Amedrix GmbH, which is based in the Life Science Center in Esslingen and currently has a staff of eight people, develops innovative acellular medical products on the basis of animal collagen. The company's ChondroFiller products have the advantage over existing cartilage treatment options such as microfracture surgery, OCT (osteochondral transplant) surgery or ACT (autologous chondrocyte transplantation) in that they can be produced without having to remove cells from patients and without requiring long-term cell culture. Just one surgical intervention is required. The new therapeutic approach is therefore considerably cheaper and less time-consuming than other cartilage treatment options, all of which is a clear advantage for patients, doctors and healthcare providers alike.
Dr. Thomas Graeve is the founder and scientific officer of Amedrix GmbH, which was established in Esslingen in 2009. Graeve and his team have long experience in the development, production and approval of collagen-based products. It all started 20 years ago, when Graeve was working on collagen-based products at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart. During his final years as head of department at the IGB, he co-founded Ars Arthro AG, which later became Arthro Kinetics AG following the company's merger with EKL Ltd., and also served as the company’s chief scientific officer.
Arthro Kinetics develops, manufactures and markets biological implants for regenerating joint mobility and spinal disc function. Graeve successfully managed the development, production and gaining of marketing authorization for a variety of collagen-based products. The first product on the market – the CaReS® (cartilage regeneration system) basic technology – is a patented collagen type I matrix colonized with autologous cartilage cells used for the regeneration of articular cartilage defects. Based on the CaReS® basic technology, Arthro Kinectics developed an implant that is based on the same type I collagen matrix, but it is primarily cell-free and colonized by cells from the environment. Amedrix GmbH’s Chondrofiller products are based on the CaReS® technology. They have a high primary stability (ChondroFillergel) and can be applied arthroscopically (ChondroFillerliquid).
The three-dimensional implant matrix is produced from rat tail collagen I and is variable in size, shape and consistency. Collagen type I is a protein that is primarily found in connective tissue, skin, tendons and bones. Collagen has a high tensile strength, which limits the elasticity of tissue. Like all other collagen proteins, collagen type I is also composed of a triple helix. It is one of the most important matrix proteins used in in vitro cell cultivation.
Collagen matrices have an excellent biocompatibility. Once inside the patient’s body, the implants are colonized by the patient’s cells, which then start to proliferate and synthesize their own collagen. ChondroFiller is used by the patient’s cells as a basic scaffold, enabling them to produce collagen type II, which is the major constituent of cartilage. Animal experiments have shown that cartilage regenerates within six weeks or so and can barely be differentiated from surrounding healthy cartilage. Clinical trials have shown that defects filled with ChondroFiller heal relatively effectively and are barely discernible from surrounding healthy cartilage within a period of six months.
Given its stability and efficacy, ChondroFiller represents a cartilage defect treatment option superior to all other methods currently on the market, including microfracture surgery and OCT (osteochondral transplant) surgery. In contrast to microfracture surgery, the application of ChondroFiller prevents the development of scar tissue and does not require the removal of an osteochondral graft like in OCT. “Compared to cellular cartilage treatments using autologous cells, our products have clear benefits, in particular for patients, doctors and healthcare systems,” said Dr. Thomas Graeve. “The quality of patient treatment improves as the quality of medical products and their application improves; minimally invasive surgical methods are an excellent example of this.” The use of implants in regenerative medicine can significantly reduce healthcare costs. “At present, cell-based cartilage transplants cost between 3,500 and 20,000 euros; our implants are considerably cheaper. Since this applies principally to costs arising from particularly complex and time-consuming treatments, I am sure that our new implant will become widely accepted,” says Dr. Thomas Graeve.
“Our lead products are for the treatment of articular cartilage defects in the knee, shoulder and ankle joints. But we are also developing products for use in veterinary medicine, for example to treat horses or small animals such as cats and dogs,” said Dr. Graeve. “Our preclinical study has shown that our collagen matrix provides optimal conditions for cartilage and stem cells, thereby stimulating the multiplication of the cells and the development of collagen type II within a relatively short time period.” ChondroFiller is the first product to combine the advantages of microfracture surgery and cell-based treatment methods such as MACT (matrix-associated autologous chondrocyte transplantation). The defect fills up individually, completely and accurately. The ChondroFillergel is a specifically form-stable gel that can be implanted quickly and easily using a minimally invasive procedure (mini-arthrotomy). This type of implant is particularly suitable for the treatment of larger defects.
ChondroFillerliquid is contained in an innovative dual-chamber syringe that is used to apply the liquid collagen. The liquid is implanted arthroscopically and applied at a temperature of around 33 degrees, which reduces gelation time and hence surgery time. A form-stable gel that is later converted into body tissue forms immediately after injection of the liquid into the defect. The ChondroFiller product line enables the efficient treatment of cartilage defects caused by injury or degeneration, which is also gentle to the joints. The early application of the liquid to smaller cartilage defects helps prevent the development of severe secondary damage.
Cartilage substitute is approved as class III medical device
In late 2012, Amedrix was awarded the CE mark and hence the authorization to market ChondroFillergel in the EU. In 2013, the company obtained marketing authorization for ChondroFillerliquid. The ChondroFiller products are classified as class III medical devices rather than as autologous cell transplants. The implants, which are mainly used for the treatment of cartilage defects, will in the future be used as regenerative cartilage replacement for any type of joint. “We are very happy to have received the confirmation that our products conform with EU regulations and are officially approved for sale on the European market,” said Dr. Thomas Graeve. “Both ChondroFiller products – the gel and the liquid – have received CE certification. This is a great breakthrough for Amedrix!”
The next plan is to carry out a European-wide observational post-marketing study which will involve GPs and hospitals at 20 to 25 centres that use Amedrix implants. “The study will of course also involve doctors and hospitals in Baden-Württemberg and here we will specifically focus on the long-term outcome,” said Dr. Graeve.
Involved in REGiNA project
The company’s experience has been put to good use in a REGiNA research project on the development of a collagen matrix for the treatment of deep wounds. “This matrix has the potential to be used in reconstructive surgery for the treatment of deep defects resulting from the removal of skin tumours. We also anticipate using the matrix as a cell membrane for the treatment of dental defects.” As the matrix is completely cell-free, Graeve believes that it will not be too long before the company obtains marketing authorization. “We are specifically focused on the development of cell-free products. This means that the journey from bench to bedside is shorter as well as cheaper than that involving cell-based products.”
Further information:Amedrix GmbHDr. Thomas GraeveSchelztorstraße 54-56D-73728 EsslingenTel.: +49 (0) 711 / 933 414 10Fax: +49 (0) 711 / 933 414 11E-mail: email@example.com