San Antonio—Bluegrass Vascular Technologies has started to enroll patients in a U.S. clinical trial for its catheter system for regaining access to obstructed veins.
Bluegrass says it eventually will study 30 patients at 10 research centers across the U.S. in the next year, including St. Joseph Hospital in Orange, CA, and Houston Methodist Hospital in Texas. The company can file for FDA approval after it collects the data from the trial, says president and CEO Gabriele Niederauer.
Bluegrass, founded in 2010, received regulatory clearance in Europe in 2016 and started selling its system, called the Surfacer Inside-Out Access Catheter System, in the U.K., Germany, Austria, Italy, Belgium, the Netherlands, and Luxembourg in 2017. Merit Medical Systems (NASDAQ: MMSI) is distributing the device in Europe and also invested in Bluegrass last year.
The system focuses on patients receiving dialysis treatment for kidney failure, particularly when a physician connects a catheter to the veins near the neck. Those veins can become blocked from overuse. Bluegrass’s product can clear a path in the blocked vein, allowing the treatment to continue, Niederauer said in 2016.
Bluegrass received $4.8 million in financing in 2014 from Targeted Technology, a San Antonio-based life science venture capital firm. As a part of that Series A investment, Bluegrass moved to San Antonio from Kentucky.