4 February 2014

TiGenix reaches major cell therapy milestone with 1000th implant of ChondroCelect

Leuven (BELGIUM) – February 4, 2014 – TiGenix (NYSE Euronext: TIG), a leader in thefield of cell therapy, announced today that it reached a major milestone with the performance of the 1000th ChondroCelect implantation for cartilage repair in the knee. ChondroCelect is the first cell therapy that was granted approval by the European Medicines Agency (EMA) as an Advanced Therapy Medicinal Product (ATMP). Today it is routinely used in orthopedic centers of excellence across several European countries.

“A 1000 patients have already benefited from this innovative therapy, further supporting its efficacy and safety profile,” said Eduardo Bravo, CEO of TiGenix. “A milestone such as today’s is a clear demonstration of how far the cell therapy field has progressed over recent years, and I have no doubt that it is on its way to become a mainstay in clinical practice. We will continue to work towards turning our ChondroCelect franchise into a cash flow positive asset, and to push the clinical development of our pipeline of stem cell programs to a successful conclusion.”

About ChondroCelect®
An innovative treatment, ChondroCelect has been shown to result in long-term durable clinical benefits in patients with recent cartilage lesions. Five-year follow-up data confirm that the therapeutic effect and the clinical benefit of ChondroCelect gained over baseline is maintained up to at least five years after the cartilage repair intervention. In addition, the data confirm that early treatment with ChondroCelect results in a superior clinical benefit over microfracture, and a lower failure rate.

Cartilage lesions of the knee are a frequent cause of disability in the active population. Caused by repetitive microtraumata, or due to sports or traffic accidents, cartilage lesions rarely heal spontaneously. When untreated, they predispose to osteoarthritis, which causes disability and represents a major socioeconomic burden. A treatment that allows symptom relief and functional recovery is key. To meet this important medical need, TiGenix developed ChondroCelect, the first cell therapy that was granted approval by the EMA as an ATMP.

ChondroCelect is administered to patients in an autologous chondrocyte implantation procedure known as Characterized Chondrocyte Implantation. TiGenix has designed a sophisticated manufacturing process to preserve the cells’ characteristics and biological activity, and to maintain their ability to produce high quality cartilage. This process meets the highest quality standards and has been approved by the EMA.

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.

Forward-looking information This document 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. Such statements, forecasts and estimates are based on various assumptions
and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix’ control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix’ expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

For more information:

Eduardo Bravo
Chief Executive


Claudia D’Augusta
Officer Chief Financial Officer