Carticept Medical Inc. is working to become the first company with a synthetic cartilage replacement device for use in the earlier stages of knee OA that allows immediate weight bearing, with future applications in the hand and foot. The company also is awaiting 510(k) clearance for its Navigator all-in-one orthopedic injection system combined with ultrasound guidance.

Start-ups and investors are looking to address the large and growing gap between palliative treatment and major joint surgery for patients with cartilage damage in the knee, toes and hands - although the FDA is putting up more roadblocks than ever before. In this issue we profile Articulinx, Carticept Medical and Orthox.

START-UP counts some 40 commercial development efforts in cartilage repair and regeneration. Some are implanting synthetic scaffolds, and some are offering cell-based therapies used with or without scaffolds. It's a crowded and confusing category. So many companies are chasing a market that is still somewhat undefined and doesn't seem large enough to support them all. What's clear, however, is that almost 15 years after the introduction of Carticel, the first cell-based implant for cartilage repari, there is still an unsatisified market of patients aged 20-60 with knee pain due to cartilage damage or degeneration.

With the era of regenerative medicine upon us, fueled in part by the Obama administration's lifting of the ban on government funding for stem cell research, advancements in biological approaches to orthopedic joint restoration are in the forefront. Most orthopedic surgeons believe that the future treatment of musculoskeletal problems no longer lies in replacing joints with metallic implants but in the development of curative therapies involving cells, growth factors, and other bioactive agents capable of regenerating bone, cartilage, and other joint structures. Although such products are still in the early stages of development, there has been a recent surge of interest in this area. Based on the wealth of new technologies presented at this year's American Academy of Orthopaedic Surgeons meeting held recently in Las Vegas, it is clear that stakeholders in this industry are in hot pursuit of this opportunity, which could one day be measured in the billions of dollars.