High Cash BurnCash burn far exceeds current revenue (~$3.6M TTM), meaning internal cash generation cannot fund growth. Persistent negative operating and free cash flow creates ongoing financing dependency, raising dilution risk and pressuring execution if equity markets or ATM programs are constrained.
Profound UnprofitabilityVery large losses relative to modest revenues indicate a cost structure not yet scalable to current sales. Continued negative profitability erodes equity and investor flexibility, forcing tradeoffs between funding commercialization, clinical studies and R&D until material margin improvement is achieved.
Reimbursement Timing & UncertaintyPayer decisions and potential pass‑through payments materially affect procedure economics and provider adoption. Multi‑year timing and conditional approvals can delay broader uptake, limit office‑based growth, and lengthen the conversion timeline from leads to durable system and consumable revenue.