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Tissue engineering deals with the production of biological replacement tissue for damaged organs and tissue. Using the body's own (autologous) cells, tissue engineering firms have already developed tissues such as skin, cartilage, bone and blood vessels as well as livers and other organs. The tissue engineering industry is seen by many analysts as a rapidly growing market with substantial development potential.
The autologous cell transplants produced by co.don AG have been used since 1997 to treat circumscribed, traumatic and degenerative cartilage defects in joints and vertebrae. Over 9,000 patients have now been treated with autologous chondrocyte transplants (as of April 2016).
co.don chondrosphere® integrates actively with the degenerative articular cartilage. This also creates the possibility of restoring the natural functionality of damaged joints. The autologous, three-dimensional pharmaceutical is cultured outside the body and has a matrix formed by the cells themselves, without the need for any extraneous scaffolds.
co.don chondrotransplant®DISC is the world's first pharmaceutical product made of autologous cells for the treatment of degenerative intervertebral discs.
According to the definition of the Federal German Health Authority, autologous tissue engineering products are classified as cell-based biological pharmaceutical products. Autologous products cannot be manufactured in advance but are produced specifically to order. They cannot be stored and are transported from the manufacturer directly to the user. The cell transplants cannot be sterilised, so the entire production process takes place in integrated isolators.
We firmly believe that the best-growing cells should only be made with the patient's own serum, without antibiotics, fungistatic agents, growth factors or genetic modification, in order to prevent an immune reaction. Our procedure is therefore described as strictly autologous. The benefits in use are furthermore the simple surgical procedure and short transplantation times, complete integration of the new cells and the possibility of minimally invasive and arthroscopic application. A characteristic feature is the high quality standard in production, which is achieved by a unique cleanroom technology; Integrated Isolator Technology (IIT®).
As the product is composed exclusively of autologous components, the risk of rejection by the patient can be ruled out.
In Germany the statutory health insurance companies reimburse the cost of treatment with autologous chondrocyte transplants in vertebral discs, knee joints, hip joints and elbow joints. In future other indications for which we already have a solution, such as the treatment of shoulder and ankle joints, may also be eligible for reimbursement.
With private health insurance, the type of treatment covered depends on the terms of the individual policy agreed with the insurance company. Based on past experience, however, private insurance companies do usually cover the costs of autologous chondrocyte transplants.
When European approval is obtained co.don AG currently believes that the product will meet the main criteria for reimbursement by health insurance providers in all European countries.
Centres of excellence are regional hospitals, medical practices and university clinics. The centres of excellence are established with the aim of promoting co.don AG's innovative products in medical circles, presenting the results of clinical applications at international congresses and providing training centres for surgeons to get to know the surgical procedures and clinical applications of co.don's products.
Assuming around 30,000 applications p.a. in the knee joint alone and a price of approximately €5,000 per individual application, there is revenue potential of around €150 million per year. This does not include the potential from hip, ankle, shoulder applications etc. co.don AG is planning to license the ACT 3D procedure once EU-wide approval has been obtained. The revenue potential described above would produce potential licensing income – based on a license fee of 10% of the sales price – of around €15 million annually. Global revenue potential (above all for the EU, the USA and Japan) can be extrapolated on the basis of population figures.
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