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CE-marking for the TIES® System
Today, OstomyCure is very pleased to announce that the TIES® System has received approval for CE marking from our Notified Body. This means that TIES® meets or surpasses all the high European quality and safety standards for a Medical Device and allows OstomyCure to initiate sales in Europe. CE marking of the TIES® System is the result of several years of research and development by the dedicated staff at OstomyCure and all affiliated entities. This marks the beginning of a new era in the treatment of ileostomy patients, and is a major step forward for the company.
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.
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.