ACCESSWIRE
29 Nov 2022, 00:31 GMT+10
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.
Get a daily dose of Kansas City Post news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Kansas City Post.
More InformationWASHINGTON D.C.: The White House said this week that Tesla Chief Executive Elon Musk met with John Podesta, a Democratic ...
MANILA, Philippines: In an effort to attract more tourists, President Ferdinand Marcos has approved a value-added tax refund program for ...
TRIPOLI, Libya: Italian prime minister Giorgia Meloni held talks on energy and migration in Libya this weekend, which are major ...
MIAMI, Florida: This decade, the US south is expected to see more new residents than any other region in the ...
NEW YORK CITY, New York: After reporting record revenues in the fourth-quarter of 2022, US airlines expect strong travel demand ...
MANILA, Philippines: After a Filipina domestic worker was killed and dumped in the desert in the oil-rich emirate of Kuwait, ...
BEIJING, China: As COVID-19 restrictions and a slowing economy curbed consumer demand in 2022, China's smartphone sales witnessed a record ...
TOKYO, Japan: After struggling for years to promote its products amid protests from conservationists, Japanese whaling company Kyodo Senpaku announced ...
NEW DELHI, India: Marking a year since the Tata Group took control of Air India, the former state-run carrier has ...
NEW YORK, New York - A slowing of wages growth in the fourth quarter, as reported by the Labor Department, ...
NEW YORK CITY, New York: As it sets aside more funds to cover potentially bad loans, American Express announced that ...
LONDON, England: Flybe, a British regional airline, abruptly closed operations on January 28. The airline offered flight to Belfast, Birmingham ...