Persistent Cash BurnSustained negative operating and free cash flow materially exceed current revenue, meaning the business remains cash‑consuming. Over the next 6–12 months continued burn will force reliance on external capital if commercialization or trial milestones slip, increasing dilution and financing risk.
Modest Absolute Revenue & Chunky SalesWhile growth rates are strong, absolute revenue remains small and uneven quarter‑to‑quarter due to timing of center conversions. This limits margin realization at scale, complicates forecasting and heightens execution risk that slower than expected conversions will extend cash runway pressure.
Pivotal Trial Not Yet CompleteThe Phase III pivotal trial is near completion but final data remain pending. Clinical and timing risk can delay broader adoption, reimbursement decisions, and planned conversions of trial sites to commercial customers, potentially deferring revenue realization and necessitating further funding.