If ever there was a company in the spine industry that has resembled a roller coaster, Amedica may be the poster child for the ups and downs of the world of spine. After raising north of $100 million to bring Silicon Nitride by storm into the industry, after making poor choices in leadership, after a failed attempt at taking the company public, could this be the defining moment that finally gives Amedica hope? As Clint Eastwood would say, "are you feeling lucky, of course to an empty chair."
On September 13th, Amedica issued two press releases announcing an expansion of its claims that their Silicon Nitride material has superior osteointegration and anti-infective capabilites when compared to the current state-of-the art. For years, PEEK has been considered the gold standard in inter-body due to its modulus of elasticity and versatility as a biomaterial. When comparing Silicon Nitride to PEEK the question must be asked, "will the expanded labeling of this product shift the standard of care for patients that need lumbar fusion?"
Amedica was quick to take advantage of these articles that were published in Acta Biomaterialia and the International Journal of Nanomedicine, which demonstrated that when comparing Silicon Nitride to PEEK or Titanium (is anyone actually using titanium interbody devices anymore?) there was superior bone formation, osteointegration, as well as anti-infective properties. Once again, questions abound whether surgeons are unhappy with the results when using PEEK and whatever magic dust is infused into an affected vertebral segment? Could these recent findings shift current market dynamics? As the government seeks to place a premium on evidence based medicine, will these findings improve patient outcomes? Is this much ado about nothing? Could this be another Hail Mary? Doug Flutie where are you? One of the most important statements in this press release focuses on the potential for higher reimbursements for surgeons and hospitals. A strategically placed statement? You be the judge. Does PEEK actually contribute to the colonization of bacteria which may reduce fusion rates? What are the infections rate in lumbar spine fusions?
Yet, before our readers go any further, we would like to know the relationship between Amedica and the surgeons involved in making statements regarding product efficacy (Skidmore) and findings regarding bacterial infections (Webster), a nano of transparency assuages everyones trepidation when reading these PR statements. TSB is not being a skeptic, TSB is asking the questions so that the court of public opinion can determine whether Amedica's claims are legitimate or as stated earlier much ado about nothing? Hey Amedica are you feeling lucky? To be? Or not to be? That is the question.