Reimbursement policy changes - CMS or commercial payer decisions on home infusion coverage rates could materially impact economics and adoption
Competitive technology displacement - alternative subcutaneous delivery systems, wearable pumps, or novel immunoglobulin formulations could erode market share
Regulatory pathway complexity - FDA requirements for device modifications or new indications create development timeline and cost uncertainty
Larger medical device competitors (Baxter, Fresenius Kabi) entering subcutaneous infusion market with superior distribution and R&D resources
Specialty pharmacy consolidation reducing negotiating leverage and potentially favoring competitors with broader product portfolios
Direct-to-patient models from immunoglobulin manufacturers bypassing third-party infusion device providers
Negative operating cash flow and free cash flow create equity dilution risk if additional capital raises are needed before reaching profitability
Small market cap of $200M limits institutional investor base and creates liquidity risk during market stress
High price-to-sales of 5.5x leaves limited valuation cushion if growth disappoints or path to profitability extends
StructuralCompetitiveBalance Sheet