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This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful. For more information, please contact: TiGenix T: +34 91 804 92 64 email@example.com About TiGenix TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Our lead product candidate from the adipose-derived stem cell technology platform is Cx601, which is in registration with the European Medicines Agency for the treatment of complex perianal fistulas in Crohn’s disease patients. Our adipose-derived stem cell product candidate Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product candidate, AlloCSC-01, is currently in a Phase II clinical trial in Acute Myocardial Infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). Read More Forward-looking information This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts.
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05, 2016 (GLOBE NEWSWIRE) — Lombard Medical, Inc. ( EVAR ), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced positive long-term data for its Aorfix endovascular stent graft system providing go to website confirmation of sustained performance in the most challenging anatomies. The data from the only IDE study to focus on high neck angulation was presented at the 43rd annual VEITHsymposium on Thursday, November 17, 2016. Aorfix is designed for highly tortuous anatomy and is the only stent graft to hold global approvals to treat abdominal aortic aneurysms with aortic neck angles up to 90 degrees. Professor Mahmoud Malas of Johns Hopkins Bayview Medical Center presented five-year results of the U.S. PYTHAGORAS trial of Aorfix in a scientific presentation titled, Long-Term Results with the Lombard Aorfix Graft and Introducing the IntelliFlex Delivery System. The trial studied 218 patients, 151 of which had neck angles 60 degrees and higher which are off-label for all other approved stent grafts available in the U.S. Professor Malas showed that this group of patients had several other characteristics that were predictive of poor outcomes, including a very high percentage of female patients and higher average age. At the fifth year, there were no type I or III endoleaks, migration was seen in 3.3% of cases, freedom from http://madeveoon.journalnewsnet.com/charities-that-offer-environmental-programs-here-are-more-of-the-most-awesome-scholarships-for-eco-minded-students-in-no-particular-order aneurysm-related mortality in patients with neck angles 60 degrees and greater was 95% and this rose to 99% in patients with neck angles less than 60 degrees. Professor Malas concluded, Despite these patients having severely challenging anatomy and multiple other predictors of poorer outcomes, the performance of Aorfix after five years of implantation is very similar to that of competitor devices used in normal risk patients. This important long-term data from a unique study into challenging anatomy supports the use of Aorfix in patients with both normal and tortuous anatomy. A paper presenting the full data at five years follow up has been accepted for publication by the Journal of Vascular Surgery. Lombard Medical CEO Simon Hubbert commented, The long-term data from PYTHAGORAS clearly demonstrates that Aorfix is a high performing, reliable graft in both the short and long term and it has demonstrated this performance in a unique study focused on patients with highly angled and challenging aortic neck anatomy. The low incidence of migration and endoleak combine to give our patients good long-term protection from their aneurysms even in this most challenging group. The new IntelliFlex delivery system has been very well received since our recent controlled launch in Europe, and we anticipate approval and launch in the important Japanese market in the coming months. About Aorfix Endovascular Stent Graft Aorfix is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs). When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. Aorfix is the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees. Visit This Link Aorfix features an exclusive helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends. Aorfix has been evaluated in three studies and used in more than 7,000 procedures worldwide. Aorfix has a CE Mark, Japan regulatory approval, and received FDA approval in 2013. About Abdominal Aortic Aneurysms (AAAs) AAAs are balloon-like enlargements of the aorta which if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year more than 500,000 new cases are diagnosed. In the U.S., aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm.
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