Modular Medical Achieves Key Manufacturing Milestone for Pivot Tubeless Insulin Patch Pump
Rhea-AI Summary
Modular Medical (NASDAQ:MODD) announced the start of validation production lots for its Pivot™ tubeless patch pump cartridge and infusion set, supporting a planned commercial launch in Q1 2026, subject to FDA 510(k) clearance. The Pivot is a removable, tubeless 3ml patch pump aimed at adults using multiple daily injections (MDI) to expand access with a lower-cost, user-friendly design. The company says scalable, low-cost manufacturing readiness derisks execution and positions Modular Medical to pursue share in the ~$8 billion insulin pump market as FDA review progresses. The Pivot system is not cleared for sale by the FDA.
Positive
- Validation production lots for cartridge and infusion set have begun
- Maintains target Q1 2026 commercial launch timeline, subject to FDA
- Product is a removable, tubeless 3ml patch pump targeting MDI users
- Scalable, low-cost manufacturing platform positioned for high-volume demand
Negative
- Commercial launch remains conditional on FDA 510(k) clearance
- Pivot system is not currently cleared for sale by the FDA
- Timing and outcome of FDA review could delay planned Q1 2026 launch
Key Figures
Market Reality Check
Peers on Argus
Moves in peers are mixed: ECOR -7.33%, MYO -2.84%, NMTC -1.18%, RBOT -2.82%, while IINN rose 4.77%. With MODD down 4.14%, action appears stock-specific rather than a coordinated medical devices sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 31 | Nasdaq extension | Neutral | +0.6% | Nasdaq granted a 180-day extension to regain $1.00 minimum bid compliance. |
| Dec 10 | Public offering priced | Negative | -30.5% | Dilutive $4.68M underwritten offering of shares and warrants at $0.77 combo pricing. |
| Dec 09 | Offering proposed | Negative | +2.1% | Announcement of proposed underwritten offering of common shares and warrants. |
| Nov 17 | IRB study approval | Positive | -2.6% | IRB approval for in-house study delivering insulin with Pivot patch pump. |
| Nov 14 | 510(k) submission | Positive | +11.2% | Submission of Pivot tubeless insulin patch pump for FDA 510(k) clearance targeting Q1 2026 launch. |
Recent history mixes positive product milestones with dilutive financings and listing-risk headlines. Clinical/regulatory updates around the Pivot pump have sometimes seen positive reactions, while financing and Nasdaq compliance items have weighed on sentiment. Price reactions split between alignment and divergence, indicating inconsistent trading responses to news.
Over the last few months, MODD has advanced its Pivot tubeless insulin patch pump while managing capital and listing constraints. A Nov 14, 2025 510(k) submission for Pivot and a Nov 17, 2025 IRB study approval underscored product progress. In Dec 2025, the company completed a $4.68M underwritten offering and later secured a 180-day Nasdaq bid-price compliance extension to June 29, 2026. Today’s manufacturing milestone continues that product-readiness trajectory.
Market Pulse Summary
This announcement underscores continued execution toward a Q1 2026 commercial launch of the Pivot tubeless insulin patch pump, following earlier 510(k) submission and IRB approval milestones. It highlights manufacturing readiness and a large $8B addressable insulin pump market. At the same time, recent public offerings and Nasdaq bid-price compliance deadlines remain relevant backdrop risks. Future FDA feedback and commercialization progress will be key metrics to monitor.
Key Terms
multiple daily injections (MDI) medical
insulin pump medical
510(k) clearance regulatory
AI-generated analysis. Not financial advice.
Targeting Q1 2026 Launch, Subject to FDA Clearance
Key Highlights:
Cartridge & Infusion Set Lots in Production: Validation production lots now being produced for launch, derisking commercial-scale production.
First Removable Tubeless Patch Pump: Pivot targets underserved "almost-pumpers" - adults with diabetes hesitant to move from multiple daily injections (MDI) due to cost and complexity - representing a significant portion of the growing ~
$8 billion global insulin pump market.Affordable, User-Friendly Design: A full 3ml removable cartridge and pump with a simple interface expands access for millions managing diabetes with MDI by providing significant clinical therapy improvement
SAN DIEGO, CA / ACCESS Newswire / February 4, 2026 / Modular Medical, Inc. ("Modular Medical" or the "Company") (NASDAQ:MODD), an innovative insulin delivery technology company, today announced the start of production of validation lots for its Pivot™ tubeless patch pump's disposable cartridge and infusion set. Achievement of this critical manufacturing milestone keeps the Company on schedule for commercial launch in Q1 2026, subject to receipt of FDA 510(k) clearance.
The Pivot system - the industry's first removable, tubeless 3ml patch pump - is designed for simplicity and affordability, addressing barriers that prevent many patients from adopting traditional pumps.
Transforming Access to Insulin Pump Therapy
Targets almost-pumpers: Millions of adults relying on MDI who avoid pumps due to high cost and complexity.
Scalable, low-cost manufacturing platform positions the Company to capture significant share in the rapidly expanding diabetes tech sector.
Remains on track post recent FDA submission, with commencement of production lots confirming readiness for high-volume demand.
"We are excited to hit this pivotal manufacturing validation on schedule, bringing us closer to delivering our Pivot pump's game-changing simplicity to patients underserved by current options," said Jeb Besser, CEO of Modular Medical. "This further derisks our expected path to Q1 2026 commercialization, which is subject to FDA response to our current 510(k) application, and would put us in position to drive market disruption."
Investor Implications
The Company believes the achievement of this milestone significantly reduces execution risk for its commercial strategy, enhancing scalability and reliability ahead of launch. With a differentiated, patient-centric product in a high-growth market, the Company believes it is well-positioned for upside as FDA review progresses and awareness builds. For more information on the Pivot system, visit the dedicated site: PivotPump.com.
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 product; whether the Company will have initial users of its Pivot product by March 31, 2026; difficulties and delays in the production, testing and marketing of the Pivot product; reliance on manufacturing partners to assist successfully with the production of the Pivot product; availability of quantities of the Pivot product supplied by its manufacturing partners at a competitive cost; the Company's ability to convert patients to use its pump products; 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; general economic, and industry or political conditions in the United States or internationally; and the occurrence of future events or circumstances, 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 in the United States. 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
FAQ
What manufacturing milestone did Modular Medical (MODD) announce on February 4, 2026?
When is Modular Medical (MODD) targeting commercial launch for the Pivot pump?
What makes the Pivot patch pump different from existing insulin pumps (MODD)?
Does the Pivot system have FDA clearance for sale now (MODD)?
How does the manufacturing milestone affect Modular Medical's (MODD) commercial readiness?
