Spinal fusion has been the gold standard for treating degenerative disc disease, but technology advances are either challenging it or transforming the procedure with the goal to improve how spinal fusion procedures are done.
Cerapedics, based in Westminster, Colorado, falls in this latter category.
The company has developed the FDA-approved i-Factor bone graft that seeks to improve the level of fusion that is achieved when spinal fusions are done in the cervical spine. The bone graft uses a synthetic small peptide bound to an anorganic bone mineral (ABM) where the latter provides a scaffolding and source of calcium for new bone growth. When spinal fusion is done with i-Factor, the peptide mimins how a type of collagen binds cells, thereby creating a more favorable environment that boosts cell attachment to the ABM scaffold.
FDA approved i-Factor in November making it the second bone graft in the market to be approved behind Medtronic's InFuse which, however, is approved for the lumbar spine.
"We are the first bone graft to be approved for the cervical spine," said Jeffrey Marx, president and chief operating officer of Cerapedics, in a recent interview.
Being the second PMA in bone graft behind InFuse has created some challenges given how Medtronic's bone graft in recent years came under fire for off-label use and adverse events connected to it. One adverse effect has been inadvertent bone formation.
"People's questions are all based on the InFuse experience and so all of those things they are concerned about, all of the potential risks with InFuse, are the things they are asking about with i-Factor," Marx said. "One of the reasons for all those challenges with InFuse is it it tells one type of cell to turn into another type of cell. Most of the time it's the right cell but there are times that it' isn't."
Cerapedics' bone graft on the other hand is a kind of active adhesive that promotes cells to be attracted and attached and the mechanism of action is quite different.
"I-Factor is simply an attachment factor that causes the local bone forming cells to be attracted and attached and by virtue of their attachment they are activated," Marx explained. "These are attachment-activated cells that are looking for these receptor sites and once they find the spot where they know they're supposed to be, their genetic programming turns on and they start doing their thing."
That sounds simple, but convincing surgeons may not be so easy. Surgeons today use a variety of products to achieve better fusion even when they sometimes claim they do not, Marx charged.
"In cervical fusions across the U.S., they use allograft, demineralized bone matrices (DBMs), synthetic bone grafts, stem cells," he said. "These are all used extensively. There's $500 million worth of bone graft products used in cervical fusions in the U.S."
Marx wants to add i-Factor to this mix and take share away from these other products and data from the clinical trial testing i-Factor is something that Cerapedics is going to use to try to sway surgeons. In the pivotal trial of 319 patients randomized against autograft in ACDF (anterior cervical discectomy with fusion) procedures, the combination product met all of its four primary endpoints (fusion rate, NDI score, neurological outcomes, and safety success). And perhaps more significantly, a responder analysis for overall success in all four primary outcomes showed 69% success for i-Factor bone graft versus 57% for autograft, in which the graft comes from the patient being treated.
"We are fortunate that we end up with a superiority claim with a non-inferiority study," Marx said.
As Cerapedics ramps up its commercialization journey following approval, it has to convince another cohort: hospital purchasing and hospital review committees both of which are interested in price.
"We priced it at a significant discount to InFuse, but at a premium to to the synthetic bone grafts and the DBMs, which are not indicated for this and have no data for the cervical spine," Marx said.
Cerapedics, which is venture-backed by OrbiMed and the venture arm of AstraZeneca, as well as smaller boutique firms has raised $60 million to date. The company is initially using distributors to sell i-Factor in the U.S. It also plans to raise another $10-$15 million this year.
While the current focus is to get revenue for i-Factor, Cerapedics is eyeing another opportunity as well.
"We are hoping to interact with the FDA for a lumbar study and if everything goes right we may be filing an IDE before the end of the year," Marx said.
[Photo Credit: iStockphoto.com user itsmejust]