Modular Medical Receives IRB Approval for Pivot Insulin Delivery System Feasibility Study
核心洞察
Modular Medical (搜索) received Institutional Review Board approval to conduct a 90-day feasibility study of its next-generation Pivot tubeless insulin patch pump using sterile saline in adult participants.
The study will evaluate device usability and extended wear performance to gather critical data for refining the Pivot pump ahead of its anticipated FDA 510(k) submission in October 2025.
The Pivot system builds on the company's FDA-cleared first-generation MODD1 patch pump and targets the $3 billion adult "almost-pumpers" diabetes market with user-friendly, affordable technology.
Modular Medical (搜索), Inc. (NASDAQ:MODD) announced it has received Institutional Review Board (IRB) approval to conduct an in-house feasibility study of its next-generation Pivot insulin delivery system. The study will simulate real-world conditions by delivering sterile saline to adult participants for up to 90 days to gather critical data on device usability, extended wear performance and user feedback.
The company is targeting the $3 billion adult "almost-pumpers" diabetes market with its user-friendly, affordable patch pump technology. According to FDA regulations, an IRB is a group that has been formally designated to review and monitor biomedical research involving human subjects.
Second-Generation Tubeless Platform
Modular Medical (搜索)'s Pivot pump represents the company's second-generation tubeless platform, building on its FDA-cleared first-generation patch pump, the MODD1. The system aims 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.
The Pivot insulin delivery system is not currently cleared for sale by the FDA.
Study Objectives and Clinical Impact
The feasibility study has three key objectives that could significantly impact the diabetes care landscape:
- Assess usability and identify challenges in prolonged wear scenarios
- Collect participant feedback to optimize design for everyday diabetes management
- Support regulatory pathways, potentially unlocking new markets and revenue streams
"This IRB approval marks another significant milestone in advancing our tubeless insulin pump technology toward market readiness," said Jeb Besser, CEO of Modular Medical (搜索). "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."
Market Positioning and Technology Innovation
Modular Medical (搜索) was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer who previously founded Tandem Diabetes (搜索) in 2005 and invented and designed its t:slim insulin pump. The company 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."
Besser emphasized the potential market impact: "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."