-Targets $3 Billion "Almost-Pumper" Market with First Simplified and Removable/Replaceable Insulin Patch Pump
- Aims to Improve Patient and Clinician Experience for the Care of Diabetes
SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company") today announced the 510(k) premarket submission of its next generation Pivot tubeless patch pump to the U.S. Food and Drug Administration (the "FDA"). The Company expects to commence the commercial launch of its Pivot pump in Q1 2026.
Key Investment Highlights
Feature | Impact |
|---|---|
First 2-part tubeless patch pump | 3 milliliter ("ml") removable reservoir; no battery recharge; detachable for showering/physical activity, no controller needed to bolus |
Targets $3B "almost-pumper" market | ~70% of insulin-dependent adults still rely on multiple daily injection; Pivot pump aims to solve the "3 Cs:" complex, cumbersome, costly |
Manufacturing on track | Validated production line conversion on track; Q1 2026 launch-ready upon clearance from FDA |
FDA timeline | Submission delayed by U.S. government shutdown; initial FDA questions expected during Q4 2025 |
"The Pivot submission is an exciting milestone in our mission to deliver a differentiated tubeless patch pump experience to those who want a simple pump to manage the treatment of diabetes," commented Jeb Besser, CEO of Modular Medical. "Our Pivot patch pump offers a 3 ml reservoir, the flexibility of removing the pump and the ability to bolus without a separate controller, all without sacrificing the accuracy, communications and clinical reporting advantages of a true electronic pump.
"Convincing a person who requires daily insulin to adopt a pump, instead of multiple daily injections, can improve the patient and clinical experience, while potentially reducing healthcare costs and improving long-term patient outcomes. We believe our two-part Pivot patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated user experience and represents a unique approach to this market." "On behalf of the board of directors, I would like to thank the entire Modular Medical team, and all of our stakeholders and shareholders for their support to allow us to achieve this major milestone. With the end of the U.S. government shutdown, we have now been able to submit the Pivot for 510(k) clearance to the FDA. We expect to receive initial questions from the FDA this quarter and are proceeding in parallel with the manufacturing preparation to be able to commercially launch our Pivot product upon clearance."
The Pivot insulin delivery system is not currently cleared for sale by the FDA.
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, whether the Company can obtain FDA clearance for its Pivot insulin delivery system, the timing of expected FDA clearance for its Pivot insulin delivery system; the Company's ability to convert patients to use its MODD1 pump; the occurrence of future events or circumstances, 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, 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.
Pivot is a trademark of Modular Medical. All other 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:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/modular-medical-submits-pivot-tubeless-insulin-patch-pump-for-fda-510-1102238