Ongoing Cash BurnConsistent negative operating and free cash flow signals reliance on external financing to fund operations. Over the medium term this constrains strategic flexibility, raises dilution or refinancing risk, and pressures the timeline to achieve breakeven as commercialization investments continue.
Deep UnprofitabilityVery large operating and net losses indicate the business is not yet self-sustaining; returns on equity remain deeply negative. Persistent unprofitability limits internal capital for growth, increases sensitivity to funding markets, and raises execution risk until margins normalize with scale.
Reimbursement UncertaintyAbsent broad national coverage today, payer uncertainty constrains addressable market and adoption cadence. Even with a future CPT code, timing and policy adoption vary by payer; prolonged coverage gaps could delay commercialization, constrain revenue realization and prolong cash burn.