US Revenue ConcentrationHeavy reliance on the U.S. market leaves growth and cash generation exposed to U.S. hospital purchasing cycles, reimbursement shifts, or budget constraints. Limited near-term international diversification amplifies cyclical sensitivity and makes multi-quarter revenue targets dependent on a single geography's capital spending patterns.
Transition & Inventory RiskManaging legacy stock while ramping a new platform creates inventory obsolescence, stocking and channel timing risks. Operational missteps could force write-downs, distort working capital, or create channel shortages that delay replacements. These execution risks can erode margins and cash conversion for multiple quarters during the transition.
Delayed International ClearancesStaggered regulatory timelines postpone international contribution and prolong geographic concentration. Delays compress near-term addressable market, slow scale economies on manufacturing, and extend the period before international disposables/maintenance revenue offsets U.S. cyclicality, making 2026 growth more execution-dependent.