Key Highlights

• MODD shares rose 3.33% intraday to $4.65.

• The company submitted software enhancements for its Pivot tubeless insulin patch pump to the FDA.

• The submission covers customization options and user-interface improvements for the recently cleared device.

• Modular Medical carries a market capitalization of approximately $9.81 million.

FDA Submission Builds on Recent Clearance

Modular Medical, Inc. (NASDAQ:MODD) shares rose Wednesday after the company announced submission to the FDA of a series of software enhancements to its Pivot insulin delivery system, providing users with additional customization options and user-interface improvements.

Modular Medical is a San Diego-based development-stage medical device company focused on the design, development and commercialization of next-generation insulin pump technology, with its flagship Pivot system, a two-part tubeless patch pump engineered for simplicity, affordability and ease of use for both type-1 and type-2 diabetes patients.

First of Planned Series of Upgrades

Company leadership described the submission as the first in a planned series of further improvements and upgrades to the Pivot platform, now that its core form factor has received FDA clearance and reached the market. The company said it expects feedback from the FDA in the coming weeks.

Modular Medical was founded by an engineer who previously founded Tandem Diabetes and invented its t:slim insulin pump. The company currently trades at a market capitalization of approximately $9.81 million, targeting an estimated $3 billion unmet market opportunity in insulin pump therapy.

Conclusion

The FDA submission for Pivot software enhancements represents an early step in Modular Medical's plan to iteratively improve its recently cleared insulin delivery platform. With the core device now in the market, continued regulatory progress on incremental upgrades will be an important factor in the company's efforts to expand adoption beyond specialized "superusers."

 

This article is for informational purposes only and does not constitute investment advice. Readers should conduct their own research before making financial decisions.