Modular Medical Announces Completion of MODD1 Cartridge Production and Commencement of Pivot Conversion
Rhea-AI Summary
Modular Medical (NASDAQ:MODD) has announced the successful completion of its MODD1 cartridge production with over 6,000 units manufactured. The company is now transitioning its manufacturing line to produce cartridges for its upcoming Pivot product, which is expected to be submitted for FDA clearance in October 2025.
The Pivot will be pioneering as the first tubeless, removable 3 milliliter patch pump in the market. The company's manufacturing platform was specifically designed for high-volume production, addressing the increased demand requirements for patch pumps. Product launch is anticipated in Q1 2026, targeting adult "almost-pumpers" with its user-friendly and affordable design.
Positive
- Successful production of over 6,000 MODD1 cartridges demonstrates manufacturing capability
- First-mover advantage with tubeless, removable 3ml patch pump design
- Manufacturing platform specifically designed for high-volume production
- FDA submission planned for October 2025 with potential launch in Q1 2026
Negative
- FDA clearance still pending and subject to regulatory uncertainty
- Market acceptance of new pump technology remains unproven
News Market Reaction 2 Alerts
On the day this news was published, MODD declined 1.28%, reflecting a mild negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $538K from the company's valuation, bringing the market cap to $41M at that time.
Data tracked by StockTitan Argus on the day of publication.
-More than 6,000 MODD1 cartridges produced
- Conversion to Pivot-ready manufacturing in preparation for product launch in 1Q26
SAN DIEGO, CA / ACCESS Newswire / August 26, 2025 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target all adult "almost-pumpers" with its user-friendly and affordable design, today announced that the MODD1 product cartridge production run has been completed and its manufacturing line is being converted to production for its Pivot product.
"I want to congratulate our operational team for the successful validation of our MODD1 manufacturing process and production of human use cartridges," said Jeb Besser, CEO of Modular Medical. We will now begin converting our cartridge line to Pivot production, and we expect it to be ready to produce cartridges for our Pivot product upon receipt of clearance from the U.S. Food and Drug Administration (the "FDA"). We expect to submit the Pivot product to the FDA for clearance in October 2025.
"The Pivot will be the first tubeless, removable 3 milliliter patch to be available to the consumer when it is cleared. Along with these features, the ability to scale production is a key differentiator in the pump space, especially given the much higher volumes required for a patch pump. Modular Medical's simple, low-cost platform was designed from the ground up for high volume manufacturing."
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 statements contained in this press release, including, but not limited to, the timing of the Company's manufacturing line producing human-use cartridges for its Pivot product; the timing of the Company's submission of the Pivot product to the FDA; the Company's ability to convert patients to use its MODD1 pump; successful development of Modular Medical's proprietary technologies; whether the market will accept Modular Medical's products and services; anticipated consumer demand for the Company's products; whether Modular Medical can successfully manufacture its products at high volumes; the occurrence of future events or circumstances; general economic, and industry or political conditions in the United States or internationally; as well as other risk factors and business considerations described in Modular Medical's SEC filings, 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 Modular Medical'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. Modular Medical assumes no obligation to update these forward-looking statements, except as required by law.
About Modular Medical
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 Modular Medical, 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 the original press release on ACCESS Newswire
FAQ
How many MODD1 cartridges has Modular Medical (NASDAQ:MODD) produced in their latest production run?
When will Modular Medical submit the Pivot product for FDA clearance?
What makes Modular Medical's Pivot pump unique in the market?
When is the expected launch date for Modular Medical's Pivot product?
What is Modular Medical's manufacturing advantage for the Pivot product?
