Weak Free Cash Flow ConversionSignificant negative FCF growth and low operating cashflow conversion limit self‑funding capacity for capex, trials and commercial rollouts. Until conversion improves, growth may require careful cash management or external funding, increasing execution risk during scale-up.
Outpatient Reimbursement UncertaintyOutpatient channel expansion hinges on CMS reimbursement clarity and likely RCT evidence. This creates structural timing and adoption risk: without coverage, commercially addressing the large outpatient market will be delayed or limited, constraining addressable market growth.
Lumpy Demand And Market VariabilityDependence on episodic, high‑variance procedures (burns) and tender delays in markets like India produce volatile volumes and uneven capacity utilization. This structural lumpy demand complicates forecasting, manufacturing cadence and the timing of revenue recognition as the business scales.