Chances are excellent that you know someone personally who suffers daily with arthritis or who has had a joint replaced. Flex Biomedical's new technology, a synthetic, injectable polymer, is hoped to provide a better solution for the 200 million people worldwide who deal with this debilitating, painful disease.
Osteoarthritis is incurable, chronic and caused by a breakdown of cartilage and synovial fluid in the joints. Traditionally, osteoarthritis is treated with hyaluronic acid (HA) viscosupplements injected into the joint to try to improve the viscosity of the synovial fluid and reduce pain and swelling in the joint. However, injected HA only stays in the joint for one to two days and often is ineffective. Some trials have shown no superior benefit when compared to placebo.
Flex Biomedical's polymer was designed to be a superior viscosupplement. We believe the polymer can both relieve pain and protect cartilage from further degradation, slowing down the progression of osteoarthritis - something current viscosupplement products cannot do.
The Flex Polymer stands out because:
- It is a superior lubricant with a low coefficient of friction.
- It exhibits superior cushioning ability with non-linear viscosity during high-impact joint loads and shear strain.
- It is slow-degrading, which means it should last longer in the joint than HA products.
- It can be synthetically manufactured much less expensively than HA products.
- It is regulated as a medical device in the United States with a straight-forward approval path.
In vitro and in vivo tests have confirmed the polymer's superior mechanical properties and its biocompatibility. Cytotoxicity, genotoxicity, sensitization, irritation, acute toxicity and other biocompatibility tests have been conducted, demonstrating the polymer's safety. Additional preclinical tests are underway.