Medical Device Daily

NuVasive (San Diego) said that it has received conditional approval of an investigational device exemption from the FDA to begin clinical trial enrollment for its NeoDisc cervical disc replacement device that its CEO said could more than double the company's revenues after two years on the market if approved.

The company, which expects to begin enrolling patients in the trial by the fourth quarter, will have a follow-up period of two years after enrollment for each patient that receives the NeoDisc device. The trial is designed to evaluate the safety and efficacy of NeoDisc by comparing the outcomes of patients to traditional anterior cervical discectomy and fusion.

“We believe that this has the potential to be a significant generator of revenue for us on the order of $100 million after the first couple of years of release to the U.S. market,” NuVasive Chairman and CEO Alexis Lukianov told Medical Device Daily, noting that the entire company has not yet crossed $100 million in sales.

NuVasive's guidance for this year put it at between $87 million and $91 million in revenue in 2006.

“The cervical side of our business is just starting to ramp up,” Lukianov said. “Everything that we've been doing until this point has been largely on the lumbar side.”

The trial is a prospective, randomized, controlled, multicenter trial. It is expected to take between nine to 10 months to enroll the patients, with two years of follow-up for each patient. Results would likely be available “somewhere around 2010” for the U.S.

If results are good, the company will file a premarket approval application to the FDA. At that point, it will be up to the FDA to decide whether or not NuVasive has to present results and make its case before the orthopedic panel or whether the FDA grants clearance.

NuVasive said that the most common form of surgery for treating cervical degenerative disease is cervical spinal fusion, which is meant to relieve an “impingement on the spinal cord or nerve root and relieve associated arm and/or neck pain.” In a cervical spine fusion, the degenerated disc is removed and replaced with an interbody implant, followed by a metal plate, which is then implanted to fuse the vertebrae together.

“I think overall we believe the cervical spine market is changing over the next couple to three years, and we believe it is going to move in the direction of motion preservation,” Lukianov said. “And we believe that [NeoDisc] is significantly different from all ther other total disc replacements that are going through their clinical trials and should start to move to the market over the next couple of years.”

Among those companies about to “move to the market” is Medtronic Sofamor Danek (Memphis, Tennessee), which Lukianov said has two total disc replacements that should hit the market in 2007-2008. Other players with similar products include DePuy (Warsaw, Indiana), Synthes (West Chester, Pennsylvania)and Stryker (Kalamazoo, Mich-igan).

“All of their products are very similar in terms of being mechanical discs in that they have mobile bearings of different kinds, but they're all very similar in terms of class of product,” Lukianov said. “What you have to do with those products is remove the disc and put in this articulating device.”

That causes the device to push against the two vertebrae in that space, requiring surgeons to either cut the bone or to have those discs with “teeth that latch onto the bone or dig into the bone.” NuVasive believes NeoDisc is unique in that it is designed to replicate the motion characteristics of an intact healthy cervical invertebral disc while minimizing the disruption to native surrounding structures. The company said the device's elastomer core “mimics the loading characteristics of an intact spine.”

Its embroidered polyester annular jacket with anterior fixation flanges envelops the core and fixates the device to the anterior surface of the spine. Also, the embroidered polyester material is designed to act as a scaffold for soft tissue ingrowth, the company said.

“Our device is completely different in that it has a soft core,” Lukianov said. “It's surrounded by a polyester material, so it does not damage whatsoever the end-plates in terms of the way a mechanical structure would.”

He expects that devices like NuVasive's “can actually trump total disc replacements.” That's because the general progression of surgeries moves from replacing the nucleus to replacing the disc, and finally, a spinal fusion procedure.

“We think with a product like NeoDisc, it has the potential of doing both – replacing the nucleus and serving as a total disc replacement,” he said. “Down the road, if the patient's symptoms worsen over a certain period of time and continue to degenerate, then it's possible to very easily remove [the device], not having burned any bridges, and go on to a fusion or different type of surgery.”

Another point in favor of NeoDisc, Lukianov said, is that mechanical discs obscure the surgeon's view of the disc area during imaging, whereas NeoDisc would allow a surgeon to “see right through [NeoDisc] and have a very clear image” of the condition of the area.

Among the criteria for patients participating in the trial are that they must be between ages 18 to 60 with a diagnosis of symptomatic cervical disc disease. They must also exhibit at least sign such as abnormal reflex, decreased motor strength, abnormal nerve sensitivity or pain in a nerve distribution. Also, they cannot have had prior cervical fusion surgery at the operative level.