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Latest update on TIES Solution
Message from CEO Ostomycure Dr Benedict Broenniman M.D.
In consultation with our Notified Body, it has been decided to collect additional clinical data in a new clinical study at specialized colorectal units in the UK & Sweden. The previous sponsored studies have shown the implant’s short and long-term safety profile. The aim of the new clinical study "TIES-C03" is to evaluate the long-term performance, safety, and impact of the TIES solution on quality of life. The patient ́s perspective on the use of the TIES solution for controlled bowel emptying will also be included in the assessment.
"We know that TIES Solution is a safe concept for ileostomy patients What we would like to establish is a scientifical base which will prove our product claims in a small number of clinical centers" says CEO Ostomycure Dr. med. Benedict Broenniman.
The new study is planned to start in April 2018 with follow-up throughout 2019. The investigators are Associate Professor Karin Strigård and Professor Ulf Gunnarsson in Umeå (Sweden), and Professor David Jayne in Leeds (UK).
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.
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.
Today, OstomyCure is very pleased to announce that the TIES® System has received approval for CE marking from our Notified Body.