The clinical and market needs for devices to address cartilage degeneration and injury while preserving motion in the knees, toes and hands earlier in the osteoarthritis (OA) disease continuum are huge and growing, driven by aging, obesity and sports injuries. The active 35 to 55 age group and baby boomer populations are in need of minimally invasive options to delay or prevent the need for major surgery. Once conservative care options are exhausted, patients would like more ways to stave off knee joint replacement, fusion in the big toe, or trapeziectomy in the basal joint of the thumb. A number of start-ups are working on innovative motion-preserving products to fill this vastly underserved void. However, the "price of admission" to this market has become very high. Getting through the FDA and into the US market is a tricky proposition indeed, and there have been casualties. Still, brave young start-ups and select investment firms are taking the risk and banking on lucrative rewards, positioning permanent or reversible implants as functional cartilage replacements and cost savers for the overburdened US health care system. Larger players seeking acquisition targets are taking notice as well. In the next five years, a select few of the best and brightest (and most well funded) are likely to make it through the long and expensive Pre-Market Approval (PMA) pathway with viable options for relieving pain and preserving natural joint motion.
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