Modular Medical filed a 510(k) pre‑market application on November 14, 2025 for its Pivot tubeless patch pump, a two‑part removable system that delivers insulin without a battery or separate bolus controller.
The Pivot features a 3 ml reservoir and is designed to be simple to use, aiming to attract the 28 % of type‑1 and 25 % of type‑2 diabetes patients who are interested in pump therapy but deterred by the complexity and cost of current devices.
The company estimates the “Almost‑Pumper” segment to be worth roughly $3 billion, positioning the Pivot to capture a sizable share of a market that remains underserved by feature‑heavy, expensive pumps.
Modular Medical is a development‑stage company with no reported revenue. Its most recent quarterly loss was $4.8 million in Q4 2024, and the full‑year 2025 loss totaled $18.82 million. Cash on hand was $6.986 million as of Q3 2025, and the company has acknowledged substantial doubt about its ability to continue as a going concern.
The Pivot builds on the company’s earlier MODD1 insulin pump, which received FDA clearance in September 2024, demonstrating the viability of its platform and manufacturing approach.
The 510(k) review is expected to take several months; the FDA typically aims for a 90‑day review but often extends the timeline. Modular Medical anticipates initial questions in Q4 2025 and plans to launch the Pivot in the first quarter of 2026 if clearance is obtained.
Competitive pressure comes from Medtronic, Tandem, and Insulet, all of which offer more feature‑rich pumps. Modular Medical’s differentiation strategy focuses on simplicity, affordability, and a user‑friendly interface to attract patients who find current pumps too complex or costly.
CEO Jeb Besser said, “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.” He added that the device’s 3 ml reservoir, removable design, and bolus capability without a separate controller combine to preserve accuracy while simplifying the user experience.
The company faces several headwinds, including the need to scale manufacturing, secure reimbursement pathways, and navigate the regulatory review process. Its financial position adds further risk, as ongoing operating losses and limited cash reserves require additional capital to reach commercialization.
While the 510(k) filing marks a significant regulatory step, Modular Medical remains in the early stages of product development and has yet to generate revenue. The company’s future success will depend on obtaining FDA clearance, achieving scale‑up, and securing payer coverage for the Pivot pump.
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