Modular Medical Reports $18.8 Million Net Loss and FDA Clearance for Insulin Pump

Modular Medical, Inc., a pre-revenue medical device company, reported significant financial developments in its recent 10-K filing for the fiscal year ending March 31, 2025. The company recorded a net loss of approximately $18.8 million, an increase from a loss of $17.5 million in the previous fiscal year. This loss was primarily attributed to rising research and development (R&D) expenses, which increased by 14.1% to $14.7 million, driven by higher personnel costs and increased depreciation related to manufacturing capabilities. General and administrative expenses decreased slightly to $4.4 million from $4.6 million, reflecting reductions in stock-based compensation and marketing expenses.

In terms of operational milestones, Modular Medical received FDA clearance for its initial insulin pump product, the MODD1, in September 2024, following a 510(k) premarket notification submission in January 2024. The company plans to commence initial shipments of the MODD1 in the quarter ending September 30, 2025. Additionally, Modular Medical is preparing to submit a 510(k) application for its successor product, the Pivot, which is expected to be filed by October 31, 2025, with a potential market launch anticipated in early 2026. The company aims to expand its product offerings and market reach, particularly targeting both Type 1 and Type 2 diabetes patients.

Financially, Modular Medical has been proactive in securing capital to support its operations. In March 2025, the company completed a private placement of 6.25 million units, generating approximately $12 million in gross proceeds. This was complemented by a public offering in November 2024 that raised an additional $7.3 million. As of March 31, 2025, the company reported cash and cash equivalents of $13.1 million, although it also noted an accumulated deficit of $84.8 million, raising concerns about its ability to continue as a going concern without further capital raises.

The company’s workforce has expanded, with an increase in employee headcount from 36 to 54, primarily in R&D roles, as it prepares for the commercialization of its insulin pump products. Modular Medical is also focusing on enhancing its manufacturing capabilities through partnerships with established medical device manufacturers. The company is actively working to address the needs of a broader market segment, particularly the "Almost Pumpers," who are insulin-requiring individuals with diabetes that have not yet adopted pump therapy due to cost and complexity barriers.

Looking ahead, Modular Medical anticipates continued increases in R&D and general administrative expenses as it gears up for product launches and market entry. The company is committed to overcoming the challenges of market acceptance and reimbursement, which are critical for its long-term success. The management's outlook emphasizes the importance of securing additional funding to support ongoing operations and product development initiatives.