FAQs

co.don^® AG is positioned at the interface between pharmacology and biotechnology in the still young field of regenerative medicine, namely, Tissue Engineering.

We specialize in the development and commercialization of cell-based biologics of highest quality for the treatment of damaged articular cartilage, invertebral discs and bone.

All products are manufactured by using the company’s platform production technology, Integrated Isolator Technology (IIT) under Good Manufacturing Practice (GMP) conditions.

Tissue Engineering is an emerging category of biotechnology that provides replacement tissue for patients suffering from tissue loss due to injury, disease, genetic abnormality, aging, and/or aging-related diseases.

This dynamic, new and interdisciplinary field, combining the principles of the life sciences, physical sciences (Physics, Chemistry and Materials), and engineering, seeks to develop biological substitutes for damaged tissues and organs. Using living cells, tissue engineers have already developed tissues such as skin, cartilage, blood vessels, bone and bone-scaffolds, liver and other organs.

Market analysts predict rapid growth of Tissue Engineering industry with substantial development potential. The biological cartilage repair market alone in the USA reached US$ 17.8 million in 2003. The European market for biological articular cartilage cell transplants grew at 32.9%.By 2008, patient demand on spine products will drive the market growth to more than US$ 500 million in the USA. In 2003, the European market for spinal implants reached € 200 million (Millenium Research Group, 2003).

The company was founded in 1993 as a limited liability company (GmbH) by Dr. Olivera Josimovic‘-Alasevic‘ and Dr. Karl-Gerd Fritsch. Since 1994 its head office has been located in Warthestr. 21 in Teltow, Brandenburg, the neighboring state of Berlin. Since February 2001 co.don^® AG has publicy quoted.

co.don chondrotransplant^®, used in the frame of Autologous Chondrocyte Transplantation (ACT), is indicated and widely accepted for the treatment of cartilage defects in the knee, caused by trauma or degeneration.

It holds the first manufacturing permit for autologous cartilage-cell transplants according to the German Drug Act as well as import licenses for Switzerland, Austria, Belgium, Iran and Singapore. More than 1200 patients have been treated with a success rate of more than 90%.

The efficacy of the product has been continuously proved through clinical studies and sufficient follow-up.

co.don chondrotransplant^® DISC is the first autologous product worldwide designed as a nucleus replacement therapy for the regeneration of intervertebral discs following surgical treatments.

The product is approved according to the German Drug Act and certified according to Good Manufacturing Practice (GMP). It is used in the frame of Autologous Disc Chondrocyte Transplantation (ADCT), which is focused on the preservation and maintenance of both the neurological and mechanical function of spine.

co.don chondrosphere^® is a patented product of the company, designed as a third generation of ACT, which holds a manufacturing permit in compliance with the German Drug Act.

The autologous three-dimensional articular cartilage cultivated outside the body contains a matrix formed by the cells and does not need any further foreign support materials.

It becomes actively and entirely integrated into degenerated articular cartilage allowing in the future a complete regenerative therapy for osteoarthritis.

co.don osteotransplant^® DENT is the first commercially available autologous bone-cell transplant with the worldwide first manufacturing permit according to the German Drug Act.

Sinus Lift (oral and dental medicine) is considered to be a promising indication. The market for private patients in oral maxillofacial surgery is an attractive future indication the company is currently pursuing.

If a new product is introduced on the German health market, it may be classified into two categories: as a drug or a medicinal product. Medicinal products are, for example, artificial implants.

According to §§ 1 and 3 of the German Drug Act (AMG) drugs are: body parts, body components and metabolic products. Cell transplants belong to the latter category. The local Health Authorities classify autologous Tissue Engineered products as “cell-based” biological drugs.

As autologous products they cannot be manufactured in advance, but are manufactured after entry of a particular order. They cannot be stored, but are transported directly from the manufacturer to the application specialist. The cell transplants cannot be sterilized and the entire manufacturing procedure runs therefore in integrated isolators.

It is the company’s belief that the best, most responsive cells, are only grown by using the patient’s own sera (autologous) and cells without antibiotics, fungistatics, exogenous growth factors or any genetically-engineered manufacturing methods. A chance of immune reaction is therefore substantially reduced.

Our manufacturing process is termed strictly autologous. The high quality standard of the manufacturing is characterized by an aseptic area (grade A zone, cleanest conditions) in the integrated isolator technique (IIT).

Furthermore, co.don^®’s platform technology is well suited to achieve our goal – providing the best cells on the market. All marketing and sales-related activities, even down to logistics such as shipment of products, are focused on achieving this clinical excellence, expected from our customers.

The most important guarantee for our success is not just the development of new marketable products, but also ongoing product refinement. Particular importance is attached to the continuous documentation of clinical results, further establishing the benchmarks of safety, efficacy and clinical durability.

“Centers of Excellence” are regional hospitals or university clinics with the expertise and desire to promote co.don®‘s innovative products in the medical community, to present clinical results at international congresses and to act as training centers for surgeons to learn surgical techniques and clinical application of company’s products.

As of January 2009, the number of employees was 30.

The company’s shares are traded on the General Standard Segment of the German Stock Market in Frankfurt and listed on the outside market in Berlin-Bremen, Düsseldorf, Stuttgart, Hamburg and Hannover.