost estimates are favorable. The CEO will attend investor conferences in late November 2022, with further updates on product development anticipated.
- Production manufacturing capabilities are ahead of schedule.
- Initial cost estimates for production are in line or better than projected.
- Submission to the FDA has been delayed due to materials/sterilization compatibility issues.
- If new sterilization qualifications are needed, further delays in the FDA submission timeline are possible.
SAN DIEGO, CA / ACCESSWIRE / October 3, 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 provided an update on its insulin pump product.
The Company has successfully completed the majority of the tests and documentation required for its 510(k) submission with the U.S. Food and Drug Administration ("FDA") of its MODD1 insulin pump product. However, in one of its qualification tests, the Company experienced a materials/sterilization process compatibility issue, which has delayed the submission to the FDA. Tests are underway to identify a solution, and, if the product needs to undergo qualification for a new sterilization method, the submission timeline will experience further delays. The Company now expects to make its submission to the FDA between December 2022 and June 2023 and intends to provide further updates after the required additional testing has been completed.
Progress on developing production manufacturing capability has been promising. The Company is in the process of transferring production to a tier 1 contract manufacturer located in North America as part of its efforts to shorten and onshore its supply chain. Currently, this project is both ahead of schedule and initial cost estimates are in line with or better than the Company's initial internal estimates. Key initiatives on manufacturability, parts list reduction, and materials cost reductions are in process.
In addition, the Company announced that its chief executive officer, Jeb Besser, will be attending the Benchmark Company and Piper Jaffrey investor conferences in New York City during the week of November 28, 2022. The Company will provide more information on presentation times and one-on-one availability at a later date.
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 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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