News

CaReS® - Permission for the clinical application in the USA received

As the first and only non American enterprise the Ars Arthro AG (Esslingen) receives approval to the IND application for the clinical application of the Cartilage-Regeneration Technology CaReS® in the US-American market from the American Food and Drug Administration (FDA).

Since mid July 2005 the cooperation partner of the Ars Arthro Inc. (Cleveland, Ohio / USA) founded in October 2004, the Cleveland Clinic Foundation (Ohio / USA), carries out first operations using the CaReS® technology. 

Already the first presentation of the CaReS® technology at the Cartilage Innovation Summit in Cleveland in May of this year inspired and persuaded the doctors team around professor Josef Lannotti, head of the orthopedic department at the Cleveland Clinic, and Dr. Tony Miniaci, head of the sports medicine at the Cleveland Clinic, of the new technology.

„Next to the strong resonance from interesting markets like China, Russia or Turkey in which the Ars Arthro AG is represented since April 2005 with the Arthro Turkey Biotechnology SRL (Istanbul), the beginning of the clinical application of CaReS® in the USA is another important confirmation of our technology – especially with a worldwide famous partner like the Cleveland Clinic “ says Robert Guilleaume, chairman of the board of the Ars Arthro AG.

Guilleaume holds the US-American market, which puts out 50 percent of the world market economically for especially interesting. Up to now, only one comparable supplier exists here, who turns over approximately 25 million USD yearly with their product, a classical cell suspension from the first generation of the ACT technology. According to the 2-year-results of a randomised comparative study of the university hospital Aachen RWTH, this technology shows considerable disadvantages compared to CaReS®.

Robert Guilleaume is sure, that „…the presence and commercial use of our technology in the US market will lead very quickly to other interesting co-operations and product developments“.

Following the first operations and following a pilot study beginning in 2005, an additional Multicenter Comparative study headed up from the doctors team of the Cleveland Clinic is expected to be started in preparation for the commercial registration of the CaReS® technology in 2006.

The Cleveland Clinic Foundation, founded in 1921, connects the hospital care with the research and education in a private, charitable group practice. About 1,200 doctors in full-time employment in Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specializations. The patients of the Clinic come from all federal states of the USA and from about 90 countries worldwide. Further information is available at http://www.clevelandclinic.org

CaReS® is an innovative cartilage cell regeneration procedure. Using a 3D-Collagen-Gel-Matrix an individual pressure and form-stable transplant is developed in only 10 to 14 days. This can be adapted perioperativ to the individual defect size. Fixation of the transplant with Fibrin glue avoids the creation of fixation seams which are unavoidable with ACT. This substantially reduces operation time and the exposure of the surrounding joint cartilage. The result: fast, long-term and optimized healing of large cartilage lesions on the knee, foot and ankle through the first safe transplantation of a defined quantity of controllable autologen cells.
For further information visit: www.ars-arthro.de

Topic: Health and Medicine, Biotechnology