Modular Medical, Inc. secured FDA 510(k) clearance for its Pivot tubeless insulin patch pump on April 9 2026, clearing the final regulatory hurdle that allows the device to be marketed and sold in the United States.
The Pivot is the first two‑part tubeless patch pump that features a removable 3 mL reservoir, a disposable battery, and smartphone connectivity for bolus delivery and monitoring. The design targets the “almost‑pumper” market, estimated at $3 billion, by offering a simple, affordable, and flexible alternative to traditional insulin pumps that many adults with diabetes find too complex or costly.
Initial customer shipments are slated for the end of Q2 2026, with a production capacity that can support roughly 6,000 users. Modular Medical also plans to obtain a CE Mark for European markets in Q4 2026 or Q1 2027, expanding its commercial reach beyond the United States.
Despite the regulatory milestone, the company remains a development‑stage firm. It reported a negative EBITDA of $25.3 million in the last twelve months, completed a 1‑for‑30 reverse stock split effective March 31 2026 to meet Nasdaq’s bid‑price requirement, and raised approximately $12 million in a recent public offering. These facts underscore the company’s ongoing cash burn and the need for sustained revenue growth to achieve profitability.
"We thank our team, stakeholders, and shareholders for their support. We now shift focus to our rapid commercialization strategy, additional software enhancements, and European CE Mark progress in the second half of 2026. We look forward to providing operational and adoption updates in the coming months," said CEO Jeb Besser. "The Pivot submission is an exciting milestone in our mission to deliver a differentiated tubeless patch pump experience to those who want a simple pump to manage the treatment of diabetes. Our Pivot patch pump offers a 3 ml reservoir, the flexibility of removing the pump and the ability to bolus without a separate controller, all without sacrificing the accuracy, communications and clinical reporting advantages of a true electronic pump," Besser added.
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