Amedica Corporation (NASDAQ:AMDA) is a mover and shaker out on the Street today, with investors sparking the stock on a 30% upturn. Why the excitement? Amedica announced FDA clearance of Valeo C+CsC with Lumen Interbody Fusion Device. This is a composite spinal fusion implant that combines different densities of medical grade silicon nitride ceramic. This clearance represents the first approval of a structural porous bioceramic available in a medical implant.
Amedica CEO Dr. Sonny Bal commented, “This FDA clearance of CsC is a significant milestone for Amedica. CsC reflects a truly unique technology. In addition to being the first structural porous bioceramic available in a medical implant, our published clinical data from the CASCADE clinical trial have shown that CsC can achieve spinal fusion sua sponte, i.e., in the absence of added bone grafts, and with success rates at least as favorable as bone autograft, i.e., the gold standard in bone fusion. The European device design was submitted earlier to the FDA, and the approved version is a design modification of the same material, based on feedback provided by the FDA.”
“Since developing silicon nitride for spinal fusion, Amedica has investigated this highly-differentiated biomaterial platform extensively, and its most recent scientific data show that under appropriate experimental conditions, silicon nitride induces the expression of hydroxyapatite and collagen, the key constituents of bone, even in the absence of living cells. Medical-grade titanium, and polymers like PEEK, which are widely used in spinal fusion, do not exhibit this osteoinductive property” Dr. Bal continued.
In a research note issued today, Kolbert explained, “As we have previously stated, we fundamentally believe that Amedica’s silicon nitride product line represents a paradigm shift in the implant industry but the company has been hampered by a lack of capital. Success with Valeo C + CSC will help establish silicon nitride as an innovative material with both osteoinductive and bacteriostatic properties. With that said, capital in this industry is one of the keys to achieving critical mass. While superior product attributes matter, the implant industry remains dominated with wellfinanced device companies that literally have an army of sales reps and account relationships that make winning market share more than just good data. We look for the company to both strengthen its balance sheet and build its revenues as management executes on business fundamentals.”