Street Calls of the Week
SAN DIEGO - Modular Medical, Inc. (NASDAQ:MODD), a $41.5 million market cap medical device company currently trading at $0.75 per share, announced Monday that it has received Institutional Review Board approval to conduct an in-house feasibility study of its next-generation Pivot insulin delivery system using sterile saline. According to InvestingPro analysis, the company appears undervalued based on its Fair Value assessment.
The study will simulate real-world conditions by delivering sterile saline to adult participants for up to 90 days, gathering data on device usability, extended wear performance and user feedback. According to the company’s statement, the insights will help refine the Pivot pump ahead of its planned 510(k) submission to the FDA in October 2025. While InvestingPro data shows the company is quickly burning through cash, it maintains a strong liquidity position with a current ratio of 4.04.
The Pivot insulin delivery system builds upon Modular Medical’s FDA-cleared first-generation patch pump, the MODD1, and targets what the company describes as the $3 billion adult "almost-pumpers" diabetes market.
Key objectives of the study include assessing usability in prolonged wear scenarios, collecting participant feedback to optimize design, and supporting regulatory pathways.
"This IRB approval marks another significant milestone in advancing our tubeless insulin pump technology toward market readiness," said Jeb Besser, CEO of Modular Medical, in the press release.
The Pivot insulin delivery system is not currently cleared for sale by the FDA. Modular Medical, founded by Paul DiPerna who previously founded Tandem Diabetes and designed its t:slim insulin pump, aims to make insulin delivery both affordable and simple to learn.
This article is based on a company press release statement. InvestingPro subscribers have access to additional insights, including 7 more ProTips and comprehensive financial metrics that help evaluate investment opportunities in the medical device sector. The company currently maintains a "Fair" overall financial health score of 1.79 out of 5, with analysts setting an $8 price target for the stock.
In other recent news, Modular Medical announced the completion of a clinical study involving its MODD1 insulin pump. The study included nine clinicians specializing in Type 1 diabetes who utilize continuous glucose monitors and other pumps. The primary aim was to gather real-world feedback to enhance the upcoming Pivot pump product. Participants offered insights into the pump’s user-friendliness, especially its capability to transition patients from multiple daily injections to pump therapy. These developments mark a significant step forward as the company prepares for the Pivot pump’s anticipated launch. The study’s findings are expected to play a crucial role in refining the product based on clinician feedback. Modular Medical continues to focus on innovation in the medical device sector, aligning with industry needs and user expectations.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.