20 patients have now been implanted with the TIES® device in our pivotal clinical trial
OstomyCure has successfully completed a crucial patient recruitment milestone in its pivotal clinical trial of the company’s TIES implant technology.
20 patients have now been implanted with the device with participating hospitals in the UK, Sweden, Poland, Austria, and India. The patients will be monitored for a further six months to fully assess safety and performance of the technology.
The milestone is important as the analysis of the clinical data from these patients will be included in the regulatory submissions for a CE Mark under the EU Medical Device Regulation (MDR).
Patients will continue to be recruited during the regulatory process to further build clinical evidence for the device.
Professor Manish Chand, Consultant Colorectal & Robotic Surgeon, University College Hospital, London said, “Implanting the TIES® device has been very straightforward. There has been very little innovation in stoma therapy for many years, so I’m really looking forward to seeing my patients enjoy the benefits of TIES® as they learn to live with this exciting new technology”.
OstomyCure, CEO, Dr Johan Jarte, added, “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. 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”.
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