The Pyrocarbon Implant Replacement (PIR) is expected to be particularly beneficial to the large under-addressed market of 35- to 65-year-olds who are too old for the regenerative therapies commonly employed in younger patients, but are too young for a total knee replacement (TKR).
In June 2015, Moirai received an Investigational Device Exemption (IDE) approval from the FDA to begin a pivotal US human clinical trial on the product.
Current Market Challenges
Osteochondral and chondral defects occur frequently – not only in young athletes, but also in older and more sedentary individuals. Articular cartilage defects of the knee are common, painful, and predispose patients to debilitating osteoarthritis. Making matters worse, avascular cartilage tissue has an extremely low capacity for repair.
The current treatment options, including regenerative and replacement treatments, are suitable for only a range of individuals. Active, middle-aged patients are left to opt for procedures that may not be suitable for their defects, often leading to poor outcomes.
Both The New York Times and CBS News have written about the troubling lack of options for patients not well suited for regenerative or TKR surgeries. In November 2014, The New York Times wrote that a number of patients would be better served finding other solutions to knee pain rather than rushing headlong into a total knee replacement. Earlier in 2014, CBS News profiled a study that was published in the journal Arthritis & Rheumatology. The study followed 175 patients who underwent total knee replacement surgery and found that only 44% of those surgeries were “appropriate,” meaning the expected benefits outweighed the likely risks for that patient.
“Researchers then analyzed the data from a large study of almost 200 men and women with aching, arthritic knees who went on to have replacement surgery within five years of entering the study. It turned out that approximately a third of the subjects would not have been regarded as appropriate candidates by the researchers.”
“In 34 percent of cases evaluated, the surgery was deemed to be inappropriate, with expected risks outweighing the benefits. The rest of the cases, 22 percent, were considered inconclusive, with risks and benefits approximately equal.”