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Clinical Evidence

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Unprecedented clinical results for the most challenging patients

PROMISE I U.S. Early Feasibility Study Data

Amputation Free Survival at 12 months
Wounds Healed or Healing at 12 Months
Results of the LimFlow System in the PROMISE I Trial (at 12 months). Presented at Vascular Interventional Advances Conference (VIVA), November 2020, Daniel Clair, MD.

LimFlow Clinical Program

150+ Patients Target

 First-in-HumanPROMISE IALPS RegistryPROMISE InternationalPROMISE II U.S. Pivotal
# Centers1742020
# Patients7323250+60-120 (adaptive)
EnrollmentCompleteCompleteCompleteOngoingOngoing
Primary EndpointMajor adverse limb and coronary eventsAFS at 6 monthsAFS at 6 monthsAFS at 6 monthsAFS at 6 months
ProtocolSingle-center, prospective, single-armMulti-center, prospective, single-armMulti-center, retrospectiveMulti-center, prospective, single-armMulti-center, prospective, efficacy and safety study
CountriesSingaporeU.S.Alkmaar, Leipzig, Paris, SingaporeUnited Kingdom, Europe, Singapore U.S., Japan
Secondary EndpointsAFS, wound healing, perfusionWound healing, patency, perfusionWound healing, patency, perfusionWound healing, patency, perfusion Wound healing, patency, perfusion
Total Length of Follow-up1 year2 years2 years1 year3 years