Although it got off to a bit of a rough start, more and more experts are claiming that adhesion barriers for spinal applications are going to be huge. Adhesions, which are fibrous scar tissue, involve an abnormal connection between the soft tissue and organs and are a common complication following abdominal, spinal, and pelvic surgery. Adhesions are generally painful for the patient and often require further surgical treatment in fact, it was estimated that the surgical removal of abdominal adhesions alone costs approximately $2 billion annually in the US. As a result, it's easy to see why there is significant interest in reducing the incidence of adhesions following surgery, and why many industry experts claim that this is a significant unmet need in the medical world.
So why the interest in the spine. Well, for one thing, spine procedures represent a multibillion dollar industry in the US due to the large number of people suffering from back pain. Spinal implants (including fusion and nonfusion devices) were used in more than 350,000 thoracolumbar spine procedures in 2011 in the US alone, and this doesn't include the many other spine procedures that can lead to the formation of adhesions.
Despite the interest in this space though, adhesion barrier technology for spinal applications struggled a bit to gain traction in the US. Although GLIATECH was briefly able to receive FDA approval for its ADCON-L, this product was later recalled due to concerns over possible contamination of the material from its aluminized paper lid liner. As a result, there are currently no adhesion barriers approved for orthopedic applications in the US.
Nonetheless, the latest results from FzioMed on its Oxiplex gel are promising, with patients treated with the product showing significant reductions in leg and back pain and lowered rates of reoperation. These results will hopefully lead to FDA approval and create a gateway for other adhesion barrier companies into the lucrative US spine product market.
Now the question is just when the adoption of these products will truly take off.