Unprecedented clinical results for the most challenging patients
PROMISE I U.S. Early Feasibility Study Data
Amputation Free Survival at 24 Months
Limb Salvage at 24 Months
Wounds Healed or Healing at 24 Months
Results of the LimFlow System in the PROMISE I Trial (at 24 months). Presented at Vascular Interventional Advances Conference (VIVA), October 2021, Daniel Clair, MD.
LimFlow Clinical Results
LimFlow Clinical Program
150+ Patients Target
| First-in-Human | PROMISE I | ALPS Registry | PROMISE International | PROMISE II U.S. Pivotal | |
|---|---|---|---|---|---|
| # Centers | 1 | 7 | 4 | 20 | 20 |
| # Patients | 7 | 32 | 32 | 50+ | 60-120 (adaptive) |
| Enrollment | Complete | Complete | Complete | Ongoing | Ongoing |
| Primary Endpoint | Major adverse limb and coronary events | AFS at 6 months | AFS at 6 months | AFS at 6 months | AFS at 6 months |
| Protocol | Single-center, prospective, single-arm | Multi-center, prospective, single-arm | Multi-center, retrospective | Multi-center, prospective, single-arm | Multi-center, prospective, efficacy and safety study |
| Countries | Singapore | U.S. | Alkmaar, Leipzig, Paris, Singapore | United Kingdom, Europe, Singapore | U.S., Japan |
| Secondary Endpoints | AFS, wound healing, perfusion | Wound healing, patency, perfusion | Wound healing, patency, perfusion | Wound healing, patency, perfusion | Wound healing, patency, perfusion |
| Total Length of Follow-up | 1 year | 2 years | 2 years | 1 year | 3 years |