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Modular Medical Announces FDA Submission of Pivot Tubeless Insulin Patch Pump Enhancements

(Very Positive)

Modular Medical (NASDAQ:MODD) announced submission to the FDA of software enhancements for its Pivot tubeless insulin patch pump. The update covers increased patient customization, UI improvements and other upgrades. According to Modular Medical, this is the first in a planned series of Pivot platform enhancements, following clearance and market launch of the core form factor.

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Positive

  • FDA submission of Pivot software enhancements announced July 1, 2026
  • Planned series of further upgrades to the Pivot insulin platform
  • Core Pivot form factor already FDA cleared and in the market

Negative

  • None.

News Market Reaction – MODD

+4.00%
2 alerts
+4.00% Session close to close
-7.4% Trough Tracked
$25.33M Market Cap
0.0x Rel. Volume

In the Jul 1 session, MODD gained 4.00%, reflecting a moderate positive market reaction. Argus tracked a trough of -7.4% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds incremental FDA-reviewed software flexibility to the Pivot platform, followin...
Analysis

This announcement adds incremental FDA-reviewed software flexibility to the Pivot platform, following earlier clinical and clearance milestones. With an effective $150,000,000 shelf and moderate short interest, future financings and execution on commercialization remain key watch points.

Previous Clinical trial Reports

1 past event · Latest: Sep 11 (Positive)
Same Type Pattern 1 events
Date Event Sentiment 24h Move Catalyst
Sep 11 Clinical study completion Positive +7.1% Completion of MODD1 clinical study supporting development of the Pivot pump.

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

Pattern Detected

Tag-specific history is limited, but the prior clinical update drew a clearly positive price reaction.

Key Terms

tubeless insulin patch pump, insulin delivery system, user-interface (ui), fda
4 terms
tubeless insulin patch pump medical
"Pivot tubeless insulin patch pump in real-world settings"
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.
insulin delivery system medical
"software enhancements to its PivotTM insulin delivery system"
A system that delivers insulin to a person with diabetes, ranging from simple pens and syringes to wearable pumps and automatic “closed‑loop” devices that use sensors to adjust doses. Investors care because these products drive recurring sales, can command higher prices for convenience or accuracy, and face clear regulatory and reimbursement hurdles—think of it as choosing between a basic appliance and a smart, subscription‑linked device that affects long‑term revenue and risk.
user-interface (ui) technical
"more customization options and user-interface (UI) improvements"
The user interface (UI) is the visible and interactive layer of a product—screens, buttons, menus, icons and gestures—that lets people access features and information. A well-designed UI makes a product intuitive and pleasant to use, increasing customer adoption, retention and revenue, while a confusing one can drive users away; think of it as the layout and signage of a store that helps or hinders shoppers from finding and buying items.
fda regulatory
"announced submission to the U.S. Food & Drug Administration (FDA)"
The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

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

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Submission Covers Software Enhancements for Patient Flexibility and Customization of Pivot

SAN DIEGO, CA / ACCESS Newswire / July 1, 2026 / Modular Medical, Inc. ("Modular Medical" or "the Company") (NASDAQ:MODD), a leader in innovative, patient-centric insulin delivery technology, today announced submission to the U.S. Food & Drug Administration (FDA) of a series of software enhancements to its PivotTM insulin delivery system, providing users with more customization options and user-interface (UI) improvements, as well as other software upgrades.

"This submission is the first of a series of further improvements and upgrades planned for the Pivot platform, now that our core form factor has been cleared by the FDA and is in the market. I want to congratulate our whole team for getting this submission in so quickly after the initial Pivot clearance," said Jeb Besser, Chief Executive Officer of Modular Medical. "We look forward to getting feedback from the FDA in the coming weeks."

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

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://www.modularmedical.com.

Pivot is a trademark of Modular Medical in the United States. All other trademarks mentioned herein are the property of their respective owners.

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 plans to make further improvements and upgrades to the Pivot platform, the timing and outcome of any FDA review process, the Company's ability to convert patients to use its Pivot pump product, 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.

Company Contact:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
IR@modular-medical.com

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

SOURCE: Modular Medical, Inc.



View the original press release on ACCESS Newswire

FAQ

What did Modular Medical (NASDAQ:MODD) submit to the FDA for its Pivot insulin pump on July 1, 2026?

Modular Medical submitted software enhancements for its Pivot insulin delivery system to the FDA. According to Modular Medical, the submission includes added customization options, user-interface improvements, and other software upgrades for the tubeless insulin patch pump platform.

How could the Pivot tubeless insulin patch pump enhancements benefit diabetes patients using MODD’s system?

The enhancements aim to give Pivot users more customization and a refined interface. According to Modular Medical, the submission covers user-interface improvements and added flexibility features, which are intended to make insulin delivery more patient-centric and potentially easier to manage.

Is Modular Medical’s Pivot insulin delivery system already FDA cleared and on the market?

Yes, the core form factor of the Pivot insulin delivery system has FDA clearance and is on the market. According to Modular Medical, the newly submitted software enhancements build on this cleared platform as part of an ongoing upgrade roadmap.

What is the next step after Modular Medical’s FDA submission for Pivot software enhancements?

After filing the software enhancements, Modular Medical expects feedback from the FDA in the coming weeks. According to Modular Medical, this submission is the first of several planned improvements for the Pivot platform following its initial regulatory clearance.

Where can investors and patients learn more about Modular Medical’s Pivot insulin delivery system (MODD)?

Information about the Pivot insulin delivery system is available at PivotPump.com and on YouTube. According to Modular Medical, the Pivot Insulin Delivery System channel, searchable as @ModularMedical, offers additional product details and educational content about the tubeless insulin patch pump.