The ChondroCelect HarvesterT receives CE mark approval
Leuven and Hasselt (BELGIUM) - November 2, 2009 - TiGenix (NYSE EURONEXT: TIG) and MedInvents announce that the ChondroCelect HarvesterT has received CE (Conformité Européenne) Mark approval. The ChondroCelect HarvesterT is a proprietary biopsy tool that will be provided to orthopedic surgeons for harvesting cartilage biopsies.
The ChondroCelect HarvesterT is a proprietary biopsy tool that will be provided to orthopedic surgeons for harvesting cartilage biopsies.
The registration of the ChondroCelect HarvesterT follows the recent approval of ChondroCelect in Europe as the first cell-based product for cartilage repair to have received a European marketing authorization. ChondroCelect consists of characterized cultured chondrocytes derived from the patient's own cartilage. The process of producing ChondroCelect starts with a small cartilage sample taken by a surgeon. The standardization of the biopsy procedure and the quality and consistency of the cartilage sample are important elements for the final quality of the ChondroCelect end product. The ChondroCelect Harvester is specifically designed to allow harvesting cartilage biopsies from
the knee in an easy and consistent manner, avoiding damage to the surrounding tissue and underlying bone. The specific design and ease of use of the ChondroCelect HarvesterT is expected to set a new standard in cartilage biopsy taking.
The Harvester was invented by and developed in close collaboration with Dr. Yves Fortems, clinical advisor to the company, and the medical device company MedInvents, who will produce the device. The device will be provided to the orthopedic surgeons as part of the ChondroCelect biopsy kit.
Dr. Yves Fortems, inventor of the ChondroCelect HarvesterT, comments: 'In designing the Harvester, we have specifically focused on the ease-of-use of the device in combination with delivering a superior and consistent quality of the cartilage biopsy. The quality of the cartilage biopsy is known to be an important factor for the quality of the ChondroCelect
product.'
Dr. Jaak Janssens, Medical Advisor to MedInvents comments: 'We are very pleased with this result of our collaboration with TiGenix' clinical and development team. What I admired
the most was the combination of patient driven research, methodological scrutiny and business competence.'
For more information, please contact:
TiGenix NV
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
Investor@tigenix.com
MedInvents NV
Johan Janssens
Chief Operating Officer
T: +32 11 27 15 57
johan.janssens@medinvents.com
________________________________________________
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic
joints.
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, longterm durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect
ChondroCelect®, the company's lead product for cartilage regeneration in the knee, is the first cellbased product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of
characterised cultured chondrocytes derived from the patient's own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited.
On October 5, 2009 ChondroCelect received European marketing authorisation as the first Advanced Therapy Medicinal Product, indicated for repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
About MedInvents
MedInvents NV is a Belgian ISO certified company, established in 2004 to investigate, develop, manufacture and distribute new and innovative applications with accessories mainly in the field of
cancer diagnostics. The Spirotome and Coramate are diagnostic macro biopsy systems, based on a well controlled, direct and frontal biopsy technology with minimal invasion and optimal patient care.
The products are CE and FDA approved for 13 clinical applications. These biopsy tools make the bridge between molecular biology laboratories and patient through high quality, representative and comfortable tissue harvest. With TiGenix, MedInvents entered the therapeutic orthopedic field in
2009.
The ChondroCelect HarvesterT is a proprietary biopsy tool that will be provided to orthopedic surgeons for harvesting cartilage biopsies.
The registration of the ChondroCelect HarvesterT follows the recent approval of ChondroCelect in Europe as the first cell-based product for cartilage repair to have received a European marketing authorization. ChondroCelect consists of characterized cultured chondrocytes derived from the patient's own cartilage. The process of producing ChondroCelect starts with a small cartilage sample taken by a surgeon. The standardization of the biopsy procedure and the quality and consistency of the cartilage sample are important elements for the final quality of the ChondroCelect end product. The ChondroCelect Harvester is specifically designed to allow harvesting cartilage biopsies from
the knee in an easy and consistent manner, avoiding damage to the surrounding tissue and underlying bone. The specific design and ease of use of the ChondroCelect HarvesterT is expected to set a new standard in cartilage biopsy taking.
The Harvester was invented by and developed in close collaboration with Dr. Yves Fortems, clinical advisor to the company, and the medical device company MedInvents, who will produce the device. The device will be provided to the orthopedic surgeons as part of the ChondroCelect biopsy kit.
Dr. Yves Fortems, inventor of the ChondroCelect HarvesterT, comments: 'In designing the Harvester, we have specifically focused on the ease-of-use of the device in combination with delivering a superior and consistent quality of the cartilage biopsy. The quality of the cartilage biopsy is known to be an important factor for the quality of the ChondroCelect
product.'
Dr. Jaak Janssens, Medical Advisor to MedInvents comments: 'We are very pleased with this result of our collaboration with TiGenix' clinical and development team. What I admired
the most was the combination of patient driven research, methodological scrutiny and business competence.'
For more information, please contact:
TiGenix NV
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
Investor@tigenix.com
MedInvents NV
Johan Janssens
Chief Operating Officer
T: +32 11 27 15 57
johan.janssens@medinvents.com
________________________________________________
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic
joints.
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, longterm durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect
ChondroCelect®, the company's lead product for cartilage regeneration in the knee, is the first cellbased product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of
characterised cultured chondrocytes derived from the patient's own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited.
On October 5, 2009 ChondroCelect received European marketing authorisation as the first Advanced Therapy Medicinal Product, indicated for repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
About MedInvents
MedInvents NV is a Belgian ISO certified company, established in 2004 to investigate, develop, manufacture and distribute new and innovative applications with accessories mainly in the field of
cancer diagnostics. The Spirotome and Coramate are diagnostic macro biopsy systems, based on a well controlled, direct and frontal biopsy technology with minimal invasion and optimal patient care.
The products are CE and FDA approved for 13 clinical applications. These biopsy tools make the bridge between molecular biology laboratories and patient through high quality, representative and comfortable tissue harvest. With TiGenix, MedInvents entered the therapeutic orthopedic field in
2009.
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