David Anderson says the the road to developing an artificial spinal disc nucleus is littered with “spectacular failures.”
But that doesn’t deter Anderson or his company, Philadelphia-based Gentis Inc., from trying to be the first to get a disc nucleus replacement device for the lower spine on the U.S. market.
Artificial nuclei hold the potential to reduce pain for patients who suffer from degenerative disc disease, a condition that can be caused by a number of factors including genetics, inflammation, disease and trauma. The nucleus pulposus is the jelly-like substance found in the interior of a spinal disc that helps the spine carry the body’s weight and, in the lower back, pivot to enable movement in the lower trunk.
Earlier this year, Disc Dynamics became one of those spectacular flameouts that Anderson mentioned. The Eden Prairie, Minn.-based company collected about $65 million in venture funding over 10 years from such heavy hitters as Medtronic and Split Rock Partners, but cash wasn’t the company’s main problem. Despite selling in Europe for three years, the company could not convince the U.S. Food & Drug Administration to let it start a clinical trial in America. A number of competitors, including CryoLife and Spine Wave, are also pushing to get a disc nucleus implant on the market.
Gentis hasn’t made it as far as Disc Dynamics did, but Anderson hopes to file early next year for European approval to begin selling its spinal implant, the DiscCell. The device has been implanted in fewer than 10 patients in an ongoing clinical trial in Europe.
While developing the polymer-based material that is used as a nucleus replacement surely hasn’t been easy, it’s nothing compared to the challenge of delivering it to a patient’s spine. Gentis is confident in its material, but it’s still working to perfect the delivery method for its DiscCell product.
The challenge is to find a way to keep the material under the proper amount of pressure for the five minutes it takes to polymerize after it’s been injected into a patient’s disc. “This ain’t easy,” Anderson said with a chuckle.
A past president of the North American Spine Society, Dr. Charles Branch Jr., agrees with Anderson on that point. Branch estimates that it could be 10 years before an artificial nucleus hits the U.S. market, and even that may be optimistic, he said.
The reasons for the difficulty in getting an artificial nucleus to the U.S. market for the lower back are many, including the cost of clinical trials, the vagaries of the FDA approval process and simply the clinical challenge. It’s tough to know how much of the damaged nucleus to take out, how much of the artificial material to put in and also difficult to get real-time imaging feedback on how the procedure’s going, according to Branch.
“Conceptually it sounds pretty easy, but when you start thinking about it in a step-by-step way, it’s a lot more complicated than it sounds,” Branch said.
While Gentis looks to perfect its delivery mechanism, it’s also in the midst of raising a $2.5 million Series B round of funding, which Anderson expects to be led by existing investors. In 2007, Gentis closed a $10 million Series A round that was led by Pappas Ventures of Durham, North Carolina, and New York-based Easton Capital.
At between $2,000 and $4,000 per treatment, Anderson estimates the U.S. market for disc nucleus replacement to be around $400 million annually. If Gentis can perfect its delivery technique, expect the big device manufacturers to beat a path to the company’s Philadelphia headquarters. “We’d become a very attractive target, but first we have to get to that point,” Anderson said.