Gil Beyen: Regenerative medicine is a new wave of medicine in which we combine cell technology, biomaterial technology, and growth factor technology to make biological implants or tissue-engineering constructs. Since January 2009, a new regulation has been implemented in Europe and all cell-based products are now under EMEA supervision, under the new ATMP regulation. The regulation says that all cell-based products need to be considered like biologics, which was already the case in the United States [where] cell-based products have been regulated by FDA since the mid-1990s. 

 

 

Beyen: We’ve been developing ChondroCelect over the past 10 years. The product is intended for repair of large cartilage lesions in the knee. By large lesions, we mean more than one or two square centimeters, and mainly full-thickness lesions where the cartilage has gone down to the underlying bone. Cartilage is a tissue that doesn’t regenerate spontaneously, and there’s not much of an alternative for patients who have these types of lesions today. To repair this cartilage in a durable way, the best technology is to take a little piece of cartilage, or biopsy, culture and harvest the cells, and bring the cells back to the patients after about four weeks. [The cells are] reimplanted into the defect, and the cells make new cartilage.

 

 

 

 

 

Beyen: We’re prelaunching the product. [Our] focus is to obtain reimbursement, which is a process that can take from six months to more than a year in Europe. In Germany, we recently received special status as an innovative new treatment, which makes it eligible for reimbursement by the sickness funds.

 

 

 

Beyen: We acquired Orthomimetics in November 2009. It’s a UK-based spinoff company of MIT [Massachusetts Institute of Technology] and the University of Cambridge that is also active in regenerative medicine, but with a different approach. We were more focused on the cell as the active ingredient, and it was more interested in the collagen and biomaterials supports of regenerative medicine. This was complementary because regenerative medicine is also about combining cells and biomaterials, and we wanted to build a biomaterials platform. It also had a product that was approved, Chondromimetic, for the same point of sale but with a different indication. It is a collagen plug that can be used to repair small but deep cartilage lesions with concurrent damage to the underlying bone. The product is CE marked in Europe. The evidence that is being built in Europe will be used for the United States, but we still have to [seek approval] for this product in the United States. ChondroCelect is for large cartilage lesions, and Chondromimetic for small lesions where you have cartilage and subchondral bone damage. 

 

Beyen: The three main strategic directions of the company are to make ChondroCelect and Chondromimetic successful in Europe, bring the products to the United States, and develop a pipeline of complementary products. We’re working toward optimizing the ChondroCelect product—for example, introducing a cryopreservation step to make it easier for planning the surgery. We’re also working on minimally invasive and arthroscopic delivery systems by using this collagen membrane in different ways.

 

 

 

Beyen: In the field of specific cell-based products for cartilage repair, I think the real pioneer in this field, and our competition, is Genzyme. They have a strong position in the United States with the Carticel product, and in Europe with the Maci product. 

 

 

Beyen: I think the consequence of this regulation will be a bit of a shake out initially, but there will be a stronger and more realistic industry emerging from this. I think it will be good for the field of regenerative medicine because more solid and more validated products will be the result. In Europe, it has been very difficult to raise money for the field of regenerative medicine, because it wasn’t really clear how you could develop a product, and there were no clear rules. The fact that there are now rules of the game means that the game can start.

 

Beyen: If you look at the spectrum of treatments for cartilage damage today, you see a range of symptom-relieving products and treatment on the one end. At the other end of the spectrum, we have the replacement, the knee prosthesis. The problem is that there’s a big gap. The 45-year-old with a big cartilage lesion that painkillers don’t help anymore, and who is too young for total knee replacement, has very few treatment options today. For these patients, we need biological solutions. Regenerative medicine bridges the gap between symptom relief and replacements by bringing biological implants and biological solutions that can prevent the progression toward osteoarthritis, or at least delay it. I see it emerging as a new field of medicine—somewhere between the drug and the device. Today we’re probably the largest company in Europe in regenerative medicine. We’re focusing on capitalizing on this and building a leadership position in this emerging and exciting field.