LimFlow is committed to methodically validating the safety and clinical benefits of its technology through a systematic clinical study effort driven by leading clinicians and experts in the field of peripheral vascular diseases.
Seven “No-Option” CLI patients were enrolled in a single-arm pilot study conducted in Singapore. Follow-up of this prospective and open-label study is currently awaiting publication in a renowned peer-reviewed journal.
In 2015 we conducted a 10-patient clinical trial that allowed CE Mark approval for the LimFlow system. Investigators included Prof. Dierk Scheinert from Leipzig University in Germany, Dr. Steven Kum from Changi Hospital in Singapore and additional key CLI centers in Europe.
Clinical plans for the US market are underway. This includes a Pre-IDE submission into an “Early Feasibility Study (EFS)”. Enrollment is planned to start in key US centers in the first half of 2017.