Osteoarthritis (OA) is a crippling disease that is caused by the breakdown of cartilage within joints. Post-traumatic injuries (e.g. ACL tear) and age-related wear-and-tear of the joints significantly increase the incidence of the disease. Over 27 million people are treated for arthritis-related pain in the US alone, placing a $180B burden on our healthcare system and economy. Missed work and excessive medical expenditure result from the lack of an effective treatment. We believe we have a safe, effective therapy for OA will have an enormous impact on human well-being and significantly improve the global economy.
Cytonics' solution to the OA problem is to deliver high concentrations of Alpha-2-Macroglobulin (A2M), a blood protein that has been shown to protect cartilage, into the joint space to slow and eventually halt the progression of arthritis. A2M functions byinhibiting destructive protease enzymes that chew up cartilage tissue.
Our first therapeutic that gained FDA approval is the Autologous Protease Integrated Concentrate (APIC) system, a device which concentrates A2M from a patients' blood to treat arthritic joints. The APIC technology has treated over 8,000 patients nationwide, serving as clinical evidence of A2M’s efficacy as a treatment for osteoarthritis.
Our current focus is the development of CYT-108, a genetically engineered variant of A2M. CYT-108 was designed with key genetic mutations to make it 2-4x more effective than naturally occurring A2M. Since our last raise, we have successfully completed the GMP manufacturing of CYT-108 and will be conducting a final pre-clinical safety study before entering Phase 1 human clinical trials. If approved by the FDA, CYT-108 will be the only therapy on the market that addresses the root causes of osteoarthritis and has the potential to reverse disease progression.