Modular Medical Achieves Key Manufacturing Milestone for Pivot Tubeless Insulin Patch Pump

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.

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

Argus Feb 4 session

-4.36% close to close Open Argus

Details

News Market Reaction – MODD

On Feb 4, the day this news came out, MODD closed 4.36% below the previous close.

Data tracked by StockTitan Argus for the Feb 4 session.

Key Figures

Pivot reservoir size: 3 ml Target launch timing: Q1 2026 Insulin pump market size: $8 billion

Pivot reservoir size

3 ml

Removable cartridge capacity for Pivot tubeless patch pump

Target launch timing

Q1 2026

Planned commercial launch of Pivot, subject to FDA 510(k) clearance

Insulin pump market size

$8 billion

Estimated global insulin pump market referenced in the release

Historical Context

5 past events · Latest: Dec 31

5 events

1. Dec 31

   Nasdaq extension

   24h Move

   +0.6%

   Nasdaq granted a 180-day extension to regain $1.00 minimum bid compliance.

2. Dec 10

   Public offering priced

   24h Move

   -30.5%

   Dilutive $4.68M underwritten offering of shares and warrants at $0.77 combo pricing.

3. Dec 09

   Offering proposed

   24h Move

   +2.1%

   Announcement of proposed underwritten offering of common shares and warrants.

4. Nov 17

   IRB study approval

   24h Move

   -2.6%

   IRB approval for in-house study delivering insulin with Pivot patch pump.

5. Nov 14

   510(k) submission

   24h Move

   +11.2%

   Submission of Pivot tubeless insulin patch pump for FDA 510(k) clearance targeting Q1 2026 launch.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

tubeless patch pump, multiple daily injections (MDI), infusion set, insulin pump, +1 more

5 terms

tubeless patch pump medical

"The Pivot system - the industry's first removable, tubeless 3ml patch pump - is designed"

A tubeless patch pump is a small, adhesive wearable device that delivers medication (most commonly insulin) directly through the skin without external tubing, combining a reservoir, pump and controller in a single patch. Investors care because it represents a consumer-friendly alternative to traditional pumps that can boost device adoption, recurring supply sales and competitive differentiation, much like a wireless headset replacing a wired one for convenience and comfort.

multiple daily injections (MDI) medical

"adults with diabetes hesitant to move from multiple daily injections (MDI) due to cost"

Multiple daily injections (MDI) is an insulin treatment approach where a person with diabetes injects short-acting insulin several times a day around meals plus one or more longer-acting injections to control baseline blood sugar. Investors care because MDI drives demand for insulin products, delivery devices (pens, needles), monitoring tools and support services; changes in adoption, cost, or clinical outcomes can affect sales, reimbursement and competitive positioning. Think of it as a multi-step routine to keep blood sugar steady, similar to refilling and adjusting settings on a home heating system throughout the day.

infusion set medical

"validation lots for its Pivot™ tubeless patch pump's disposable cartridge and infusion set."

An infusion set is the small medical kit—tube, connector and tiny plastic or soft tube that sits on or under the skin—that delivers drugs or fluids from a pump or IV into a patient’s bloodstream or tissue. For investors it matters because these parts are high-volume, regulated consumables whose reliability, safety and supply affect recurring revenue, product recalls and regulatory risk for companies that make or sell them — like the hose and nozzle for a pump.

insulin pump medical

"representing a significant portion of the growing ~$8 billion global insulin pump market."

A small wearable medical device that delivers measured doses of insulin automatically or on demand to help people with diabetes regulate their blood sugar, often replacing multiple daily injections. Investors care because these devices combine hardware, software and supplies to create recurring revenue, are subject to regulatory approval and reimbursement decisions, and can change competitive dynamics in a large, growing healthcare market much like a smartphone platform reshapes accessory sales.

510(k) clearance regulatory

"subject to receipt of FDA 510(k) clearance."

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What manufacturing milestone did Modular Medical (MODD) announce on February 4, 2026?

The company began production of validation lots for the Pivot cartridge and infusion set. According to the company, this step demonstrates manufacturing readiness and helps derisk commercial-scale production ahead of a planned Q1 2026 launch.

When is Modular Medical (MODD) targeting commercial launch for the Pivot pump?

Modular Medical is targeting a commercial launch in Q1 2026, subject to FDA clearance. According to the company, the timeline depends on the FDA 510(k) review and successful completion of validation production lots.

What makes the Pivot patch pump different from existing insulin pumps (MODD)?

Pivot is a removable, tubeless 3ml patch pump designed for affordability and simplicity. According to the company, it targets adults on multiple daily injections who avoid pumps due to cost and complexity.

Does the Pivot system have FDA clearance for sale now (MODD)?

No, the Pivot system is not currently cleared for sale by the FDA. According to the company, commercial launch remains conditional on receipt of FDA 510(k) clearance and the agency's response to the submission.

How does the manufacturing milestone affect Modular Medical's (MODD) commercial readiness?

Starting validation production lots signals readiness for high-volume demand and reduces execution risk. According to the company, this milestone supports scalability and reliability ahead of the planned Q1 2026 commercialization.