Clinical Trial Primary Endpoint MissThe pivotal study did not achieve statistical significance on its primary effectiveness endpoint, creating concern about the robustness of evidence needed to expand clinical indications.
Mixed Trial Results And Evidence UncertaintyMissing the primary endpoint at the 12‑month analysis, despite positive secondary outcomes, raises questions about consistency of benefit and could complicate adoption by clinicians.
Regulatory Approval RiskMixed primary and secondary trial results increase the risk that regulators may delay or limit label expansion, which could postpone broader commercial access and revenue potential.