The FDA cleared Cortoss for this use under streamlined Section 510(k) of the Food and Drug Act because it's physically "equivalent" to other bone-repair products already on the market, said FDA spokeswoman Karen Riley.
The difference is in how Cortoss is mixed and applied: "We've used for decades a cement that you have to mix, a powder and a liquid, with radiological material added" to track it through the body, said Dr. Philip Maurer MD a partner in Penn-affiliated 3B Orthopedics PC, who was principal investigator in FDA's blind clinical trials of Cortoss as used on vertebral-compression fractures in osteoperosis patients. By contrast, "Cortoss is synthesized." It's "pre-mixed... It's more like an epoxy. It comes out like a toothpaste. And it has a negatively-charged biological 'glass' that... attracts bone cells... to grow onto it." The clinical trial data shows better pain, strength and re-fracture results vs. earlier cements, Maurer told me.
Shares of Orthovita hit a five-year high of $5.18 in afternoon trading on the Nasdaq stock market. "We're on track do to $90 million, possibly $100 million in sales this year" of Vitoss Bone Graft Substitute, Vitagel Surgical Hemostat, and other Orthovita products, not counting Cortoss, Koblish told me. The company expects the first Cortoss surgeries will be done "in about 30 days," and that Cortoss sales will hit $100 million by 2012.
Orthovita employs around 250, of whom 150 work at its Malvern headquarters and manufacturing plant, the rest in its national sales force.