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For any OA grade 1, 2, or 3 patient, A2M should be the first regenerative medicine step, as you can perform a FAC test to determine if the patient is a good candidate. In the beginning, most physicians will pull a synovial sample for the test prior to giving a cortisone or an HA injection in order to be prepared for the next treatment when the patients return. Those providers that are seeing patients after these therapies have been completed perform this test in the initial patient consult and then determine a treatment protocol based on the outcome. Please see below and attached for more detailed information.

Cytonics' award winning Autologous Platelet Integrated Concentrate (APIC) System is a filtered plasma therapy process that concentrates the master protease inhibitor, Alpha-2-Macroglobulin (A2M). A2M binds to the enzyme protease to stop tissue degradation, as protease breaks down cartilage and is found in large quantities in joint spaces and discs. While A2M is found readily in our blood, it is too large to enter the joint or disc space and therefore is not able to flush out the high presence of protease causing degradation and pain for millions of patients. With the A2M Injection, patients can biologically “clean out” the joint and stop cartilage catabolism as well as prevent further degradation. Additionally, potential patient candidates can be verified by performing a Fibronectin-Aggrecan Complex Test (FACT) which determines the presence of FAC, a biomarker of cartilage catabolism, and predicts a positive functional outcome.

Animal studies for OA use are already complete (attached) as well as a 24 patient case series for DDD (attached) which helped Cytonics secure one of Orthopedics This Week’s 2015 Best New Spine Technology spots. The formal patient study for an OA indication started in June 2015 and is still underway (press release w/ study guidelines attached). Additionally, I have included an article from Orthopedics This Week that provides a background for the APIC System and discusses how A2M Injections will potentially replace HA in the future. Lastly, I have included the most prominent paper on A2M and its abilities.

APIC – A2M Injection
· Autologous Platelet Integrated Concentrate (APIC) System – filtered plasma
· 1st and only system that centrifuges and filters plasma for the optimal combination of high platelets and low white blood cells
· Platelet Rich and 6 times the Alpha-2-Macroglobulin (A2M) concentration
· Leukocyte poor
· Fibronectin Aggrecan Complex Test (FACT) performed pre-injection to determine injection efficacy (attached)
· Ortho This Week’s 2015 Best New Spine Technology Award Recipient