NuVasive gets FDA blessing for spinal cord surgical device

Spinal device specialist NuVasive ($NUVA) got an FDA nod for its spinal cord surgical product, building out its portfolio as the company fights for dominance in a competitive market.

Regulators cleared the San Diego-based company's NuVasive X-Core Mini Cervical Expandable VBR system to replace a diseased or damaged part of the spinal vertebrae caused by tumors, fractures or bone infections, and also to reconstruct a part of the spine after a corpectomy, or a procedure that removes part of the vertebrae to help decompress the spinal cord and nerves.

NuVasive COO Pat Miles

The FDA tacked on a condition to its OK, requiring the device to be used with a supplemental fixation cleared by the agency for applications in the cervical spine. The fixation includes NuVasive's Archon-R plate, which helps make X-Core Mini more sturdy compared to traditionally designed products, the company said in a statement.

"This assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive's commitment to providing single-source, integrated procedural solutions to our customers," COO Pat Miles said in a statement. "Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine."

Last year, NuVasive snagged the number three spot in the spinal device market, beating out rival Stryker ($SYK) and nipping at Medtronic ($MDT) and Johnson & Johnson's ($JNJ) heels. International growth partly drove revenues, as did stronger-than-expected sales for its lumbar and biologics products, the company said at the time, allowing it to grab a bigger piece of an estimated $9 billion market.

But in April, NuVasive hit a speed bump after CEO Alexis Lukianov abruptly resigned amid allegations that he violated the company's expense reimbursement and personnel policies. The devicemaker was quick to reassure investors about Lukianov's departure, appointing board member Greg Lucier as interim CEO and pledging to continue business as usual.

"The company's strengths have enabled NuVasive to become the number three player in the global spine market. Going forward, we will remain focused on market share-taking strategies that have been responsible for driving double-digit revenue growth," Lucier said at the time. "At the same time, we will continue to leverage meaningful scale and efficiencies in our business, which are translating to both accelerated profit growth and strong free cash flow."

At least so far, NuVasive has delivered on its promise. In May, the company launched software and an app to help surgeons improve spinal alignment after surgery. In August, NuVasive said it would build out its new medical device manufacturing facility, planning to open up shop by the end of 2016 and add hundreds of jobs in the process.

"In addition to providing expanded capacity to meet increased demand, the expansion of our manufacturing facility footprint will enable NuVasive to realize increased operating efficiencies and further our ability to achieve our goal of 20%+ operating margins as we drive beyond $1 billion in revenue," Lucier said in a statement.

- read the statement

Special Report: Top 10 med tech market movers in 2014 - NuVasive

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