Modular Medical Receives IRB Approval for Pivot Insulin Delivery System Feasibility Study
Rhea-AI Summary
Modular Medical (NASDAQ:MODD) has received IRB approval to conduct a feasibility study for its next-generation Pivot insulin delivery system. The study will evaluate the device's usability and extended wear performance by delivering sterile saline to adult participants for up to 90 days.
The Pivot pump builds upon MODD's FDA-cleared first-generation MODD1 patch pump, targeting the $3 billion adult "almost-pumpers" diabetes market. The company plans to use study insights to refine the Pivot pump before its anticipated 510(k) submission to the FDA in October 2025. The study aims to assess usability, identify wear challenges, and collect participant feedback to optimize design for everyday diabetes management.
Positive
- Targeting large $3 billion market opportunity in adult diabetes care
- Building on existing FDA-cleared first-generation product (MODD1)
- Clear regulatory pathway with 510(k) submission planned for October 2025
- Extended 90-day wear testing period demonstrates product durability focus
Negative
- Pivot insulin delivery system not yet FDA-cleared
- Product still in feasibility study phase, indicating lengthy path to commercialization
News Market Reaction
On the day this news was published, MODD declined 0.31%, reflecting a mild negative market reaction. Argus tracked a peak move of +21.4% during that session. Argus tracked a trough of -5.5% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $129K from the company's valuation, bringing the market cap to $41M at that time.
Data tracked by StockTitan Argus on the day of publication.
-Study to Evaluate Usability and Extended Wear for Next-Generation Tubeless Patch Pump
SAN DIEGO, CA / ACCESS Newswire / September 15, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery technology targeting the
Modular Medical's second-generation tubeless platform, its Pivot pump, builds on the Company's FDA-cleared first-generation patch pump, the MODD1, and aims to continue to enhance accessibility for underserved patients with diabetes and drive market expansion. The insights derived from the Study will be used to refine the Pivot pump ahead of its 510(k) submission to the FDA, which is anticipated in October 2025.
Key objectives and potential impacts of the Study include:
Assess usability and identify challenges in prolonged wear scenarios;
Collect participant feedback to optimize design for everyday diabetes management; and
Support regulatory pathways, potentially unlocking new markets and revenue streams.
The Pivot insulin delivery system is not currently cleared for sale by the FDA.
"This IRB approval marks another significant milestone in advancing our tubeless insulin pump technology toward market readiness," said Jeb Besser, CEO of Modular Medical. "By testing extended wear in real-world simulations, we expect to gather invaluable data to make our Pivot pump more intuitive and reliable for adults with diabetes. Once FDA clearance is achieved, we believe our Pivot pump will be well positioned to achieve rapid adoption in the growing wearable diabetes technology sector. This progress underscores our commitment to innovation, as we look to achieve long-term growth in the expanding diabetes care landscape and bring value to the Company's shareholders."
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 products to persons with diabetes; the Company's ability to convert patients to use its pump products; 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; and general economic, industry and 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.
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 is the market size for Modular Medical's (NASDAQ:MODD) Pivot insulin delivery system?
When will Modular Medical submit the Pivot insulin pump for FDA approval?
How long will MODD's Pivot insulin pump feasibility study last?
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What products does Modular Medical currently have FDA clearance for?
