Modular Medical Advances Tubeless Pivot Insulin Pump with October FDA Filing and Gamified Training Platform
Key Insights
Modular Medical (search) plans to file a special 510(k) application with the FDA in October 2025 for its next-generation tubeless Pivot patch pump targeting "almost-pumpers" with user-friendly design.
The company is partnering with Level Ex (search) to develop a gamified training application for the Pivot pump, building on Level Ex's successful Level One diabetes management game endorsed by Breakthrough T1D (search).
Modular Medical (search) is also pursuing European market clearance for its MODD1 insulin pump through BSI Group (search), targeting Q1 2026 for expected EU regulatory approval.
Modular Medical (search), Inc. (Nasdaq: MODD) is advancing its next-generation insulin delivery technology with plans to file for FDA clearance of its tubeless Pivot patch pump in October 2025, while simultaneously developing innovative training solutions to address adoption barriers in diabetes care.
The San Diego-based insulin delivery technology company announced its participation at the Association of Diabetes Care & Education Specialists (ADCES) Conference in Phoenix, Arizona, where it showcased the Pivot pump designed specifically for "almost-pumpers" - adult patients who could benefit from pump therapy but have not yet adopted the technology.
Regulatory Pathway and Market Strategy
Modular Medical (search) expects to submit a special 510(k) filing for the Pivot product in October 2025, marking a significant milestone in the company's regulatory strategy. The tubeless patch pump design targets accessibility and user-friendliness, addressing key barriers that prevent diabetes patients from adopting pump therapy.
"The ADCES conference is an ideal location for us to showcase our next-generation patch pump, branded as Pivot, for which we plan to file for U.S. Food and Drug Administration clearance in October 2025," stated Jeb Besser, CEO of Modular Medical (search). "Diabetes care and education specialists are crucial in offering and prescribing pumps to achieve improved clinical outcomes, and we believe they will appreciate the user-friendly design of the Pivot pump and our focus on making diabetes care simpler to learn and manage for our targeted audience of Almost Pumpers."
Gamified Training Innovation
The company is partnering with Level Ex (search) to develop a gamified training application for the Pivot pump, introducing the first playable level at the ADCES conference. Level Ex, powered by Relevate, developed the Level One diabetes management game, which is endorsed by Breakthrough T1D (search), a leading global type 1 diabetes research and advocacy organization.
"Level One is free because diabetes mastery shouldn't come with a price tag. Modular Medical (search) is breaking barriers too - bringing pump therapy to more people through smart, accessible design," commented Sam Glassenberg, CEO of Level Ex (search). "Together, we intend to make diabetes management simpler and more inclusive."
The gamification approach addresses complexity concerns that serve as barriers to pump adoption, impacting both patients and healthcare providers. Glassenberg explained that gamification has proven to make medical training more effective and efficient while dramatically improving knowledge retention.
"People learn best through play - and we believe they want to learn about insulin pumps the same way," Glassenberg continued. "In Level One, players aren't just mastering diabetes management through gameplay - they're asking to 'play' with pumps: to explore how they work, understand their benefits, and build confidence before using them in real life."
European Market Expansion
Modular Medical (search) has engaged BSI Group (search) to initiate the regulatory clearance process for the MODD1, its next-generation insulin pump, in the European market. The company is targeting Q1 2026 for expected clearance of the MODD1 in the European Union, representing a significant expansion of its market reach.
Advanced Insulin Delivery Systems
The company is also developing next-generation automated insulin delivery technology through a collaboration with Nudge BG (search). This partnership aims to bring to market an adaptive full closed-loop Automated Insulin Delivery system that eliminates the need for mealtime announcements. The effort is being led by Nudge BG founder Lane Desborough, a noted expert in automated insulin delivery systems.
Clinical Research Findings
Recent studies have demonstrated the potential for enhanced therapeutic outcomes through innovative delivery approaches. Research showed more potent weight loss and blood glucose control with the addition of a mealtime bolus of rapid-acting GLP-1 (search) to basal delivery. The observed weight loss was 17% at 28 days, representing a 25% improvement over GLP-1 delivered as basal therapy alone.
These findings suggest that pump delivery may be a viable approach to achieve GLP-1 (search) weight and blood glucose benefits comparable with current treatment standards, either as initial treatment or for maintenance therapy, while providing personalized dosing flexibility.