Modular Medical Announces Commercial Availability of Pivot Tubeless Insulin Patch Pump Ahead of Commercial Expansion

Rhea-AI Summary

Modular Medical (NASDAQ:MODD) announced U.S. commercial availability of its Pivot tubeless insulin patch pump following FDA 510(k) clearance in April. This begins real-world patient use and marks its shift to a commercial-stage, revenue-generating business.

Pivot is the second fully electronic, tubeless insulin pump in the U.S., targeting insulin-dependent adults on multiple daily injections—an estimated 70% of this population and a multi-billion-dollar market. Initial shipments start immediately, with phased commercial expansion from select high-volume endocrinology practices to multiple metropolitan markets by late 2026. Broader commercial activities are expected to ramp in Q4 2026.

Positive

• Pivot tubeless insulin patch pump now commercially available in the U.S.
• Company transitions from development-stage to revenue-generating commercial business
• Second fully electronic, tubeless insulin pump available in the U.S. market
• Targets estimated 70% of insulin-dependent adults still on daily injections
• Addresses multi-billion-dollar diabetes technology market opportunity
• Phased expansion plan into multiple metropolitan markets by late 2026

Negative

• Full commercial expansion activities not expected until Q4 2026
• Initial rollout limited to select high-volume endocrinology practices

News Market Reaction – MODD

-2.21% 11.3x vol

15 alerts

-2.21% Session close to close

+3.4% Peak Tracked

-19.8% Trough Tracked

$23.21M Market Cap

11.3x Rel. Volume

In the Jun 24 session, MODD declined 2.21%, reflecting a moderate negative market reaction. Argus tracked a peak move of +3.4% during that session. Argus tracked a trough of -19.8% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 11.3x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement confirms U.S. commercial availability of Pivot, targeting an estimated 70% of insu...

Analysis

This announcement confirms U.S. commercial availability of Pivot, targeting an estimated 70% of insulin-dependent adults still on injections. With an effective $150,000,000 shelf and prior raises, future funding actions remain a key factor to watch alongside phased launch execution.

Key Figures

Reservoir volume: 3 mL Almost-pumper share: 70% of insulin-dependent adults Shelf registration capacity: $150,000,000 +5 more

8 metrics

Reservoir volume 3 mL Pivot tubeless insulin patch pump design

Almost-pumper share 70% of insulin-dependent adults Estimated share remaining on multiple daily injections

Shelf registration capacity $150,000,000 Maximum securities under Form S-3 shelf filed April 23, 2026

ATM program size $100,000,000 At-the-market common stock sales agreement with Maxim Group LLC

April 2026 offering $3.375 million Registered direct offering expected gross proceeds before fees

March 2026 financing $12.0 million Registered direct offering proceeds disclosed in S-3 prospectus

Reverse split ratio 1-for-30 Reverse stock split effective March 31, 2026

Ownership cap 9.99% Warrant exercise cap for AWM Investment Company, Inc.

Historical Context

5 past events · Latest: Jun 04 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 04	Product marketing update	Neutral	+6.4%	Launch of PivotPump.com site and timeline reminders for Pivot commercialization.
Apr 29	Investor webinar notice	Neutral	-3.3%	Announcement of CEO presentation and Q&A webinar on FDA wins and manufacturing.
Apr 19	Equity financing	Neutral	-7.7%	Pricing of registered direct offering of 750,000 shares at $4.50 per share.
Apr 16	Nasdaq compliance	Neutral	+3.0%	Regaining compliance with Nasdaq minimum bid price listing requirement.
Apr 09	Regulatory clearance	Neutral	-1.6%	FDA 510(k) clearance for Pivot tubeless insulin patch pump enabling U.S. sales.

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

Pattern Detected

Recent news for MODD has produced mixed price reactions, with both gains and declines following regulatory, financing, and product-related updates.

Key Terms

510(k) clearance, tubeless insulin patch pump, registered direct offering, shelf registration, +2 more

6 terms

510(k) clearance regulatory

"following FDA 510(k) clearance in April"

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 insulin patch pump medical

"The Pivot tubeless insulin patch pump is now commercially available"

A tubeless insulin patch pump is a small, wearable device that sticks to the skin like a patch and delivers measured doses of insulin without any tubing. It acts like an automatic medicine dispenser, replacing multiple daily injections and helping keep blood sugar steadier, which matters to investors because it targets a large, growing diabetes market, can drive recurring sales and service revenue, and depends on regulatory approval and insurance coverage for commercial success.

registered direct offering financial

"pricing of $3.4 Million Registered Direct Offering of Common Stock"

A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.

shelf registration regulatory

"filed a shelf registration to offer up to $150,000,000 of securities"

Shelf registration is when a company gets permission ahead of time to sell new stocks or bonds over a period of time instead of all at once. It matters to investors because it lets a company raise money quickly when needed, but it can also change the value of existing shares if many new ones are sold.

