Eximo Medical said a 20-patient pivotal trial in Europe, aimed at winning CE Mark approval there for its hybrid peripheral catheter, met its safety and efficacy endpoints.
Rehovot, Israel-based Eximo’s device is designed to combine laser ablation with a blunt, bladed tip to clear partial or full peripheral blockages. The company said it’s pursuing the CE Mark and “will be looking to receive FDA approval in 2017.”
The primary safety endpoints in the trial are freedom from major adverse events at 30 days and freedom from device/procedure-related adverse events until discharge, expected to be 2 days. The efficacy endpoint is technical success rate, or the ability of the catheter to cross the lesion, according to ClinicalTrials.gov.
“We are pleased to announce the successful completion of a 1st-in-human study with a PAD application, which constitutes a significant milestone that will enable the receipt of CE marketing approval in Europe. We are proud that thanks to the unique technology developed by our company, we were able to alleviate patients’ suffering and prevent complicated, unnecessary surgeries, which could, in extreme cases, even have led to amputation of the leg. The completion of the trial represents an additional significant step toward a multi-participant FDA trial in the United States – a potential market of billions of dollars,” CEO Yoel Zabar said in prepared remarks.
“We are proud to be the 1st medical center in the world to have treated patients with the Eximo system. The treatment of all 14 patients by us was highly successful, without any complications. All of the patients have experienced significant pain relief in the treated limb and significant improvement in quality of life,” added Dr. Waclaw Kuczmik of the Medical University of Silesia in Katowice, Poland.
Eximo was founded by Accelmed, which led a $1.6 million Series A round last year for the company, with participation from the Alfred Mann Institute at the Technion, the Technion R&D Foundation and a private investor.