- Job postings
Technical File submitted for CE approval of TIES®
Comprising an implantable medical device, the TIES® System requires approval from a Notified Body in order to obtain CE marking and to be marketed in Europe. A complete Technical File for the TIES® System has now been submitted to the Notified Body for OstomyCure for thorough evaluation and subsequent approval.
Today the first patient was enrolled in the TIES03 study of the OstomyCure Transcuteous Implant Evacuation System (TIES®). A 64-year-old female from the UK had the TIES port successfully implanted in a procedure that took less than an hour with no complications.
OstomyCure AS® has received a EU grant of € 2.5 Mio. via the Horizon 2020 Project.
Approval for multicenter study “TIES-C03” in major university hospitals in Leeds, UK & Umeå, Sweden. OstomyCure AS has achieved an important milestone on the way to making the revolutionary TIES® Solution available to ileostomy patients, a patient population that has not experienced any meaningful improvements in “standard of care” in the last 30-40 years. The study aims to gather more and longer term clinical data regarding safety, performance and Quality of Life. The study has started at Norrland University Hospital, Umeå, Sweden with Associate Professor Karin Strigård and Prof. Ulf Gunnarsson and at St. James Hospital, Leeds with Professor David Jayne as the main investigators. OstomyCure plans to commit additional clinical centers (primarily in the UK) to participate in the “TIES-C03” study.
Message from CEO Ostomycure Dr Benedict Broenniman M.D.
OstomyCure today announced the appointment of Cindy Wong, M.D. as Chief Medical Officer (CMO).
OstomyCure AS has been published in The Ileostomy & Internal Pouch Support Groups latest issue of the IA Journal.
OstomyCure AS engages Morten Gunvad, currently founder and Head of GP Consulting GmbH, as Chief Commercial Officer of the TIES® System.
The TIES® Implant and Lid will be represented at Almedalsveckan, an annual political event taking place in Visby, Sweden.
Aimed to dramatically improve the patient’s quality of life, the TIES® System, a new concept in continent ileostomy receives CE marking.