A 1994 article in the New England Journal of Medicine (“Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation” by Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L.) effectively launched cartilage repair in the United States.
One year later Boston-based Genzyme Corporation took the autologous chondrocyte transplantation (ACI) technology described in the NEJM article and created a cartilage repair product and process named Carticel.
Two years after that, the FDA granted Genzyme a license for Carticel. It was the first time the FDA had licensed/approved or cleared a living cell technology for commercial sale.
Jump ahead 25 years, and after more than 1 million annual cartilage treatment procedures in the U.S., including 430,000 debridement procedures and 220,000 microfracture surgeries (source: SmartTRAK.net – Cartilage Replacement – U.S., January 3, 2019), cartilage repair remains more a hope than a standard of care.
Carticel along with another ACI treatment, MACI (autologous cultured chondrocytes on porcine collagen membrane), are the most popular cartilage repair technologies in the United States. Those treatments (along with a related technology for wound repair—Epicel) generate about $40-45 million in annual product sales.
Other cartilage repair products that were also developed include Zimmer’s DeNovo-NT, plug-type scaffolds for arthroscopic delivery like Dunlop Corp’s carbon fiber plug or Smith & Nephew’s True-Fit plug, Tigenex’s Chondromimetic implant and Histogenic’s NeoCart (collagen scaffold with autologous living cells).
Even so, within the overall market to treat deteriorating knees, cartilage repair product sales barely register.
In terms of dollars ($7 billion), knee replacement surgery is the principal treatment modality for patients suffering from end-stage osteoarthritis. Hospitals, physicians, suppliers and payers understand that that is the bread and butter of the industry.
A quick perusal of American Academy of Orthopaedic Surgeons’ (AAOS) clinical practice guidelines for osteoarthritis (OA) of the knee finds a whole range of pre-knee replacement therapies including NSAIDs, cortisone shots, platelet rich plasma injections and osteotomies.
But no technologies for cartilage repair or regeneration.
Sanofi, the company that came to own Carticel, Epicel and MACI sold that 230 employee business in 2014 for just $4.0 million (with a $2.5 million note) to Aastrom Biosciences, since renamed Vericel Corporation.
Cartilage repair, for sure, is not burdened by great expectations.
