Modular Medical Announces Successful Validation of Controller Line for Pivot Insulin Delivery System
Rhea-AI Summary
Modular Medical (Nasdaq:MODD) announced successful validation of its Pivot controller line, a manufacturing milestone supporting planned Q1 2026 commercial launch for the Pivot tubeless, removable 3 milliliter patch pump. The company said the validated line demonstrates readiness for high-volume human-use production and aims to address a roughly $3 billion market for adult “almost-pumpers” with an affordable, easy-to-learn design. Modular Medical described the validation as derisking its path to commercial manufacturing, while noting Pivot is not currently cleared by the FDA and the launch remains subject to forward-looking risks.
Positive
- Pivot controller line validated for human-use production
- Product targets Q1 2026 market launch
- Pivot is a 3 milliliter removable tubeless patch pump
- Company cites high-volume manufacturing readiness for scaling
Negative
- Pivot insulin delivery system is not cleared for sale by the FDA
- Planned Q1 2026 launch is subject to forward-looking risks
- Market conversion and commercial acceptance remain uncertain
News Market Reaction 21 Alerts
On the day this news was published, MODD gained 12.37%, reflecting a significant positive market reaction. Argus tracked a peak move of +42.3% during that session. Argus tracked a trough of -17.9% from its starting point during tracking. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $4M to the company's valuation, bringing the market cap to $34M at that time. Trading volume was exceptionally heavy at 44.6x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Highlights:
Pivot Controller Line Validated: Manufacturing line has now been validated for human-use production in support of expected Q1 2026 market launch.
Pivot will be First Two-Part Tubeless Patch Pump: Pivot, a 3 milliliter removable patch pump, targets the
$3 billion dollar market for adult "almost-pumpers" with its affordable, user-friendly, easy-to-learn design.
High-Volume Manufacturing Readiness: Modular Medical's scalable platform positions it to target a significant share of the insulin pump market.
SAN DIEGO, CA / ACCESS Newswire / November 3, 2025 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery technology, today announced the successful validation of its Pivot controller line, a critical milestone in preparing for the commercial launch of its Pivot patch pump targeted for Q1 2026. The Pivot controller line validation further demonstrates manufacturing readiness for high-volume production, positioning Modular Medical to meet the growing demand in the diabetes treatment market for advanced technology.
Transforming Diabetes Management - The Pivot is the first tubeless, removable 3 milliliter patch pump designed for adult "almost-pumpers" - individuals with diabetes who hesitate to adopt traditional insulin pumps due to cost, complexity, or design. With its user-friendly interface and affordability, the Pivot expands the insulin pump market to an underserved segment.
"Validating the Pivot controller line further evidences our ability to scale production efficiently, which is a key differentiator in the patch pump space. We remain on track for a Q1 2026 market launch, as we look to introduce our Pivot product to millions of patients who deserve better diabetes management options," said Jeb Besser, CEO of Modular Medical.
Market Impact and Investor Opportunity - The successful validation derisks Modular Medical's path to commercial manufacturing, ensuring reliability and scalability for the launch of the Pivot product. The Company's low-cost, high-volume, manufacturing optimized platform is designed to support the Company's goal to capture significant market share, for the benefit of both patients and investors. Modular Medical's focus on accessibility and innovation positions it as a leader in the rapidly expanding diabetes technology market.
The Pivot insulin delivery system is not currently cleared for sale by the United States Food and Drug Administration (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, the Company's expected launch to the market of the Pivot insulin delivery system in the first calendar quarter of 2026; the Company's ability to convert patients to use its Pivot pump product and gain market share; 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. Its 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.
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
What did Modular Medical (MODD) validate on November 3, 2025?
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Is the Pivot insulin delivery system cleared by the FDA for sale?
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