Persistent Cash BurnSustained negative operating and free cash flow at multi-million dollar annualized levels creates a structural need for external capital to fund operations and growth. Ongoing cash burn increases dilution risk, constrains strategic optionality, and forces prioritization between commercialization investments and clinical evidence generation unless revenue scale accelerates materially.
Rising Operating Expenses And LossesIncreasing sales, R&D and G&A spend has elevated fixed cost base and widened operating losses. These commercialization-driven expense trends lengthen the runway to operating leverage and require sustained, above-trend revenue growth to achieve profitability, making execution on scaling utilization and payer wins critical for long-term margin recovery.
Uneven Institutional Adoption And Delayed Adult CoverageAdoption is top‑heavy and hampered by institutional barriers (committee approvals, lack of champions), limiting near-term throughput. Broader adult payer policies depend on a large RCT (estimated ~18 months), meaning material portions of the addressable market may remain inaccessible until trial results and subsequent policy updates occur.