Persistent Cash Burn And Operating LossesOngoing negative operating and free cash flows demonstrate the business currently cannot self-fund growth. Continued cash burn necessitates further financings or rapid margin and revenue scaling; failure to materially reduce burn would pressure liquidity and force dilution or cutbacks, constraining durable commercialization plans.
Gross Margin Pressure From Product Mix, Discounts, InventoryErosion of high gross margins due to lower‑margin product mix, inventory reserves and increased financial assistance undermines the company’s attractive unit economics. If the mix shift persists, it will slow margin expansion, extend the time to positive operating cash flow, and make the business more dependent on scale to offset lower per-unit profitability.
Concentrated Adoption And Delayed Adult Coverage Requiring RCTAdoption is currently top‑heavy and constrained by institutional processes, limiting near-term utilization upside even with reimbursement in place. Additionally, the need for a large adult RCT to unlock broader adult payer policies delays expansion into the larger adult market, making meaningful scale dependent on clinical trial execution and multi-quarter outcomes.