The Syracuse, New York-based company says the milestone makes its system the first ever reusable intermittent urinary catheter system to gain clearance through this pathway. It plans to begin commercial efforts with a launch into the Veterans Health Administration spinal cord injury hospitals later this year.
Aurie’s system features a 100-use no-touch intermittent catheter, a portable catheter washer-disinfector and pre-packaged supply pods. The system delivers single-use, no-touch catheter features at lower costs, the company said in a news release. Aurie said rigorous testing demonstrated safety and effectiveness for its system to “set the standard for all reusable catheter systems to come.”
With the FDA clearance, the company also announced new personnel appointments, including the naming of Manu Varma to its board. Varma, who has more than two decades of leadership experience in chronic care, joins as an independent director. His most recent post was president of North America at Coloplast, overseeing several business lines, including intermittent catheters.
“Aurie is addressing the industry’s biggest challenge by combining sustainability and user-centered design to define a new standard of care. The de novo clearance is a major milestone, and I’m excited to work with this team as they take the business to the next level,” said Varma.
The company also added Dr. Christopher Elliott to its scientific advisory board. Elliott, a clinical associate professor of urology at Stanford University, serves as a leading voice for sustainable alternatives to single-use catheters.
Aurie also promoted Sergey Grigoryants from VP of engineering to chief technology officer. Responsibilities include overseeing the company’s technology roadmap, including infection-detecting sensor-enabled catheters.
