TiGenix : reaches major cell therapy milestone with 1000th.

REGULATED INFORMATION FEBRUARY 4, 2014

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

Leuven (BELGIUM) - February 4, 2014 - TiGenix (NYSE Euronext: TIG), a leader in the field 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.

For more information: Eduardo Bravo Chief Executive Officer eduardo.bravo@tigenix.com

Claudia D'Augusta Chief Financial Officer claudia.daugusta@tigenix.com

About TiGenix

See more here:
TiGenix : reaches major cell therapy milestone with 1000th.