Unprecedented clinical results for the most challenging patients
PROMISE I U.S. Early Feasibility Study Data
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 & UK | PROMISE II U.S. Pivotal | PROMISE III | |
|---|---|---|---|---|---|---|
| # Centers | 1 | 7 | 4 | 16 | 105 | 25 |
| # Patients | 7 | 32 | 32 | 62 | 60-120 (adaptive) | 100 |
| Enrollment | Complete | Complete | Complete | Complete | Complete | Ongoing |
| Primary Endpoint | Major adverse limb and coronary events | AFS at 6 months | AFS at 6 months | AFS at 12 months | AFS at 6 months | AFS at 6 months |
| Protocol | Single-center, prospective | Multi-center, prospective | Multi-center, retrospective | Multi-center, prospective | Multi-center, prospective, efficacy and safety study | Multi-center, prospective |
| Countries | Singapore | U.S. | Alkmaar, Leipzig, Paris, Singapore | UK, Germany, Netherlands, Singapore, New Zealand | U.S. | U.S. |
| Secondary Endpoints | AFS, wound healing, perfusion | Wound healing, patency, 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 | 3 years |