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Certification Represents Another Milestone Toward CE Mark Submission for Pivot
Game-Based Education Tools Designed to Help Improve Patient Familiarity with Pump Therapy and Support Healthcare Providers in Identifying Candidates for Pump Adoption
Clearance Covers Software Enhancements for Greater Patient Flexibility and Pivot Customization
Meet with Modular Medical CEO Jeb Besser.
Discover The Pivot tubeless patch pump, a simple, wearable insulin delivery platform designed to provide continuous subcutaneous insulin infusion with both basal and bolus insulin delivery over a three-day wear period.
Explore How the Pivot represents a differentiated solution for insulin-dependent adults still on multiple daily injections, representing a multi-billion-dollar market opportunity.
Register at PivotLaunch.TribePublic.com.
First Phase of Strategic Rollout Targets Markets with Leading Insulin Pump Prescribers and Strong New Pump Adoption. Inizio will Provide Commercialization Expertise to Accelerate Awareness and Adoption of the Pivot Pump.
- Council to Provide Strategic Clinical Guidance on Commercialization, Patient Identification, Workflow Integration, and Evidence Generation
Pilot Combines Clinician Guided Phenotypes with IMO Health's Unique Terminology Identifiers to Help Clinicians Easily Identify Patients Most Likely to Benefit from Pivot Insulin Pump Therapy
Advancing Towards Fourth Quarter Commercial Launch of Pivot Pump
Completed Independent Study Strongly Supports Favorable Payor Receptivity to Pivot's Differentiated Design and Simplified User Experience, and provides further validation of significant progress towards goal of achieving broad market access for Pivot
97% of Surveyed Injection Users Would Consider Pump Therapy - if Easier to Learn and Improved Outcomes
Conducting Additional Research Initiative in Conjunction with Commercialization of the Pivot Tubeless Insulin Patch Pump
Company to Showcase Pivot at Association of Diabetes Care & Education Specialists (ADCES) Annual Conference, August 7-10, 2026
Submission Covers Software Enhancements for Patient Flexibility and Customization of Pivot
First Patients Began Device Training and Insulin Delivery Today, Marking Transition to a Commercial Company
Pivot is the First Insulin Pump Designed to Address the Large, Underserved Population of Insulin-Dependent Adults Still Relying on Multiple Daily Injections, a Multibillion-Dollar Market
Pivot starter kits are now shipping to multiple endocrinology practices
The Pivot tubeless insulin patch pump is now commercially available in the U.S. following FDA 510(k) clearance in April
Pivot represents a differentiated solution for insulin-dependent adults still on multiple daily injections, representing a multi-billion-dollar market
Commercial expansion activities are expected to begin in Q4 2026
Initial patients expected in June 2026
Meet with Modular Medical CEO Jeb Besser
There are 4.8 million individuals with diabetes in the US that require daily insulin. Only 20% currently use an insulin pump.
Discover Modular Medical's Pivot, the first FDA-cleared, two-part tubeless patch pump featuring a removable 3 mL reservoir, disposable battery, smartphone connectivity for bolus and monitoring, and true electronic accuracy without tubes or constant wear and its associated commercial & manufacturing timeline.
Register at MODD-May-Watch.TribePublic.com
First Removable 2-Part Design Targets $3 Billion "Almost-Pumper" Market with Expected Q2 2026 initial deployment.
Key Milestones & Investment Highlights:
FDA 510(k) Clearance Achieved: Pivot™ pump now cleared for commercial sale in the U.S. - major de-risking event unlocking revenue path.
First-in-Class Removable Tubeless Patch Pump: 3 mL detachable reservoir; no battery recharging required; removable for showering, sports or discretion; quick bolus button without a separate controller.
Targets Massive Underserved Market: ~70% of insulin-dependent adults remain on multiple daily injections (MDI) due to complexity, cumbersomeness and cost - Pivot addresses the "3 Cs" for "almost-pumpers" with its 2-part reusable pump.
Manufacturing Readiness: Production validation lots well underway; initial capacity supports ~6,000 users with scalable low-cost platform enabling a rapid production ramp-up.
Commercial Timeline: Initial customers expected by end of Q2 2026; software enhancements (e.g., variable bolus, improved alarms, ACE/AID compatibility) in development; CE Mark targeted Q4 2026/Q1 2027.
Targeting Q1 2026 Launch, Subject to FDA Clearance
Key Highlights:
Cartridge & Infusion Set Lots in Production: Validation production lots now being produced for launch, derisking commercial-scale production.
First Removable Tubeless Patch Pump: Pivot targets underserved "almost-pumpers" - adults with diabetes hesitant to move from multiple daily injections (MDI) due to cost and complexity - representing a significant portion of the growing ~$8 billion global insulin pump market.
Affordable, User-Friendly Design: A full 3ml removable cartridge and pump with a simple interface expands access for millions managing diabetes with MDI by providing significant clinical therapy improvement
Study to Deliver Insulin to Internal Testers Wearing Continuous Glucose Monitors
-Targets $3 Billion "Almost-Pumper" Market with First Simplified and Removable/Replaceable Insulin Patch Pump
- Aims to Improve Patient and Clinician Experience for the Care of Diabetes
Key Highlights:
Pivot Controller Line Validated: Manufacturing line has now been validated for human-use production in support of expected Q1 2026 market launch.
Pivot will be First Two-Part Tubeless Patch Pump: Pivot, a 3 milliliter removable patch pump, targets the $3 billion dollar market for adult "almost-pumpers" with its affordable, user-friendly, easy-to-learn design.
High-Volume Manufacturing Readiness: Modular Medical's scalable platform positions it to target a significant share of the insulin pump market.
Key Highlights:
Pivot continues to progress toward CE Mark certification in 2026
Stage 1 ISO Audit completed with Stage 2 planned for 1H2026
-Seasoned Executive with Proven Track Record in International Pump Launches to Accelerate Global Adoption of User Friendly, Affordable Patch Pumps
-Study to Evaluate Usability and Extended Wear for Next-Generation Tubeless Patch Pump
- Use of MODD1 on clinicians with Type 1 diabetes
-More than 6,000 MODD1 cartridges produced
- Conversion to Pivot-ready manufacturing in preparation for product launch in 1Q26
-Debuting a "coming soon" campaign for tubeless Pivot patch pump
- Expects special 510(k) filing for Pivot product in October
- Will introduce first level of its gamified training application developed by Level Ex, developers of the Level One diabetes-management game
- Use of MODD1 on clinician with Type 1 diabetes
- Modular Medical intends to deploy the MODD1 on a larger number of clinicians in mid August
-Line has been in production at risk since early July
- Production to continue until late August when conversion to Pivot manufacturing will begin
Meet with Modular Medical CEO Jeb Besser
There are 1.9 million individuals with Type 1 Diabetes in the US. 100% of patient population require daily insulin injection. Only 1 out of 3 currently use an insulin pump.
Discover how Modular Medical is developing technology to empower the whole diabetes community with MODD1
Register at MODD-Therapy.TribePublic.com
- Engaged BSI Group to start the process of obtaining regulatory clearance of the MODD1, next-generation insulin pump for the European market
- Targeting Q1 2026 for expected clearance of the MODD1 in the E.U.
-Modular Medical will collaborate with Nudge BG to bring to market an adaptive full closed loop Automated Insulin Delivery system that does not require mealtime announcements
-Effort will be led be Nudge BG founder and noted AID expert, Lane Desborough