Catheter developer Spinal Singularity said yesterday it launched a clinical feasibility trial of its Connected Catheter, a smart catheter designed for adult men with chronic urinary retention or neurogenic lower urinary tract dysfunction.
The trial is being led by West Coast Urology co-founder Dr. Ernest Agatstein, the San Clemente, Calif.-based company said.
“It has been amazing to watch the Connected Catheter develop and mature over the past couple of years. What started as a simple idea being relentlessly pursued by passionate founders is now a real medical device that has the potential to radically improve the quality of life for millions of catheter users. I am honored to have treated the first patient in the US with this device and look forward to collecting more data during this study,” Spinal Singularity scientific advisor Dr. Agatstein said in a press release.
Spinal Singularity said it has received IRB approval to expand its study to two extra sites, adding the Surprise, Ariz.-based Arizona Center for Cancer Care and Murrieta, Calif.-based Tri-Valley Urology. Research at the newly added Arizona and California-based sites will be led by Dr. Ian Goldman and Dr. Sreenivas Vemulapalli, respectively.
“I have dedicated years of my life working to solve this problem and am confident that our product can truly change people’s lives. With more clinical data we aim to prove the safety and efficacy of our device as we work to bring it to market,” Spinal Singularity founder Derek Herrera said in a prepared statement.
Last October, Spinal Singularity raised $3.1 million in a seed funding round to support its Connected Catheter designed for adult males with chronic lower urinary tract dysfunction.