Cytex Therapeutics was formed to develop and commercialize the tissue regeneration technology discoveries coming out of the lab of Dr. Farshid Guilak at Duke University. The original Cytex business plan received numerous innovation awards, including seed capital for the startup phase. Since its founding, Cytex has gone on to win numerous state and federal grants, each recognizing the novelty of the research and its enormous potential contribution to the clinical management of patients with osteoarthritis. The three Cytex co-founders form the core leadership of the company as it continues to develop its novel products.
The Osteoarthritis Challenge
Articular cartilage lines the ends of bones that form joints in the human body. The slippery surfaces created by the cartilage lining enable joints to function smoothly, without pain. Problems arise when the surface cartilage is injured or damaged, causing pain and joint dysfunction. Damaged cartilage does not heal like many other tissues in the body primarily because it lacks adequate blood supply. Untreated, damaged cartilage continues to erode and can eventually lead to a painful chronic condition called osteoarthritis, or OA. Osteoarthritis is a major global public health challenge. The Institute of Health Metrics and Evaluation published a study in 2017 on the Global Burden of Diseases. This study found that arthritis and OA placed in the Top 20 Global Burden of Disease with a total economic burden in excess of $400 Billion annually. The Centers for Disease Control (CDC) estimates that OA affects more than 32 million people in the US. This number is forecast to grow as the population ages. The most commonly affected joints in OA are the knees and hips. Cytex is focusing its initial product development efforts on implants to replace damaged cartilage in the hip, especially in younger, more active patients for whom surgical options offer limited long-lasting benefits.
There are several available options for physicians and surgeons who treat patients with OA. These include physical therapy, pain management with pharmaceuticals (NSAIDS and opiates), and surgical interventions including hip resurfacing and total joint replacement.
Unfortunately, patients under 60 with an active life style face a dearth of surgical options. The first choice may be hip resurfacing, a surgical intervention that replaces only the articular surface of the femoral head, preserving most (but not all) of the bony structure of the joint. The surgeon may also perform procedures such as microfracture, intended to promote cartilage re-growth. If hip resurfacing does not provide the desired outcome, or if the patient is not a good fit for the procedure, the last resort is total hip replacement. Hip replacement involves removing the femoral head and replacing it, and the acetabulum, with a metal or metal-ceramic ball and joint. Total hip replacement surgery is a very effective option for older, less active patients but is less than ideal for younger patients. The reason is that the metal and metal-ceramic replacement parts have a limited lifespan, typically in the range of 20-25 years. After this time, the implant will need to be replaced in a procedure called hip revision surgery. Revision surgery is less successful and carries higher risk of failure because the prior procedure removed so much of the stabilizing natural bone.
The choice of hip replacement surgery is even less attractive for younger patients. One of the main factors that decreases the lifespan of the implant is the activity level of the patient. For example, an active 40-year old patient who has undergone a total hip replacement faces the prospect of multiple revision surgeries over his or her lifetime. This is one reason why so many younger, active patients who are offered total hip replacement as a last resort choose to forego the procedure.