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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 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.
The ongoing TIES® clinical study is moving forward and is now fully enrolled with the planned number of patients.
OstomyCure certification was upgraded to a higher level.
OstomyCure is pleased to announce the participation of the Ahus University Hospital in Norway in the ongoing TIES® clinical study.