FLEXISEQ is the only twice daily topical, medical device with twelve week trial data for lubricating the cartilage in joints to relieve pain and stiffness, and improve joint function associated with all stages of osteoarthritis.
Patients with joint disorders such as OA have been found to have reduced levels of synovial lubricants that play a key role in protecting articulating cartilage. It has been suggested that where mechanical abnormalities have triggered the body’s repair process, which manifest themselves in pain and inflammation, such processes are ineffective if the original mechanical defect remains unresolved. Further research has shown that liposomal aggregates that are highly compressible, soft and are highly hydrated make for efficient biolubricants.
Experiments with topically applied, fluorescently labelled Sequessome vesicles showed that not only did the topically applied devices travel to the synovium, but that they were intact and located preferentially on the surface of the cartilage, forming a protective, lubricating layer.
Exploiting this lubricating mechanism, FLEXISEQ demonstrated clear efficacy in a large scale Phase III 12 week trial, comparable to the oral selective, COX2 painkiller, celecoxib. These data are shown below:
In all Phase III trials, the mean reduction in pain has been between 38% and 50% from baseline.
And just as significantly, the data showed a very clean safety profile, avoiding the GI-problems associated with the NSAID class of pain killers:
The excellent safety profile has been further demonstrated by the lack of any systemic side effects being related to the product in over 45 million doses.
The advantages of FLEXISEQ have been recognised by key persons within the arthritis medical community and leading physio-therapy/sports rehabilitation:
"There are fewer and fewer safe, available, pain-relieving options for people with osteoarthritis. If this product can relieve their long-term pain without side-effects, then that's good news for the millions of people who suffer with this debilitating condition." Arthritis Research UK
"This is a fantastic product and one the medical team are proud and happy to have associated with the Club" – Joe Collins, former Head of Saracens Medical Team and now Head of Buffalo Sabres (ice hockey) Medical Team
FLEXISEQ is for sale in the United Kingdom, Estonia, Germany, Ireland, Italy, Latvia, Lithuania and Malta as well as Australia, Hong Kong, Malaysia, Singapore, South Africa and Turkey. It is expected to launch in the United States in H1 2017.
Further details can be found at www.flexiseq.com.