OstomyCure announced today that it completed patient recruitment in the pivotal clinical trial of its proprietary TIES implant technology.
Oslo, Norway-based OstomyCure developed TIES as an innovative titanium port. It designed it for implantation within a stoma, attaching lid to effectively open and close the stoma at the user’s convenience.
The company said it designed the device to end the reliance on a permanent ostomy bag for those with ileostomy.
OstomyCure said that 20 patients received TIES implants across participating hospitals in the UK, Sweden, Poland, Austria and India. The trial will monitor them for a further six months. It evaluates the safety and performance of the technology. OstomyCure plans to submit the analysis of its clinical data in its regulatory submissions for CE mark. It also intends to continue recruiting patients to build further evidence for the device.
“Completing this milestone for our pivotal clinical trial is a crucial step in bringing this novel device closer to regulatory clearance and introducing it to a large patient population urgently in need of solutions to improve their quality of life,” said OstomyCure CEO Dr. Johan Jarte. “We will quickly compile the data ready for our EU regulatory submissions. We are incredibly grateful for the commitment and enthusiasm of patients and clinicians who have taken part in the trial”.