NIA Small Business Showcase: CytexOrtho

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Cartilage damage arises from a combination of activity and the cumulative effects of aging. Damaged cartilage does not heal and eventually leads to osteoarthritis (OA), which is a leading cause of disability in adults, according to data from the Centers for Disease Control and Prevention. The net effect of damaged cartilage is that the affected joints experienced accelerated aging in terms of loss of function. One in four people in the United States, or more than 50 million people, report leisure- and work-related activity limitations due to joint pain caused by OA. OA is diagnosed in more than 90% of the 470,000 hip replacement surgeries done annually in the United States, at a direct cost of at least $25 billion. The current standard of care is hip replacement surgery, but there is a clear unmet need for an intervention that reverses the effects of aging and wear on arthritic joints.

CytexOrtho has developed patented technologies that are being used to create implants that integrate into the cartilage defect of an injured joint, restoring anatomic structure and function while preserving natural bone. The implants are made of polycaprolactone (PCL), a material with a well-established regulatory history of biocompatibility and safety, supported by data from PCL-based products currently on the market. Preclinical studies in a model of OA show that CytexOrtho implants restore damaged cartilage, enabling 100% of test animals to return to pain-free joint function. By contrast, the control group animals evidenced disease progression and never regained joint function.

Of the 470,000 hip replacement surgeries done annually in the United States, more than 90% are elective. Of these, 92% have OA as a primary diagnosis. About half of patients undergoing hip replacement surgery are 25 to 55 years of age. Joint replacement is not ideal, due to the limited lifespan of the implants. Unfortunately, surgeons lack an effective treatment that restores damaged cartilage, arrests disease progression, and delays joint replacement surgery. The hip replacement market is growing at 4% annually, but utilization among younger patients increased at a higher rate from 2013 to 2017: 14% for patients ages 35 to 44; 25% for patients ages 45 to 54; and 42% for patients ages 55 to 64 (BCBS Report, 2019). This reflects the need for multiple revision procedures in a patient’s lifetime, which reduces the effectiveness of the procedure and, accordingly, the quality of life as the population ages. This is alarming, because joint replacement surgery is clinically suboptimal for these patients. The lack of an alternative procedure that restores joint health and function is driving this excess utilization, an issue that CytexOrtho hopes to address with its implants.

Surgeons treating OA patients are limited to joint replacement, which is effective in older, less active patients. Cartilage restoration, though, remains elusive. Current restorative techniques (e.g., microfracture) are not effective in treating the cartilage defects that are the hallmark of OA and other conditions affecting older patients and, increasingly, younger patients. CytexOrtho believes that cartilage restoration may delay OA progression and postpone or eliminate the need for joint replacement until such time as is medically appropriate. As a result, the preservation of joint tissues earlier in life ensures a better quality of life as the patient ages. CytexOrtho is the leading innovator in cartilage restoration implants for the hip and is pursuing a first-to-market strategy for its products.