View in glossary

at-the-market sales financial

"permitting at-the-market sales of up to $100,000,000 of common stock"

At-the-market sales are a way for a company to raise cash by gradually selling new shares directly into the open market at current trading prices through a broker, rather than in a single big offering. Investors should care because this drip-feed approach can dilute existing shareholdings and put modest downward pressure on the stock as supply increases, but it also gives the company flexible, on-demand funding without a fixed share price.

reverse stock split financial

"a 1-for-30 reverse stock split effective March 31, 2026"

A reverse stock split reduces a company's number of outstanding shares while raising the price per share proportionally, so the total value of each investor's holding is unchanged; a 1-for-10 split turns 100 shares worth $1 each into 10 shares worth $10 each. Companies often do this to regain compliance with an exchange's minimum price rule or to attract investors who avoid very low-priced stocks.

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

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• The Pivot tubeless insulin patch pump is now commercially available in the U.S. following FDA 510(k) clearance in April

• Pivot represents a differentiated solution for insulin-dependent adults still on multiple daily injections, representing a multi-billion-dollar market

• Commercial expansion activities are expected to begin in Q4 2026

SAN DIEGO, CA / ACCESS Newswire / June 24, 2026 / Modular Medical, Inc. (NASDAQ:MODD), a leader in innovative, patient-centric insulin delivery technology, today announced that the Pivot^™ tubeless insulin patch pump is now commercially available. This marks the start of real-world patient use, and the Company's transition to a commercial-stage medical device company.

As only the second fully electronic, tubeless insulin pump available in the United States, Pivot is designed to make pump therapy simpler to learn and easier to live with. Its removable two-part design and 3 mL reservoir, intuitive interface, and flexible, wearable form factor support everyday activities, such as showering and sports, with no battery recharging required - all while maintaining clinical accuracy and connectivity.

"Reaching commercial availability is a transformational milestone that marks Modular Medical's transition from a development-stage company to a revenue-generating commercial business," said Jeb Besser, Chief Executive Officer of Modular Medical. "As only the second fully electronic tubeless pump on the U.S. market, Pivot is positioned to serve a large, underserved 'almost-pumper' population. With first shipments beginning this week, we are focused on disciplined execution, as we scale adoption and seek to build long-term value for patients and shareholders."

Pivot is purpose-built for adults with diabetes on daily injections who have faced cost, complexity, and usability barriers with traditional pump systems. This group, which the Company calls the "almost-pumpers," represents an estimated 70% of insulin-dependent adults who remain on multiple daily injections, a multi-billion-dollar opportunity within the diabetes technology market.

Full commercial launch is expected to roll out in phases, initially targeting select high-volume endocrinology practices and expanding across multiple metropolitan markets by late 2026.

For more information on the Pivot system, visit the dedicated site: PivotPump.com and the YouTube Pivot Insulin Delivery System channel searchable @ModularMedical.

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, 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, and 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 commercial-stage medical device company that is commercializing 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.

Company Contact:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com

Investor Relations Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
ModularMedical@KSCA.com

SOURCE: Modular Medical, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Modular Medical (NASDAQ:MODD) announce about the Pivot insulin pump on June 24, 2026?

Modular Medical announced that its Pivot tubeless insulin patch pump is now commercially available in the U.S. According to Modular Medical, this marks the start of real-world patient use and its transition into a revenue-generating commercial-stage medical device company.

What is the Pivot tubeless insulin patch pump and who is it for (MODD)?

Pivot is a fully electronic, tubeless insulin patch pump designed for insulin-dependent adults on multiple daily injections. According to Modular Medical, it specifically targets "almost-pumpers" who have faced cost, complexity, and usability barriers with traditional pump systems, representing a large treatment segment.

How is Pivot differentiated from other insulin pumps in the U.S. market for MODD investors?

Pivot is described as only the second fully electronic, tubeless insulin pump available in the United States. According to Modular Medical, it features a removable two-part design, 3 mL reservoir, intuitive interface, wearable form factor, and no battery recharging, while maintaining clinical accuracy and connectivity.

What market opportunity does Pivot target for Modular Medical (NASDAQ:MODD)?

Pivot targets insulin-dependent adults who remain on multiple daily injections, which Modular Medical estimates at about 70% of this population. According to Modular Medical, this "almost-pumper" segment represents a multi-billion-dollar opportunity within the diabetes technology market for the Pivot system.

What is the commercial launch timeline for Pivot and MODD’s expansion plans?

Initial shipments of Pivot are beginning immediately, with a phased commercial rollout planned. According to Modular Medical, launch will start with select high-volume endocrinology practices and expand across multiple metropolitan markets by late 2026, with broader commercial activities expected to ramp in Q4 2026.

How might Pivot’s launch affect Modular Medical’s business model and revenues (MODD)?

Pivot’s commercial availability marks Modular Medical’s move from development-stage to a revenue-generating commercial business. According to Modular Medical, the product’s entry into a multi-billion-dollar "almost-pumper" market positions the company to begin generating revenue from its insulin delivery technology platform.

Where can patients and investors learn more about the Pivot insulin delivery system from Modular Medical?

Information about Pivot is available on the dedicated website PivotPump.com and via YouTube. According to Modular Medical, the Pivot Insulin Delivery System channel can be found by searching @ModularMedical, offering additional product and usage details for interested patients and stakeholders.