Oslo, Norway (ots/PRNewswire) - Aimed to dramatically improve the patients' quality of life, The TIES® System, a new concept of continent ileostomy receives CE-mark. The CE-mark allows the company to launch the product in the EU/EEU area.
(Photo: http://photos.prnewswire.com/prnh/20160621/381856 )
Today OstomyCure AS, a Norwegian medical technology company, announced that TIES® received its CE-mark and will be available in selected markets. The new solution is a one of a kind revolution for continent ileostomy, suitable for patients with a permanent ileostomy.
The TIES® System consists of a small titanium tube implanted into the abdomen where the intestine and soft tissue grow into it: it is then sealed with a lid that the patient can open to drain waste whenever necessary. The lid functions as a stopper.
In conventional stoma surgery, the intestine is extended a few centimeters outside the abdominal wall, ending in a stoma bag that adheres to the stomach. Many stoma patients experience difficult situations at times where the stoma controls their lives. The bag often creates social limitations for the patients with discomforts such as skin irritations, infections, allergies and negative stress due to several toilet visits each day. Other well-known complications of the conventional ileostomies are parastomal hernias, leakages, smell and unwanted noise.
"The current USD 2B stoma bag market has only experienced minor improvements during the last 30 years. TIES® will be a paradigm shift for the stoma bag users and improve the lives of thousands of patients" says Dr. Ben Broennimann, M.D. and CEO of OstomyCure.
"The CE-mark is a major milestone and achievement for OstomyCure and for the patients who will benefit greatly from this significant technological breakthrough that will increase their quality of life and give them a new sense of freedom. Without the dedicated, tenacious hard work of our employees and our research partners with the vision and patience of our owners we would not have come this far."
In addition to the groundbreaking benefits for the patients, TIES® will also provide excellent health economic savings for the local health authorities. "Our preliminary health economic calculations have shown that TIES® over a period of a few years will be a less expensive solution" says Dr. Broennimann, and concludes, "It is our mission to provide better healthcare and better quality of life for the stoma users as well as cost benefits for the health authorities and health care payers."
The TIES® System will initially be launched in a selected number of countries in Europe.
OstomyCure AS is a medical technology company with its main office in Oslo, Norway. The company develops a revolutionary technology called Transcutaneous Implant Evacuation System, The TIES® System for permanent ileostomies.
The TIES® System is the result of several years of research combined with the latest 3D manufacturing technology, developed and produced in accordance with regulatory standards to ensure safety for the patients.
The company is since August 2011 certified against ISO 13485 Quality Management System for Medical Devices.
The TIES® System received the CE marking in June 2016.
The market that OstomyCure potentially could address is estimated to be USD 2 billion per year.
Dr. Ben Broennimann, M.D.
Chairman, OstomyCure AS
Oslo Science Park,
0349 OSLO, Norway
Growhouse, Isafjordsgatan 39B