Modular Medical Receives FDA 510(k) Clearance for Pivot Tubeless Insulin Patch Pump

Modular Medical (NASDAQ:MODD) received FDA 510(k) clearance for the Pivot tubeless insulin patch pump on April 9, 2026, clearing the path for U.S. commercial sales.

Rhea-AI Summary

Modular Medical (NASDAQ:MODD) received FDA 510(k) clearance for the Pivot tubeless insulin patch pump on April 9, 2026, clearing the path for U.S. commercial sales.

Pivot is a first-of-its-kind two-part tubeless pump with a removable 3 mL reservoir, disposable battery, smartphone bolus/control, initial production capacity for ~6,000 users, and expected initial customer shipments by end of Q2 2026.

Positive

• FDA 510(k) clearance for Pivot (enables U.S. commercial sales)
• First removable 2-part tubeless patch pump with 3 mL reservoir
• Initial manufacturing capacity supports ~6,000 users
• Planned Q2 2026 initial customer shipments
• Targeted CE Mark Q4 2026/Q1 2027 for Europe

Negative

• Initial capacity (~6,000 users) may limit near-term revenue scale
• AID and advanced software features are in development but not yet available
• Commercial success depends on adoption from 'almost-pumper' segment

Argus Apr 9 session

-1.57% close to close Open Argus

Details

News Market Reaction – MODD

On Apr 9, the day this news came out, MODD closed 1.57% below the previous close.

Data tracked by StockTitan Argus for the Apr 9 session.

Key Figures

Target market size: $3 Billion Reservoir volume: 3 mL MDI prevalence: ~70% +5 more

Target market size

$3 Billion

"Almost-pumper" insulin market targeted by Pivot pump

Reservoir volume

3 mL

Removable reservoir in Pivot tubeless insulin patch pump

MDI prevalence

~70%

Insulin-dependent adults remaining on multiple daily injections

Initial capacity

~6,000 users

Manufacturing capacity supported by production validation lots

Clearance type

510(k)

FDA clearance pathway for Pivot tubeless insulin patch pump

Initial deployment timing

Q2 2026

Expected initial customer shipments and deployment of Pivot

CE Mark timing

Q4 2026/Q1 2027

Targeted European CE Mark window for Pivot

Design parts

2-part design

Removable, reusable pump architecture for Pivot system

Historical Context

5 past events · Latest: Mar 26

5 events

1. Mar 26

   Reverse stock split

   24h Move

   -9.8%

   1-for-30 reverse split to address Nasdaq minimum bid price requirement.

2. Mar 03

   Equity offering

   24h Move

   +7.0%

   $12.0M public offering of shares and warrants priced at a premium.

3. Feb 04

   Manufacturing milestone

   24h Move

   -4.4%

   Validation production lots for Pivot pump ahead of planned commercial launch.

4. Dec 31

   Nasdaq extension

   24h Move

   +0.6%

   180-day extension to regain compliance with Nasdaq minimum bid price rule.

5. Dec 10

   Underwritten offering

   24h Move

   -30.5%

   $4.68M underwritten offering of common shares and warrants from existing shelf.

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

Key Terms

510(k) clearance, tubeless patch pump, multiple daily injections, bolus, +2 more

6 terms

510(k) clearance regulatory

"today announced U.S. Food and Drug Administration ("FDA") 510(k) clearance for its next-generation"

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.

tubeless patch pump medical

"Pivot tubeless insulin patch pump. This milestone clears the path for commercial availability"

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 medical

"adults with type 1 or type 2 diabetes hesitant about traditional pumps - Pivot offers"

Multiple daily injections (MDI) is a diabetes treatment approach where a person takes several separate insulin shots each day—typically a long-acting dose to cover baseline needs and additional short-acting doses around meals. For investors, MDI signals demand for insulin supplies, injection devices and support services, and can affect adherence and health outcomes; think of it like needing both a monthly subscription and frequent one-off purchases, which shapes recurring revenue and product design opportunities.

bolus medical

"smartphone connectivity for bolus and monitoring, and true electronic accuracy without tubes"

A bolus is a single, concentrated dose of a drug or fluid given all at once rather than slowly over time, like taking a quick gulp instead of sipping. Investors should care because a bolus can change how fast a medicine works, its side effect risks, and how regulators view dosing safety; those factors can materially affect clinical trial outcomes, approval chances and commercial prospects.

automated insulin delivery medical

"software roadmap advancing toward automated insulin delivery ("AID") features, we believe this"

A system that links a glucose sensor, an insulin pump, and control software so insulin is adjusted automatically to keep blood sugar near a target range, similar to a smart thermostat that regulates room temperature. It matters to investors because it replaces manual dosing with continuous, data-driven care, which can drive device sales, recurring subscription software services, better health outcomes, and regulatory interest—factors that affect market growth and company valuation.

ce mark regulatory

"software enhancements ... in development; CE Mark targeted Q4 2026/Q1 2027."

