OstomyCure Announces Completion of Patient Recruitment Milestone in Pivotal TIES® Clinical Trial

• Pivotal clinical trial of OstomyCure's proprietary TIES implant for people with an ileostomy
• 20 patients implanted and now living with the technology
• Clinical trial data will be used in forthcoming EU regulatory submissions for a CE Mark

STOCKHOLM and OSLO, Norway, Jan. 18, 2023 /PRNewswire/ -- OstomyCure, a clinical-stage medtech company developing revolutionary technologies to transform the lives of people with a stoma, today announced that it has successfully completed a crucial patient recruitment milestone in its pivotal clinical trial of the company's proprietary TIES implant technology.

TIES is an innovative titanium port, which is implanted within a stoma and used to attach a lid to effectively open and close the stoma at the user's convenience. The device is designed to end the reliance on a permanent ostomy bag for people with an ileostomy, enabling patients to take back control of their lives.

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 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."

About TIES®

TIES is an innovative titanium port that a surgeon implants within a stoma. During the patient's recovery from the surgical procedure, the port integrates into the soft tissue of the abdomen and acts as a holder for a lid, which can then effectively open and close the stoma. The technology enables patients to empty their stoma at their own convenience in contrast to a conventional stoma which continuously empties into a bag, causing discomfort, noise, smell, and often inconvenience for the user.

About OstomyCure

OstomyCure develops and markets innovative technologies to help people with a stoma to take back control of their lives. The company is headquartered in Norway with offices in Stockholm, Sweden. The TIES technology is the company's first product. Clinical data from the trial will be submitted in regulatory submissions for a CE Mark under the EU Medical Device Regulation (MDR). Patients will continue to be recruited in the UK, Sweden, Poland, Austria, and India during the regulatory process to further build clinical evidence.

For more information visit: http://www.ostomycure.com and follow OstomyCure on LinkedIn and Twitter.

Press contact:

Ms Jo O'Shea
T: +44 7891 250 241
E: [email protected]

Photo: https://mma.prnewswire.com/media/1981367/OstomyCure_TIES_implant_port.jpg

SOURCE OstomyCure AS