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Clinical Evidence

Unprecedented clinical results for the most challenging patients

PROMISE II U.S. Pivotal Trial at 6 Months

Limb Salvage*

Functional Limb Preservation in No-Option Patients

Wounds Healed or Healing*

Wound Healing in Patients With Non-Healing Chronic Wounds

*Results of the LimFlow System in the PROMISE II US Pivotal Trial (at 6 months).
Shishehbor, M et al. Transcatheter arterialization of deep veins in chronic limb-threatening ischemia. N Engl J Med, 2023; 388, 1171–1180.

See LimFlow’s article, ‘Transcatheter Arterialization of Deep Veins in
Chronic Limb-Threatening Ischemia’ in NEJM.

LimFlow Clinical Program

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  First-in-Human PROMISE I ALPS Registry PROMISE International & UK PROMISE II U.S. Pivotal PROMISE III
# Centers 1 7 4 16 20 25
# Patients 7 32 32 62 105 100
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