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

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First Removable 2-Part Design Targets $3 Billion "Almost-Pumper" Market with Expected Q2 2026 initial deployment.

Key Milestones & Investment Highlights:

• FDA 510(k) Clearance Achieved: Pivot^™ pump now cleared for commercial sale in the U.S. - major de-risking event unlocking revenue path.

• First-in-Class Removable Tubeless Patch Pump: 3 mL detachable reservoir; no battery recharging required; removable for showering, sports or discretion; quick bolus button without a separate controller.

• Targets Massive Underserved Market: ~70% of insulin-dependent adults remain on multiple daily injections (MDI) due to complexity, cumbersomeness and cost - Pivot addresses the "3 Cs" for "almost-pumpers" with its 2-part reusable pump.

• Manufacturing Readiness: Production validation lots well underway; initial capacity supports ~6,000 users with scalable low-cost platform enabling a rapid production ramp-up.

• Commercial Timeline: Initial customers expected by end of Q2 2026; software enhancements (e.g., variable bolus, improved alarms, ACE/AID compatibility) in development; CE Mark targeted Q4 2026/Q1 2027.

SAN DIEGO, CA / ACCESS Newswire / April 9, 2026 / Modular Medical, Inc. ("Modular Medical" or the "Company") (NASDAQ:MODD), a leader in innovative, patient-centric insulin delivery, today announced U.S. Food and Drug Administration ("FDA") 510(k) clearance for its next-generation Pivot tubeless insulin patch pump. This milestone clears the path for commercial availability, with initial customer shipments planned by the end of Q2 2026.

The Pivot is the first two-part tubeless patch pump featuring a removable 3 mL reservoir, disposable battery, smartphone connectivity for bolus and monitoring, and true electronic accuracy without tubes or constant wear. Designed specifically for "almost-pumpers" - adults with type 1 or type 2 diabetes hesitant about traditional pumps - Pivot offers simplicity, affordability, and flexibility to improve adoption and long-term outcomes while potentially reducing healthcare costs.

Jeb Besser, CEO of Modular Medical, said: "FDA clearance for Pivot represents years of focused innovation to deliver a truly differentiated tubeless patch pump. By addressing the key barriers - complexity, bulkiness, and high cost - we believe we are positioned to convert millions still on injections to pump therapy. With manufacturing on track and our software roadmap advancing toward automated insulin delivery ("AID") features, we believe this clearance significantly de-risks our commercial launch and opens a clear path to capturing share in the growing diabetes technology market.

"We thank our team, stakeholders, and shareholders for their support. We now shift focus to our rapid commercialization strategy, additional software enhancements, and European CE Mark progress in the second half of 2026. We look forward to providing operational and adoption updates in the coming months."

For more information on the Pivot system, visit the dedicated site: PivotPump.com.

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 ability to convert patients to use its Pivot pump product; whether the Company will have initial users by June 30, 2026; whether the Company can obtain the C.E. Mark for its Pivot product to allow it to sell in European and other international markets; 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.

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 does Modular Medical's FDA 510(k) clearance for Pivot (MODD) mean for U.S. launch timing?

It allows commercial sale and distribution in the U.S., enabling a launch by end of Q2 2026. According to Modular Medical, initial customer shipments are planned by the end of Q2 2026 and manufacturing validation lots are underway to support early demand.

How does the Pivot tubeless pump (MODD) differ from other insulin pumps on the market?

Pivot is a two-part removable tubeless pump with a 3 mL detachable reservoir and disposable battery. According to Modular Medical, it offers smartphone bolus control, no constant wear, and design choices targeting adults who remain on injections.

What is Modular Medical's initial manufacturing capacity for Pivot and near-term production outlook?

Initial production capacity supports roughly 6,000 users with scalable processes for ramp-up. According to Modular Medical, production validation lots are underway and the platform is designed for rapid, low-cost scaling to meet increasing demand.

Will Pivot include automated insulin delivery (AID) features at launch for MODD users?

No, AID features are not included at launch; they are part of the software roadmap in development. According to Modular Medical, software enhancements like variable bolus and AID compatibility are planned for future updates after initial commercial release.

What regulatory milestones remain for Pivot outside the U.S. and what is the timeline for MODD?

Modular Medical targets a European CE Mark in Q4 2026 or Q1 2027 to enable EU commercialization. According to Modular Medical, CE Mark progress is planned in the second half of 2026 following the U.S. 510(k) clearance.