Modular Medical Announces Completion of Clinical Study of MODD1 Pump

Rhea-AI Summary

Modular Medical (NASDAQ:MODD) has successfully completed a clinical study of its MODD1 insulin pump. The study involved nine clinicians with Type 1 diabetes who currently use CGM and other pumps, providing real-world experience and feedback for the company's next-generation Pivot pump development.

The MODD1 pump, which is the first FDA-cleared patch pump specifically designed for the $3 billion adult "almost-pumpers" market, focuses on user-friendliness and affordability. The company plans to submit its Pivot pump to the FDA for clearance in October 2025.

Positive

• First FDA-cleared patch pump targeting the $3 billion adult 'almost-pumpers' market
• Successful completion of clinical study with nine clinicians providing real-world feedback
• Clear timeline for FDA submission of next-generation Pivot pump in October 2025

Negative

• Limited study size with only nine participants
• Additional refinements needed before Pivot launch based on study feedback

Insights

Medical Device Regulatory Specialist

MODD completed a small feedback study with their FDA-cleared pump as they prepare for next-gen Pivot submission in October 2025.

Modular Medical has completed a small-scale clinical study of its MODD1 insulin pump involving nine clinicians with Type 1 diabetes who already use CGMs and insulin pumps. This study wasn't designed to establish safety or efficacy (as MODD1 is already FDA-cleared) but rather focused on gathering real-world user experience to refine the company's next-generation Pivot pump product ahead of its planned FDA submission.

The strategic significance of this study lies in its target demographic. Modular Medical is specifically focusing on the "almost-pumpers" market—patients currently using multiple daily injections who could benefit from pump therapy but haven't adopted it. This segment represents an estimated $3 billion opportunity. The company is testing MODD1's usability specifically for converting these injection-dependent patients to automated pump systems.

From a regulatory perspective, the company's announcement of an October 2025 FDA submission timeline for the Pivot pump provides a concrete milestone for investors. This suggests confidence in their development progress and regulatory strategy. However, it's important to note this is a 510(k) clearance pathway (implied by their description of the MODD1 as "FDA-cleared" rather than "FDA-approved"), which typically has a shorter review cycle than PMA approvals but still carries regulatory uncertainty.

The fact that they're conducting additional user testing with the current MODD1 to refine the Pivot indicates they're taking a methodical approach to product development, which could potentially reduce regulatory risks in the upcoming submission.

- Use of MODD1 on clinicians with Type 1 diabetes

SAN DIEGO, CA / ACCESS Newswire / September 11, 2025 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target the estimated $3 billion dollar adult "almost-pumpers" market with its user-friendly and affordable design, today announced the successful completion of a clinical study with the MODD1 pump. The MODD1 was worn by nine clinicians with Type 1diabetes who currently wear a continuous glucose monitor ("CGM") and other pumps to provide the Company with real-world experience and feedback to make further refinements for the launch of its next-generation Pivot pump product. This MODD1 study was conducted to test and refine its ease of use for converting multiple daily injectors to this system and will continue as we prepare for the Pivot launch.

"We want to thank the clinicians who participated in this trial deployment for their time and feedback on our MODD1 pump, and we look forward to demonstrating improvements in usability when we repeat this trial with the Pivot," said Jeb Besser, CEO of Modular Medical.

The Company expects to submit its Pivot pump product to the U.S. Food and Drug Administration ("FDA") for clearance in October 2025.

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 timing of the Company's submission of its Pivot product to the FDA; the performance of the Company's products; expected deployments of the Company's pump product to persons with diabetes, the Company's ability to convert patients to use its MODD1 pump; and the occurrence of future events or circumstances, 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. 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.

All 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 were the results of Modular Medical's (MODD) MODD1 pump clinical study?

The clinical study involved nine clinicians with Type 1 diabetes who tested the MODD1 pump, providing real-world experience and feedback for future product refinements.

When will Modular Medical submit the Pivot pump to the FDA?

Modular Medical plans to submit its Pivot pump to the FDA for clearance in October 2025.

What is the target market size for Modular Medical's MODD1 pump?

The MODD1 pump targets the $3 billion adult 'almost-pumpers' market with its user-friendly and affordable design.

How does the MODD1 pump differ from other insulin pumps?

The MODD1 is the first FDA-cleared patch pump specifically designed to be user-friendly and affordable for adults who currently use multiple daily injections.

What is the purpose of Modular Medical's MODD1 clinical study?

The study was conducted to test and refine the pump's ease of use for converting multiple daily injectors to this system and gather feedback for improvements in the next-generation Pivot pump.