0001493152-26-014117
SEC filingFiscal 2025 delivered modest year-over-year revenue growth and narrowed operating losses, offset by wider net losses and ongoing liquidity and going concern risks.
Fiscal 2025 delivered modest year-over-year revenue growth, with gross margin coming in at 71.4% for the period. The slight decline in gross margin relative to 2024 is attributable to shifts in product mix and changes to the company’s cost structure during the year. Core products including The Wand®/STA® System and CompuFlo®-enabled epidural devices are manufactured by a U.S.-based supplier under individual purchase orders with no minimum volume commitments, creating flexible supply chain capacity but also contributing to variable cost dynamics that impacted margin results.
Operating losses narrowed 15.7% year-over-year to $5.7M in fiscal 2025, driven primarily by reduced research and development expenses. The R&D cost cuts reflect management’s intentional focus on cost containment and prioritization of resources toward commercialization and core operational activities during the year. Management regularly reviews revenue trends, operating forecasts, inventory levels, and cost structures to identify additional efficiency opportunities across the business.
Free cash flow for fiscal 2025 was -$2.9M, roughly flat year-over-year with stable operating cash burn levels. Management’s assessment of the company’s ability to continue as a going concern requires significant judgment, and is based on estimates of future revenues, operating expenses, working capital requirements, cash flow timing, and access to additional sources of capital. Management continues to actively monitor the company’s cash position and implement targeted cost-containment measures to extend operating runway.
Operating losses are expected to continue for the foreseeable future, with no predictable timeline for achieving or sustaining profitability. Key operational risks include the potential for previously unknown issues with products, manufacturing partners, or facilities to result in regulatory restrictions, fines, delays or suspensions of regulatory clearances, product seizures or recalls, operating limitations, or criminal prosecution. Management remains focused on prioritizing resources to support core commercial activities while evaluating paths to secure additional capital to fund ongoing operations.