Exclusive Summary

• - Patents have expired and generics are established in the US/EU, enabling rapid global rollout.
• - Stable demand anchored in PCI, with approximately 5–6 million PCI procedures annually worldwide.
• - Recommended by ESC and ACC/AHA for PCI anticoagulation, especially in high-bleeding-risk or HIT patients.
• - Registered in the US and 27 EU countries, ensuring strong compliance and enabling fast distribution partnerships.
• - Significant cost advantage versus originator; typical 1–2 vials per PCI can materially reduce hospital anticoagulation costs.