Leuven (Belgium), February 19, 2007 - TiGenix, the late-stage biomedical company focused on innovative local treatments for damaged and osteoarthritic joints, announced today that: * The results of a phase III landmark trial comparing its lead product ChondroCelect to current standard of care for cartilage defects in the knee were presented by Dr. Daniël Saris (University Medical Centre Utrecht) at the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego, United States. * The ChondroCelect trial results at 12 and 18 months demonstrate that the structural and clinical primary endpoints of the study have been achieved. * The trial results open the path for regulatory submission in Europe and in the United States. * The Company is planning to raise new funds through an initial public offering and a listing on Eurolist by Euronext Brussels in the next few months. In 2002, TiGenix initiated a multi-centre prospective randomised controlled trial to assess ChondroCelect's efficacy as a first-line treatment for symptomatic cartilage defects of the knee, by comparison with the current standard of care, microfracture. 118 patients were treated in 13 orthopaedic centres (Belgium, The Netherlands, Germany and Croatia). The Company designed the study to assess structural superiority (i.e. better quality of repair tissue at 12 months) as a precursor for long-term clinical benefit for the patients. The primary endpoints of the study were to asses that: a) structural repair at 12 months with ChondroCelect is superior to the repair tissue following microfracture with debridement, assessed by independent histopathologists blinded to the treatment using (i) computerized histomorphometry and (ii) evaluation of overall histology of biopsies taken 12 months after treatment b) improvement of clinical outcome (symptom relief and improvement of functional outcome and quality of life) at 12 and 18 months with ChondroCelect is as good as improvement of clinical outcome with microfracture, measured by the KOOS (Knee Injury and Osteoarthritis Outcome Score) The ChondroCelect trial results at 12 and 18 months demonstrate that the structural and clinical primary endpoints of the study have been achieved: a) ChondroCelect formed a tissue regenerate superior to the repair tissue formed following microfracture, as assessed by histomorphometry (p=0.003) and overall histology (p=0.012) of biopsies taken 12 months after treatment. The repair tissue in patients treated with ChondroCelect was found to be less fibrous and to display features indicative of more durable hyaline-like cartilage. b) Clinical outcome was similar for both treatment groups with an advantage for ChondroCelect. A comparison of the rates of improvement on clinical outcome parameters, such as pain and function, at 12 and 18 months demonstrated a slight advantage in improvement from baseline in patients treated with ChondroCelect. In addition, a sub-group of patients treated within two years since the onset of symptoms showed a statistically significant superior clinical outcome in patients treated with ChondroCelect. In conclusion, the use of characterized chondrocytes in autologous cartilage repair represents a new class of treatment which is associated with superior structural repair of cartilage tissue, compared to microfracture. In the short-term, the risk-benefit profile for ChondroCelect and microfracture appears to be similar, and supporting a first-line use. Long-term data should confirm the durability of repair and further strengthen the outcome of this sub-analysis. Patients in the study will be followed up to 5 years. The improved structural repair recorded in patients receiving ChondroCelect during the Phase III clinical trial confirms the results obtained in preclinical experiments and validates the Company's development strategy. Based on these data, TiGenix believes that ChondroCelect has the potential to significantly increase the success rate of cartilage regeneration procedures. As far as the Company is aware, TiGenix is currently the only company to have completed successfully a GCP-controlled, prospective, randomised multi-centre clinical trial for a cell-based therapy product intended for cartilage repair. The Company believes that a trial of this level of stringency is necessary for cell- and tissue-based products, in order to obtain marketing authorisation in Europe and the United States. Prof. Dr. Johan Bellemans, head of orthopedic surgery at the University Hospitals in Leuven, and principal investigator of the study says "The ChondroCelect study represents a landmark in clinical investigation for cell-based products in orthopedics. It will become an important reference for the future of biological treatments of damaged and osteoarthritic joints." Gil Beyen, CEO of TiGenix says: "We are very pleased with the results of the ChondroCelect trial. Not only did TiGenix demonstrate that its well-characterised and potency-based product, ChondroCelect, can regenerate hyaline-like cartilage, we also demonstrated that it is possible to conduct these types of studies. With the announcement of these positive results, TiGenix is entering a new phase of its development." To finance the registration, production and marketing of ChondroCelect and to expand and accelerate the development of its pipeline of innovative cell based products, TiGenix is planning to raise new funds through an initial public offering (IPO) and a listing of the Company on Eurolist by Euronext Brussels. In connection with the proposed IPO, PiperJaffray and ING have been appointed as lead managers and Petercam as co-lead manager for the transaction. It is expected the IPO and listing could be completed in the next few months. Further details of the proposed offering will be announced at a later date. About TiGenix TiGenix is a private, late-stage biomedical company that focuses on innovative local treatments for damaged and osteoarthritic joints. The Company is exploiting the power of regenerative medicine to develop durable treatments, validated through controlled clinical trials, for these indications. Based in Leuven, Belgium, TiGenix was founded as a spin-off from the Katholieke Universiteit Leuven and the Universiteit Gent. TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical need. Current therapies do not provide satisfying, long-term durable repair and TiGenix therefore believes there is a need for more effective treatments for cartilage damage. About ChondroCelect ChondroCelect is TiGenix' lead product for cartilage repair, an innovative cell-based therapy focusing on durable repair of cartilage defects of the knee. The product is used in combination with autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects by using patient's own cells. Cartilage defects of the knee are very common and the spontaneous healing capacity of cartilage is limited. Patients having had a traumatic cartilage injury at a younger age are at risk of developing osteoarthritis (OA) later in life. By focusing on the regeneration of stable hyaline-like cartilage, ChondroCelect aims at realizing durable repair of cartilage defects and postponing the progression towards OA. ChondroCelect has successfully completed a randomised Phase III clinical trial and will be launched in Europe and/or in the United States, pending necessary regulatory approvals. Subject to obtaining such approval, TiGenix aims to commercially launch ChondroCelect in Europe in 2008. For further information, please contact at TiGenix: Gil Beyen Kris Motmans Chief Executive representative of MC-Services Officer Group Corporate Communications +32 16 39 60 60 +32 16 39 60 63 [email protected] [email protected] The press release can be downloaded from the following link: